Vol 18 | Issue 02 | SEPTEMBER 2019 | Mumbai | Total Pages 60 | Price ` 150
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PHARMA BIO WORLD Vol 18 Issue 02 SEPTEMBER 2019 MUMBAI
Packaging and Labelling
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INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES
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4 ◄ September 2019
Pharma Bio World
India's Presence in Global Pharma Market as on FY 18
19.40%
6.60%
6.80%
Market Insight Snapshot: Indian Pharmaceutical Market By Jayati Mukherjee
features 16 Innovative and Smart Label Solutions for Injectables to Enhance Patient Safety and User Experience Stefan Wiedemann,Senior Director - Strategic Marketing, and Business Development, Schreiner, MediPharm - a Business Unit of Schreiner Group GmbH & Co KG
31%
15.90%
5%
12
15.30%
12
23 The Need for a Robust and Secured Supply Chain Management to Conduct Clinical Trials in the Country Mr. Amit Chopra, Managing Director, India and Middle East, Thermo Fisher Scientific 25
28
Indian Pharma Packaging Industry: The Need to Unlock Untapped Potential Aparna Balasubramanian, Senior Consultant, Sathguru Management Consultants; Hansini Mutte, Senior Consultant, Sathguru Management Consultants Packaging and Labelling of Pharmaceuticals and Nutraceuticals Rohini S, Food Scientist, NutriParadise Foods
30 Sustainability in processing and packaging technology; Technological solutions for ecological challenges Dr. Ing. Carsten Weiß, Vice President Engineering, Bosch Packaging Technology 34
20
36
Internet of Things (IoT): The New Prescription for Pharmaceuticals Manufacturing and Supply Chain Ram Meenakshisundaram, Senior Vice President and Global Delivery Head - Life Sciences Cognizant Contract Manufacturing Organizations: Navigating Serialization Implementation Arthur Smith,Vertical Marketing Manager, Videojet Technologies
38 Child-resistant Packaging: As Easy as Possible, As Difficult as Needed Ursula Hahn, Product Management, Sanner Group
23
40
Falsified Medicine Directive: Don’t Lose Track of Compliance Arthur Smith, Global Marketing Manager, Videojet Technologies
42
Staying Compliant and Profitable in the Pharmaceutical Packaging Process with Checkweighing Jana Meier, Marketing Team Leader, Product Inspection & Head of Marketing, Checkweighing, Mettler-Toledo, Mettler-Toledo Garvens
News Press Release
45
CORPORATE AFFAIRS 49 Products
32
6 ◄ September 2019
53
Events
54
interview ACG Group is into Further Augmentation in National and Global Context Ajit Singh, Chairman, ACG Group
57
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market insight
Snapshot: Indian Pharmaceutical Market
India's Presence in Global Pharma Market as on FY 18
19.40%
31%
15.90%
5%
6.60%
# EU = European Union # ASEAN = Association of South-east Asian Nation # LAC = Latin America and Caribbean Countries
6.80%
15.30%
Datasource: www.ibef.org
By Jayati Mukherjee
Indian pharmaceutical industry contributes a prominent share to overall Indian economy. Not only that, it even has stretched its reach beyond the national level and captured a bright spot at the global corridor. This article endeavored to provide a comprehensive snapshot of the industry to the readers for a better gauge about where the industry is now, compared to where it was before, and also where it is heading to. 12 â—„ September 2019
Pharma Bio World
market insight Indian Pharma Market is Expected to Grow to USD 55 bn by 2020 Projected size of Indian Pharma Market USD Billion CAGR ~17%
70
USD billion
55
35
Source: McKinsey Analysis, Secondary Research
1
Country’s Growth in Pharmaceuticals:
Indian pharmaceutical market in projected to grow significantly with a forecast value of USD 55bn by 2020 in comparison to USD 12.6bn market size as prevailed in 2009. Further to add, it has a potential to reach USD 70bn in an aggressive growth scenario. The growth drivers have been grouped under four dimensions: epidemiological factors, increasing affordability, enhanced accessibility, and rising acceptability. With market diversity on rise, these growth drivers are proliferated and become more nuanced. In a pessimistic scenario characterized by regulatory control and economic slowdown, the market may be depressed to reach USD 35 bn.
2
Overall Economy Context:
Indian as a
Indian economy is driven by strong domestic demand and an increased focus on export market. Being characterised by developing market economy, it is the world’s fifth largest economy by nominal GDP and third
largest by purchasing power parity. With the influence of economic liberalisation and free market orientation, over the period of 2014 to 2019, Indian economy has become world’s one of the fast growing major economies. The Asian Development Bank initially forecasted India’s growth for this financial year to 7.2 percent, and to 7.3 percent for next financial year. However, the growth has been trimmed down owing to moderation in global demand and the likely shortfall of revenue at the domestic front. Pharma Bio World
September 2019 ► 13
market insight Advantage India
High economic growth is factored in due to improved drug affordability and with increasing penetration of pharmacies especially in rural areas. It even facilitated the over the counter (OTC) drugs availability in rural part.
High Economic Growth
India’s cost of production is approximately 33 percent lower than that of US. Country’s ability to manufacture high-quality low-priced medicine presents a huge business opportunity.
Low Production Cost
Increasing investment in R&D boosts the efficiency of Indian pharma companies and drives the sectorial growth, thus leading to competitive exports. In FY 18, Indian pharma companies invested about 8.8 percent of their sales in R&D.
Increasing R&D Investment
strong position of a global pharma supply destination with its ability to produce high-quality medicines being backed by strong innovation capabilities and a structural cost advantage. The cost of manufacturing in our country is about 30 to 40 percent lower compared to China and eastern Europe, notwithstanding low productivity level
4
Indian Pharma in Context of Changing Global Market Dynamics:
• Consolidation amongst distributions and pharmacy chains has been continuing to cause a steep fall in generic drug prices in the US, the largest healthcare market in the world.
Export feature of the country has been experiencing a steady upward growth due to low cost of production, improvement in R&D, and introduction of innovation.
Ever Increasing Export
• Sharp
rise
approvals
and
competition
in
generics
in
product resultant
the
space
global
with
an
increasing number of Indian companies vying to share the
Increasing Penetration to Health Insurance
Increasing penetration to health insurance to drive expenditure on medicine also confers to high economic growth of the country.
same pie, will keep up the competition and therefore the price erosion as a consequence in the coming years.
3
• Increasing price control and
Advantage India: Indian pharmaceuticals market is the
protectionism in various global market will significantly impact
third largest one in terms of volume and thirteenth largest
the value of exports, thus contributing to around half of the Indian
one in terms of value. It caters to 50 percent of global demand
pharmaceutical industry’s value.
for various vaccines, 20 percent of global export for generics, 40 percent of generic demand in US, and 25 percent of all medicines in UK. On export ground the country stood at USD 17.27 billion in 2017 - 18; and on progression, has crossed USD 19 billion in 2018 – 19. Further, in near future, it is expected to reach USD 20 billion by 2020. It is worth mentioning that India’s biotech industry is projected to reach to USD 100 bn by 2024 - 25. India has also acquired a
14 ◄ September 2019
Indian market is also likely to be impacted in the near term due to several forces viz evolving regulatory landscape, alternate means to engage with doctors, increasing patient involvement, and greater role of pharmacists. Despite the likely severe short-term impact, the Indian industry would eventually be buoyed up by a sustainable cost Pharma Bio World
market insight pharma economy by 2030 through capitalization of the enormous opportunities that lie ahead. However, to realize this aspiration, a concerted effort is needed from all the stakeholders viz Indian pharmaceutical companies, Government & regulatory bodies, and all others concerned. To proclaim its world-class position, Indian pharmaceutiocal companies are to make a gallant move to uncharted areas in terms of geography, product, and technology. Governement is also to play a crucial and integral role here by imparting support through necessary policy formulation and facilitation, regulatory intervention, and adequate financial investment wherever needed.
Institutionalizing Quality
In this journey, Government advantage, robust new product pipeline, pricing corrections, launch of nex-gen assets, and scale up with the rest-of-theworld business. Emerging technology and business model innovations would also prompt a transformation. It is very likely that many Indian pharma companies would adopt a mix of advanced business strategic components viz. cost leadership, operational excellence for revenue and profit enhancement, strategic merger and acquisition for value buy, advancement in specialty and differentiated drug business model, embracing digitalization and advanced analytics, linking organizational talents to value, etc.
5
will be the key enabler for the following strategic interventions: a. Strengthening health-care infrastructure b. Accelerating health-care programs c. Facilitating active pharmaceutical ingredients (API) production in India, thus reducing the import d. Promoting innovation by creating a research eco-system e. Expanding and upskilling the talent pool f. Collaborating with internal regulatory bodies to be in track with international regulations and guidelines g. Expanding and consolidating global foot-prints
Way Forward: Indian pharma industry has established
its strong presence in global economy by delivering quality at scale. The break-through innovations in technology, process, and formulation have made the drugs affordable and accessible to its consumers, thereby making the country a reliable, high-quality, and cost-effective drug supplier at the global space. By being equipped with these competitive edges, the country is progressing towards USD 130 billion Pharma Bio World
Data-source:
1. 2. 3. 4. 5.
Asian Development Bank, Asian Development Outlook 2019 www.ibef.org www.ficci.in McKinsey analysis report based on secondary research (www. McKinsey.com) www.ipa-india.org September 2019 â–ş 15
Innovative and Smart Label Solutions for Injectables to Enhance Patient Safety and User Experience Smart labels enhance the drug packaging with unprecedented level of communication with consumers about the product or the solution or the brand. The author here threw light on various features viz radio frequency identification technology (RFID), NFC tag & smart-phone equipped NFC technology, and many other features. The article also describes the contribution of labeling solution on supply chain security and patient safety.
Figure 1 : A novel security concept, combining a label and a film cap, clearly and irreversibly shows first-opening indication of primary containers.
W
ithin a complex regulatory landscape as well as diversified markets and medications, the pharmaceutical industry is facing many challenges today. While some of the key objectives remain as the product & patient safety and the reliable dispensing of drugs by healthcare providers, the well-informed patient becomes increasingly important; and requires convenient tools for selfadministration of drugs. Sophisticated label solutions can play an important role
Stefan Wiedemann Senior Director - Strategic Marketing and Business Development, Schreiner MediPharm - a Business Unit of Schreiner Group GmbH & Co. KG 16 â—„ September 2019
in product and patient safety by providing additional functionalities beyond mere product identification. In addition, they add value to the product by enhancing user convenience and supporting the trend towards patient-centricity.
Supply Chain Security: Label Solutions for Effective Protection against Tampering, Glass Breakage, and Surface Contamination End-to-End Supply Chain Integrity plays a
Sophisticated label solutions can play an important role in product and patient safety by providing additional functionalities, along with patient centricity, beyond mere product identification. Pharma Bio World
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space for bar code printing or NFC chip integration for electronic tracking. Adding extra security features to the label such as holographs, color-shifting inks, guilloches, or hidden features such as void effects or covert color pigments give suppliers, pharmacists, healthcare personnel, and patients additional certainty that the product is genuine.
Figure 2: A label-integrated needle trap ensures needle-stick prevention after the injection
major role for the pharmaceutical industry to ensure product safety. Injectables are often delivered in glass containers, such as vials or bottles; and container integrity is crucial to avoid drug contamination. Also, pharmaceutical manufacturers are exposed to a growing threat posed by counterfeit medicines, particularly in developing countries and emerging markets. In addition, there is a risk of re-imports and illegal reuse of original containers. Regulatory demands in various countries require special packaging and labeling solutions for product and brand protection, as well as for tracking the entire supply chain. When it comes to injectables in vials and bottles, intelligent labeling solutions ensure product integrity at unit level and can avoid illegal re-use of original containers. An innovative security concept, combining a label and a film cap, clearly and
18 â—„ September 2019
irreversibly shows first-opening of primary containers. The film cap is first put over the closed container; then the label is applied without covering the peel-open tab on the opening strip. Once the strip is opened, the bottom part of the cap, together with the label, remains attached to the container. Attempting to remove the rest of the cap destroys the label. This eliminates the possibility of illegal, unnoticed reuse. The flexible solution can be adapted to different container types, forms, and sizes. Unlike shrinkwrap solutions, the label construction can be applied without using heat, making it suitable for temperature-sensitive medicines. The top of the film cap allows
Packaging and labeling are critical to product authentication; and should provide a reliable hurdle against tampering and counterfeiting. Ideally, integrated security concepts should combine several security technologies in a multi-layered approach including overt and covert features. Ultimately, the objective should be to work closely with the pharmaceutical manufacturer in a consultative approach to identify the optimal solution that suits his specific security requirements, while integrating easily into the existing brand appearance. The label and cap security concept can even be developed further by adding an additional cap to protect the bottom of bottles or vials against glass breakage and surface contamination. In addition to the cap which covers the closure and upper part of the container, a second cap is added to protect the bottom and lower part. Both caps are affixed to the container using a label, which can optionally be provided with an integrated foam layer to provide further protection against lateral impact. Consequently, the container’s surface is completely protected. In addition, the upper cap offers space for imprinting warning notices or codes for track & trace systems. This concept is especially
Smart e-Labeling solution meets digitization trends and allows to easily check product authenticity, expiry date, or relevant recalls via a smartphone. Pharma Bio World
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Figure 3: Smart, multi-functional labels for injection devices allow interactive applications via integrated NFC chips
suited for highly toxic drugs, such as oncology products, since glass breakage of primary containers with cytostatics can have serious consequences.
Healthcare Personnel and Patient Safety Combined: Label-integrated Needle Protection A growing number of injectables are administered in pre-filled syringes, which are ready to use and easy to handle. However, needle-stick injuries harbor a high risk for healthcare personnel to be infected by contaminated blood after the injection. Roughly three and a half million work-related needle-stick injuries occur globally every year. Regulatory requirements by the USFDA and NIOSH
demand that sharp instruments have to be equipped with safety devices. In the European Union, member states had to implement directive 2010/32/EU on the prevention of sharp-injuries into national legislation in May 2013 to improve occupational health and safety. By integrating safety mechanism into the syringe label, regulatory demands can be met in a smart and user-friendly manner. The compact design of the needle trap label allows the blood-contaminated needle to be simply and safely secured after the injection, and can be easily operated by healthcare personnel in a controlled, single-handed fashion. After the needle is locked into the plastic trap,
Regulatory demands in various countries require special packaging and labeling solutions for product and brand protection, as well as for tracking the entire supply chain. 20 â—„ September 2019
it is irreversibly protected. Additional features to cover patient safety aspects may be integrated into the label, like peel-off parts for documentation of the administered injection, graduation lines for delivery of the right dose, or anti-counterfeiting features for product security and brand protection. For the pharmaceutical manufacturer, equipping a syringe with a needle protection system frequently involves the need to change the complete packaging design for the product. This is not required with a label-integrated solution: The blister pack remains the same, and the user is able to immediately recognize the product. Consistency in brand presentation of pharmaceutical products avoids confusion when using the products. Due to its compact design the label-integrated needle trap system, like conventional labels, can be easily processed on commonly used labeling Pharma Bio World
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equipment at the same speed. Only minor modifications to existing labeling equipment and processes are required. Unlike more complex and so called passive injection devices, a needle trap label needs minimal storage space and decreases transport cost, while reducing the environmental footprint.
Reliable Self-medication and Enhanced User Experience: Smart Labels for Pens and Auto-injectors User safety and comfort are the primary concern in the development of pens and auto-injectors for self-injection. Multi-functional label solutions can be individually customized to further enhance reliability and ease of use of these injection devices. The range of functionalities that can be realized include a temperature indicator producing a reversible color shift that shows when a defined room or cooling temperature has been reached. A special varnish coating improves the grip and feel of the surface and helps patients to safely use the pen. In addition, integrated tactile elements make it easier to identify similar systems containing different active ingredients through touch. If the pen has a transparent window to check the medication, sensitive contents can be protected against UV rays by a doublelayered label which can be easily opened and closed again. Alternatively, the transparent window included in the label can be equipped with UV protection. Integrated peel-off parts serve to remind the patient to regularly check the contents. First opening indication as well as anti-counterfeiting features can be integrated as well, to ensure product safety.
Smart e-Labeling solutions with integrated RFID (Radio Frequency Identification) and NFC (Near Field Communication) technology provide an innovative approach to equip injection systems with interactive functionalities that enhance patient safety and user experience. This meets digitization trends and allows, for instance, to easily check product authenticity, expiry date, or relevant recalls via a smartphone. In addition, the patient may access important additional information or explanatory videos on the medicine or the use of the injection device by simply tapping the label with an NFC-enabled phone. Due to their thin and flexible construction, NFC or RFID labels inconspicuously blend into the existing design and can simply be applied to the primary containers during the production process. The wide-spread use of NFCcapable smartphones enables easy and convenient use by the patient.
Conclusion Innovative and sophisticated label solutions for injectables address current market trends in the pharmaceutical industry and can further enhance the end product. They integrate multiple functions that are optimally tailored to the specific product and its application, thus helping to ensure product security and patient safety, while enhancing user experience. Last but not the least, the customized labels have to be easily and efficiently integrated into the production processes at the pharmaceutical manufacturer.
In addition, patient compliance plays an important role – especially with regard to an aging population and a growing homecare market. Non-compliance to prescribed drugs can harbour severe risks for patients, particularly in case of chronic diseases. Also, in clinical trials, medication adherence is crucial to prove effectiveness of tested ingredients. More advanced NFC or RFID labels in combination with printed electronics solutions can support patient compliance by app downloads that allow recording and tracking of patient compliance behaviour, or enable reminder options for regular medicine use. Additionally, the attending physician – based on the data gathered – can adjust the therapeutic regimen and optimize compliance together with the
Ideally, integrated security concepts should combine several security technologies in a multi-layered approach including overt and covert features. 22 ◄ September 2019
patient. Thus, patients can be treated effectively, while saving healthcare costs that might arise from additional health problems in case of non-compliance.
Contact: info@schreiner-medipharm.com Pharma Bio World
The Need for a Robust and Secured Supply Chain Management to Conduct Clinical Trials in the Country
Mr. Amit Chopra Managing Director India and Middle East Thermo Fisher Scientific Pharma Bio World
Clinical trial is important for evaluating the safety and efficacy of any new drug. It is the mainstay of bringing out any new drug to the market. The factorials viz patient availability, cost efficiency, relevant expertise, and regulatory conditions have made our country a favourable place to conduct clinical trials in-house over outsourcing. However, to progress further, India needs a robust and secure supply chain management. This article provides a comprehensive account of it. September 2019 â–ş 23
A
promising market: India has emerged as one of the world’s fast growing pharmaceutical markets over the past decade. The pharma industry is expected to expand at a compound-annual-growth-rate (CAGR) of around 22 percent over 2015–2020 to reach USD 55 billion. Increased research and development initiatives have transformed some deadly diseases into manageable chronic conditions giving a boost to bio-pharma companies. Apart from these, India is an emerging market for clinical trials; and factors viz a large & diverse patient base, and low costs provide significant advantages for conducting clinical trials in India. Other than clinical research organizations (CROs), India now has the support of clinical trial supply (CTS) companies, life science logistics companies, clinical trial material depot providers, specialized packaging companies, software solution providers, clinical trial data management companies, and a host of other organizations that have emerged in last few years to contribute to the growth of the clinical trials market in India. While the growth trajectory looks promising, it is evident that there is a significant gap between the strategic vision and operational realities in the sector. Indian pharmaceutical companies are facing a unique set of challenges that are creating significant pressure to transform their supply chain management systems. Biological
materials, whether research specimens, active pharmaceutical ingredients, cell lines or vaccines, all require critical and specialized care. There is a clear need for a comprehensive solution to ensure end-to-end integrity of materials to mitigate potential risks. Driving Clinical Trial Innovation & Customer Expectations: The clinical trials sector has witnessed a lot of innovation in the past few years. From adopting a patient-centric approach to digitizing trial process and systems, clinical trials innovation is entering a new phase each year. Also, to be competitive in the marketplace, the industry is starting to see key players investing in innovative labs equipped with advanced infrastructure and well-trained staff. They are also looking to be more agile with their supply chain in order to respond with flexibility while maintaining timely deliveries. Thermo Fisher Scientific as the global player in the sector: Thermo Fisher ’s clinical trials business has recently announced the opening of an advanced facility in Ahmedabad, to help meet the growing demands for the development of supply chain services in India. The additional new facility in the domestic tariff area will predominantly support the unique needs of local manufacturers for India’s market. The state-of-the-art facility is FDA (India) compliant, and offers services that include blistering, bottle filling, capsule filling, over
encapsulation, walleting, blinding solutions for biologics, primary and secondary packaging, comparator sourcing, labeling, storage and distribution of clinical supplies. Being backed, by robust quality management system, infrastructure, resources, and training support, the new facility brings higher level of technology, quality, and expertise to serve the needs of both multi-national and local pharmaceutical companies in the clinical trial space. Conclusion: There is a well-defined need for a seamless clinical trials supply chain management that will benefit pharma manufacturers all over the world. Companies with global presence and expertise to offer unmatched technical know-how can be the game changers for this sector. It is imperative to have a strong quality organization with visibility and oversight across all practices in the supply chain. This will enable pharmaceutical and biotech companies to disrupt clinical trial expectations from Indian pharmaceutical companies and help deliver an efficient and risk controlled clinical supply chain to investigators and patients in India.
India now has the support of clinical research organizations (CROs), clinical trial supply (CTS) companies, life science logistics companies, clinical trial material depot providers, specialized packaging companies, software solution providers, clinical trial data management companies, and a host of other organizations that have emerged in last few years to contribute to the growth of the clinical trials market in India. 24 ◄ September 2019
Pharma Bio World
Indian Pharma Packaging Industry: The Need to Unlock Untapped Potential The global pharma packaging industry is thriving with modernization due to several drivers - regulatory changes, evolving product composition with biologics rapidly expanding, and other end-user trends such as patient adherence, child locking, and dose monitoring driving. Consolidation in the Indian pharma packaging industry is imminent in this evolving landscape. With no upstream innovation backbone, Indian companies will choose between status quo implying stagnant presence in an industry rapidly adapting to change or to seek growth capital, adopt technologies and seek growth propelled by partnerships for technology and market access. This will create continued momentum for in-bound strategic investments as well as trigger a surge in joint ventures and PE investments in the segment.
Aparna Balasubramanian Senior Consultant Sathguru Management Consultants
Hansini Mutte Senior Consultant Sathguru Management Consultants Pharma Bio World
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ackaging plays a crucial role in the pharma industry, where its function extends beyond serving as a branding aid and providing barrier protection to products for the shelf life period. It is playing a vital role in ensuring overall patient safety by carrying key information pertaining to the product, ensuring tamper-evidence and traceability of products. The global pharma packaging industry is thriving with modernization due to several drivers.
in the context of packaging. With most biologic drugs being injectables, glass is the logical choice for primary packaging. However, some biologic drugs are found to interact with glass, delaminate it, causing flaking. Silicon oil, a commonly used lubricant in plunger of pre-filled syringes as well as in rubber stoppers in glass vials, is susceptible to drug interactions and capable of denaturing / aggregating protein drugs and in some cases, even making the drug immunogenic.
Regulatory Changes Driving Packaging Innovation Globally
Research is being pursued on low-silicon or silicon-free alternate packaging to circumvent this challenge. Industry is also considering cyclic olefin copolymers based packaging as replacements for glass in biologic drugs. Excellent moisture barrier properties combined with their intrinsically inert and non-reactive nature makes them excellent choices for biologic drugs. Outstanding material clarity also makes it visually comparable, yet a sturdier alternative to glass. In essence, with continual innovation in drugs and delivery technologies, there is simultaneous need for synergistic evolution from the packaging industry. With cell therapy and gene therapy gaining momentum globally, there are more packaging questions looming in the horizon that need addressing.
Serialization is a global buzz word that is transforming packaging industry as a whole, more so in pharma where counterfeit products have perilous consequences. There is growing regulatory thrust in this direction with complete unit level track and trace becoming an everyday reality. The US’ Drug Quality and Security Act (DQSA) and the EU Falsified Medicines Directive (FMD) are newer developments that stipulate issue of unique serialization codes to the smallest saleable units of pharma products. Although being implemented in a phased manner, there is high frenzy around compliance preparedness in the industry given the strategic importance of these target markets for the global pharma industry. Multinationals such as Pharma Packaging Solutions (PPS) are already offering comprehensive track and trace solutions for packaging today. Evolving Product Composition Rethinking Primary Packaging
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Expanding share of large molecule drugs within the pharma pie has raised questions on extractables and leachables
Patient-centric Packaging Innovation Changing patient lifestyles and growing middle class affordability across the world is changing drug delivery landscape and bringing new unmet needs that provide pharma packaging companies impetus to innovate: • Patient Adherence / Compliance: With ageing population and increasing life expectancy, share of geriatric September 2019 ► 25
patients within the pharma target population is growing and provides room for targeted innovation. While digital medicine with in-built sensors is making inroads in compliance monitoring and connected care, Abilify MyCite from Otsuka and Proteus Digital Health, for schizophrenia, being the first digital pill approved by FDA last year, packaging innovations also contribute their share in enhancing patient adherence. While features such as daily dose markings on the pack are fairly common, advanced features such as digital timers and alarms on pill bottles reminding patients of the time for next dose are already on the market in the western world. • Accurate Dosing and Dose Monitoring: Dose monitoring features in packaging are increasingly playing a role in abuse deterrence as well as patient adherence. Novel technologies range from simple metered dosing systems to calendar-enabled closure technologies that tracks, counts pills as they get dispensed and send the data to a smart phone. Unit-dose packaging with key drug details incorporated in every dose are increasingly finding preferred applications in hospitals and clinics as a convenient and safe option, driving allied trends in packaging. • Tamper protection and Child Lock: With high contribution of pharmaceuticals in non-fatal childhood poisoning, need for child locking mechanisms in pharmaceuticals is critical. Although such solutions are commonplace, packaging companies continue to incrementally innovate in striking the right balance between making it inaccessible to children but not too difficult for geriatric patients. Several innovative packaging mechanisms are evolving in blister packs for tablets as well as bottles and inhalers. 26 ◄ September 2019
• Sustainability and Carbon Footprint: Although not a principal concern in pharma industry, growing importance in other packaging industries such as FMCG has trickled into due convergence in packaging suppliers. Factors such as lean manufacturing and energy-conserving packaging lines are being given importance in the pharma sector. There are also product innovations in primary packaging such as Formpack Ultra from Australian packaging firm Amcor. A technology innovation in blister pack segment for oral solids allows cavities to be drawn deeper, thereby minimizing overall size of the blister pack and volume of secondary and tertiary packaging, eventually translating a cascading effect on waste minimization across the value chain. There is also growing focus on minimizing PVC content in pharma packaging due to unfavorable environmental footprint. Indian Pharma Packaging Industry – Current Landscape & Potential Impact of Global Trends Today, India is undoubtedly the pharmacy of the world, exerting indomitable strength in manufacturing of generic drugs for US and other global markets. Increasing regulatory scrutiny in global markets thus has a direct bearing on sustaining competitiveness of Indian industry. While Indian pharma companies are escalating themselves in the value chain, transitioning into higher value areas such as specialty pharma and NCEs, the allied industries of pharma packaging have been slower to evolve. Indian pharma packaging industry is structured in the form of a pyramid with an extended base. At the top, there are multinationals such as West Pharma, Huhtamaki, Amcor, and SGD Pharma with marketing offices or manufacturing units in India as well as large Indian companies
such as UFlex and Essel Propack. At the base, the industry is deeply fragmented with multiple smaller companies dotting the landscape, with most being generalized suppliers catering to multiple sectors such as food, pharma, and personal care, with generic product offerings. These smaller companies tend to focus exclusively on specific parts of the value chain, whether it is in segments of primary packaging like blister packaging, HDPE bottles, ampoules etc. or in segments of secondary packaging including labels, pouches and cartons. The industry is therefore largely commoditized with no significant differentiation being offered by smaller companies. As Indian pharma companies continue to expand further into regulated markets, it is imperative that the allied industries of packaging move beyond the value proposition of cost advantage, especially the rapidly evolving regulatory landscape. Indian packaging companies need to rise to the challenge and get futureready to support the pharma players in their quest for growth. However, while there is high level of cognizance in the industry of the evolving regulatory and innovation landscape, it has not resulted in significant change in Indian industry’s engagement in technology development or adoption. Some established players such as Bilcare are embracing global technology advancements, but considering the fragmented nature of the market, the momentum needs to be accelerated. Future growth for packaging companies will be driven by the food and pharma sectors, and given regulatory implications in both of these industries; companies which can offer clients reliability and a familiarity with regulatory requirements will be able to stand out in this crowded space. Therefore packaging companies should consider development of specialized focus in these sectors. Between the two Pharma Bio World
M&A Transactions Year
Target
Acquirer
Deal Value ($M)
Deal Type
2017
Sunrise Containers
Thai Plaspac
- Inbound
2017
3D Technopack
Hoffmann Neopac AG
- Inbound
2017
Super Label Manufacturing LLP
Pacman M.E LLC
2017
Four M Propack
Shriji Polymers India.
2016
Essel Deutschland
Essel Propack Ltd.
24 Outbound
2015
Packaging India
Amcor Flexibles India
26 Domestic
2014
Positive Packaging
Huhtamaki PPL Ltd.
2014/2012
Skanem Interlabels
Skanem AS
3.75 Inbound
• Indian companies partnering with global majors for technology access in dilutive and non-dilutive partnership models
2.82 Domestic
• Indian companies forging access centric partnership
137 Inbound 39 Inbound
Year
Target
Investor
2016
AVI Global Plast
Multiple investors
2015
Shriji Polymers
Tata Capital
2015
Manjushree Technopack
Kedaara
23
2014
Radha Madhav Corporation
Multiple investors
2.4
Budding M&A Landscape and Need to Catapult Innovation Appetite Given the low levels of technology innovation and relatively small size of companies in the fragmented industry, private equity transactions have been few and far between. However, there has been increased M&A activity in the recent past, especially in 2017, with interest from global companies. Pharma Bio World
market
• Surge in growth capital investments for infrastructure improvement, capacity addition, technology innovation
Private Equity Transactions
segments, pharma offers wider possibility of margin accretion compared to food where higher realization could be limited to segments such as organic or ready-toeat foods.
transaction led by Sathguru’s investment banking team – Oaktree Capital and SGD Glass investing in Cogent Glass, an Indian company that now benefits from SGD’s upstream innovation backbone and specialty technology strengths. We foresee four major M&A trends in near future:
Deal Value ($M) 0.07 -
• Global companies acquiring Indian firms for their manufacturing capabilities, technology innovation or market access With imminent consolidation – pharma packaging providers from India are poised for significant growth - realization of which will depend on adapting, aggressively and rapidly to the evolving landscape.
Some of the notable transactions are given below. Consolidation in the Indian industry is imminent in this evolving landscape. With no upstream innovation backbone, Indian companies will choose between status quo implying stagnant presence in an industry rapidly adapting to change or will need to seek growth capital, adapt technologies and pursue growth propelled by partnerships for technology and market access. This will create continued momentum for in-bound strategic investments as well as trigger a surge in joint ventures and PE investments in the segment. Case in point is an investment
Contact: healthcare@sathguru.com September 2019 ► 27
Packaging and Labelling of Pharmaceuticals and Nutraceuticals You might not pay attention to the packaging of a product, but the absence of it, or the bad quality of it will definitely be noticed. Packaging of any product is a multifaceted process that helps in safeguarding the product as well as in ensuring branding and recognition. Pharma packaging and labelling carry more nuances.
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harmaceuticals and nutraceuticals require critical packaging. There are key metrics to be kept in mind and to be followed for these products to ensure adherence to quality control metrics, safety, ease of handling, ensuring longevity - before and after opening the seal. Let’s consider the case of certain nutraceuticals that contain bioactive compounds. The packaging needs to ensure that the product is microbiologically safe with easy accessibility throughout the processing and storage phase. In the case of nutraceutical beverages, it becomes more critical to ensure proper sealing even after the product is opened. Recent research has enabled the implementation of dispenser-cap made of polycarbonate and tritan for beverages. In these type of caps, the dry premix for the beverage is filled in the cap and sealed. This is particularly advantageous because the ready beverage containing nutrients and bioactive components may be prone to microbial spoilage and deterioration with time. When dispensing caps are employed, the ingredients are dispensed into the liquid while opening the bottle and the drink is made freshly just before consumption. This can also be a great way to preserve the bioactivity of a photosensitive ingredient since it won’t be exposed to sunlight at all. In recent times, packaging has also evolved to consider single serves more, since this reduces the risk of contamination and in case of pharmaceuticals, the dosage can be easily monitored.
Rohini S Food Scientist NutriParadise Foods 28 ◄ September 2019
Pharmaceuticals have to keep mind the potential pollutants and QC Checks. In nutraceuticals, the company has to keep in mind the potential consumer brand
image, eco-friendliness of the packaging, sustainability and more. The consumer, who would not particularly delve on these aspects in a tablet, would consider this quite strongly in nutraceuticals. New Forms of Packaging Plastic, which was the go-to favourite for packaging various food and drink items has slowly evolved to include various ecofriendly options. It is vastly prevalent in the market, and the consumer behaviour typically leans towards reusing these plastic objects instead of safe disposal. Several companies are replacing plastic with ‘edible packaging’, which is more ecofriendly. Smoothies and other drinks can be primarily packaged in such material, which has low oxygen and moisture permeability. Then these edible pouches are laid down in a secondary pouch made of metalized polyethylene terephthalate, which protects the edible packaging from external factors and keeps the product intact. This method ensures reduction of packaging material that must be disposed. Edible packages are also impregnated with antimicrobials to enhance the safety, with flavors, bioactive compounds for sustained release, antioxidants to preserve the product can also be used to increase the quality and shelf life of the pharmaceutical and nutraceutical products. Pharma and nutraceuticals are also increasingly using ‘smart package systems’. Intelligent sensors used in the packaging systems indicate the status of the product inside by various mechanisms. The indicators detect the volatile compounds produced by the products, especially in beverages and syrups, to assess the quality and freshness. The Pharma Bio World
packaging is designed to change colours, or embedded with a sensor strip to indicate changes in the status of the product. This is especially useful in pharmaceutical packaging and can prevent the fatal mistake of consumption of expired drugs leading to serious consequences. Some products have begun to include temperature sensors, which change color based on the storage temperature and helps in monitoring the shelf-life of the product. The idea of incorporation of gas concentration indicators in gas flushed functional products has been conceptualized in the company in the interest of consumer safety. These indicators detect the concentration of gases such as oxygen and nitrogen flushed inside the packaging for better shelf life. This may help consumers to choose the best product to pick up from the shelves. Biosensors such as polydiacetylenes are to be used in some products in the coming years to make it easier for consumers to find out microbial contamination and spoilage of the products. Microbiological safety and least cross contamination even during consumption of the product are of utmost importance when it comes to convenient therapeutic products. Self-heating pouches come in handy when ready-to-cook therapeutic products are to be cooked without taking them out. The concept is essentially based on a simple exothermic reaction. A layer of salt is placed between two layers of metalized polyethylene terephthalate. Water can be added through a nozzle, strategically placed on the top. When the water is poured on the salt, exothermic reaction takes place which heats up the pouch cooking the product inside. This will minimize the cross contamination that might happen while transferring products to utensils and during cooking. It is also quite convenient for the patients admitted in hospitals as well as at home not to bother about cooking and straining themselves for the sake of having nutritious food. Pharma Bio World
Automation and application of robotics to conserve microbial safety are swaying especially the convenient-therapeutic food and pharmaceutical industries as they attest for quality, safety and efficiency. Complete automation of manufacturing and packaging processes can minimize errors and enhance accuracy. Reduction of headcount in the manufacturing area can greatly reduce the risks of contamination and hazards. This can be accomplished by employing robots instead of human resource in manufacturing units which can be sterilized regularly to practice good manufacturing practices. Labelling Despite all the care taken during packaging, labelling becomes an essential part of completing the process. Packaging and labeling have a major hand in appealing to the consumer by showing off the sophistication, assuring safety and promising wholesomeness. A proper labelling can have a magnetic effect on the buyer with the information provided. Increasing health consciousness and awareness in the field of pharma and nutraceuticals are demanding for thorough and detailed labelling. This creates a sense of trust in the consumer and promotes brand loyalty. An attractive and relevant packaging can drive the consumer to buy the product but only the efficiency of the packaging material can force him to stay with brand. Packaging and labelling are the most powerful salesmen one can have. They speak of the products and market them without voice but they can be louder than any representative when they are designed the best. World is transforming into a highly developed place calling for advancement in every field. Packaging technology is growing at lightning speed alongside futuristic product development. Innovation and creativity have made way for inventions that once were thought impossible. Aim to make everything convenient, nature friendly and long lasting has opened doors to development
of technologies which make life easier. Development in the field of packaging technology is never ending as long as there is product development. It is also equally true that advances in packaging technology have made it possible to design products in a better and innovative way. It has also aided in delivering the best quality products in every field. Pharma labelling is more critical, with manufacturers having to comply with the latest QC checks and regulations. The industry is a mix of functional performance requirements, compliance, meeting multicultural demands and brand positioning; and then the most critical function - establishing the validity of the product and avoiding counterfeits. Labelling in the nutraceutical industry is still growing. Nutraceuticals are catching on the B2C segment as people grow more consciousness about their lifestyles and health. Newer classifications are required in almost every few months, adding more product categories, changing guidelines and more. Labelling in this industry is a lot more strict since these are not need-based products; therefore to indulge in marketing to entice the potential customer. The product has to be packaged attractively, and labeled such as to attract the customer and make them believe there is a need for the product without misleading them. Guidelines regarding nutraceutical labels are yet evolving in India. There are more regulations for labelling nutraceuticals than even 5 years ago, but there is a long way to go. Apart from food safety certifications, there needs to be an entity to pass the labelling for nutraceuticals as well. The Food & Safety Authority of India has issued various guidelines for nutraceuticals. But as we evolve and process more products in this category, and the competition in this field heats up, changes are inevitable.
September 2019 â–ş 29
Sustainability in processing and packaging technology; Technological solutions for ecological challenges The article analyses current ways for the pharma industry to come up with more sustainable packaging and manufacturing processes, from utilising biodegradable plastics and fibre-based packaging to integrating energy-saving process equipment into their manufacturing lines. Further, the article takes a deep dive into how the connected industry solutions can help reduce and optimize energy consumption.
Dr Ing Carsten Weiß Vice President Engineering Bosch Packaging Technology 30 ◄ September 2019
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ncreasing urbanization, smaller household sizes and an ageing population are fundamentally changing the expectations for food and pharmaceutical packaging. At the same time, there is a growing need for more sustainable packaging solutions and processes. But according to Carsten Weiß, Vice President Engineering at Bosch Packaging Technology, no single company can rise to this challenge alone. In order to develop packaging concepts that are both truly sustainable and appealing to consumers, manufacturers, material and packaging suppliers, as well as mechanical engineering and waste management companies need to join forces.
the circular economy. There is a greater demand for packages that are “designed for recycling”, for example by using easily separable materials, mono-material packaging, and renewable materials. But what good does the most environmentally friendly packaging design do if it is not compatible with processing and packaging machinery? Or if the process steps involved in its manufacturing, filling, packaging and disposal involve much higher energy consumption? All parties involved in the production and supply chain have to work together to devise more sustainable solutions. The outcomes of key initiatives like Save Food, CEFLEX, and European Bioplastics can offer valuable insights into future needs.
In the majority of industrialized nations, the “Supersize Me” mentality is now a thing of the past. Given the demographic change and more responsible consumer behavior, the current trend is toward smaller portions. This can also be seen in the growing demand for convenience and on-the-go products. In many growth markets, small portions are also the number one choice due to consumers’ limited financial resources. As a result, packaging sizes are becoming smaller, yet the number of individual packages is constantly on the rise. Although the sense of environmental responsibility among the general public is improving, every year more than eight million metric tons of plastic litter find their way into the ocean, due in part to insufficiently established or poorly implemented waste disposal processes. According to figures from the UN, this amounts to roughly one garbage-truck load per minute. In parallel, more and more effort is being put into the development of sustainable packaging and environmentally friendlier manufacturing processes.
On the lookout for new packaging concepts
In the future, there will be a greater focus on fulfilling the requirements of
Some of the most important trends on the packaging market include the further development of conventional materials, research into new combinations of materials, and the introduction of more efficient processes. In this regard, various parties are already working hand in hand to find new solutions that reflect the spirit of sustainability. When it comes to achieving these goals, expertise from disparate, not directly related fields can be vital. For example, the automotive industry has been investing heavily in optimizing materials and processes for the past several years. With regard to products with extremely high barrier requirements, like battery cells, the spotlight is on optimizing flexible packaging materials. Lessons learned from these efforts can – provided they are available – be directly applied to the development of new packaging solutions and production concepts for food and pharmaceuticals. Many research activities focus on the development of bio-based or biodegradable plastics that satisfy the requirements for food packaging. BioPharma Bio World
Figure 1: Bosch Packaging Technology is investing in new technical solutions to ensure more sustainability in processing and packaging engineering. based plastics often offer a better CO 2 balance than conventional plastics. Biodegradable plastics are particularly advantageous if they can easily be broken down by microorganisms. Compostable materials are an especially good choice for food packaging where the product and its packaging often enter the waste disposal cycle together – as is the case with coffee capsules or teabags. Nonetheless, biodegradable plastics do not represent a cure-all for the pollution of our environment and oceans: as they break down, carbon dioxide, water and methane are released. Methane has a much more higher effect on global warming than CO 2, which is why it is burned to CO 2 and H 2O at managed waste disposal plants. Biodegradable plastics that are additionally bio-based offer a much better CO 2 balance, while those that are based on renewable raw materials can produce other negative environmental impacts, including eutrophication, increased soil acidity, and air pollutants. Generally speaking, rapidly degradable plastics are particularly advantageous for the environment when they are “marine degradable,” that is when they break down in seawater. Needless to say, it should Pharma Bio World
still be our goal to reduce the amount of marine litter to a minimum; in this context, good recycling solutions and smoothly running disposal systems are elementary. First concepts already put into practice Companies are also working intensively on new concepts in the area of fiber-based packages, so as to satisfy the circular economy’s criteria for recyclability and the use of renewable materials without compromising product protection. For example, the first sealed paper packaging consists of mono-material paper instead of polymer film, making it completely recyclable. It is suitable for dry food like sugar, pasta, cereal or powder. Until recently, packaging products in monomaterial paper was only possible with glued, premanufactured bags or with glued paper packaging produced by mandrelwheel systems. With the new solution, food products can now also be packaged and sealed with vertical form fill seal (VFFS) machines, which translates into higher flexibility concerning the choice of format and packing style. Moreover, VFFS sealing delivers improved product protection and dust tightness. Thanks to
the use of FSC- or PEFC-certified paper, this approach is truly sustainable – from the raw material to recycling – and offers a viable alternative to plastic for products with low barrier requirements. In addition to mono-material packaging and compatibility with VFFS machines, additional future applications are imaginable. By suitably modifying current packages, the number of different materials needed could be reduced. Also, the increasingly stringent barrier requirements for product protection could be satisfied. However, a good deal of further development work will be needed to keep costs low while achieving a high degree of product protection and environmental protection, as a recent analysis (see graphic 1) shows. While the majority of materials are out of the question for use in the pharmaceutical industry due to the extremely high standards for product protection, the food segment also often has to sacrifice shelf life for the sake of higher sustainability. Accordingly, all parties involved will continue to have their hands full trying to optimally reconcile packaging requirements, cost efficiency and environmental protection. September 2019 ► 31
Figure 2: The first sealed paper packaging consists of mono-material paper instead of polymer film, making it completely recyclable. Although the pharmaceutical industry faces more complex challenges given the high barrier requirements for its products, some secondary packaging concepts are already available that may prove to be visionary. When it comes to fragile products like syringes, vials and ampoules, as well as applicators such as insulin pens, conventionally a mix of materials has been used to ensure their safety. However, a new, tray folding carton made entirely of cardboard and featuring variable inlays could offer an alternative solution. Thanks to the use of a single packaging material, there is no more need for plastic trays. Consequently, there is also no need to separate different classes of materials during recycling, which translates into better sorting and more efficient recycling outcomes. 32 â—„ September 2019
Energy recovery during ongoing processes Conserving resources is another key aspect of sustainability in the processing and packaging industry. In the energyintensive pharmaceutical industry, for example, innovative energy recovery concepts are yielding significant savings. In the sterilization process, heating and cooling energy are recovered, which can mean up to 40 percent lower heating costs and 60 percent lower cooling costs. When it comes to ultra pure steam generation and distillation, the latestgeneration systems use a preheater to reduce hot steam consumption by roughly 30 percent. In cleanroom production, up to 65 percent lower energy costs in connection with hot and cold water, steam and electricity can be achieved with the help of cutting-edge isolator
technology depending on the air supply system used. Similar concepts can now be found in the food sector: thanks to heat recovery, new systems used, for instance, to separate masses in the manufacture of jelly products consume only half as much energy. In addition to lower overall operating costs through reduced energy consumption, reducing the steam pressure in the separation process by 0.3 bar subjects the product to less thermal strain, helping preserve both quality and taste. Keeping an eye on resource consumption with industry 4.0 The latest software solutions in the area of digitization show how manufacturers can conserve resources with their existing machines and lines, by asking questions Pharma Bio World
Figure 3: arious packaging materials are used in the food industry, depending on the specific product and barrier requirements. like: which machines consume the most electricity? At which point in which process step do we use most energy? Thanks to the progressive connectivity of production, we now enjoy access to more and more data, which can also be used for consumption analysis: sensors provide data, for instance on energy and compressed-air consumption, allowing us to analyze these parameters over a given timeframe. These very different types of data can often be bundled and analyzed on a single platform, and displayed in real-time on the Human Machine Interface (HMI) of a given machine or line. In this way, fluctuations, peak loads and irregularities can be identified – and effectively remedied. Thanks to industry 4.0, we will soon be able to use increasingly detailed data, paving the way for more fundamental analysis ranging from individual machines to entire plants. In turn, predictive analytics will help us spot potential sources of higher consumption and errors in advance – and identify corresponding potentials for optimization, leading to more efficient and resource-conserving production processes. Pharma Bio World
Trinity of design, material and machine Several different aspects are important in the context of selecting suitable packages and processes: in addition to cost efficiency, more attention is being paid to barrier properties, processability, mechanical requirements, quality, and compliance with regulations. In this regard, sustainability will become more and more important in the future. When it comes to developing new packaging concepts and systems, factors like recycling, energy and resource efficiency have already become an integral part of performance specifications. Leading processing and packaging machinery providers are already working closely together with their customers in various pilot projects to develop comprehensive solutions based on a trinity of design, material and machine.
developments. In addition to individual customer needs, regional specifications like legal requirements, consumer mentality and the degree of automation in production also have to be kept in mind. Only then can solutions be found that will allow the emerging markets to establish ecologically sound production, packaging and disposal concepts in their own regions. And this can only succeed if producers and material developers, packaging manufacturers and mechanical engineering firms, as well as logistics, waste management and recycling companies act in concert, so that the entire packaging industry actively contributes to more sustainability.
This can best be achieved by getting material manufacturers, brand owners and their customers on board at an early stage. As part of the UX (User Experience) approach, feedback is collected on various parties’ expectations and needs, and is then directly integrated into further September 2019 ► 33
Internet of Things (IoT): The New Prescription for Pharmaceuticals Manufacturing and Supply Chain The application of Internet of Things (IoT) in the pharmaceutical industry will be the next phase of growth for pharma companies. IoT refers to the networking of physical objects through the use of embedded sensors, actuators, and other devices that can collect or transmit information about the objects. Advances in wireless networking technology have made it possible to collect data from these sensors almost anywhere at any time.
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magine running a pharmaceutical manufacturing company. You are not only managing the complexities of the batch manufacturing process, but also looking at plugging all gaps in your logistics chain, and ensuring complete quality to your customer. Although industrial automation and control technologies are well established in life science manufacturing facilities, integral information on real-time status of equipment is still not readily available to the management to take timely decisions. Moreover, stringent cGMP (Current Good Manufacturing Practice) regulations expect top quality compliance across all your equipment. A rising number of biologics (temperature-sensitive, short shelflife drugs) in the market would mean that you have to ensure temperature consistency and loss-free shipping from the source to the point where the drug is administered. Operating costs run high due to expensive cold chain logistics, and also because of losses due to bad handling. The challenge is accentuated in the manufacturing and distribution of generic drugs, which constitute up to 80 percent of today's pharma market. To handle the stiff competition in the market for generics, you also need highly developed logistics capabilities with the highest efficiencies at the lowest cost.
Ram Meenakshisundaram Senior Vice President and Global Delivery Head - Life Sciences Cognizant 34 â—„ September 2019
Warehousing, a vital component in the manufacture of pharmaceuticals, is costly, and its efficiency and quality are crucial for the company's survival.
Many companies choose to manage the processes internally, given the sensitive nature of the products. A McKinsey study says that warehousing accounts for 95 per cent of all pharma logistics costs. Today, pharmaceutical companies have a compelling opportunity to adopt and profit from the gamechanging technological advancement called the Internet of Things (IoT) that promises to fix all the aforementioned gaps. In an IoT environment, every 'thing' is equipped with a sensor that allows it to intelligently communicate and interact with other objects and systems within the IoT ecosystem. The IoT environment helps pharmaceutical companies to automate and revitalise their manufacturing and supply chain management operations. IoT extends visibility into every area of the business from development through manufacturing, transport, distribution, dispensing, and consumption. On the shop floor, real-time data from sensors will allow visibility across all areas of work, and result in improved productivity, efficiency, reduced cycle time, and manufacturing costs. Smart warehouse management systems enabled by IoT integration will bring in increased visibility, provide real-time data to track and report inconsistencies (for example, storage temperature), and ensure that the right data is available at the right time to enable the right people to act when it truly matters. In logistics, tracking drug inventory movements in real time can save billions of dollars. Smart pharma packaging can help ensure that Pharma Bio World
shipments and medications are accurately tracked, and the supply chain remains fluid, efficient, and cost-effective. According to IDC, there were 9.1 billion IoT units installed in 2013, which is predicted to increase to 28.1 billion in 2020. In such a fast-changing world, connected equipment, men and material tracking, sample lifecycle management,
smart
packaging,
and
•• Invest in IoT-based security solutions because security is paramount and workarounds are costly.
•• Focus on robust change management to make sure people, processes, and responsibilities adapt seamlessly and make the transition successful.
•• Think big, start small, fail fast, and scale quickly.
•• Make sure that key decision-makers
cold-chain monitoring are among the
are on board and success criteria in project lifecycle are defined early.
top IoT applications suited for the
•• Perform pilots, establish business
pharmaceutical industry. Investing in these transformational technologies comes with its challenges. Below are some recommendations and best practices for pharmaceutical companies to fully benefit from their IoT integration.
benefits through proofs-of-concept (POCs), employ agile methodologies, choose suitable partners, and leverage expert teams to effect this digital transformation.
•• Invest in supportive IoT infrastructure and be future-ready.
media, and a growing portfolio of smart products are sure to bring real-time actionable intelligence. Enterprises must constantly use emerging technologies to innovate, stay relevant, constantly hone competitiveness and make profits. The risks of doing nothing must be evaluated. The time for pharmaceutical companies to accelerate implementation and use of IoT platforms and solutions is now.
Looking ahead, the advances in digital technologies, ubiquity of mobile computing, dominance of social
“IoT extends visibility into every area of the business from development through manufacturing, transport, distribution, dispensing, and consumption.” Pharma Bio World
September 2019 ► 35
Contract Manufacturing Organizations: Navigating Serialization Implementation In this article, author looks at the importance of getting serialization right for Contract Manufacturing Organizations (CMOs).
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n recent years the pharmaceutical industry has seen a significant change to the way its manufacturers and supply chains operate, due to the establishment of several serialization and track and trace regulations mandated globally. The prominent driving force behind such regulations is the issue of counterfeit medications and supply chain diversion. It is estimated that in the developed world around 1 per cent of all medications sold are counterfeit. In developing countries that percentage rises as far as 30 per cent. Governments around the world have recognised the severity of this issue, and as a result are beginning to put in place several major serialization regulations. Deadlines for implementation in key markets such as the US and EU are close, while in countries such as Turkey, Brazil and Argentina, regulations have been commonplace for many years now. In Europe, the Falsified Medicine Directive (FMD) was published in February 2016 and gives the industry three years to comply from that date. In the US, the Drug Supply Chain Security Act (DSCSA) has three key deadlines; lot-level management was already established in January 2015, item-level serialization on each individual product was required by November 2017, and by 2023 electric pedigree and full aggregation of products throughout the supply will be mandated. Challenges of Implementing Serialization Regulations for CMOs
Arthur Smith Vertical Marketing Manager Videojet Technologies 36 â—„ September 2019
For Contract Manufacturing Organizations (CMOs) the process of implementing serialization is complicated, mainly
due to the lack of certainty among their customer base as to their requirements. This can cause delays for the CMOs and pose a real concern now that deadlines are approaching. For CMOs there are two key considerations to address when implementing serialization into existing packaging lines; understanding what is required from them as a company and also understanding what their customers need. Furthermore, CMOs need to understand what markets their customers sell in, be it global or local, as regulatory requirements can differ. Similar to traditional manufacturing operations, CMOs must also be conscious of the fact that, as they implement more complex processes to their packaging lines, the Overall Equipment Efficiency (OEE) of their systems may be negatively affected. It is important to understand that good preparation, the right equipment and a focus on operator training can significantly reduce the negative impacts on operations. Ensuring that code formatting is correct and lead times on key equipment accounted for are other important factors to overcome the challenges. Operational Framework Undertaking a serialization programme requires a comprehensive understanding of the stages of implementation. The typical framework for implementing a serialization programme consists of six phases.
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The initial phase involves defining the strategy, identifying what needs Pharma Bio World
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to be done in terms of serialization, which stakeholders need to be involved and what the goals of implementation are. Once the strategy has been established, an organization must undertake an in-depth analysis of each system, as well as the IT infrastructure, and identify what needs to be replaced and what new systems are required. At this point, stakeholders and others involved in the project going forward should also commence the training process. Next follows the design phase; based on a clear definition of what needs to be achieved the contract manufacturer starts to design the solution, examining the hardware and process facets, as well as the IT and qualification, testing and validation features. Now is the time to start preparing what is called the organizational change management identifying how the program affects how people work within the company. This is vital, as serialization implementation will impact both processes at the manufacturing line and also at the warehouse stage when it comes to shipping and receiving goods. The forth phase involves the building of the solution based on individual, well defined user requirements. Changing and testing of the individual equipment commences and customers start to look at how the systems will be integrated from an IT point of view. The penultimate phase is where the final solution is built and the project goes live. The final phase involves dealing with issues which arise as a result of the implementation, such as temporary reduction of efficiency on the packaging line, and also measuring whether the benefits of implementation are being realized once the process is underway
Pharma Bio World
If an organization engages in a structured framework of serialization implementation there is an opportunity to create real business value from a programme. Preferred Equipment As packaging standards continue to grow in complexity due to regulatory developments, both manufacturers and contract manufacturers are faced with the challenge of how to gain a return on the investments they make in their packaging lines. Improperly selected printer technologies can seriously impede the speed and productivity of packaging lines, which can have a detrimental effect on profit margins. Selecting the correct printing technology from a dependable supplier is one of the most important considerations manufacturers need to make when implementing a serialization program. Along with regulatory factors, the need for high resolution printing and printer cleanliness have also been the driving forces behind the innovation of existing and new printing technologies in recent years. Consequently, packaging engineers now have a varied selection of printing technologies from which to pick, the most popular being Thermal Inkjet (TIJ) and Laser.
infrared light focused and steered with a series of carefully controlled small mirrors to create marks where the heat of the beam interacts with the packaging surface. Laser marking can be used to print 2D bar codes as well as human readable codes. Conclusion Serialization and track & trace regulations are becoming commonplace within the pharmaceutical packaging industry, and interpreting how to implement serialization practices within existing packaging lines does not come without its challenges for manufacturers across the board. However, understanding how to structure a serialization programme, being conscious of key regulatory deadlines and understanding customer requirements are keys to success for CMOs in the pharmaceutical industry. Finding a partner who is able to support that process from start to finish has significant benefits, as smoother the transition, lesser the downtime will be experienced. Having the backing of a global service network is something to be mindful of, as is finding a partner who has significant experience in implementing serialization solutions and the structure in place to deliver to requirements - from a single coding unit to a turnkey project.
TIJ coding and marking systems are inkbased, non-contact printers generally used to print traceability information, including 2D DataMatrix codes, onto commonly used packaging. The printer uses small resistors to propel ink drops onto packaging as it passes by the printhead. This system is used for high-resolution printing, utilizing heat and surface tension to move ink onto a package surface. Laser printing systems use a beam of September 2019 ► 37
Child-resistant Packaging: As Easy as Possible, As Difficult as Needed Child-resistant (CR) packaging is used to minimize the risk of children accessing or ingesting medication and is one of the best-documented successes in preventing the unintentional poisoning to children. So, manufacturers & companies are utilizing the techniques of child resistant packaging for medicinal products as per the established norms & standards of the country.
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good plastic packaging solution for pharmaceutical and healthcare products must fulfil many requirements. It should protect the product from exterior influences and inform users about the content, while conveying marketing messages and boosting sales. At the same time, it must make sure that the content is easy to remove and that the package can be re-closed and re-opened effortlessly. Another highly important prerequisite is child safety. Every package should be designed in a way to protect children from unintentional ingestion of medication. Regulatory bodies have issued guidelines; and industry has already undertaken measures to conform to regulations and to make their packaging solutions safer for children. Packaging as Safety Hazard Children often show unexpected skills when they want to access the content of pharmaceutical packaging. At the one hand, some exterior package designs suggest they might contain sweets of some sort. On the other hand, many tablets and pills actually do taste rather sweet due to their sugar coating. However, this infantile drive and curiosity can have dramatic consequences. Toddlers are especially vulnerable, as they discover their environment through touching, sucking and chewing. Children between just below one year and approximately four and a half years of age tend to put objects in their mouths or even swallow them.
Ursula Hahn Product Management Sanner Group 38 â—„ September 2019
Child-resistant packaging, also known as CR packaging, can help prevent
unintended child poisoning. To open such a package, for instance a plastic tube or other container, you need to know a certain "trick". This trick is often too difficult for infants to learn. For example, a three year-old will most likely not find out how to open a package that requires the closure to be tipped while it is pushed open simultaneously. At the same time, access to medication must still be granted for patients depending on their regular dose. For this reason, CR packaging should always be senior-friendly in terms of opening and handling - according to the motto "as easy as possible, as difficult as needed". Differing Regulations CR packaging is already subject to national and international regulations, however not on a uniform basis. This is especially true for pharmaceutical products. Here, the US takes a leading role. As far back as 1970, the "Poison Prevention Packaging Act" (PPPA) took on this topic due to the rising number of poisoning through toxic chemicals used in households. The regulation US 16 CFR § 1700.20 defines consistent rules for dangerous chemical-technical and pharmaceutical products. Apart from few exceptions, all prescription drugs must be packaged in a child-resistant manner. Moreover, the regulation determines which requirements are valid for CR packaging and which tests need to be carried out. The Indian standard determined in 1995 defines CR packaging as "any packaging which is difficult for young children under Pharma Bio World
Manufacturers of primary plastic packaging with long-term market experience have clear processes installed, including efficient project management and reliable quality management. During product development, a stage-gate process with regular re-tests makes sure that the packages fulfil all requirements. Documentation and reproducibility of the CR features are important. If a partner meets these prerequisites, the specific CR solution can be chosen. Combination of Strength Cognitive Component
the age of five to open (or gain access to the contents), but which is not difficult for adults". Here, too, the philosophy "as easy as possible, as difficult as needed" is applied. The aim of this standard is to form a practical basis for the development of packages with acceptable childresistant features and to offer an advice to manufacturers when selecting unit dose packaging with a view to child safety. Small Modification, Large Effect There is no mistaking that CR packaging can save lives. This is why many drug producers are not waiting for continentwide or even worldwide regulations. Instead, they have already begun to look for suitable packaging solutions years ago. So what is most important when choosing the ideal plastic packaging? It should be costefficient, user-friendly and child-resistant. To fulfil all three criteria, pharmaceutical and healthcare companies are welladvised to cooperate with a supplier who is experienced in packaging engineering and can optimise a packaging concept in line with regulatory requirements with only a small modification. Pharma Bio World
and
Two aspects should be taken into account - purely "mechanic", that is forcerelated safety, as well as the cognitive component. On the one hand, a learning effect is required, for instance when a closure can only be opened through a certain sequence of movements. On the other hand, the force needed to open a package is just as important as the
previous factor. Apart from the push/turn version commonly used for large tablet containers in North America, there are numerous further possibilities to make primary plastic packaging child-resistant through a combination of movements. When pushing and tipping, for instance, not much strength is required. This, in turn, makes the packaging suitable for grown-up users, especially senior citizens. The motto "as easy as possible, as difficult as needed" brings it to the point: two pressure points, which are incorporated into the closure, enable grown-ups to easily open this selfexplanatory packaging. Children, however, find it difficult, especially due to the fact that the push movement is followed by a tipping movement. A clear upper and lower limit for the applicable force should be defined at an early development stage. This way, relatively simple changes to a packaging such as the aforementioned pressure points can ensure additional safety. In the past years, a number of respective plastic packaging solutions have been developed and introduced to the market. They not only show how important child-resistant packaging is. They also prove that safety and userfriendliness can be combined without much effort
September 2019 â–ş 39
Falsified Medicine Directive: Don’t Lose Track of Compliance This article looks at the Falsified Medicines Directive and the delegated act that makes coding and marking technology vital to compliance
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he Falsified Medicines Directive (FMD), otherwise known as Directive 2011/62/EU, was implemented in July 2011 due to a marked increase in falsified medicines making their way into European supply chains. Member states of the EU were required to comply by January 2013, which added to the already heavily regulated sector, and licensing, manufacturing and distribution of medicines remains tightly controlled. Rise in the number of falsified medicines globally have been dramatic. In 2013, the World Health Organization (WHO) launched a global surveillance and monitoring system designed to encourage Member States to report incidents of substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products in a structured and systematic way. Up until January 2016, 920 medical products had been reported across all main therapeutic categories and included both innovator and generic medicines from inexpensive pain medication to very expensive products for the treatment of cancer. Benoit Goyens of the World Customs Organization (WCO), speaking at the Medicines for Europe Conference in Croatia last year, predicted that criminal organisations could generate up to GBP 1bn in 2017 from the sale of illicit medicines – many of which will be purchased through seemingly bonafide websites via the internet. The figures are staggering, therefore improvements to the regulations were necessary to help in the fight against this highly dangerous, often fatal , practice. What are falsified medicines?
Arthur Smith Global Marketing Manager Videojet Technologies 40 ◄ September 2019
Falsified medicines are products that have been made illegally to ‘mimic’ real medicines. Essentially they are fake that pass themselves off as the real thing. The ingredients used in these products can be of a significantly lower quality than the approved genuine version and often have
lower levels of the active ingredient require for effectiveness. Dosage levels can also be wrong, or the wrong ingredients altogether could be used in their preparation, and fake packaging is generally used to conceal the source of the product and the identity of its manufacturer. Medicines that are falsified are often confused with counterfeit products and it is very important to make the distinction between the two. While counterfeit products are illegal, they are generally produced using patented technologies that are not the rightful property of the manufacturer. This technology can be used accurately to produce medicines that do not comply with intellectual property rights or trademark laws – thus making them counterfeit. Falsified medicines, by contrast, represent a higher risk to the public as they are made to resemble genuine products. Unfortunately, this distinction between falsified products and counterfeit products made in the EU is not necessarily used around the world, and in the language people use they will sometimes refer to counterfeit when they actually mean falsified. How has the FMD changed where coding and marking is concerned? The introduction of the FMD has presented challenges to the pharmaceutical industry, in that it requires a far higher level of data management than ever before. Section 11 of the FMD states that: ‘Safety features for medicinal products should be harmonised within the [European] Union in order to take account of new risk profiles, while ensuring the functioning of the internal market for medicinal products. Those safety features should allow verification of the authenticity and identification of individual packs, and provide evidence of tampering’ . These requirements were set out recently in a Deregulated Regulation (EU2016/161), Pharma Bio World
published in February 2016. It states that two new safety features must be present on the packaging of most medicines that are intended for human use – a unique identifier and an anti-tampering device. Serialization will be required at secondary pack level, information for which must be provided via a 2D barcode and in human readable form. The information present must include a unique serial number, expiry date, batch number and product code. At present, there are differences that exist in terms of classification of medicines. Some member states may consider a product a prescription item, for example, while another deems it an over the counter product. The directive only applies to prescribed medicinal products; so, depending on the destination country, a national reimbursement number may also be required. This will be added by manufacturers and repackagers accordingly. Products will need to be guaranteed and authentic via an end to end verification system, in addition to risk-based verification by wholesalers. A final level of security is provided by further verification of the product at pharmacy level – ensuring authenticity at point of sale. For products sold through internet, a new online logo has also been designed to indicate companies that are operating legally. This can be clicked to check the authenticity of the company in question against a verified database. Coding and marking – a vital piece of the FMD puzzle The two most common technologies for serialized marking are laser and thermal inkjet (TIJ), as both are able to produce high resolution codes that meet the detail requirements for 2D DataMatrix codes. TIJ printers fire tiny ink drops onto packaging as it passes by the cartridge, or printhead. These ink drops are propelled out of a row (or rows) of fine-gauge nozzles by the rapid cycling of a small resistor underneath each nozzle. These resistors boil a small amount of ink which creates a small steam bubble that propels the ink drop. In contrast, laser coders use a focused beam of light to Pharma Bio World
inscribe or physically alter the top layer of a substrate. The beam of light is steered by two mirror galvanometers which direct the laser beam in two planes. In the first instance, manufacturers should look at the packaging substrate they intend to code or mark. Pharmaceutical cartons and paper labels are commonly used and often feature an aqueous overcoat to protect the packaging material. Historically this would be an issue for TIJ, as water-based inks would not adhere to the surface of the packaging. Advances in ink technology, however, have seen the introduction of methyl ethyl ketone (MEK) or other light-solvents - broadening the spectrum of applications TIJ can address. Substrates such as foils, films, plastics and coated paper stocks are all now addressable with a TIJ technology that utilizes MEKbased inks. Laser systems are able to mark on a wider range of materials, such as paper, plastics, metal and glass. Lasers are also able to code on curved surfaces such as vials or bottles. There are two considerations when it comes to verifying suitability of the substrate with laser technology: absorption of laser light and creating a print window with sufficient contrast for high quality codes. Absorption is a function of the substrate and the selected wavelength of the laser and the correct combination should be recommended by an expert coding and marking supplier. For proper code contrast, it is commonly required to modify packaging with a print window of dark ink, referred to as a “flood fill.” The laser burns off the top layer of dark ink to expose the underlying lighter substrate – making a negative image. Data management is critical Manufacturers will find it necessary to adopt track and trace technology to enable compliance with the FMD and its associated delegated regulations, and the ability of coding and marking systems to interact with these technologies cannot be overlooked. There are a number of ways in which these interactions can take place.
Asynchronous communications, for example, allows the coder to send unsolicited information to the line control system. This functionality provides the dual benefits of active notification of a printer event and reduced network traffic, which translates to faster notifications and higher potential throughput. Remote communication protocols too enable sensitive information and commands to be passed between the coding system and the host data system. This is important to remember when choosing a coding and marking system, as using a printer that features a tested, validated secured protocol and command set designed specifically for managing sophisticated communication are critical. Finally, buffer management is key to consider. Can your chosen system code and mark unbuffered, where variable data is received and printed one record at a time, or buffered, where multiple records are sent at the same time but are only printed once each. These features are particularly important to consider in countries where serial numbers have to be purchased. Correct management will enable manufacturers to redeem those codes that have not been used, which represents a useful cost saving. Whichever technology is best for your individual needs, what is clear from the legislation is that coding solutions for FMD need to feature robust data management, seamless integration into manufacturing equipment and high resolution print capability to convey information throughout the supply chain. Through working with an expert supplier, manufacturers can ensure that the products they produce can be 100% authenticated at all points along the supply chain – helping to make the illegal falsification of medicines a far more difficult practice going forward.
September 2019 ► 41
Staying Compliant and Profitable in the Pharmaceutical Packaging Process with Checkweighing This article highlights use of checkweighing technology in pharma packaging and how it can help manufacturers improve their productivity through lowering changeover downtime and greater traceability.
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igh demand in the pharmaceutical industry is a constant. Manufacturers both large and small must look to optimize their production lines in order to ensure production quotas are met in a timely, profitable and above all safe manner. Larger producers running single product batches seek outstanding reliability and accuracy in checkweighing, whilst smaller contract packagers - who are likely servicing multiple clients - need the flexibility to effect quick changeovers in order to keep throughput to a maximum.
As manufacturers need to remain certified in order to produce pharmaceutical products, compliance is also critical. Products entering the supply chain that do not meet the required standard threaten patient safety, retailer confidence and in the worst case scenario a company's ability to continue production. All are damaging to profit margins to varying degrees and the risks can be mitigated with a well executed product inspection programme. Automation is a given in these environments and it is universally recognized that checkweighers play an instrumental role in day to day production. A checkweigher's main function in a pharmaceutical environment is to check the package for missing components such as the leaflet or complete blisters. This is a vital part of the package, as a box of tablets for example will not be considered safe or compliant without it.
Jana Meier Marketing Team Leader Product Inspection & Head of Marketing Checkweighing Mettler-Toledo, Mettler-Toledo Garvens 42 â—„ September 2019
End of line applications are also commonplace, where systems are used to check the completeness of secondary and tertiary packaging, ensuring that what is sent into the supply chain is exactly what is expected.
Checkweighers automatically inspect 100 per cent of products on the line - which is highly recommended compared with random off-line sampling, as the latter gives a sample size that is now considered to be of little statistical significance. Checkweighing solutions can help pharmaceutical manufacturers to maximize productivity Downtime is the enemy of any manufacturer, therefore identifying areas that affect this directly is important when looking at Overall Equipment Effectiveness (OEE). System setup is one such area that can be optimized, and checkweighing features such as digital position control help to verify this is carried out correctly - otherwise the batch cannot be run at all. Running a batch with incorrect inputs can be very costly to correct due to the wastage involved. Also, should these products enter the supply chain it could have significant consequences, both in terms of consumer safety and brand reputation. Another feature that increases OEE is In-Process-Testing. The test procedure, to be followed step by step, is normally written down on a separate instruction document and the results are manually entered on separate documents. Such testing procedures are very labour intensive, cause operational downtime and rely heavily on the operator consistently testing for reliable results. In-Process Tests significantly reduce the risk of errors during test procedures and are highly flexible - so are able to adapt Pharma Bio World
to customers' specific requirements. They are easy to operate, generate automatic reports for each test scenario, and - most importantly of all - require no shutdown of production. In-Process Tests are carried out with the help of special screen prompts, which guide the operator through the complete procedure and automatically record the results, which can then be saved and printed. Clear guidance during testing reduces labour time and possible operator errors and manufacturers benefit from more consistent, reliable results and higher operational uptime. In-Process Tests enable several configurable test scenarios. In addition, there is an easy to operate, intuitive Graphical User Interface (GUI), that helps the user to make changes easily. Mettler-Toledo also offers ProdX, a product inspection data management software application, which can significantly increase OEE as it enables nearly all processes on the line to be monitored from a central point.
Compliance with Good Manufacturing Practice (GMP) guidelines
Minimizing changeover downtime with checkweighing technology
Pharmaceutical checkweighers in particular are designed to meet the regulatory requirements of the pharmaceutical industry. First of all, GMP offers a broad guidance, although GMP regulations are not prescriptive instructions but consist of guidelines based on general principles.
Minimizing changeover downtime is critical. Advanced checkweighing systems offer useful features such as digital positioning control. Due to a plausibility check the system does not allow users to enter false parameters. Users are immediatley alerted if settings are entered incorrectly and the system will not start if the parameters are wrong - another factor that influences the usability of the GUI also helps users to save time and therefore minimize changeover times - key factors when looking to increase productivity.
These include, for example, the validation of processes, record keeping, operator training or prevention of cross-contamination. It is always up to the manufacturer to design the production process and quality programs in accordance with GMP principles, to interpret the guidelines and asseses process risks accurately. MettlerToledo, in order to maintain process safety, offers equipment qualification, which is a huge benefit to users as it reduces the qualification and validation time in order to comply with FDA or cGMP (Current Good Manufacturing Practice) requirements. Equipment qualification comprises all aspects of design, installation, operational and performance qualification.
Statistical Process Control (SPC), in addition, is possible via software functions that can be utilised to predict issues on the line. SPC measures and refers to industry standard values of process capability CP and CPK. Standalone or integrated systems allow users access to the statistical data needed to understand, document and control profitability and production efficiency. This way, early detection of problems can be achieved ahead of any major issues that may have a significant impact on uptime. The ability to monitor performance is directly linked to OEE, and the net effect of reduced machine downtime is that higher production levels can be achieved using the same amount of resources. This leads to a faster return on investment with regard to capital purchases such as checkweighers. Tracebility of Process Changes Individual boxes, for blister packs of pills for example, are lightweight, therefore the load cell of a checkweigher has to be very precise. The checkweigher helps to check for product completeness, to reject falsely produced products and ensure the safety of the processes comply with FDA requirements.
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September 2019 â–ş 43
Manufacturers generally deal with multiple facilities, that will all have to be enhanced with hardened serialization software to comply with these regulations. Overall serialization is the key to success here and the EUFDM will require a unique serialization number on every salable unit of drug product intended for dispensation to a patient. So, for instance, a batch of 60 boxes of blister pack pills will have 60 different identifiers, not just one at the lot level. During production every aggregation level will have to be integrated into the serialization process and can be supported by checkweighing technology. Added value can be generated either by checkweighers with integrated serialization functionality, tamper evident sealing or aggregation solutions for the secondary and tertiary packaging at the end of the line.
Another demand is the legal compliance with CFR 21 Part 11, which describes the way the access to information is managed and changes made to the checkweigher. Everything has to be traceable and logged. This is integrated into the audit trail feature that the pharmaceutical checkweigher offers and a local audit trail operates completely automatically in the background and usually requires no user intervention. Another useful feature is the domain login server, which enables the manufacturer to use accounts, passwords and rules issued and administered by the company's IT department for the checkweighers. Operators, maintenance personnel, supervisors and quality managers can 44 â—„ September 2019
use their normal network log-in name and password for tasks at the checkweigher just as they would with a network PC. This is not an FDA requirement but is a very valuable addition to the system. Regulations: Looking to the Future A challenge for pharmaceutical manufacturers will be the European Falsified Medicine Directive (EUFMD), that is expected to be implemented by the first half of 2018. Two years may sound like a long time, but depending on how many products the manufacturer has, how they are produced and whether they are produced using internally owned facilities or with external partners, it really isn't a great deal of time at all.
If a pharmaceutical manufacturer works together with contract packagers, which is quite common in Europe, it should keep in mind that those contractors may not be ready for serialization when it needs them to be. In addition to upcoming regulatory requirements, the US Drug Supply Chain Security Act (DSCSA) is in development for the pharmaceutical industry, which is to be applied in three phases for the US market up until 2023. First is to ensure lot traceability, followed by unique serialization and last, but not the least, a combination of the two. Like the EUFMD, this act will involve an increase in work, and systems such as checkweighers will be instrumental in helping manufacturers to remain both compliant and profitable as the regulatory landscape continues to evolve.
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press release Government of Maharashtra, Zipline, and SII Announced India's First Autonomous Instant Drone Delivery Service
Mumbai, India: The Government of Maharashtra and Zipline, the world’s first and only national-scale drone delivery service, has recently announced a partnership to use a logistics network of autonomous delivery drones to help transform emergency medicine and critical care in one of India’s most populous and dynamic states. The launch of this ground-breaking initiative will be supported through a grant from SII (Serum Institute of India), the largest vaccine manufacturer in the world. The revolutionary new service, which is expected to launch operations in early 2020, is part of Government of Maharashtra's bold vision of using drone delivery to establish universal, seven-days-a-week access to lifesaving and critical medicines for each of its 120 million citizens over the coming years. Zipline drones will make on-demand and emergency deliveries of blood products, vaccines, and life-saving medications. The Government of Maharashtra's vision is for Zipline to establish a total of 10 distribution centres across Maharashtra in phases over the next several years. The Government's goal is to put almost all of its 120 million citizens within minutes of a lifesaving medical delivery by drone. In the first phase of operations, two distribution centres located near Pune and Nandurbar will be established to service public health facilities in those regions beginning in early 2020. The operations in Pune and Nandurbar will be financed through a grant from SII. Future distribution centers will be financed by the Government of Maharashtra and other private and philanthropic partners. “Maharashtra has one of the best health care systems in India. But while we celebrate our successes, we must also recognize that we have much more work to do to create universal access to critical healthcare for all”, said Maharashtra Chief Minister Devendra Fadnavis. “This new emergency drone delivery service is a great solution to deliver vaccines, blood, and other lifesaving products instantly when time is of essence. It will help ensure that millions of people in Maharashtra will always get the care they need." “Millions of people across the world die each year because they can’t get the medicine they need when they need it,” said Zipline CEO Keller Rinaudo. “Instant drone delivery can help solve that problem. We’re proud to partner with the Government of Maharashtra and The Serum Institute of India to ensure that millions of people have on-demand and instant access to the blood, vaccines, and critical medicines they need to stay healthy and alive.” “At SII, we are committed to ensure full immunization cover and better healthcare solutions for citizens across the country”, Mr. Adar Poonawalla, CEO of SII said. “With this association and the support provided by the Government of Maharashtra as well as the technological advancements provided by Zipline, we hope to create deeper impact and extend immunization cover in the state, bringing our vision to life.” Pharma Bio World
Access to vital health products, in India and around the world, is hampered by the last mile problem: the difficulty of matching the supply of medicine from central storage to the demand at urban and rural health facilities to the people requiring lifesaving care and do not get the medicine they need when they need it. Zipline's medical drone delivery system is designed to eliminate this problem.
Cadila Pharma Raises Awareness on National Bone and Joint Day
Ahmedabad, India: Cadila Pharmaceuticals celebrated National Bone and Joint Day on August 4, 2019 to raise awareness about unhealthy lifestyle, how it can be hazardous to one’s bone and joint health, and how it can be overcome. This Pharma major has roped in leading orthopaedics from various cities to raise awareness for bone and joint health to mark National Bone and Joint Day celebrations on August 4. The theme of the celebration day for this year was “Healthy aging with strong bones”. Six leading doctors shared their tips to improve bone and joint health as a part of the Facebook campaign, which generated more than 35,000 impressions in just two days. All of them opined that injuries and disorders associated with bones can be avoided with a simple change in diet and lifestyle. They recommended inclusion of milk, milk products, and high protein foods like pulses in daily diet for getting proper nutrition for bones and joints. “Bone and joint disorders can be prevented by taking proper diet such as vegetables and proteins, making minor lifestyle changes and exercising regularly,” Dr B S Hunjan from Hunjan Bone and Joint Hospital, Ludhiana, said in his message. Dr Vineet Agarwal, Orthopaedic Surgeon at Lucknow, says that poor work practices which create unnecessary stress on the body, and habits such as smoking and drinking, can affect one’s bone and joint health. “Even not taking proper rest can lead to bone and joint disorders,” Dr Awdesh Kumar Singh, an orthopaedic doctor from Ranchi, warned. Dr Gautam Chakravarti, an Orthopaedic Surgeon at Varanasi, said that the human body should be exposed to sunlight in the morning, while habits such as sitting for prolonged hours on chairs should be avoided for healthy bones. “Right diet and right lifestyle are must to avoid bone and health disorders. Taking small breaks from work and walking on regular basis are healthy habits; and should be incorporated in our daily lifestyles”, said Dr Anoop Agarwal, Orthopaedic from Lucknow. Kanpur-based orthopaedic surgeon, Dr A S Prasad said that cultivating weight consciousness is also an essential part of good bone and joint health. He stressed on teaching children the importance of nutritious food so that they develop a healthy diet from an early age. Cadila Pharmaceuticals Ltd is one of the large privately held pharmaceutical companies. Over the past six decades, we have been developing and manufacturing affordable medicines for patients around the world. Its innovation-led drug discovery processes ensure the health and well-being of people around the world. Being a care-focused and research-driven company, we are committed to comply the highest ethical standard in clinical research and medical practice. September 2019 ► 45
press release SCHOTT Repeatedly Increases Production Sygnature Discovery Moves its US Base to Capacity for Pharmaceutical Tubing in India Kendall Square
Mainz, Germany; Jambusar, India: The German technology group SCHOTT is investing an additional double-digit million-euro figure into a new glass tank at its tubing manufacturing plant in Jambusar, Gujarat. The expansion follows recent investments at the site including the construction of another additional tank facility just last year. Production of pharmaceutical FIOLAX tubing from the new tank is scheduled to begin in the second half of 2020. The capacity expansion is part of the company’s global growth strategy of its pharma tubing and packaging business segments. “The pharmaceutical market is booming worldwide with a very high demand for premium pharmaceutical packaging and tubing”, commented Dr. Patrick Markschlaeger, Executive Vice President at SCHOTT, Business Unit Tubing. “In order to supply the rapidly growing domestic and Asian market, we are investing once again a multimillion-euro figure in our Jambusar site to increase our manufacturing capacity in India.” FIOLAX borosilicate glass tubing features a high hydrolytic resistance, which makes it an ideal material for primary packaging of medicines. “Since its development in 1911, FIOLAX has been established as the gold-standard material for pharmaceutical containers; its behavior with drugs is well researched and proven. In India, it is primarily used to manufacture glass vials and ampoules”, adds Sundeep Prabhu, Vice President Sales & Marketing, Jambusar at SCHOTT Glass India Pvt. Ltd. In line with the company’s aim to manufacture zero defect tubing, the tank will feature the unique big data approach perfexion. The process, which has been rolled-out globally by SCHOTT since 2017, ensures 100 percent quality control of each tube on the line by using cameras, laser, and IR inspection systems. “In Jambusar we are combining Indian and European technologies and local skills. With the additional tank, we are also adding new workplaces,” explains Georg Sparschuh, Managing Director at SCHOTT Glass India Pvt Ltd India. The new tank will be built and equipped with the latest state-of-theart machinery according to the high standard of all SCHOTT Tubing production sites. Besides the tank facility, the investment includes an extension of the batch house, warehouses, and a new chimney. 46 ◄ September 2019
Sygnature Discovery's New US Office at 245 First Street, Cambridge, MA.
Cambridge, MA: Sygnature Discovery, the leading independent drug discovery and pre-clinical service company, has recently announced that its US office has moved. The new office at 245 First Street in Cambridge MA is near Kendall Square, the heart of the Cambridge–Boston biotech hub. It’s only a small move geographically – just a couple of miles down the road from the old location near Harvard Square; but it is significant. There are more than 100 pharma / biotech companies within a mile of the new office, and many more in the wider Boston–Cambridge area. ‘We have seen the benefits of having a physical presence in Harvard Square, and it has served us really well,’ said Anders Lindstrom, Director of Marketing at Sygnature. ‘The opportunity to move closer to the Kendall Square centre of the biotech cluster was one we could not pass up. One of our key strengths is our collaborative approach to drug discovery. A physical presence as close as possible to customers is important; so this crucible of drug discovery is the perfect place for us.’ Lindstrom added. The US has been a significant market for Sygnature ever since it entered the drug discovery sector 15 years ago, and the first customer was USbased. Many Sygnature scientists studied and worked at US institutions, including MIT and Harvard. Half of the company’s business is now in the US, with customers all across the country from West Coast to East Coast and between. The company is experiencing huge demand from US companies, ranging from big pharma to small university spinouts. Sygnature’s SVP of Business Development, Paul Clewlow commented: ‘We believe the services and expertise we have within Sygnature is perfectly tuned to providing the resource and expertise our customers need to take forward their innovative drug discovery programmes. A huge amount of exciting drug discovery is going on in the Boston– Cambridge area – not just biotechs, but big pharma is congregating there now as well. It is a great hub for us from where to better serve our North American customer base’. Pharma Bio World
press release Ultra-compact IPC Series Further Expanded with PCIe Modules to Accommodate Additional Interfaces
computing power is flexibly scalable to suit individual requirements C6015 and C6017 for medium performance requirements viz with Intel Atom CPUs (up to four cores), C6030 and C6032 as high-end devices with Core-i processors with up to 3.9 GHz per core (for dual core processors).
Glenmark Receives Orphan Drug Designation for GBR 1342, a Bispecific Antibody Candidate under Evaluation for the Treatment of Multiple Myeloma
Thane, India: C6032 ultra-compact industrial PC is extremely compact, extremely flexible. With dimensions of only 129 x 133 x 104 mm, the C6032 industrial PC extends the range of ultra-compact industrial PCs by a high-performance device in modular design. For this purpose, the C6032 adds a further circuit board level to the C6030 single-board industrial PC, which is comparable in terms of computing power, to allow for accommodation of modular interface and functional extensions. With the use of compact PCIe modules, the C6032 can be optimally adapted to the requirement profile of individual applications. Equipped with Intel Core-i processors of the 6th and 7th generation – up to the Core i7 with four 3.6 GHz cores – the C6032 is ideal to support extensive axis controls, complex HMI applications, extremely short cycle times or handling of large data volumes. Both the compact motherboard and the die-cast zinc and aluminium housing have been newly developed in accordance with the familiar high Beckhoff standards such as industrial compatibility, made in Germany quality, reliability, and premium look and feel. Other features are the exceptionally compact design that is typical of the ultra-compact IPC series and the flexible installation with vertical or horizontal mounting options on the rear panel – and a free orientation of the connection area. High flexibility through PCIe modules: By means of two PCIe compact module slots, the freely accessible connection area on the front of the device can be flexibly expanded. The first PCIe modules to be available are: 2 x Gbit Ethernet, 2 x USB 3.0, 2 x RS232, 1 x CP-Link 4. The use of an extremely durable, speed-monitored and controlled fan makes the C6032 suitable for a temperature range of up to 55 °C. Available options are Windows 7 or Windows 10 operating systems as well as a second M.2 SSD in RAID configuration. The C6032 offers storage capacity of 40 GB M.2 SSD, 3D flash even in the basic configuration. A device generation designed for universal use: the Microsoft Azurecertified devices of the ultra-compact IPC series are ideal to meet current requirements in machine building, such as increasing modularisation, reduced space requirements in control cabinets, increased computing power, and growing price pressure. Designed exactly with all these requirements in mind, the new device generation is suitable for use in a broad range of application scenarios such as distributed architectures and current IoT (Internet of Things) or Industry 4.0 concepts. The Pharma Bio World
Mumbai, India: Glenmark Pharmaceuticals (Glenmark), a research-led, integrated global pharmaceutical company, has recently announced that the US Food and Drug Administration (USFDA) has granted Orphan Drug Designation to its bispecific antibody candidate GBR 1342 for the treatment of patients with multiple myeloma who have received prior therapies. Derived from the company’s proprietary BEAT (Bispecific Engagement by Antibodies based on the T cell receptor) technology, GBR 1342 is being investigated for the treatment of multiple myeloma. The candidate is one of five clinical-stage assets in the pipeline of Glenmark’s new innovation company. GBR 1342 is designed to bind to both CD3 on T cells and CD38, an antigen known to be implicated in hematological malignancies on target cells. This activates T cells and redirects them toward CD38+ tumor cells found in multiple myeloma. Once directed at the right target, the T cells help destroy the tumor cells. A first-in-human, open-label, Phase 1 trial of GBR 1342 in multiple myeloma, is ongoing to assess the safety and tolerability of increasing doses of GBR 1342, and will also evaluate biomarkers, immunogenicity, and additional measures of disease activity. “Patients who are struggling with diseases like multiple myeloma are seeking new treatment options and innovative approaches. We believe the focus of our new company is essential to these patients and to the healthcare system,” said Alessandro Riva, MD, CEO of the new company. “As one of our first important pipeline milestones, we are excited that the FDA has recognized the potential for GBR 1342 to offer a significant advancement for patients with multiple myeloma.” Multiple myeloma is a rare blood disorder in which plasma cells in the bone marrow become malignant and replicate if unchecked. The malignant plasma cells can displace normal blood cells in the body, leading to anemia and uncontrolled bleeding. It can also cause issues with bone density and strength, as well as lead to an increased risk of infection by lowering the body’s immune response. More than 32,000 new cases of multiple myeloma are expected to be diagnosed in 2019 in the US. During that same time, about 13,000 people are expected to die from the disease. The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and upon regulatory approval, 7 years of market exclusivity. September 2019 ► 47
press release Ground-breaking Trial Demonstrates Potential of Blood Test which Harnesses the Power of the Immune System to Reduce Late Detection of Lung Cancer Nottingham, UK: Oncimmune Holdings Plc, a leading global immunodiagnostics group, has recently welcome the presentation of data by Professor Frank Sullivan (Chief Investigator on the ECLS trial) which has demonstrated the potential of Oncimmune’s EarlyCDT Lung test to reduce the incidence of patients with late-stage lung cancer at diagnosis, compared with standard clinical diagnosis.
In a randomised controlled trial of 12,209 people in Scotland at high risk of developing lung cancer, it was shown that more people were diagnosed at an early stage of the disease in the two years after taking the EarlyCDT Lung Test than those in the control arm who received standard clinical care. The findings, recently presented at the 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (IASLC) in Barcelona, are an important validation of Oncimmune’s diagnostic platform technology which harnesses the power of the immune system, to detect evidence of the body’s natural response to cancer. The technology can detect cancer four years or more before standard clinical diagnosis. Oncimmune’s patented technology works by detecting the presence of autoantibodies generated by the body’s immune system as a natural defence against cancer cells. Lung cancer was chosen as the first target of the technology because it is the world’s leading cause of cancer-related death and is often detected at an advanced stage with approximately 85 percent of patients in the UK undiagnosed until the disease has spread to other parts of the body. The ECLS trial is believed to be the largest randomised controlled trial for the detection of lung cancer using biomarkers conducted anywhere in the world. Among those people who received the EarlyCDT Lung test and went on to develop lung cancer within the next two years, 41.1 percent were diagnosed at an early stage (stage 1&2) of the disease, compared with 26.8 percent among the control group subject to standard clinical practice. This resulted in a 36 percent reduction in late stage presentation after 2 years of follow up in subjects randomised to the EarlyCDT test. The trial also showed a lower rate of deaths among people in the intervention arm of the trial after two years compared with people in the control group. Lung cancer-specific deaths were also lower in the intervention group. This suggests that the EarlyCDT Lung test followed by CT imaging could produce a mortality benefit, although the trial was not powered to demonstrate such a trend after two years. The next step is to move to a larger population-based evaluation in up to 200,000 patients to assess the implications of diagnosis with EarlyCDT Lung on survival and mortality in a real-world setting. Adam Hill, Chief Executive Officer of Oncimmune, commented: “We are thrilled that the ECLS trial has demonstrated so clearly the potential 48 ◄ September 2019
of our EarlyCDT technology platform to transform the way cancer is diagnosed. We look forward to working with health authorities in Scotland and beyond to roll out EarlyCDT Lung more widely, with the aim of saving lives and reducing costs for the NHS and other healthcare systems around the world. Meanwhile, we are continuing to test our technology on other forms of cancer, including liver, ovarian, breast, and prostate in pursuit of our ambition to build the leading immunodiagnostic platform in the field of oncology.” Professor Frank Sullivan, Professor of Primary Care Medicine at the University of St. Andrews, the Chief Investigator for the ECLS trial, commented: “These landmark findings are likely to have globally significant implications for the early detection of lung cancer by showing how a simple blood test, followed by CT scans, is able to increase the number of patients diagnosed at an earlier stage of the disease, when surgery is still possible and prospects for survival much higher.”
Glenmark Pharmaceuticals Received ANDA Approval for Pimecrolimus Cream, 1%
Mumbai, India: Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Pimecrolimus Cream, 1 percent, a generic version of Elidel Cream, 1 percent, of Bausch Health US, LLC. According to IQVIA sales data for the 12 month period ending July 2019, the Elidel Cream, 1 percent market achieved annual sales of approximately USD 198.8 million. Glenmark’s current portfolio consists of 160 products authorized for distribution in the US marketplace and 55 ANDA’s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
Glenmark Pharmaceuticals receives ANDA approval for Fulvestrant Injection
Mumbai, India: Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Fulvestrant Injection, 250 mg/5 mL (50 mg/ mL), a generic version of Faslodex1 injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals LP. According to IQVIA sales data for the 12 month period ending June 2019, the Faslodex Injection, 250 mg/5 mL (50 mg/mL) market* achieved annual sales of approximately USD 549.9 million. Glenmark’s current portfolio consists of 159 products authorized for distribution in the US marketplace and 56 ANDA’s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. *Market includes brand and all available therapeutic equivalents Pharma Bio World
Water Meter Toshniwal provides a comprehensive residential meter portfolio to meet the world’s water utility requirements. Toshniwal Series continues to be in the water industry standards. Their quiet, rugged and reliable apartment and domestic water meters achieve ultra-low flow measurement and meets or exceeds all standards. The ISO standard assures you that Toshniwal has achieved the highest possible standards for both manufacturing and customer service quality. A perfect measuring technique for cold and warm water and is easy to install even on existing pipelines.
For more information, please contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshniwal.net
Liquid Ring Vacuum Pumps Toshniwal leader in vacuum engineering provides further solution to your vacuum needs in manufacturing of liquid ring vacuum pumps that offer optimum performance and reliability. They offer minimal water consumption and an innovative impeller design that assure extremely quite operation and extends its life even under harsh condition the most advanced manufacturing process with the objective to reduce manufacturing and delivery time. Hydrotwin, PLC controlled roots + LRVP package for high vacuum application with total liquid recirculation capacity to 3,900-m 3/hr and max vacuum 2-mbar. Hydrosys, centralized package vacuum units with total or partial water recirculation capacity to 3,500-m 3/hr and max vacuum 33-mbar. It finds application in distillation, drying, material transfer, power and steel, food processing, paper, general vacuum and textile.
For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshniwal.net
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Pitched Blade Turbines These are axial mixing impellers with considerable amount of radial flow. It produces suction when placed near the liquid surface. Hence used for blending of immiscible liquids, solid incorporation, etc. It is also a preferred choice for applications where the viscosity change during the process is large. These are mostly available in four blades at 45 degree. But different number of blades with various angles is also used depending on the application. For more information, please contact:
FEDA Inc B-37 Maruti Indl Estate Plot No: 59/1/2/3, Phase 1, GIDC Vatva Ahmedabad, Gujarat 382 445 E-mail: ashok@fedainc.com / reena@fedainc.com
Counter-flow Impellers Flow generated by impellers tip is opposite to the bulk flow produced by the central part. In many cases the slurry fluidity reduces due to high solid concentration. Tip of the impeller provides momentum to the fluid near vessel wall. These are mainly used for slurry with high solid concentration. It efficiently operates at much higher impeller to tank dia ratio and have higher flow capacity than conventional impellers.
For more information, please contact:
FEDA Inc B-37 Maruti Indl Estate Plot No: 59/1/2/3, Phase 1, GIDC Vatva Ahmedabad, Gujarat 382 445 E-mail: ashok@fedainc.com / reena@fedainc.com
AODD Pumps Almatec, part of PSG, a Dover company, has extended its line of solid plastic C-Series air-operated double-diaphragm (AODD) pumps to include new C 40 (1-1/2”) and C 50 (2”) Models. Engineered to be a more cost-effective alternative to similar plastic pumps, Almatec C-Series pumps feature an industry-leading design that increases bolt torque to improve pump safety when compared to competitive pumps. What further separates the C-Series is the incorporation of Almatec’s exclusive Perswing P air control system, which offers superior efficiency to optimize production rates and lower energy costs. Ideally suited for the most difficult pumping applications, C-Series pumps ensure the suction and discharge ports are available as separate housing parts with different footprints. This feature allows the C-Series to be quickly and easily matched to existing installations. C-Series pumps do not have any mechanical seals, drives or rotating parts that cause wear over time, which improves reliability and extends product life. C-Series pumps feature self-priming and dry run capabilities, critical considerations for most pumping applications. The C-Series pump line now consists of five pump sizes – C 10 (3/8”), C 15 (1/2”), C 25 (1”), C 40 (1-1/2”) and C 50 (2”). The wetted housing parts are made of either abrasion-resistant polyethylene or chemically resistant PTFE. For applications in explosive atmospheres, C-Series pumps are available in versions that conform to ATEX requirements according to the 2014/34/EU directive. For more information, please contact: Dover India Pvt Ltd – PSG 40 Poonamallee By-pass Sanneerkuppam Chennai 600 056 Tel: 044-26271020, 25271023 E-mail: sales.psgindia@psgdover.com
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Pharma Bio World
Bottle Top Dispensers MICROLIT ULTIMUS with dual inlet technology is fully autoclavable at 121 oC and 15 psi for duration of 10-15 minutes. Dual Inlet technology enhances your productivity with four modes of operation. In Standard Dispensing, knob A open, knob B closed mode, the dispenser dispenses the liquid normally into the receiver from the bottle it is mounted on. In Purging, knob A closed and knob B closed mode, the liquid is re-circulated into the same bottle on which the dispenser is mounted. This process removes the air from the dispenser, without wasting any reagent.In Dilution/Rinsing/Second Liquid Dispensing, knob A open, knob B open mode, the liquid from a second source can be dispensed into the receiver. The second liquid can be distilled water, thus allowing the user to rinse the instrument without dismounting it or dilute the reagent within the receiver. In Bottle Refilling, knob A closed and knob B open mode, the liquid from a second source can be used to refill the bottle, without dismounting the dispenser. For more information, please contact: MICROLIT 629 Pakramau, Kursi Road Lucknow, Uttar Pradesh 226 026 E-mail: customercare@microlit.com
Stirrers For many, a standard stirrer does the trick. However, certain benchtop constraints and price point can often create a barrier of entry and require a unique solution. Cole-Parmer, a leading manufacturer and supplier of laboratory and industrial products, instrumentation, and supplies, has alleviated these issues with two different offerings from the Cole-Parmer elements line. Both offer a solution to cost and a crowded working area. With the ColeParmer elements Modular Magnetic Stirrer, up to ten stirrers can be connected to one controller in almost an infinite amount of combinations. By either connecting a module directly to another module, or tethering the modules with a USB connector, any lab layout can be accommodated. This stirrer is ideal for anyone who needs more stirring equipment but has minimal work space or does not want a bunch of bulky stirrers sitting around in their laboratory. These stir plates come with many features including the ability to attach up to 10 stir plates based on need, simple touch and slide operation, LCD display with real time parameters, corrosion-resistant glass stir top, and waterproof USB attachments. Multiple stirring options allow a choice between one direction or reversing every 45 seconds for thorough mixing. The built-in timer can be set for up to 9 hours or continuous operation. The modular magnetic stirrers are adaptable to any application required to mix up to 1-L at 1,500 RPM, and is IP44. When something small, cost-effective and reliable is needed, the Cole-Parmer elements ultrathin magnetic stirrer is appropriate This stirrer is sleek with a top plate diameter of 10 cm, a length of 18 cm, and a height of 1.2 cm. This makes the device easy to store, and easy to operate in the tightest spot on the lab bench. It can also handle a robust workload with a max stirring volume of 1-L and a max RPM of 1,500. Combined with its small footprint it also boosts a simple touch and slide operation, LCD display with real time parameters, and is IP65. For more information, please contact: Cole-Parmer India 403, A-Wing, Delphi Hiranandani Business Park, Powai Mumbai 400 076 Tel: 022-61394444, Fax: 91-022-61394422 E-mail: response@coleparmer.in
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Forced Circulation Evaporator Forced circulation evaporator for concentration of high viscosity material and products with higher solids is also used as evaporative crystalizer. To achieve desired concentration, falling film evaporator followed by forced circulation evaporator is used to minimise the operating cost. In this type of evaporator, the liquid is pumped through tube side of calandria at high velocity avoiding precipitation and fouling the liquid is then passed through vapour separator for separation of vapour. Concentrated liquid is continuously discharged from bottom of the vapour separator with pump.
For more information, please contact:
KEP Engg Services Pvt Ltd 6-A-52, Opp: Park, Nr Vedant International School Apurupa Colony, Jeedimetla Hyderabad, Telangana 500 055 Tel: 040-23096275 E-mail: info@kepengg.com
Spectrophotometer Experience an easier way to perform spectrophotometry with IoT in the lab. Cole-Parmer offers the new Jenway 76 Series Visible and UV/Visible Scanning Spectrophotometer featuring splitbeam optics and CPLive connectivity. Split-beam technology offers improved accuracy and repeatability when determining samples. CPLive connectivity gives users the ability to safely and securely upload and archive data to the cloud, manage multiple devices at one time with the CPLive App, share data with colleagues and access complimentary unlimited data storage. The spectrophotometer provides fast and reliable results ideal for a variety of applications from teaching, to R&D, to routine sample analysis in quality control environments. Available as Jenway model 7615, it has a 1.5 nm spectral bandwidth, and the split-beam optics offset any signal fluctuations for increased stability over prolonged use, making it ideal for time course and kinetic measurement. The high-definition, colour touchscreen and intuitive user interface makes the spectrophotometer easy to use. The touchscreen interface is fast and responsive even when wearing gloves. This spectrophotometer is compatible with both Android and iOS devices, has 10 GB of onboard storage for methods and results, is designed with multiple USB ports for data storage and printer connectivity, features multi-language options and is versatile with a range of optional accessories. The Jenway 76 Series joins the existing Jenway family of products that include the Jenway 74 Series also equipped with CPLive connectivity. This family of ‘live’ spectrophotometers complement one another and provide accurate and reliable results. They are also pre-programmed with measurement modes that are relevant to their applications. For more information, please contact:
Cole-Parmer India 403, A-Wing, Delphi Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-61394444 Fax: 91-022-61394422 E-mail: response@coleparmer.in
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Pharma Bio World
events diary CPhI Worldwide
Global Pharmaceutical Biotechnology Summit
Date: 05 – 07 Nov 2019 Venue: Congress Center Messe Frankfurt, Frankfurt, Germany
Date: 20 – 21 Nov 2019 Venue: Toronto, Canada
About the event: CPhI Worldwide is world’s largest pharmaceutical exhibition and the most important fair in the pharmaceutical industry. Source solutions from suppliers in dedicated zones covering ingredients, contract services, machinery, finished dosage, packaging, and more. It combines all the key suppliers and customers in the chemical and pharmaceutical industry.
About the event: In the light of theme, assessment &advancements in the field of pharma-biotechnology, the conference aims to provide a forum for international researchers from various areas of pharmaceutical, biotechnological mastery where academicians: university faculties, pharmaceutical research, biopharmaceutical industry practitioners, manufacturing medical device, and data management companies, private, public investors and government agencies are contributing existing mastery & collaborating to nurture subject knowledge to accelerate innovations by providing a platform for critical analysis of new data, and to share latest cuttingedge research findings and results about all aspects of pharmabiotechnology. This meeting will be a multidisciplinary gathering and present major areas in the field of bio-pharma.
Highlights of the event: • World’s largest pharmaceutical exhibition • Category & type: pharma & medical, packing & packaging • Expected participants: 45000 visitors and 2500 exhibitors Contact: UBM EMEA, UK – a Division of UBM Plc Informa Plc 240 Blackfriars Rd, London SE1 8BF, UK Tel.: +44 20 7921 5000 E-mail: media@informa.com Website: https://informa.com
Highlights of the event: • Hone your aptitudes with new thoughts and methodologies • Category & type: conference on pharma and medical • Expected participants: approximate 1000 delegates and 50 exhibitors Contact: Organizer: Lexis, Switzerland Communication: https://10times.com/pharma-biotech
CPhI & P-MEC India
BioPharma World Expo 2019 ( South )
Date: 26 – 28 Nov 2019 Venue: India Exposition Mart, Greater Noida, India
Date: 4-6 December, 2019 Venue: HITEX Exhibition Centre, Hyderbad, India
About the event: CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. Attendees will meet the movers and shakers from India’s pharma machinery, technology, and ingredients industries, giving you a competitive advantage that will help grow your business.
BioPharma World Expo 2019 is the best platform for both Indian and international manufacturers/service providers/startups connected with pharma machinery, CRAMS, CROs/CMOs, packaging, logistics, exports, APIs, generics, biotech, regulatory affairs, etc . It offers a unique opportunity to meet, network, and establish business partnerships. The concurrent conference tracks would highlight latest technological developments, market trends, investment opportunities, and challenges facing the industry. The technical sessions would cover pharmaceutical technology, biosimilars, green chemistry, compliance, etc.
Highlights of the event: • Source high quality, low cost Pharma solutions • Category & type: pharma & medical • Expected participants: 59296 Visitors and 1509 Exhibitors Contact: UBM India Pvt Ltd Informa Markets India Times Square Unit No. 1 & 2, B Wing, 5 th Floor, Andheri-Kurla Road, Marol, Andheri East, Mumbai, Maharashtra 400059 Phone: +91-22- 6172 7000 https://www.informamarkets.com/en
Pharma Bio World
Contact: Jasubhai Media Taj Building, 210, Dr. D.N. Road, Fort, Mumbai - 400 001 Tel: 91-22- 40373636 Email: amrita_patil@jasubhai.com
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interview
ACG Group is into Further Augmentation in National and Global Context
In an exclusive interaction with Jayati Mukherjee of PharmaBio World, Ajit Singh threw light on ACG Group’s endeavor in Pharmaceutical Packaging Industry. He spoke about company’s positioning as well as growth outlook in national and global context, its competitive edge, future strategy, technological break-through, quality control, anti-falsification approach, Ajit Singh Chairman, ACG Group
digital aspiration, research & development initiatives, people centricity, and many more other aspects.
ACG Group is a prominent name in the Pharma Packaging Industry. Please acquaint our readers with the detailed growth trend of the company during these days since the commencement of your journey with ACG. ACG Group has been serving the global pharmaceutical industry since over past 50 years. Its product-line is ranging from the world’s largest array of empty capsules (in which it is also the second largest global producer by volume), to other products viz sophisticated packaging films, and high precision pharmaceutical as well as packaging machineries. The Group is the world leader in capsule filling machines and related equipment. It also makes camera inspection equipment and track & trace systems which has become mandatory in the pharma industry in present context. ACG has been experiencing an average double digit growth in all its products. The company belongs to strong growth sector. It’s worth mentioning that we seek to take 54 ◄ September 2019
charge as a positive driver of the market instead of being driven by the continuous flow of high-s and low-s. With respect to Indian market scenario, how do you plan to hold on to, as well as to enhance, the market share with respect to your topline and bottom line growth outlook? What’s your plan for overseas exploration? In order to accelerate the growth and to be close to the customer, we have put up plants in the EU and Brazil. In addition to this, we have offices, warehouses, and agents across the globe. 50 percent of our production, covering the entire range, is being exported regularly to over 100 countries. As per our business strategy, we foresee a further augmentation in coming days. At the home-country context, we are going to expand our operations by covering all our products. The Company has recently set up a huge production-centre near Pune for spare-and-component manufacturing.
The hub takes care of over 20,000 of its machines operating around the world and enables quicker delivery with high, unwavering quality for customers. This facility is the largest of its type in the world and covers almost the entire range including automatic production machines, the latest plating lines, and metallurgy labs that have now been made in-house with close supervision and high precision. Counterfeit pharmaceutical pr oduc t is a huge problem in terms of serious health hazard and damage in brand reputation. What strategy do you adopt to implement anti-counterfeiting? I would recommend the use of the word ‘falsified’ in place of ‘counterfeit’. World Health Organization (WHO) also advocates this as because counterfeit can mean other things as well. Though overstated, the menace of falsified medicines is a problem. Even just a few spurious medicinal packs out of millions could be hazardous. Pharma Bio World
interview ACG has been conscious of this issue since long. Unfortunately, the problem has not received widespread attention and public concern until global trade in pharmaceuticals has taken off. As an internal business policy, we have put in extra efforts in designing and producing our products with anti-falsification feature. This feature enables the protection of product quality for its customers across the globe.
complex tablet tooling can be provided.
For example – empty capsules, if unprinted, are susceptible to substitution by look-alikes. ACG has developed special complex printing methodology for their capsules, which appears in several colours. Like a currency note or a postage stamp, the printing on a capsule dosage form is extremely tiny and complex. ACG has the world’s largest capacity for capsule printing; and its complexity makes the operation a virtual factory within a factory.
With regard to your quality control strategy, how do you optimize the materials, equipment, and processes to maintain high internal quality standard. ACG’s incoming raw materials are quarantined and thoroughly checked before release and usage. Elaborate in-process controls have been installed; equipment and processes are continuously upgraded. However optimized quality standards are also a matter of attitude, ethics, and discipline. Our performance in these areas account for the continued success of our products in so many countries and with constantly repeated orders forming a major part of our business.
Such complex printing effectively deters any attempt to insert falsified medicines into the supply chain. In addition to printing, we offer overt and covert features in a capsule and make it possible for the FDA to determine whether a product is fake or genuine. We have developed capsule liquid filling and band sealing, a novel dosage form with many advantages and cost saving. This process is difficult to copy without installing sophisticated equipment made by the Group. It also provides superior efficacy, dissolution, and absorption of active ingredients into the blood stream. In pharma packaging films, we provide complex holograms and other features to prevent falsification. With tableting machines,
Blister packs of various unusual configurations make the pack more difficult to copy. Finally, our track & trace equipment and solutions provide a near foolproof protection for the high quality products of its customers.
What is ACG’s digital aspiration to enhance productivity and efficiency? ACG is going digital within its plants as well as right across the supply chain. Our Managing Director Karan Singh himself looks after this initiative. He is very young, dynamic, and trained from Harvard Business School. We strongly believe and perceive that this digital transformation accrues value adding benefits to our customers. We would like to know your research & development initiatives and resultant technological breakthrough-s.
“ACG Group is the world leader in capsule filling machines and related equipment. The Group is also the second largest producer of empty capsules by volume globally. ” Pharma Bio World
ACG has given importance to innovation right from its inception. We started small, but grew through innovations – not only for technology vertical, but also for customer centricity. Our technological breakthroughs, new product and process development, and new offerings to the market are very well recognized by the industry, and also by the academia. Our investment on R&D is way above the industry average with over 50 patents shared by the Group and its affiliates. How do you prioritize innovation in your business and integrate it to your packaging processes? As I mentioned before, innovation is in the DNA of the ACG Group. It’s an integral and essential part of our business philosophy, which has made us sustainable and a market leader since many decades. Our company is valued for its highly integrated products and services. We offer almost a complete range of equipments and processes for solid dosage forms covering processing equipment of primary and secondary packaging, inspection, and track & trace solutions along with individualised software developments. Recently ACG inspection has installed 1000th Track & Trace line in India, Europe, and USA. Please acquaint our readers with the journey. The inspection wing of ACG is being led by Ettore Cucchetti. He is an expat and very well acquainted with the industry. We have been relatively an early player in this sophisticated business which caters to pharma customers. Mandated Government requirements across the globe have assisted us in our rapid business growth. In recent past, we acquired a high-tech EU based Company which belongs to this sector, and set up a research-centre in Switzerland. With such initiatives, we are pioneering the import and development of contemporary global technologies in our country. September 2019 ► 55
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Instead of using the term employees, we prefer to call the people working with us as associates or team members; and our agents as partners. This terminology is an indicative of our people concern and acquaintance with the future trend. In the coming years, we are sure that it is going to be a norm for other organizations to follow.
CHEMICAL ENGINEERING WORLD
What strategy does your business adopt to address the traceability need? The strategy is to address the global pharma industry and focus is only on pharma. We already have dozens of projects in progress. Going forward, we expect to focus our inspection systems and track & trace expertise in other industries as well.
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We have started a very ingenuitive initiative to instigate motivation of our associates, customers, suppliers, global partners, advisors, and all other stakeholders. All our visiting cards are having people-centric messages and values enshrined at the back; and these are being affirmed continuously during the card-exchange procedure while meeting people. This open statement has become our signature towards people centricity. Let me share this here.
OFFSHORE WORLD
We would like to know your people-centric initiatives for their potential development towards meeting the business objective. Our brand is of international repute for our people development initiatives. We take adequate care of our employees for their potential expansion to the fullest possible extent. In acknowledgement of this initiative, we have recently been recognized with the “Great Place to Work” award.
Our HR and Training division is being led by industry experienced professionals known for their expertise and excellence. In line of our people-centricity, we have upgraded our existing activities and introduced many new initiatives. A large number of properly designed training programs are being run to take care of over 4,000 associates. We have made those programs documented in a printed book format with over 200 pages, which itself suggests its extensity. Department heads nominate their members in advance for the year.
PHarMa bIo WorlD
Last year, ACG consolidated its multiple businesses and regional brands into a single entity. What was the thought behind this consolidation procedure? The consolidation process is being led by Richard Stedman coming with extensive industry-relevant experience. Consolidation is still in progression. The thought behind the process is: through this, we aim to offer greater standardization of processes and components, more effective reach to our customers across the globe, as well as to obtain economies of scale.
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----------------------- Our Values -----------------------Transparent / Aesthetics / Nurturing / Safety Synergy / Customer centric / Empowering / Dignity ACG Group’s Signature towards People-Centricity 56 ◄ September 2019
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bookshelf Pediatric Drug Research: The Study and Labeling of Drugs for Pediatric Use under the Best Pharmaceuticals for Children Act: GAO-07-898T Author: US Government Accountability Office (GAO) Publication: Bibliogov Page Count: 22 Price: ` 1019.00 About the Book: The US Government Accountability Office (GAO) is an independent agency, which works for congress. About two-third of drugs that are prescribed for children have not been studied and labeled for pediatric use, placing children at risk of being exposed to ineffective treatment or incorrect dosing. The best pharmaceuticals for children act (BPCA), enacted in 2002, encourages the manufacturers or sponsors of drugs that still have marketing exclusivity to conduct pediatric drug studies as requested by food and drug administration (FDA). If they do so, FDA may extend for six months during which no equivalent generic drugs can be marketed. This is referred to as pediatric exclusivity. BPCA also provides for the study of off-patent drugs. GAO was asked to testify on the study and labeling of drugs for pediatric use under BPCA. This book gives an account of the assessment done by GAO about the extent to which pediatric drug studies are being conducted under BPCA for on-patent drugs, the extent to which the pediatric drug studies were being conducted under BPCA for off-patent drugs, the impact of BPCA on the labeling of drugs for pediatric use, and the process by which the labeling was changed.
Pharmaceutical Packaging Technology Author: U K Jain and D C Goupale Publisher: PharmMed Press, a Unit of BSP Books Pvt Ltd Page Count: 283 Price: ` 335.75 About the Book: The pharmaceutical packaging is a very crucial subject. It is as much important as the medicine or drug itself. If the packaging is faulty, the medicine itself will not give the desired therapeutic effect. Packaging technology has become a separate subject in pharmaceutical sciences due to its vital applications in preserving therapeutic efficacy of drugs. This book provides a detailed account of packaging technology. The book comprises 16 chapters viz pharmaceutical packaging and design, packaging materials, polymers and plastics in packaging, glass as a packaging material, metals in packaging, blister and strip packages, quality control in packaging, defects in packaging, stability of packages, ancillary materials used in packaging, sterilization of packaging, packaging of parenterals ophthalmic and aerosols, corrugated fiberboard and cartons, labeling of pharmaceutical packages, regulatory aspect of pharmaceutical packaging, and blow-fill-seal (BFS) in pharmaceutical packaging.
Quality Control of Packaging Materials in the Pharmaceutical Industry Author: Kenneth Harburn Publisher: CRC Press Page Count: 200 Price: ` 4960.00 About the Book: In this book, towards addressing the need of pharmaceutical industry, the author illustrates the use of systems such as in-process control, quality auditing, specifications, stressing a troubleshooting, cost-effective approach to product packaging to maximize early lead time to the customer . The chapters in this book are earmarked as packaging design and specifications, supplier quality auditing, quality control at the supplier’s premises, the packaging material quality control, laboratory on the pharmaceutical premises, packaging and filling equipment, and pharmaceutical packaging customer complaints. Pharma Bio World
September 2019 â–ş 57
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