Pharma Bio World

VOL 17 | ISSUE 3 | OCTOBER 2018 | MUMBAI | TOTAL PAGES 60 | ` 150

www.pharmabioworld.com PHARMA BIO WORLD VOL 17 ISSUE 3 OCTOBER 2018 MUMBAI

Pharma Packaging

TOTAL PAGES 60 ` 150 BioPharma World Expo 2019 20-23, February 2019 Venue: Bombay Exhibition Centre, Goregaon (East), Mumbai, India

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VOL. 17 | NO. 3 | October 2018 | MUMBAI | ` 150

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4 ◄ October 2018

Pharma Bio World

INTERVIEW 8

Technoloy & Innovation from Schott Dr. Patrick Markschlaeger, Executive Vice President, SCHOTT AG

16

Integrated packaging solutions from Nichrome Ms. Mrunal Joshi, Executive Director, Nichrome FEATURES

20

Technology: the turning point for healthcare solutions Vipul Jain, CEO, Advancells

26

Pharmaceutical Product Labeling Tips: Calculating the True Cost of TCO Bob Neagle, Business Unit Manager, Secondary Packaging, Videojet Technologies

30

Supply Chain Management in Pharmaceutical Industry Taneli Ruda, Senior Vice President and MD, Global Trade Management Tax & Accounting Business Thomson Reuters

32

Keeping Pharmaceutical Manufacturing in Check Dirk Bettels, Senior Product Manager, Mettler-Toledo Garvens

34

Protein Quality Control in SPR and BLI High-Throughput Screening Studies Daniel Some, PhD, Principle Scientist, Wyatt Technology Corp

37

The Crossroads of Compliance, Audit Readiness, Profitability, and Data Integrity Michalle Adkins, Industry Consultants, Life Sciences Industry Solutions Group, Emerson

08

20

MARKET INSIGHTS 40

Make in India! SCHOTT Tubing India to further invest 20 million Euros MARKETING INITIATIVE

42

Liquid Ring Vacuum Pump Vexations

43

Innovative Vacuum Solutions in Pharma Industry: The Right Solution

44

Energy-efficient Range of HRS FUNKE Plate Heat Exchanger

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Press Release

49 56

CORPORATE AFFAIRS Products Events

57 58

BACKYARD Book Shelf Ad Index

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6 ◄ October 2018

NEWS

Next Issue Focus: Talent Management in Pharma

Pharma Bio World

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interview

Dr. Patrick Markschlaeger

Technoloy & Innovation from SCHOTT AG

8 ◄ October 2018

The German technology group, SCHOTT Tubing, manufacturers of pharmaceutical glass and packaging is further growing its production capacity through the launch of a new glass tank in its Indian m a n u f a c t u r i n g p l a n t a t J a m b u s a r, Gujarat. The expansion is in response to the increasing demand for high-quality pharmaceutical packaging material in the global market.

Dr. Patrick Markschlaeger, Executive Vice President, SCHOTT AG, Business Unit Tubing, in an exclusive interview with PBW shares how SCHOTT AG has been leading the pharma innovation.

With perfeXion® initiative, SCHOTT has set out to elevate pharmaceutical glass quality.

Could you give us a briefly explain the concept of perfeXion?

Last year, SCHOTT implemented perfeXion® - the new era of quality processing - in all its global plants, to achieve unparalleled quality control standards for its FIOLAX® pharmaceutical glass tubing. By harnessing big data, we have moved from a statistical samplebased quality-control process to 100% inspection of each individual FIOLAX® tube. This also allows us to customize the specification of the glass tubing according to specific needs of the container format. perfeXion® uses state-of-the-art cameras and lasers to pinpoint potential defects along the production line. A process control and integrated data management system works as an integrated network for real-time collection and evaluation of the data.

More than 100,000 data tags per minute are collected in this system. All this generates valuable data for controlling and stabilizing the tubing production process. As a result, we now offer an improved product with superior auditability and traceability for the pharmaceutical industry.

This leads to a unique approach to the market. How do you proceed?

The pharmaceutical companies put their patients first by ensuring high-quality products. We owe them that same level of dedication towards constant improvement, right from the beginning of the manufacturing value chain. With perfeXion®, we implemented a zero-defect philosophy, so that the tubing, used as basic material for the production of vials, syringes, cartridges, and ampoules, can now be produced at an even higher quality from the beginning. This even applies for parameters such as the inside diameter, which were difficult to measure online previously. Moreover, by improving the measurement of visual quality characteristics, SCHOTT can offer individual specifications tailored even closer to customers’ requirements.

What are the impact of glass tubing on the future packaging challenges?

One of the key challenges that the packaging industry foresees is that of supply. There has been recent surge in demand for pharmaceutical packaging, and is expected to grow at a rapid rate globally in the next Pharma Bio World

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interview years. This has resulted in emergence of lower quality alternatives, which pose an imminent threat to patient safety. This, in fact, is one of the key reasons why SCHOTT decided to invest in increasing the production capacity of its Jambusar plant in India. With further investment of over 20 million Euros, SCHOTT Tubing India has begun construction of a new tank facility that would increase the plant capacity by 50%. This will facilitate our supply to the Indian as well as export markets, especially in Asia.

Apart from quality and quality-related issues such as delamination, extractables and leachables, etc., which result in drug contamination, the industry is also coping with the issue of growing complexity of drugs, fostered by increasing lifestyle diseases, growing health awareness and aging population. This brings more focus towards need for highest standards of quality to be maintained in the glass tubing, as well as capabilities to customize our product according to the client needs.

What are your strengths to succeed in this market?

Our main product, FIOLAX® glass tubing, has grown since 1911 to become the gold standard ‘raw material’ for glass containers in the global pharma industry. Known for its unmatched quality, our packaging material is the first preference for most of India’s leading pharmaceutical companies. Our continuous R&D initiatives help us to be abreast with the market trends and requirements, and hence, we are able to introduce unprecedented advancements in the industry. For instance, through perfeXion®, process- and product quality data of each individual glass tube is collected online and in real-time. We foresee that these precise data points will not only be instrumental in terms of technology advancements at our plants, but will also help provide intelligence that can be passed further down the supply chain in future.

Why should the pharmaceutical industry give special consideration to pharma glass?

The current environment especially calls for pharmaceutical players to focus on their packaging material. There is a strong trend 10 ◄ October 2018

of highly sensitive drug formulations, which require unique and stable packaging that minimizes drug and container interaction over the shelf life of the product. Also, there is an increasing number of higher dosage volumes, which leads to longer durations for which the packaging remains in use. Such expectations call for the containers to have very accurate dimensions, especially regarding the inside diameter. Thus, usage of precise tubing becomes critical.

Smart packaging emerges as the key to tackle the complexities and challenges facing the pharma packaging industry. Your comments.

With the ever-increasing customer expectations and product complexity, smart packaging is definitely the need of the hour. Smart packaging is already being seen as essential for optimising logistics operations and stock control throughout the product lifecycle, for providing information and validation around issues such as anti-counterfeiting, product tampering, etc.

SCHOTT is continuously working to introduce Germany’s Industry 4.0 concept of bringing digitalization and automation in different processes at its manufacturing sites. Be it the fully controlled environment for stacking the end product, or 100% inspection of the tubes through the automated system, we have been pioneers in bringing the latest German technology to the country.

Conducting automated controls seems logic, why is this not yet a standard in the glass tubing industry given the rising quality demands?

I am sure this will become a standard in the industry, and we are now seeing many players and clients taking a number of R&D and investment initiatives. However, we must appreciate that analysis of such a specialized product, that too at high drawing speeds is difficult to perform and requires heavy investments. Our technology group developed the inspection devices in-house based on many years of R&D and has taken a conscious decision to always keep its focus on innovation, and this is what reflects in our end product for our clients.

Looking at the challenges that lie ahead — what current trends in the pharmaceutical industry can you support on the part of glass tubing?

What are the key trends shaping the pharma Packaging industry?

There are few trends that I feel SCHOTT has been actively supporting. Firstly, the push to capitalize on huge marketplaces in rapidly developing nations is a common aim for all global players. With this, adherence to complex standards becomes a basic expectation. SCHOTT has manufacturing plants for pharmaceutical tubing glass on three continents, and all plants manufacture glass of the same quality as per the same global standards, and thus, all serve as export hubs for various markets.

In addition, developing and implementing superior processes related to rapidly evolving client as well as new regulatory requirements has been a constant endeavor for SCHOTT. One of the greatest threats to patient safety is counterfeit drugs. Smart packaging is instrumental to combat this issue. SCHOTT has pioneered many advancements that have supported the industry with critical knowledge sharing on issues such as anti-counterfeit, qualitative concerns, etc.

Lastly, we run initiatives for the general development of the industry, such as the FIOLAX® Academy which informs industry partners, clients, and other stakeholders on the latest trends, best practices, etc. and topics, such as why not all glass is the same, breakage risks or drug-container interaction.

SCHOTT’s pharma packaging experts also see a number of trends in the primary packaging industry itself. For example, an increase in formulations with sensitive and complex molecule structures, e.g. biotech drugs, which require innovative packaging solutions to ensure drug stability. Another trend shaping the industry is the move from hospital to homecare to enable patients to selfadminister the drugs in an environment they feel most comfortable in. Such trends require the containers and subsequently the tubing to have highly accurate dimensions, especially in regards to the inside diameter. We achieve this through our perfeXion® process.

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interview

Ms. Mrunal Joshi

Integrated packaging solutions from Nichrome

16 â—„ October 2018

Nichrome a renowned Packaging M ac hines Manuf act urer has 40 years of experience in providing packaging solutions to a wide array of industries and applications.

Nichrome’s versatile, high quality and flexible range of machines have won the trust of many established brands in the market. Ms. Mrunal Joshi, Executive Director, Nic hrome in conver sation with PBW talks about how Nichrome provides complete suppor t to customers, from consultation and customized machine development to production of packaging machine, complemented with extensive after sales service.

Pharma Bio World

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interview

TOTAL PAGES 64

Chemtech Hyderabad World Expo 2017

` 150

18 ◄ October 2018

MUMBAI

Nichrome offers End-to-End packaging solutions that include the Material handling systems, Primary packaging, Secondary

Nichrome offers an intelligent Data over Internet system for all its machines and secondary systems that enables to capture and analyze all the production data. In addition, we also offer the warehouse management systems.

DECEMBER 2017

Tell us more about the secondary packaging initiative by Nichrome.

VOL 16 ISSUE 05

Our machines are compliant with all the norms related to the pharmaceutical industry.

For the pharma industry ‘Smart Packaging’ will mean a complete information system of its production and packaging set up.

www.pharmabioworld.com PHARMA BIO WORLD

One issue that affects the packaging of all drug products – small molecules as well as biologics - is quality. What are the steps taken by Nichorme to ensure quality?

Smart packaging emerges as the key to tackle the complexities and challenges facing the pharma packaging industry. Your comments.

` 150

Nichrome is a reputed name in the packaging industry. Nichrome believes in working in partnership with its customers, to cater to their needs and requirements. With a strong infrastructure and experienced R&D team, Nichrome is continuously innovating the right fit technology for its customers.

Nichrome plans to pave in roads in the pharma industry with its offering in Primary packaging as well as the secondary packaging. In totality, Nichrome aims to become an important partner in the packaging scenario of the Pharma industry.

TOTAL PAGES 60

What are your strengths to succeed in this market?

Looking forward three to five years, what are some of the key goals, or strategic initiatives, you hope to achieve in Pharma packaging?

VOL 16 | ISSUE 05 | DECEMBER 2017 | MUMBAI | TOTAL PAGES 60 | PRICE ` 150

www.pharmabioworld.com

MUMBAI

Nichrome has been supplying small sachet packaging machines for pharma powders, neutraceutical powders, ORS powders, lotions and liquids in sachets. Nichrome offers a range of Horizontal, Multilane and Stickpack machines for high speed sachet packing.

Nichrome is also offering Bottle and Jar filling lines for powders and tablets.

VOL 16 | ISSUE 04 | NOVEMBER 2017 | MUMBAI | TOTAL PAGES 60 | PRICE ` 150

NOVEMBER 2017

Tell us more about Nichrome and its role in Pharma Packaging. What are the opportunities you identify for the company?

Contribute to PBW VOL 16 ISSUE 04

Nichrome is a leading company providing integrated packaging solutions to the Pharma and Food industry over 40 years. Nichrome specializes in Flexible packaging as well as rigid jar and bottle packaging.

packing in flexible bags or cartons, Palletizing and Warehouse management. Nichrome has a special cell of experts handling projects related to the secondary packaging.

PHARMA BIO WORLD

The term ‘pharma packaging’ may not immediately evoke excitement – but without innovation in the field, some therapies wouldn’t even reach market. Where does Nichrome see itself in this market?

HYDERABAD - 2017

GUJARAT - 2018

13-15, December 2017 Venue: Hyderabad, India

23-25, January 2018 20-23, February 2019 Venue: Ahmedabad, Gujarat, India Venue: Mumbai, India

MUMBAI - 2019

GUJARAT - 2018

MUMBAI - 2019

23-25, January 2018 20-23, February 2019 Venue: Ahmedabad, Gujarat, India Venue: Mumbai, India

Dear Readers, Launched by Chemtech Foundation in 1992, Pharma Bio World (PBW) features contents from Pharmaceutical and Biotechnology industries. PBW provides in-depth information on business practices, latest trends, technologies, research & innovation and processes across the entire industry pipeline.

Each monthly edition of PBW covers a separate area of pharma and biotech industry and includes articles from a range of peers, consultants and commentators, interview with industry experts, Market research analyzing industry trends, News Features, News Updates, Product Trends, Events Diary and Bookshelf.

Target readers for PBW are Drug manufacturers, Intermediates, Pharma machinery/equipment manufacturers and suppliers, Pharma packaging firms, Research institutes, Academic institutes, Biotechnology firms, Consultants and Government bodies.

You are most welcome to share editorial content with us such as technical articles, case studies and product write-ups. The length of the article should not exceed 1500 words with maximum three illustrations, images, graphs, charts etc. All the images should be high-resolution (300 DPI) and attached separately in JPEG or JPG format.

Have a look at our editorial calendar on our website www.pharmabioworld.com.

To know more about Chemtech Foundation, Jasubhai Media and other publications and events, please visit our website – www. chemtechonline.com Thank you, Regards, Mittravinda Ranjan Editor Jasubhai Media Pvt Ltd T : +91-22-40373636 D: +91-22-40373615 E-mail: mittra_ranjan@jasubhai.com

Pharma Bio World

Technology: the turning point for healthcare solutions Continuous technological developments in healthcare have saved countless lives and improved the quality of life for even more. Not only has technology changed experiences for patients and their families, but it’s also had a huge impact on medical processes and the practices of healthcare professionals.

Vipul Jain, CEO, Advancells is taking a look at the latest technological innovations, and the benefits and disadvantages they bring to both patients and professionals.

N

eedless to say, technology has paved a path for better healthcare solutions. With several technological advancements, countless lives have been saved and for many more, it has improved the quality of life.

Not only has it done wonders for patients with chronic ailments, but it’s also had an impact on medical practices of the healthcare professionals.

But what are these medical advancements?

How have they benefited the patients and professionals alike? And how are future technological innovations going to improve healthcare sector?

Let’s find all these answers here: Presentation of Electronic Health Records - The presentation of Electronic Health Records (EHRs) in supplanting physical records has been a distinct advantage for some united medicinal services experts.

Medical practitioners, medical records and healthcare information experts (MRHITs), medicinal billing and coding experts, and enlisted attendants are only a portion of

the group associated affected by this new advancement.

Medical practitioners and experts are currently in charge of contributing patient information, for example, crucial signs, weight, reports, and so forth into a focal, digitized framework. From an organization’s point of view, medical billers and coders utilize EHRs for booking arrangements, refreshing patient records with symptomatic codes, and submitting medicinal cases.

Enhanced Public Healthcare – Years from now, a focal and institutionalized framework will let doctors recognize a viral or bacterial disease rapidly. This can give bits of knowledge into how far reaching an epidemic is, empowering deterrent measures to be set up considerably faster.

Increase in Quality, Decrease in Healthcare Costs - The transition from paper to electronic records can diminish the cost of healthcare by 3%. Scientists evaluated this as $5.14 in funds per person per month.

Vipul Jain CEO Advancells 20 ◄ October 2018

Pharma Bio World

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Whatever the future of healthcare may look like today, the professionals and practitioners have sworn to continue improving the quality of life by acquiring sound knowledge of technology and integrating it into their dealings with patients.

Could Artificial Intelligence be the Future of Medicine?

Cloud computing for the Healthcare Sector - The Cloud utilizes equipment and programming to convey administrations through the internet. With this technology, the experts and patients can get access to specific records and information, and utilize applications from any internet enabled gadget. With an expanded dependence on EHR frameworks, Cloud computing ensures against the loss of delicate information with solid reinforcement.

Digitalized Medical Consultations These days, the idea of telemedicine makes so much sense. The digital era of medical consultations will give an access to qualified healthcare suppliers, personalized consultation, diagnosis and prognosis and a lot more benefits.

Versatile Health Apps - There’s an application for nearly everything today, and healthcare applications are continually being created for both for doctors and patient alike. Truth be told, medical applications are one of the quickest developing markets in versatile mobile application market. There are roughly 100,000 healthcare applications right now accessible, and 300 thousand paid applications are downloaded each day. Some create better healthcare knowledge, while at the same time others helps promoting effective discussion between the patients and care suppliers.

Artificial Intelligence has a massive potential. Looking at the pace with which AI is entering different areas of our life, it is definite to say that soon it is going to be all over. And there’s nothing to worry about that! For those cautious of a robotic evolution shouldn’t fear anything; the arrival of AI into health care industry is more about the expansion, sharpening, and easing the minds of physician so that the doctors can do the same to their patients.

The applications for AI in medication go past authoritative basic work, however.

From intense symptomatic calculations to finely-tuned careful robots, the innovation is making its essence known across medical verticals. Unmistakably, AI has a place in pharmaceutical; what we don’t

Mobile Equipment - Smartphones enable doctors to finish diagnosis in remote areas. For instance, a doctor can utilize his/her cell phone or tablet to get to a patient’s EHR, survey medicinal accounts, send follow-up messages, and even complete solutions.

Enhanced correspondence helps the medical billers in many ways, enabling them to send instant message alerts about installment plans and unpaid bills.

E-communication can likewise eliminate mails, paper usage, and time spent on telephone calls.

22 ◄ October 2018

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know yet is its worth. To envision a future in which AI is an established portion of a patient’s caretaking team, let’s first understand how AI measures up to human specialists?

According to a recent exam held by Babylon Health, a digital healthcare startup, the company’s AI, in a series of robust tests (including the relevant sections of the MRCGP exam), has demonstrated its ability to provide heath

advice which is on-par with practicing clinicians. The key results of the test are: 1) Babylon’s innovation gives health data, instead of medical conclusions, for administrative reasons. The tests completed identify with the analytic exams taken by specialists as a benchmark for accuracy, be that as it may, Babylon’s AI benefit remains a data benefit, as opposed to a medicinal diagnosis.

2) In a few cases, AI is equipped for beating human doctors in diagnosing challenges that require a fast careful decision, for example, deciding whether a wound is harmful. While human radiologists may do well when they have unhindered time to audit cases, in reality (particularly in high-volume, fast turnaround situations like emergency rooms) a quick determination could have the effect between life and death for patients.

But even after a number of developments in this sector, the question for the past couple of decades has been the same – could surgical robots be trusted?

According to a data analyzed by MIT, it was revealed that there were 144 deaths and 1,391 patients injured during surgeries performed by the AI, which were mainly due to technical glitches or complications. The report also mentioned that in spite of a relatively high number of casualties, a vast majority of procedures were successful as well. Hence, even though the robotic surgery could perform well in some special cases, the more complex surgeries are best taken care by human surgeons until the AI becomes reliable enough.

The takeaway would appear to be that, in the years to come, AI’s part in medicine will just develop. In any case, the industry might boom, however we shouldn’t accept AI speedily or unsystematically.

24 ◄ October 2018

Pharma Bio World

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Pharmaceutical Product Labeling Tips: Calculating the True Cost of TCO The selling of counterfeit products is a world-wide issue and is increasing due to the consumer trend to purchase drugs online. As it is difficult to track the original source of the supply of counterfeit goods, preventing further production is a huge challenge for authorities. However, by developing anti-counterfeit packaging, manufacturers can help in the fight to prevent fraudsters from capitalizing on their brand names. Investing in permanent coding and effective labeling solutions are some of the ways that pharmaceutical companies can combat counterfeiting. In addition, around the world many countries are implementing legislation to mandate the coding and marking of pharmaceutical products in order to reduce counterfeiting, ensure reliable product information is displayed, and protect consumer safety.

Bob Neagle Business Unit Manager Secondary Packaging Videojet Technologies 26 ◄ October 2018

W

ith the global anti-counterfeit packaging market accounting for USD 57.4 billion in 2013, and forecasted to generate revenue of USD 142.7 billion by 2020 , the demand for standardized serialization of pharmaceutical packaging is a major issue.

Across Europe, for example, the European Union’s Directive 2011/62/EU requires all pharmaceutical products distributed within the EU to have a serialization number or unique code printed onto each pack. This allows products to be tracked throughout the supply chain and traced back to their origins. In the US, the Drug Supply Chain Security Act (DSCSA) was enacted to set federally mandated requirements for the traceability of pharmaceutical products throughout the drug supply chain. By late 2017, this multi-phased plan will require by each product to have a unique identifier at the package and homogeneous case level. This unique identifier includes its National Drug Code (NDC) or Global Trade Identification Number (GTIN), unique to the drug, based on chemical composition, as well as serial number, lot number and expiration date. The EU Directive is expected to mirror the specifications of DSCSA. In order to do business in these countries, pharmaceutical packaging must be in compliance with regulatory requirements.

For homogenous case coding, this means that pharmaceutical companies must integrate labeling systems onto their packaging lines that are capable of reliable coding and marking that is easily readable b y b oth m ac hi n es a nd pe op l e. Whi l e these compliance efforts are mandatory, pharmaceutical companies must also consider the bottom line, specifying cost-effective equipment that allows for increased productivity, as well as consistent coding. That is where calculating total cost of ownership (TCO) comes into play.

Capital and Operating Cost Considerations TCO is achieved by calculating both capital and operating costs. The capital outlay for a labeling system has a clear and obvious cost – but it’s just the beginning of an ongoing investment. It is also important for manufacturers to consider the costs of running and maintaining the equipment, as well as any potential costs of lost production due to downtime and decreased efficiency caused by repeated “touches” necessary to operate a labeling system.

To help accurately calculate cost and facilitate smart purchasing decisions, there are a few guidelines to help ensure manufacturers are measuring not just the total cost of ownership (TCO), but the true cost of ownership. For the purposes of illustrating what to consider when calculating TCO, we will take the Videojet 9550 Print and Apply Labeling System (LPA) as an example for printing on outer case packaging.

Capital Costs The capital outlay to acquire a Print and Apply Labeling (LPA) system represents a significant portion of the TCO. Capital costs include the initial spend to purchase and install equipment, including any backup units. Also included is any additional material handling. Prices vary among different vendors and are easy to compare o n t h e s u r f a c e . W h a t ’s i m p o r t a n t t o take into account is how the piece of equipment will help you achieve your ultimate goal - getting safe and compliant shipments of your product out the door.

A simple way to evaluate this is use the individual components that make up an Overall Equipment Effectiveness (OEE) calculation: • Availability – Will the LPA equipment be ready and able to do its’ job when you need it to? Any savings in capital outlay Pharma Bio World

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The Direct Apply™ labeling (LPA) system achieves higher throughput of up to 150 packs per minute for typical 4” x 6” GS1 barcode labels as the gaps required between packs are reduced.

spent on less expensive solutions can be quickly negated when the equipment is down and business is lost. With this in mind, consider whether you feel confident enough in the reliability of any one system, or if you should lay out additional capital for back-up units.

• Performance – Can the LPA equipment run at speeds that match peak labeling requirements or do you have to accommodate its’ throughput limitations?

Direct apply systems, that are coupled with a near-edge print design, such as the Videojet 9550, provide high print speeds – up to 150 packs per minute for typical 4” x 6” GS1 barcode labels.

• Quality – Can you rely on the LPA equipment to accurately place a label on every outer case? Missing or misapplied labels are not only not in compliance with regulatory requirements, but also cost time and money to rework. In addition, can the system help prevent human errors related to applying the wrong information, often leading to stiff penalties and fines if not caught before the product enters the supply chain?

with a flat-head print head design, which will use a wax ribbon, or near-edge print head using a wax-resin ribbon. While wax ribbons tend to be less expensive than wax-resin, this difference is typically offset by the ability of the near-edge print head to lift between prints and thus eliminate the associated gap i.e. neither the blank space on the label nor label gaps will be printed.

Additionally, many LPA systems have the option of running in direct thermal mode, which eliminates the ribbon altogether.

Ultimately, the type of label application method you choose will determine whether or not plant air is required. Direct apply or ‘wipe’ applicators do not require air, thus eliminating both the installation cost of the air line and the ongoing running costs.

Eliminating plant air usage is also typically aligned with many manufacturing facilities’ sustainability initiatives – reducing energy usage, thus lowering carbon dioxide (CO 2) emissions.

Service and Maintenance This component of TCO has obvious elements related to repairing a down system and necessary periodic maintenance procedures. This includes weekly or monthly maintenance, as well as unplanned work that could result in unscheduled downtime. In addition, with an LPA system, it is equally important to understand other

Consumable Running Costs The difference in the total cost of consumables based on what type of LPA system you choose can add up over its useful product lifetime. The biggest consideration is the ribbon, which is directly related to whether you choose a system 28 ◄ October 2018

required interactions. Many models need a series of manual adjustments on a daily basis, which are not only time consuming but can lead to unplanned downtime if not done correctly. Taking this into account, Videojet developed its labeling system w i t h I n t e l l i g e n t M o t i o n ™ t e c h n o l o g y, which precisely and automatically controls the label path, ensuring web tension is maintained thus removing issues of slipping clutches, nip rollers or manual adjustments. In addition, a simple web path and collapsible mandrel enables label and ribbon changes to be completed in less than 60 seconds, therefore reducing operator handling time. Advanced LPA’s are now designed without the mechanisms that frequently cause everyday operational problems, such as label jams. With the LPA directly placing labels onto every pack, without the need for a tamp or air blast applicator, the need for spare parts is reduced, as 80 per cent of the potential wear parts are eliminated.

With so many factors to consider, selecting a new LPA system can be tricky, but it is essential to remember that your choice will determine whether your company is operating as efficiently as possible to maintain the bottom line. In order to make an informed decision, it is important to look beyond the cost of the initial investment to additional material handling, operating and maintenance c o s t s . H o w e v e r, t h e m o s t i m p o r t a n t thing to consider is how an investment in state-of-the-art LPA technology will allow pharmaceutical products to be quickly and reliably labeled in total compliance with strict regional regulations. This will allow pharmaceutical manufacturers to operate safely and profitably, across various global markets, increasing the potential to grow your business.

Reference:

The innovative design of the Videojet 9550 Print and Apply Labeling system removes the mechanical adjustments, wear parts and failure points that cause everyday operational problems and downtime.

1) http://www.alliedmarketresearch.com/ anti-counterfeit-market Contact: sli@abipr.com Pharma Bio World

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Supply Chain Management in Pharmaceutical Industry Supply Chain Management in pharmaceutical industry plays a very critical part as availability of the product at right time has to be ensured for unpredictable demand patterns.

This article provides an overview of various verticals in pharmaceutical supply chain management.

G

lobal trade in pharmaceutical products has a unique set of risks. Prescription drugs are heavily regulated, perishable, subject to counterfeiting and other forms of graft and have high production costs.

So, getting a pharmaceutical shipment from India to the United States or the United States to Brazil intact and on time can present difficulties that other industries don’t have to deal with. Any disruption in the supply chain can be extremely costly to buyer and seller.

Significant supply chain disruptions lower the share price of affected companies by an average of 7 per cent, according to the management consulting firm Accenture.

What’s needed is technology that can track a shipment from beginning to end and take the stress and confusion out of importing and exporting by making the whole process transparent to customers.

Regulation Pharmaceuticals “are among the most highly regulated of all products, with many nations enforcing strict regulations on the marketing and sale of drugs,” said an academic study led by Ann Marucheck of the University of North Carolina.

Regulations affecting the pharmaceutical industry vary from country to country.

Taneli Ruda Senior Vice President and MD Global Trade Management Tax & Accounting Business Thomson Reuters 30 ◄ October 2018

The 2011 study, entitled “Product Safety and Security in the Global Supply Chain: Issues, Challenges and Research Opportunities,” noted that governments world-wide have increased their regulatory oversight of pharmaceutical products as a reaction to tampering, counterfeiting and other problems that have caused sickness and deaths.

The pharma industry is a heavily regulated segment and has a lot of

special requirements, like import and export licenses, which are required in most countries.

License management is a particularly troublesome regulatory issue for pharmaceutical companies. A myriad of import and export restrictions apply both to ingredients and finished products in every country where pharmaceutical companies operate. Managing them is tricky and requires a state of the art workflow solution, as failure to comply with them can lead to costly supply chain disruptions.

Counterfeiting Counterfeiting of prescription drugs is rampant and “can occur at each point in a multi-tier supply chain, particularly when the contamination is intentional or where there is fraudulent certification that the product has met all the regulations and passed inspection,” the Marucheck study says.

Counterfeiters use the Internet to market fake drugs to consumers around the world.

About 30 per cent of the drugs sold online are counterfeits according to the US National Institutes of Health.

The World Health Organization estimates that about 30 per cent of the medicines sold in parts of Asia, Africa and Latin America are counterfeit. In 2011, 64 per cent of anti-malarial drugs in Nigeria were found to be counterfeit.

Most countries’ customs services lack the wherewithal to detect counterfeit drugs in incoming shipments. Consequently, an incoming shipment labelled as anti-anxiety drug may be something else altogether.

That is harmful to patients who rely on the drug and to the perceived integrity of the Pharma Bio World

company that makes it. Companies that are victims of counterfeiting can suffer revenue losses, plummeting stock prices and litigation.

The counterfeiting issue came to the fore in 2008, when fake batches of the anticoagulant Heparin exported from China killed at least 81 people in North America, Europe and elsewhere.

Free Trade Agreements There are more than 370 free trade agreements in effect worldwide and many more under negotiation. India is a party to more than a dozen FTAs, several of them with more than one country.

Taking advantage of the privileges that FTAs offer, such as duty-free access and intellectual property rights protection, can be confusing and onerous to comply with, particularly for small exporters. They need licenses, country-of-origin certifications and other documentation. Compliance can be particularly difficult in a multinational production process. On the other hand, ignoring FTA benefits means leaving money on the table and putting the producer at a competitive disadvantage.

So How Does Technology Support Big Pharma?

Globalization and rapidly growing global trade have increased the prevalence of these supply chain issues.

In some countries, an import license is required for each shipment of a single p r o d u c t . Te c h n o l o g y c a n p r o v i d e a

workflow to control these licenses, including due dates and screen each transaction to identify when the licenses are required.

Batch management is a good example of how technology helps the pharmaceutical industry take advantage of FTAs and other special incentive programs. To make use of various export incentive programs, each batch needs to be tracked separately, because each needs to be matched with the sources of raw materials and ingredients it consists of. Pharmaceutical companies use a lot of specialty and commodity chemicals and they often procure them from multiple countries.

That leads to complex country-of-origin management issues.

As for free trade agreements, pharmaceutical companies are typical

“Counterfeiting of prescription drugs can occur at each point in a multi-tier supply chain, particularly when the contamination is intentional or where there is fraudulent certification that the product has met all the regulations and passed inspection.”

Pharma Bio World

users of FTAs between countries and trading blocks. Technology can support companies by doing all the calculations and the country-of-origin determination process needed to qualify for preferential treatment under an FTA.

Batch management can also help pharmaceutical companies combat counterfeiting. In addition, here are technologies today that can spot counterfeits for example by scanning pharmaceutical product labels and detecting what kind of ink is on them.

Even with the best supply chain management technology, importers and exporters need to understand who they’re doing business with. They themselves have the responsibility to do the due diligence on their trading partners to assure themselves that they’re legitimate.

Again, many companies are harnessing Restricted Party Screening technologies t o e n s u r e t h e y a r e o n l y d e a l i n g wi t h legitimate trading partners, both upstream and downstream.

Contact: gaurav@avian-media.com October 2018 ► 31

Keeping Pharmaceutical Manufacturing in Check Dirk Bettels, Senior Product Manager of Mettler-Toledo Garvens spoke with Mahesh Kallayil on the challenges faced by the pharmaceutical industry in ensuring quality control and how checkweigher connectivity and serialisation technology can help pharmaceutical manufacturers adapt to the dynamic regulatory landscape.

Edited excerpts from the interview.

T

he pharmaceutical industry is, as ever, a resilient sector of the global economy, but it too has faced its fair share of challenges in recent years. Costly product recalls, spurious counterfeit drugs, and changing regulatory landscapes are the key challenges faced by manufacturers worldwide from emerging Asian hubs such as China and India to the US. These challenges have redoubled demand from pharmaceutical manufacturers for highly advanced integrated product inspections systems capable of upholding product safety and quality while boosting line efficiency to meet global consumer demand. For a growing number of manufacturers, it is essential to find ways of centralising data collection from their product inspection equipment and monitor performance across multiple manufacturing facilities in real time to not only meet strict internal quality assurance standards resulting from increasing quality awareness, but also comply with stringent legal requirements from national and international regulatory bodies.

Market Factors Affecting Innovation in Checkweighing and Serialisation Technologies Stringent regulations have been put in place worldwide in recent years to curb the growing menace of counterfeit drugs. In addition, pharmaceutical manufacturers are under pressure to ensure product safety in their production processes and supply chain from the sourcing of raw ingredients to the transport of finished products to end users.

Dirk Bettels Senior Product Manager Mettler-Toledo Garvens 32 â&#x2014;&#x201E; October 2018

Manufacturers operating in multiple international markets must contend with changing regulations as well as regional and geographical variations in pharmaceutical safety standards. Requirements concerning the marking and serial number verification for pharmaceutical products, the display of weight, net content and the maximum

permitted variation in the net value of content in packs vary from region to region. Manufacturers need to be aware of relevant regulatory standards not only in countries where they operate but also where they export to protect consumers against counterfeit pharmaceutical drugs entering the marketplace.

In the US, on the November 27, 2013, the Public Law 113-54, referred to also as Drug Supply Chain Security Act (DSCSA) was made law. This document established new federal requirements for traceability, with penalties for breach of legislation.

Currently pharmaceutical companies are required to share transaction information of prescription drugs, extending to full serialisation information in 2017 and traceability documentation about the entire supply chain in 2023.

Manufacturers looking to trade in Germany and in other EU countries will have to ensure they meet the requirements of the new EU Directive on Falsified Medicines. Due to come into force in 2018, the directive stipulates that serialisation be undertaken for all pharmaceutical products sold in the region to enable them to be traced to their point of origin and ensure consumer safety.

Manufacturers will face similar requirements when exporting to Brazil and Saudi Arabia, both of which have serialisation legislation due to come into force in 2016. Russia too is enacting legislation to enhance safety across the pharmaceutical supply chain.

Indian manufacturers exporting products overseas must adhere to the countryâ&#x20AC;&#x2122;s 2011-2012 Directorate General of Foreign Trade (DGFT) requirements for serialisation on pharmaceutical packages exported from India. According to Directorate General of Foreign Trade (DGFT) Public Notice No. 21 issued in January 2011, it is mandatory for Indian exporters of pharmaceutical products to label unique numbers and bar codes, encoding GTIN, serial number, Pharma Bio World

batch number, and expiry date, on tertiary, secondary and primary level packaging.

Pharmaceutical manufacturers need to gain control over marking and verification of serial numbers on products to comply with various regulatory requirements at each step of the manufacturing process so that products can be identified back to the producer, preventing end users from potentially harmful and fatal counterfeiting products. It is also essential to ensure full traceability throughout the supply chain which requires high level of system integration and efficient data management capabilities. A networked, consolidated checkweigher and serialisation solution installed on a production line and connected to a centralised data collection system can help manufacturers monitor product inspection data in real-time from multiple locations. It provides an at-a-glance window into their operations, enabling immediate identification and resolution of problems that occur along a production line to minimise production downtime.

Challenges in Implementing Connectivity Solutions Many pharmaceutical manufacturers fear that networking product inspection technology on a processing line will be timeconsuming and require production downtime.

However, working with an experienced and knowledgeable product inspection equipment provider can streamline the connectivity process and minimise any necessary downtime. The gains in line efficiency that can result from enhanced product inspection connectivity have the potential to outweigh any initial expenditure.

Another challenge for manufacturers is data security. As with any networked application, companies must guard against potential hacking. A growing number of product inspection equipment suppliers are developing data collection solutions that enable manufacturers to connect geographically isolated processing lines to a centralised location while maximising data security. This allows manufacturers to benefit from optimised system connectivity Pharma Bio World

without compromising the security of their product inspection records.

Connectivity Options for Pharmaceutical Manufacturers

Benefits of Linking Product Inspection Systems

There are a number of highly sophisticated software solutions available for management and control for all track and trace lines.

These programmes enable connectivity and integration of checkweighing, metal detection and x-ray inspection devices within a production line to give an at-aglance, holistic overview of the entire processing line by providing central user and access management. Other connectivity options include interface modules and object linking and embedding servers for process control. These linking technologies enable automatic communication between product inspection machinery and therefore provide a more accurate and extensive overview of the processing line.

There are a number of benefits to networking th e p ro d u c t i n s p ec t i o n s y s te m s o n a processing line. By enabling all product inspection data to be accessed from one centralised Human Machine Interface (HMI), a supervisor can successfully monitor performance across the entire processing line in real time. This makes it possible to immediately identify any adverse trends in, for example portion control in the packaging line, or a machine that is in need of maintenance anywhere along the line.

Supervisors can be proactive rather than reactive in undertaking corrective actions so that line disruptions can be handled and resolved quickly and with minimal downtime. Centralised data collection can save an enormous amount of labour as fewer personnel are needed to manually collect data from individual machines. Data is instead collected online, minimising time and reducing the possibility of human error.

By gathering detailed information about the performance of the packaging line from checkweighers, for example, connectivity solutions can be used by manufacturers to reduce wasteful product giveaway, such as overfilled cream in a tube or powder in a box; as well as minimise instances of underfilled packages that do not comply with metrology legislation, such as the European Measuring Instruments Directive (MID), avoiding costly product recalls.

What is more, an integrated product inspection system boosts product traceability, enabling manufacturers to protect themselves and their consumers from counterfeit drugs and demonstrate due diligence in the event of a safety incident.

Moreover, in case of product recall an integrated database helps identify and tracks the specific defective product batch thereby eliminating the necessity of recalling the entire shipment.

With each of these solutions, valuable information such as mean value charts and product reject reports can be accessed and produced easily, facilitating data monitoring.

If the manufacturer has a PC or PC network available, data interfaces can be installed to deliver weight data and serialisation details directly to a centralised computer.

Remote HMIs enable processors to interface with checkweighers to deliver statistics to optimise production management and facilitate product changeovers to enhance production line flexibility.

Future of Connectivity for Checkweighing Systems More and more checkweighers will include features that enable them to be networked to pharmaceutical manufacturersâ&#x20AC;&#x2122; data collection solutions. On-going market pressures, such as the increase in the cost of raw materials, are making such solutions desirable to pharmaceutical manufacturers - and legislation requiring enhanced traceability due to be introduced over the next few years will make it a necessity. Checkweighing system suppliers are working to ensure their technology continues to help manufacturers comply with regulations and enhance efficiency well into the future.

October 2018 â&#x2013;ş 33

Protein Quality Control in SPR and BLI High-Throughput Screening Studies This article outlines the benefits of the use of high throughput dynamic light scattering for screening and discovery of candidate biotherapeutics.

S

urface Plasmon Resonance (SPR) and Bio Layer Interferometry (BLI) are powerful techniques, widely used in the discovery of candidate biotherapeutics. High-throughput screening by SPR and BLI is utilized to rank c andidates for adv antageous properties such as high affinity for the therapeutic target and rapid binding kinetics. Important considerations in this process, often overlooked, are the purity and solution properties of analytes w h i c h c a n a d v e r s e l y a ff e c t t h e d a t a quality and reliability. ‘Dirty’ samples can even impact the microfluidic integrity of the instrumentation. Sample quality is therefore critical to optimal candidate selection. High-throughput dynamic l i g h t s c a t t e r i n g ( H T- D L S ) e ff e c t i v e l y evaluates the quality of protein samples prior to screening without compromising the analytes.

SPR and BLI High Throughput Screening In high-throughput SPR, active compound molecules are immobilized on the surface of a chip and potential binding partner solutions are added at various concentrations to determine affinity and kinetics of interaction between the two substances. In BLI the target molecules are attached to fiber-optic probes which are then immersed into protein samples contained within a microwell plate.

Daniel Some, PhD Principle Scientist Wyatt Technology Corp 34 ◄ October 2018

Typical SPR and BLI processes often require testing dozens to hundreds of candidates. The short amount of time involved in these rapid screens is critical in the race to discover the next biotherapeutic. SPR commonly draws samples from microwell plates and injects into microfluidic channels. The analytes flow over the immobilized target molecule; good candidates will be strongly attracted

to the target on the surface of the chip as detected by the optical system. A similar process occurs in BLI but no microfluidics are involved. In both cases an optical probe provides a signal proportional to the increase in surface-bound mass. Analysis of these signals over multiple analyte concentrations yields affinity and kinetics.

Importance of Analyte Quality Impurities of a low molecular weight such as extractables and leachables rarely affect SPR or BLI measurements.

However, larger particulates such as aggregates and foreign particles can have an adverse effect on the results of both techniques. These unwanted particulates can give rise to inaccurate experimental assumptions in addition to generating noisy and spurious signals in the recorded data. It is therefore beneficial for researchers to be able to identify poorquality protein solutions before proceeding with screening. Such a quality assessment is absolutely necessary to achieve reliable results and, ultimately, passing down the pipeline the best therapeutic candidates for clinical development.

Evanescent optical fields extend a few hundred nanometers into the solution.

It is sufficient for any nanoparticle or aggregate passing within that distance from the surface of the chip or fiber probe to cause a signal spike approximately proportional to its mass. Consider a 100 x 100 µm² surface immobilized with bound ligand and illuminated by the SPR beam.

Exposing this surface to a concentration of analyte >> Kd results in full coverage and a maximum binding signal. Now, consider a single large contaminating nanoparticle of ~5 µm diameter in that analyte solution.

Since the contaminant contains the same volume as the bound analyte, the Pharma Bio World

employed in the experiment. Poorly formulated or otherwise ‘sticky’ analytes may result in self-association and the creation of oligomers, such as dimers or tetramers, and the actual concentration of monomer varies with protein concentration.

Figure 1: Sensorgram obtained in the presence of aggregated analyte (simulated).

contaminant particle can generate a noise spike in the binding signal equivalent to the entire bound analyte, if passing close enough to the surface of the chip.

Smaller nanoparticles and aggregates do not generate such noticeable interference in the results, however their presence is known to produce a steady stream of small signal fluctuations leading to a degraded optical response. Both effects are represented in the simulated sensorgrams shown in Figure 1.

The presence of active analyte aggregates in sufficient quantities will generate a larger signal than would be expected of the monomeric-target molecule interaction.

This leads to higher affinity readings and on rates which in turn distorts the binding response. Aggregates presenting multiple binding sites may exhibit ‘avidity’ effects, interacting simultaneously with multiple immobilized molecules or exhibiting a reduced dissociation rate by hop-scotching along the surface of the chip. This too leads to affinity being considerably overestimated. In the case of inactive analyte aggregates, effective concentrations are lower than the measured total concentration, causing a n a p p a r e n t d e c r e a s e i n a ff i n i t y. A s demonstrated in Figure 2, the presence of aggregates, active or inactive, leads to the incorrect quantification of candidate binding properties.

Due to the complications that arise from the presence of aggregates, standard SPR and BLI analyses require analyte solutions to be monomeric at the concentrations Pharma Bio World

Much as aggregated analytes can cause experimental errors, so too can aggregated immobilized proteins. In particular, the presence of protein aggregates on the chip or fiber probe surface can result in a reduction in active material or in the average number of exposed epitopes per immobilized mass. Consequently, aggregated substrate proteins also lead to a significant decrease in the apparent affinity.

Large aggregates and foreign particulates are especially undesirable in multichannel SPR as the long and narrow fluidic channels are prone to plugging by agglomerated proteins or other ‘nanocrud’ 1.

The occurrence of clogging during a screen of dozens or hundreds of candidates can result in the invalidation of entire studies involving exhaustive protein expression, purification and preparation. In addition to the loss of work, the recovery of plugged microfluidics can be extremely costly in both lost time and money repairing damaged equipment.

Inactive aggregates decreased monomer concentration

Ensuring Protein Quality with Dynamic Light Scattering Dynamic Light Scattering (DLS) is a non-invasive, non-perturbative optical technique that provides measurements of the size distribution of nanoparticles in solution/suspension and offers a number of unique benefits for the pre-screening of protein solutions. Relying on the principles of Brownian motion to determine diffusion rates of particles in solution, DLS can resolve size distributions over sizes ranging from less than 1 nm up to several micrometers. Once the data has been transformed by software such as DYNAMICS (Wyatt Technology) into a particle size distribution, this can be evaluated to determine whether the solution may safely be injected into SPR microfluidics and whether the SPR or BLI measurements will produce reliable results.

DYNAMICS provides automated analysis and visualization of DLS results as a heat map indicating good, intermediate, a n d p o o r p r o t e i n q u a l i t y. T h e e n t i r e process may be completed rapidly prior to loading onto the interaction apparatus simply by transferring the microwell plate into the DynaPro HT-DLS system (Wyatt

Active aggregates avidity

Figure 2: The possible interactions between aggregates and target molecules in SPR and BLI screening.

October 2018 ► 35

Technology), running the sample screen, and then--when not contra-indicated-loading the same microwell plate onto the SPR or BLI instrument. Microwells that show low-quality material can then be deselected in the interaction screening protocol, helping to ensure the quality of proteins being screened.

Fast, Easy and Effective Resolution of Protein Quality with HT-DLS Traditional DLS is conducted manually in a microcuvette, one sample at a time.

Though this is a valuable process for certain quality assays, it is not feasible to test the hundreds of candidates that are screened using SPR and BLI processes to identify the most promising candidate. In order to establish a viable pre-screening analysis it is necessary to consider accurate, high-throughput processes that save time and laboratory resources. Highthroughput systems such as the DynaPro Plate Reader II (Wyatt Technology), allow for the analysis process to be completed accurately in situ and in rapid succession, typically requiring only around 10-30 seconds per well including transition time between wells. In addition, with no fluidics, the DynaPro presents no concern for potential carryover of samples between

the wells, and the entire screen is set up to proceed unattended.

Another advantageous feature of the DynaPro is the compatibility of the industry-standard microwell plates used for DLS analysis with SPR and BLI apparatus. Once the initial analysis has been completed, the plate can simply be transferred onto the SPR or BLI instrument, and the samples that do not meet quality standards (as determined by DLS) deselected in the interaction screening protocol. An added benefit of HT-DLS is the determination of the analyteâ&#x20AC;&#x2122;s diffusion coefficient, an important property in certain SPR experiments for identifying mass transfer limitations.

In HTS-DLS applications, DYNAMICS is usually configured to bin the data as a heat map based on poor-, intermediate- and high-quality size distributions according to bin definitions specified by the user.

For example, a sample showing a single, narrow peak at a size corresponding to that of the monomeric analyte may be classified as high quality and allowed to proceed to the binding assay with high confidence (Figure 3, red wells). An adjoining sample that shows a broadened

Monodisperse / low aggregation Polydisperse / moderate aggregation Significant aggregate content

monomeric peak indicative of some oligomers, and perhaps low levels of additional particulates tens of nanometers in size, may be classified as intermediate quality and allowed to proceed with a warning flag regarding confidence in the results (Figure 3, blue wells). A sample exhibiting significant particulate content in the micron-size range can be assumed to be either contaminated or highly prone to aggregation and prevented from continuing on to the binding assay (Figure 3, black wells).

Conclusion As with most experimental techniques, the quality of the sample ultimately affects the quality of the results. Selection of candidate molecules with the highest potential for optimal therapeutic effect and patient benefit depends on a reliable target binding screen, as performed with SPR or BLI. In order to ensure accurate results from these processes it is necessary to evaluate the quality of sample solutions prior to testing. Those which do not meet standards must then be removed from the screening process to eliminate questionable data and wasted time, as well as prevent potential clogging in microfluidic channels.

HT-DLS can be seamlessly integrated into existing screening workflows to provide classification on the quality of solutions. The addition of a HT-DLS pre-screen process can prevent much of the uncertainty and productivity loss associated with variable ligand quality, leading to more-reliable binding data and confidence for the final candidate selection.

References:

Figure 3. Visualization of protein quality as a heat map. Total data acquisition time for 96 wells was < 45 minutes.

Data courtesy of Sabin Vaccine Institute and Texas Childrenâ&#x20AC;&#x2122;s Hospital Center at Baylor College of Medicine.

36 â&#x2014;&#x201E; October 2018

1) http:/www.chi-peptalk.com/biologicsformulation/ 2) K a r l s s o n , R . e t a l . , M e t h o d s : a companion to Methods in Enzymology, 6, 99-110, (1994) Contact: hmj@scottpr.com Pharma Bio World

The Crossroads of Compliance, Audit Readiness, Profitability, and Data Integrity True compliance and audit readiness starts with a well thought out, holistic, structured approach that aligns with an organization’s business and quality objectives. Profitably and safely managing a batch production facility while maintaining the compliance and quality of the product and production facility is a challenge that every pharmaceutical and biotech company faces.

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any organizations struggle with prioritizing changes that can effectively improve profitability, safety, and compliance, which are often seen as competing goals. Yet there is one place where these goals can be met together – reducing the variability in manufacturing and associated business processes. Data integrity is front and center in this overall battle.

Understanding and detecting sources of variability before and using this information to prevent deviations is essential to running an operationally e x c e l l e n t f a c i l i t y. T h e r e a r e s e v e r a l w a y s t o r e d u c e v a r i a b i l i t y. M i s t a k e proofing processes, eliminating sources of controllable variability, and knowing how to respond to the remaining sources of variability are all important methods to consider.

O n e o f t h e m o s t e ff e c t i v e m e a n s o f reducing variability is automating production and business processes.

Automation is a solution that enables predictability, detection of variability, and the ability to appropriately respond to remaining variability. Compliance ready systems along with a structured project approach are keys to ensuring the data integrity of these types of solutions.

The right people with the right experiences and skills, adequate planning, and appropriate technology are necessary for an appropriately designed intersection of compliance, audit readiness, profitability, and data integrity.

Michalle Adkins Industry Consultants Life Sciences Industry Solutions Group Emerson Pharma Bio World

Involving experienced, knowledgeable people in the process When embarking on an operational excellence journey, including an individual who understands manufacturing and

business processes is important. Yet it is equally as important that the internal resource or an external consultant have a breadth of experience working with many companies in the industry to take advantage of best practices, incorporate a view of where the industry as a whole is heading, and know what automation solutions are available. It is also important for this individual or team to be able to show the alignment of solutions to a company’s business and quality objectives.

Often, companies do not have the time and resources available to develop a holistic, structured approach to operational excellence. For this reason, it can be helpful to look outside of the organization to find a suitable partner.

Appropriate technology Integration of manufacturing control systems with day to day business needs is a difficult problem to solve. Because the needs and benchmarks for success can differ so greatly between the plant floor and the enterprise, finding commonality between solutions requires experience and careful planning.

The ISA S95 standard of automation can help develop consistency between all levels of business when implementing automation systems. At every level of the enterprise, ISA S95 provides guidelines that help organizations develop best in class solutions for integrating automation at all levels.

The right partners, who have a breadth of knowledge and experience developing systems that integrate business and manufacturing needs, will be able to develop a complete compliance wrapper that sets the standards for ensuring that a project is developed to meet all October 2018 ► 37

regulations while keeping each layer of the ISA S95 standard in mind.

Layer 1 Layer 1 of the ISA standard considers the manufacturing floor. At this layer, the focus is on properly sensing and manipulating the production process. The primary concern for level 1 is standards adherence: equipment must comply with and enforce quality regulations.

The complete compliance wrapper focuses on implementing monitoring devices that are accurate and reliable for the long-haul.

Not only is it essential to select the right instruments and right control valves for the right applications, but these devices must also deliver data that can be used in higher levels of the ISA S95 architecture.

Knowing that the right sensors are reporting the correct information at all times means reducing variability in product. For example, Emerson’s field devices offer the scalability and flexibility needed to meet the monitoring needs of today and the future. It is important to select intelligent sensors that enable prediction of downtime and reduce process variability by keeping devices and instruments performing at their best.

Additionally it is important to select the best in class smart field devices that are delivered pre-calibrated with documentation and certification to ensure that regulatory standards are met, building compliance into the architecture.

Integration specialists can help tie these sensors back to the control system, d e v e l o p i n g s o ph ist ica t e d a la rm s t h a t notify operators of variability and faults in manufacturing.

Layer 2 At layer 2 of the ISA standard, the focus shifts to monitoring processes, providing supervisory and automated control of the production process.

38 ◄ October 2018

“Batch manufacturing requires sophisticated sequencing across a plant, while at the same time ensuring that only the correct equipment is used, while in the correct state. ” With proper automation, organizations c a n l i m i t v a r i a b i l i t y, w h i c h m e a n s simplifying compliance.

Batch manufacturing requires sophisticated sequencing across a plant, while at the same time ensuring that only the correct equipment is used, while in the correct state. Defining the process specific requirements and using best in class process control systems (PCS) are keys to success at this layer.

E m ers on’s Del taV di s tri buted c ontrol system, delivered 21 CFR part 11 compliant, is a key part of the compliance wrapper’s integration of systems. Equipped with simple to use yet powerful applications for recipe configuration and management, the PCS is designed to ensure that product quality is the same on every single batch.

In addition, DeltaV Batch Historian automatically collects and displays detailed recipe execution and process management event data. After capture, this data can be examined locally or remotely through a web interface using the History Analysis application.

Using class-based and S-88 recipe management to automate manufacturing lines means ensuring that every stage of the production process is completed and verified. This not only means improving product quality and yields, but also being able to continuously verify that critical process parameters are controlled properly with data available at any t im e , s uc h as when an audit oc c urs .

Appropriate use of an overall compliance and quality plan that includes risk based validation approaches can help any user get the most out of the class-based, S-88 approach for the project and the life of the system by minimizing validation costs while maintaining compliance.

Layer 3 Layer 3 of ISA S95 connects the concepts of the organizational management system (ERP) to the activity taking place on the production floor.

Because the operational needs and requirements of the business and management office are often very different from those of manufacturing and production, operating without a data integrity plan often results in production managers trying to connect isolated islands of process, quality, operations and logistics data by paper, databases, and other mechanisms which may incidentally cause a data integrity issue.

As part of the compliance wrapper around these solutions, key personnel on a project with multi-layered and cross-company experience help organizations select the right Manufacturing Execution System (MES), such as Emerson’s Syncade smart operations management suite, for order, resource, master batch record, batch execution, and document management.

An MES solution can be used to help minimize paper-based traps with electronic verifications of equipment and recipes to reduce variability and deviations, reducing errors associated with these activities.

When properly integrated with the PCS and asset and machinery management, the MES provides access at time of use, ensuring all production records can be easily produced, stored, and approved with electronic signatures. Additionally, as errors are reduced and all the processing data including the remaining manual steps is now more readily available, the need for war-room investigations of paper batch records can be virtually eliminated.

Pharma Bio World

The MES can also be integrated with ERP systems to allow for tracking of materials, manufacturing orders, inventory transactions and more. Syncade’s functionality can eliminate manual, error-prone data transactions, resolving inventory and production discrepancies.

Layer 4 Layer 4 is the level at which business planning and logistics happen. At this level, planners develop the basic plant schedule, monitor material use, track ordering/delivery, and schedule shipping of product.

Inventory control and shipping schedules are directly tied to production ability on the plant floor. If production and materials use records don’t correlate with inventory and delivery records, an organization can

find itself producing too little product, or having to store excess inventory that simply sits around.

Conclusion Organizational excellence experts can help promote data integrity by ensuring that technology and practices are coordinated between the layers of t h e ISA S95 model. Work ing through a conceptual design, these experts help organizations develop future state requirements. The result is a road map that includes automation standards to meet the most pressing business and quality needs, encompassing both process qualification and process verification, as well as implementing change control and deviation procedures for long-term stability. Up front planning means less rework both during and after the project.

As organizations have the most control over costs at project inception, this can mean substantial savings of both money and time.

Thinking downstream, these experts can also help an organization prepare for transition to market. As a company moves from research to clinical manufacturing, and from clinical to commercial manufacturing, procedures must be established to ensure that operators have the right recipes, have all the critical process parameters and attributes identified, and are prepared to transfer the information from one part of the organization to another without data loss. Drawing on best practice knowledge and extensive field experience, these experts can make this process as simple and efficient as possible.

Contact: reckon@vsnl.com

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Jasubhai Media Pvt. Ltd.

Taj Building, 3rd Floor, 210 Dr D N Road Fort, Mumbai - 400 001 Tel: 022-4037 3636, Fax: 022-4037 3635 Email: industrialmags@jasubhai.com Pharma Bio World

October 2018 ► 39

Market Insights

Make in India! SCHOTT Tubing India to further invest 20 million Euros SCHOTT AG, a global pioneer in manufacturing pharmaceutical glass and packaging, has announced the launch of a new glass tank in its Indian manufacturing plant at Jambusar, Gujarat. The German technology group is further growing its production capacity through this new tank facility with a total investment of more than 20 million euros (approximately INR 180 crores). The invest comes at a time when the company is celebrating 20 years of operations in India

T

he expansion is in response to the increasing demand for high-quality pharmaceutical packaging material in the global market. Construction work on the new tank facility has already begun and is expected to be completed within 18 months. Production from the new tank is scheduled to begin by January 2020. The new glass tank facility will help fulfil the constantly growing demand of

premium borosilicate glass tubing like FIOLAX® clear. It is used for high quality pharmaceutical packaging, especially vials and ampoules for India as well as for export markets Commenting on the role of India’s growth in the pharma sector, in realizing SCHOTT Tubing’s global ambitions Dr. Patrick Markschlaeger, Executive Vice President,

SCHOTT AG, Business Unit Tubing shared, ‘‘The rapid development of the Indian pharmaceutical market requires a strong growth of high-end pharmaceutical packaging and in consequence high-end pharmaceutical tubing. We estimate a market growth for premium packaging and therefore for tubing to continue on a very strong level in the coming years.

In addition to the supply of the domestic

Figure 1: SCHOTT Glass India manufacturing plant at Jambusar, India 40 ◄ October 2018

Pharma Bio World

Market Insights Training Centre and Parthesh Vyas, Head, CII Vadodara graced the ground-breaking ceremony of the new tank facility.

Dr. Jürgen Morhard also shared, “SCHOTT Tubing India is one of the finest examples of bringing together the expertise of German technology and Indian skill force. I would like to congratulate all the employees of this plant, as it is their excellent performance which is driving this expansion of the company. SCHOTT has well showcased how foreign manufacturing companies can partner with India to take the ‘Make in India’ campaign to the next level. I am confident that its approach will be followed by similar German companies who want to pursue business in India and Figure 2: Dignitaries and employees during the ground-breaking ceremony of new tank further establish the city of Vadodara as a facility at SCHOTT Glass India German industrial hub.” market, SCHOTT Tubing India will also important hub for the Asian market.” serve the strong growing Asian market SCHOTT’s India plant functions outside of India and will therefore be an Speaking on the relevance of SCHOTT’s as a production hub for SCHOTT investment and employment pharmaceutical tubing in Asia and opportunities, Mr. Georg produces the branded FIOLAX® Sparschuh: Managing Director, pharmaceutical tubing. FIOLAX® glass SCHOTT Glass India Pvt. India exists since 1911 and provides an said, “We feel proud that unprecedented quality standard in the SCHOTT’s manufacturing journey industry through SCHOTT’s perfeXion® is a resounding success story of process since 2017. perfeXion® stands ”Make in India” campaign wherein for the transition from statistical quality not only world class products control to 100% automated inspection of are manufactured for domestic each individual FIOLAX® tube – based and export markets, but also new on big data. Hence, it is introducing talents are nurtured in the process. Germany’s Industry 4.0 to its Indian The new facility will help us factory in the most effective manner. increase the production capacity by an additional 50%. I am excited to announce that our investment in the new tank will provide jobs for 70 additional local workers, bringing the total count to 425”.

Dignitaries including Maharani Radhikaraje Gaekwad of Baroda, Dr. Jürgen Morhard, German Figure 3: SCHOTT’s product offering_ Fiolax® Consul General, Mumbai, Radhieka glass tubings Mehta, Director, Indo-German Pharma Bio World

October 2018 ► 41

marketing initiative

Liquid Ring Vacuum Pump Vexations

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ur liquid ring vacuum pump repeatedly tripped during high pressure, high flow conditions at startup.

When it finally started, the pump started making noise. On inspection, we noticed it was installed backward. We reversed the direction of the pump but got only low vacuum and the motor became very hot exceeding the temperature ratings on the motor insulation.

We are operating at 300 Torr with water.

Why did the pump operate, with a loud noise, with the flow reversed? What is causing it to run so poorly now? Is the pump shot?

Take a Number of Steps Installing and operating a liquid ring vacuum pump (LRVP) backward will severely impact its operation.

On these machines, the vapour inlet port is several times larger than the outlet port.

When operated backwards, the smaller discharge port (now acting as the inlet) will cause a restriction and impede the flow

of vapours into the LRVP. The resulting turbulence will create unusual noises.

your readings against the manufacturer’s recommendations.

After the rotation was corrected you noticed the motor became very hot. Assuming there are no problems with the motor itself, high motor temperature would indicate high horsepower draw. Ampere readings can be taken off the motor leads to verify the approximate horsepower draw.

If necessary, throttle back the seal liquid flow and you should see improvement in the power draw. As a final check, look at the temperature rise of the seal liquid.

Compare the seal liquid inlet with the LRVP discharge. A temperature rise of 10-15 oF is typical. Readings well outside these values should be further investigated. “Is the pump shot?” Once the horsepower issue is solved, you can concentrate on performance. However, more information is needed. How does the operating level of 300 Torr compare to design? How does the mass flow rate from your process compare to design? Is the process load constant or does it changes during operation? How accurate is the pressure gauge that is being used? Very important and often overlooked: the pressure gauge must be an absolute pressure gauge and must be recently calibrated.

High draw is often the result of: 1) High discharge pressure 2) Mechanical problems such as a bad bearing, foreign object or product buildup inside the machine, and 3) High seal liquid flow rate.

First, verify the discharge pressure is within design by checking the pressure at the separator vessel. Be sure to check the pressure during startup, as the higher mass flow rates can result in high pressure downstream of the LRVP. To check for internal mechanical problems without disassembly of the LRVP, remove the coupling and rotate the pump by hand.

Check for severe binding or scraping, or other problems. Some scraping, especially if you can still rotate the pump by hand, is not unusual and can be ignored.

However, a stainless steel pump can not tolerate any scraping. If it is stainless steel, then have the pump repaired immediately.

If the above checks are okay, you may have too high a seal flow rate. Install a regulating valve, compound pressure gauge (or better yet a flow meter) and temperature gauge in the seal liquid piping near its entrance into the LRVP. With the pump operating in vacuum service, the seal liquid pressure reading should typically be close to O PSIG. Compare

42 ◄ October 2018

If the mass flow rate from the process can not be measured,can the non-condensable flow rate be measured downstream of the LRVP, perhaps by adding a rotameter at the separator discharge?

Do this in a manner that the rotameter is only used to check capacity, as hard piping it can lead to back pressure, especially during startup.

Finally, an off-line capacity test can be performed. Disconnect the LRVP suction from the process and run a dry air test using an appropriately sized set of orifices.

Compare the test results to the book performance curve to evaluate the condition of the LRVP. For details contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26445626, 26445626 E-mail: sales@toshniwal.net Website: www.toshniwal.net Pharma Bio World

marketing initiative

Innovative Vacuum Solutions in Pharma Industry: The Right Solution

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purer end products; reduce the amount of heat energy required for drying, and also to recover any of the solvents evaporated off thereby not affecting thermally sensitive products. Pumps that are reliable and easy to service in the field are the most important for this industry. If an unreliable pump is tried and it fails in the middle of a drying cycle, then the product is not useable and profit is lost.

acuum pumps and systems are common place across a tremendous range of industries. Once the essential principles are understood, the possibilities for application become apparent.

what vacuum is and how to select the right type of equipment. It is very important to size vacuum piping correctly to minimize pressure loss. The greater the pressure loss, the larger the vacuum equipment needs to be.

In order to properly select a vacuum system, the principles of basic vacuum technology should be understood. Once the application is clearly defined, a solution can be found by applying these methods. Since we understand and can relate to atmospheric pressure, it is chosen as a reference point.

Vacuum is simply a pressure that exists below atmospheric pressure.

The type, quantity of gas handled and the operating pressure, normally defines what vacuum pump can be used. If the gas consists of mainly non-condensable, then most types of pumps can be used. If A typical setup used for this application is by cmbining mechanical roots blower along the gas consists of condensable and nonwith oil lubricated vacuum pump. condensable, then the choices will be limited.

Therefore, a right solution considering the This kind of setup is used to minimize utility load of condensable and ultimate vacuum costs, drying cycle time and contamination. should be struck.

A properly designed process condenser between your vacuum process and vacuum producing system will yield significant System Selection advantages. A process vacuum condenser To select the best system for a particular can significantly reduce the size of the application, the following list needs to be vacuum producing system, recover for considered. Once it is determined which reuse valuable product carried from your criteria is the most important from the list, process with non-condensable gases, then the vacuum pump that best meets this reduce amount of wastes produced by the can be selected. vacuum system, and lower the operating cost of your process.

• Operating cost • Solvent recovery Matching a vacuum condenser with the • Effect on process vacuum producing equipment is the • Materials of construction best way to meet the objectives of your • Operating range process. Toshniwal manufactures both • Reliability the process condenser and the vacuum • Waste generation producing equipment. This single-source • Pollution abatement responsibility provides you with an unitized • Emission reduction system matched to your process.

• Maintenance cost • Ease of cleaning • Serviceability • Purchase price

To create a vacuum in a vessel, a vacuum producing device needs to remove mass from it. The more the mass is removed, the lower will be the pressure inside the vessel.

This is why it is important to understand

Pharma and Chemical Industry The pharmaceutical and specialty chemical industries use vacuum for distillation and drying. Various types of dryers are used to purify products under vacuum. Chemicals are precisely mixed and then heat is applied in the dryer to evaporate the excess chemicals. This is done under vacuum for Pharma Bio World

For details contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshniwal.net Website: www.toshniwal.net October 2018 ► 43

marketing initiative

Energy-efficient Range of HRS FUNKE Plate Heat Exchanger

H

RS Process Systems Ltd is the trusted heat transfer technology provider to a range of process sectors across India and has licence to manufacture, design, supply and service of Plate Heat Exchanger (PHE) in collaboration with FUNKE Warmeaustauscher GmbH. Funke is a leading company in quality heat exchangers, having a state-of-the-art facility in Germany focused on plate heat exchangers.

The construction of a PHE is the stack of embossed plates with suitable portholes fitted parallel to each other, resulting in equal fluid distribution on each side. Each plate is separated from the next with a gasket which separates the two and seals the flow gap from the atmosphere. The heat transfer plates separate two fluids and avoid mixing of process and utility fluids.

There are a variety of corrugation patterns designed on heat transfer plates, which can be selected for specific applications to achieve higher heat transfer rate and optimum pressure drops. These plates allow different heat transfer area with acute and obtuse angled corrugation.

Heat transfer plates are mostly produced in: 1.4404/ AISI 316 as this material

44 â&#x2014;&#x201E; October 2018

generally more corrosion-resistant and more resistant to chloride damage than 1.4301/AISI 304; 1.4529/254 SMO (higher chloride and acid-resistance than 1.4401/ AISI 316); Hastelloy for highly resistance against acids and chlorides; Titanium ASTM B 256; Titanium-Palladium for chlorides at higher temperatures; 1.4539/ AISI 904L (with good nickel content against stress corrosion cracking, good performance ratio in the case of media with the low acid and chloride content).

HRS Funke also offers a wide range of plate sizes designed for a range of processes right from pharma, chemical to power, marine, shipping, etc, sectors.

The heat transfer plates comes with double gaskets in the entry and exit area with leakage groove between two media; it prevents the media from mixing if the gasket leaks. The installation of gaskets NBR (Nitrile-butadiene rubber) EPDM rubber)

is depending upon the design and type of plate heat exchanger; it comes with two different types, ie, adhesive and clip-on gasket. Following are the various types of gaskets available for suitable processes, (see Table) HRS FUNKE PHE comes in following different models: â&#x20AC;˘ Gasketed Plate Heat Exchanger: It is the most widely used variant of PHE which consists of a set of embossed plates fitted adjoining to each other and each plate separated by a gasket.

This is used for most oil, water, etc, applications. The gasket, which is mechanically secured or glued on to every plate, ensures that the flow gaps are securely sealed to the outside and from the second medium involved in the heat exchange. Also, for different

Universal use for water or oil applications

(Ethylene-propylene Uses for chemical compound which do not contain mineral oil and grease and also for water and steam application

Flororubber (Viton)

Uses for high temperature of vegetable oil, sulphuric acid and organic solvents

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marketing initiative

compositions and corrosive properties, the best fit material of construction of plates and gaskets are used.

• Brazed Plate Heat Exchanger: Consists of embossed plates, fit into one another and vacuum brazed with copper, nickel or stainless steel to form a compact and pressure proof unit. It is designed for applications like cooling of lube oil, condensing in refrigeration plant.

• Cladded Plate Heat Exchanger: This is a well-researched in-house design where the fixed plate and pressure plates are cladded with stainless steel or similar metals to make the outer surfaces compatible with process and utility fluids.

This is effective in food, dairy, brewery and similar hygienic applications.

Thermodynamically optimized designs make HRS FUNKE PHE efficient and cost-effective equipment for the heat transfer industry. Depending on the conditions of use, the plates and gaskets can be replaced, added, removed and reassembled several times. HRS FUNKE PHEs are low investment and lower in operation and maintenance cost as well.

They have self-cleaning quality due to Pharma Bio World

highly turbulent flow behaviour. It can also be used for smallest temperature difference </=1 oC. HRS FUNKE PHEs are effectively used in applications like heating, cooling, chilling, pasteurizing, sterilizing and the industries who perform such applications are food and beverages, chemical processing, polymers, pharmaceutical, pulp and paper, vegetable oil, textile, sugar processing, power, HVAC, marine.

HRS PSL has extensive service support network all across India. PHE spares, ie, gasket, plates, etc, as required are easily made available to the customers. HRS PSL provides following service support solution to enhance productivity: • Servicing of PHE at site • Root cause detection for PHE malfunction • Deputation of HRS personnel at site • Expert telephonic and online support • Performance validation of PHE. HRS PSL is part of UK-based HRS Group of Companies, is at the forefront in innovative thermal process technology.

HRS Group is equipped with a strong network all across the globe in UK, Spain, USA, India, Australia, New Zealand and

Malaysia. With a well-equipped ISO and ASME Certified design and manufacturing set-up in India, HRS PSL empowered to supply heat exchangers and systems to the domestic and international geographies.

HRS FUNKE PHE is one of the most reliable thermal processing equipment for a wide spectrum of processes adding to the accountability on HRS PSL as an innovative and trusted brand in the heat exchangers market.

For details contact: HRS Process Systems Ltd 201/202 Karan Selene 851 Bhandarkar Institute Road Pune, Maharashtra 411 004 Tel: 020-25663581, 25663582, 66047894, 66047895 Fax: 91-020-25663583 E-mail: mktcom@hrsasia.co.in info@hrsasia.co.in October 2018 ► 45

press release Natural Product Synthesis: One Step Closer to Entering Your Medicine Cabinet Molecules isolated from natural sources have a wide range of biological effects: caffeine in coffee gives you an energy boost, morphine from poppy seeds alleviates pain, and muscarine in fly agarics is a dangerous poison. In order to study and apply such natural products as medicine, we have to synthesize them in the laboratory.

In his organic chemistry PhD thesis Juha Siitonen from Department of Chemnistry at the University of Jyväskylä, Finland has focused on syntheses of natural products isolated from Stemona- and Cephalotaxus-plants. Stemona derived natural products have a wide variety of applications, ranging all the way from antitussive effects to insecticidal properties. Cephalotaxus natural products, on the other hand, have proven effective against cancer. ”Half of world’s drugs are either natural products or take their inspiration from natural products. For example, willow tree bark contains salicylic acid which is a precursor to aspirin”, Siitonen points out.

Serves pharmaceutical and agrochemical industries The PhD thesis presents synthetic pathways to three different Stemona natural products, as well as a significantly shorter method to access the core structure of Cephalotaxus natural products.

Several new synthetic methods had to be developed to accomplish these goals. In the future, the developed methods can find use in synthesis of new drugs, agrochemicals as well as new materials.

“Molecular structures of natural products are intriguing. The complex structures can be seen as synthetic challenges that very quickly reveal the shortcomings and limitations of our current methods for chemical synthesis”, Siitonen explains.

MSc Juha Siitonen defends his doctoral dissertation in organic chemistry "Synthetic Studies on 1-Azabicyclo[5.3.0]decane Alkaloids" on Thursday 4th of October 2018 at noon 12:00 in lecture hall YlistöKem4. Opponent professor Annette Bayer (University of Tromsø – The Arctic University of Norway) and custos professor Petri Pihko (University of Jyväskylä). The doctoral dissertation is held in English.

Ashland announces price increases for composites products in India Ashland announced it will increase the price of its portfolio of all composites products in India by 7.5 INR per kilo (+/-100US$ per 46 ◄ October 2018

ton). This increase will take effect immediately, or as soon as possible thereafter as contracts allow. This increase is primarily driven by continued escalation of costs in key raw materials. Ashland continues to make these decisions with the intent to ensure we are servicing our customers with the utmost quality and performance and the ability to continue reinvesting in our product line.

Sun Pharma Announces Receipt of European Commission Approval For ILUMETRI® (tildrakizumab) Sun Pharmaceutical Industries Ltd. announced that Almirall has received the European Commission (EC) approval for ILUMETRI® (tildrakizumab) for the treatment of adults with moderate-tosevere chronic plaque psoriasis who are candidates for systemic therapy. As indicated by Almirall, roll out of ILUMETRI® in Europe will start in the next few weeks. In July 2016, Sun Pharma outlicensed tildrakizumab to Almirall, for the development and commercialization of the product for psoriasis in Europe.

Tildrakizumab is a humanized high-affinity anti-IL-23p19 monoclonal antibody1. Due to its specific mechanism of action, it selectively blocks interleukin-23 (IL-23), an upstream inflammatory mediator cytokine, and acts by modifying the pathogenesis of the disease with limited impact on the rest of the immune system.

Its approval in Europe is based on the positive results from reSURFACE 1 and 2 phase-3 clinical trials3, presented for the first time in October 2016 at the 25th European Academy of Dermatology and Venerology (EADV) Congress in Vienna (Austria). Both pivotal phase-3 clinical trials, which included over 1,800 patients from more than 200 clinical sites worldwide, showed ILUMETRI® has a high level of safety and efficacy.

According to both studies data, an average of 63% of patients achieved 75% of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) by week 12 and an average of 78% at week 28.

Moreover, an average of 59% of patients achieved PASI 90 and an average of 30% reached PASI 100 at week 28. Over a year, more than 92% of patients who responded to ILUMETRI® within 28 weeks maintained a PASI 75 response.

Moreover, the results of a pooled analysis through three years2 from resurface 1 and 2 phase-3 trials show the consistent maintenance of efficacy and safety over three years of ILUMETRI® in patients with moderate-to-severe chronic plaque psoriasis who were responders at week 28. According to the data, PASI 75 responses were maintained with continued treatment with ILUMETRI® in 90% of patients up to week 1482. ILUMETRI® was well-tolerated with very low drug-related serious adverse events and discontinuation rates.

Pharma Bio World

press release LifeCell launches ‘Transformational’ Dr. Reddy's Laboratories announces the sale of Cloderm® (clocortolone pivalate) Newborn Screening Program Cream, 0.1% Franchise to EPI Health, LLC

Dr. Reddy’s Laboratories Ltd announced that its wholly owned subsidiary Promius Pharma, LLC, has sold its rights of Cloderm® (clocortolone pivalate) Cream, 0.1% and its authorized generic to EPI Health, LLC, an affiliate of EPI Group, LLC. Under the terms of the agreement, Promius Pharma is eligible to receive an upfront payment followed by future royalties as the consideration for Cloderm® Cream and its authorized generic in the United States, effective immediately. “We look forward to EPI continuing to support Cloderm, a brand that providers have prescribed for several decades and find as an important treatment option for their patients.” says Anil Namboodiripad, Ph.D., Senior Vice President, Proprietary Products, and President, Promius Pharma.

LifeCell International, India’s premier stem cell bank and mother & baby diagnostics company today announced the launch of “RightStart” - the world’s first Integrated DNA testing for Newborn Screening to detect over 50 medical conditions. This technology has been proven to be more accurate than current screening methods and has also been found to drastically reduce the false-positive reporting thereby avoiding unnecessary follow-up tests and anxiety of the parents.

In current process of newborn screening, a few drops of blood are obtained through heel prick from the baby’s heel, usually 48 hours after childbirth, and is analysed by profiling a specific set of metabolites present in the blood. If an abnormal metabolic profile is found further testing is recommended for confirmation.

The confirmatory test would need an additional sample to be taken once again from the child. Since most routine screening labs do not have DNA testing capabilities, the child is referred to specialised labs leading to further delays in diagnosis & treatment apart from causing further agony for the parents. The DNA based test is considered a gold standard and is most reliable for confirmation as it does not get impacted by interferences such as medications, nutrition, temperature, or preterm status.

LifeCell’s “RightStart” Newborn screening, which adopts an integrated DNA testing approach, does not require an additional sample since a portion of the sample collected initially can be used. Also, no additional costs would need to be incurred by the parents. “RightStart” provides more accurate results and also saves time & effort enabling a speedy diagnosis to initiate treatment. More importantly, the parents are alerted to the risk only if the DNA tests are positive thereby reducing parental anxiety.

Pharma Bio World

New Single Quadrupole Mass Spectrometry Technology Designed for Chromatographers Performing LC-MS Routine Analysis

Driven by industry demand for a robust, easy to implement system, Thermo Fisher Scientific designed the Thermo Scientific ISQ EM single quadrupole mass spectrometer for high performance and productivity standards in laboratories. With a mass range of 10–2000 m/z, the system offers the power to detect and quantify small and large molecules, and supports analytical needs across an extensive range of applications – from drug development to manufacturing support and quality control. The system’s highperforming heated electrospray ionization (HESI) and dual HESI/atmospheric pressure chemical ionization (APCI) probes facilitate the measurement of polar and non-polar analytes, enabling application flexibility. Chromatographers looking for bold confidence in their samples can now benefit from a single quadrupole mass spectrometer designed for ease-of-use while offering application flexibility and reliable results for challenging mass confirmation analyses.

The ISQ EM is integrated with HPLC systems and fully controlled

by Thermo Scientific Chromeleon Chromatography Data System (CDS), which offers tools to guide users through LC-MS method development and select appropriate source conditions. Thermo Scientific Chromeleon XPS Open Access software also supports the ISQ EM with walk-up workflows for simple daily operation.

Additionally, full integration with native control in Chromeleon CDS enables users to benefit from the entire productivity suite, from method creation through final reporting. A built-in reference standard also automates instrument calibration for a userfriendly experience.

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press release State-of-the art cancer screening systems for over 17 lakh women TAKE Solutions Ltd a globally recognized domain intensive services provider in Life Sciences, today announced its support for Preventive Oncology with Cancer Institute (WIA) in Chennai as part of its CSR initiative. This project is particularly important as this aligns with TAKE’s core expertise in Oncology and is fitting that it is being initiated in the Breast Cancer Awareness Month. Navitas Life Sciences, a TAKE Solutions Enterprise has supported over 650 oncology studies with some of the largest players in the therapeutic area. Cervical cancer and breast cancer are the most common cause of cancer deaths among women in India, but early detection and proper treatment can improve this prognosis and can make cancer curable. A study conducted by E&Y and FICCI has reported that in India, 2,000 women are newly diagnosed with cancer every day.

1,200 of these cases are detected in late stages, which reduces the 5-year survival rate by 3 to 17 times for breast and cervical cancer.

This late detection also raises the cost of treatment by 1.5 to 2 times that for early-stage cancers.

The major thrust in cancer control is early detection and prevention.

Towards this, the Cancer Institute has a functional preventive oncology department set- up for early detection screening, education centres in Villupuram, Gummidipoondi, Pudukkottai and Thiruvannamaalai and a Cancer Exhibition and mammomobile for breast cancer screening.

The department also functions as the training centre to train staff and coordinate the activities at the different centres. Through their efforts, the Cancer Institute has covered nearly 2,18,000 households across 260 villages in Tamil Nadu and enabled early detection screening for over 90,820 women and men.

Glenmark Pharmaceuticals receives ANDA approval for Hydrocortisone Valerate Cream USP, 0.2% Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Hydrocortisone Valerate Cream USP, 0.2%, a generic version of Westcort®1 Cream, 0.2%, of Sun Pharmaceutical Industries Inc. Glenmark’s current portfolio consists of 139 products authorized for distribution in the U.S. marketplace and 60 ANDA’s pending approval with the U.S. FDA. 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.

Strand Life Sciences Acquires India Diagnostics Business from Quest Diagnostics Strand Life Sciences, a Bangalore-based specialized research and diagnostics company today announced an agreement to acquire the India medical diagnostics business of Quest Diagnostics, 48 ◄ October 2018

the world's leading provider of diagnostic information services.

“This acquisition is an important addition to our network of 24 diagnostic labs across India, especially as we continue to expand our work in oncology, genomics, and precision medicine. It adds strong North India presence and marquee clientele that includes leading hospital chains, corporates and pharmaceutical clients to our portfolio, making us India’s leading specialized diagnostics company”, said Dr. Ramesh Hariharan, Chief Executive Officer, Strand Life Sciences. Steve Rusckowski, Chairman, President and CEO, Quest Diagnostics, commented: “We have built a diagnostic laboratory in India with a reputation for quality over the past 10 years. As our business model has evolved, we believe Strand Life Sciences is well positioned to continue the important work of empowering the people of India to improve their health with diagnostic insights.” The two companies will work together to manage the transition, and aim to close the sale by the end of first quarter 2019. Terms of this transaction were not disclosed.

Neurimmune Achieves Milestone in Collaboration with Ono Pharmaceutical Neurimmune has the achieved a key preclinical milestone in the ongoing collaboration with Ono Pharmaceutical Co., Ltd. In November 2017, the parties entered into a collaboration focused on the development of human-derived antibodies against a novel therapeutic target for neurodegenerative diseases. Under the terms of the collaboration agreement Neurimmune conducts research to generate and validate human-derived monoclonal antibodies using its proprietary Reverse Translational Medicine™ (RTM™) technology platform. The milestone triggers a pre-agreed milestone payment to Neurimmune. “We highly appreciate a key success in drug discovery of human-derived monoclonal antibodies with Neurimmune’s proprietary platform.”, said Hiromu Habashita, Ph.D., Corporate Officer and Executive Director, Discovery and Research of Ono. “We believe this progress will lead to the delivery of a novel and innovative treatment for patients with neurodegenerative diseases.”

Dr. Reddy's Laboratories receives approval for Aspirin and Extended-Release Dipyridamole Capsules in the U.S. Market Dr. Reddy’s Laboratories Ltd has received approval for Aspirin and Extended-Release Dipyridamole Capsules, a therapeutic equivalent generic version of Aggrenox (aspirin and extendedrelease dipyridamole) Capsules in the United States market from the U.S. Food and Drug Administration (USFDA). The Company is working towards launching the product. The Aggrenox brand and generic had U.S. sales of approximately $183 million MAT for the most recent twelve months ending in August 2018 according to IMS Health*. Dr. Reddy’s Aspirin and Extended-Release Dipyridamole Capsules is available in 25 mg/200 mg strength with 60 count bottle size. Aggrenox is a registered trademark of Boehringer Ingelheim.

Pharma Bio World

Hybrid - LRVP Toshniwal leader in vacuum engineering for over 60 years, now provides further solution to your vacuum needs. Pompetravini’s experience in manufacturing of liquid ring vacuum pumps has acquired over 70 years led to the creation of new improved liquid ring 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. Pompetravini has the most advanced manufacturing process with the objective to reduce manufacturing times which leads to shortening of delivery time.

For more information, please contact:

Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26448983, 26448558, Fax: 91-044-26441820 E-mail: sales@toshniwal.net

Electromagnetic Meter The instrument works on the principle of Faraday’s law of Electromagnetic Induction. A magnetic field is generated by the instrument in the flow tube. The fluid flowing through this magnetic field generates a voltage that is proportional to the flow velocity. This voltage is measured by the electronics and a corresponding output provided. It accepts any voltage from 90 to 265 V AC; measures the flow in both forward and reverse directions; provides a separate totalized volume value for flow in each direction; and monitors the process even in hard to reach places. Designed to meet global requirements and available with international approvals.

For more information, please contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-2644 8558, 26448983 E-mail: sales@toshniwal.net

Sheet Metal Structured Packing EVERPACK SM Column Packing is the sheet metal version of the popular EVERPACK WM (wire mesh) and HYFLUX (knitted wire mesh) packing. Their development is a part of EVERGREEN’s continuous and comprehensive development program to improve column packing performance. EVERPACK SM is supplied in modules, which consists of parallel layers of uniquely designed embossed sheet metal strips which are corrugated and arranged vertically. These modules are then stacked with an alternating 90 degree orientation of every other layer which gives a good lateral distribution of liquid. The embossed metal strips help to draw the liquid in all directions into a thin film and provides a marked improvement in uniform wetting of the packing bed. With the improved internal liquid distribution, high volumetric mass transfer efficiency is achieved and low pressure drop is maintained. Also because liquid is evenly distributed through the packing as a thin film, the total liquid hold-up in the packing is substantially reduced.The standard packing version has specific surface area of 250 m2/m3 (EVERPACK SMY 250). However, other variants with specific surface areas of 125 m2/m3 (SMY 125), 175 m2/m3 (SMY 175), 350 m2/m3 (SMY 350), 500 m2/m3 (SMY 500), 750 m2/m3 (SMY 750) and X crimp (60 degree crimp alignment) are also. Evergreen Technologies Pvt Ltd also manufacture high efficiency column internals (distributors, collectors, support grids, etc). Good initial distribution together with systematic redistribution is critical to optimum tower performance. It finds application in vacuum distillation where relatively low pressure drop is critical to maintaining low bottom temperatures to reduce products degradation; atmospheric operations where a large number of theoretical stages are required and/or where there are restrictions to overall column height; debottlenecking/energy reduction programs with the advantages of a high efficiency packing used to reduce reflux requirements and increase throughputs; and increase product purity which is possible due to availability of more equilibrium stages from same size column.

For more information, please contact:

Evergreen Technologies Pvt Ltd 3-D, Maker Bhavan-2, 18 New Marine Lines, Mumbai 400 020 Tel: 022-22012461, 22012706, 61566969 Fax: 91-022-22010024 E-mail: info@evergreenindia.com

Pharma Bio World

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Liquid Analysis

Liquid Analysis Liquiline is the platform for all liquid analysis applications.

It forms the basis of their ultra-modern transmitters, samplers and analysers.

Liquiline CM44 is the most flexible transmitter for all Memosens sensors. It measures twelve different parameters and allows up to eight sensors to be connected. Liquiline CM44 is available as a field device and also for mounting in control cabinets and on DIN rails.

For more information, please contact:

Endress+Hauser (India) Pvt Ltd 7B, 7 th Floor, Godrej One Pirojshanagar, Vikhroli (E) Mumbai 400 079 Tel: 022-30236100 Fax: 91-022-30236219 E-mail: info@in.endress.com

Liquiline is the platform for all liquid analysis applications. It forms the basis of their ultra modern transmitters, samplers and analysers.

Liquiline M CM42, the two-wire transmitter for the parameters pH/ORP, conductivity and oxygen, impresses with reliable data transmission and easy operation. It can be used in all areas of process automation including hazardous areas and hygienic applications.

For more information, please contact:

Endress+Hauser (India) Pvt Ltd 7B, 7 th Floor, Godrej One Pirojshanagar, Vikhroli (E) Mumbai 400 079 Tel: 022-30236100 Fax: 91-022-30236219 E-mail: info@in.endress.com

Submersible Pumps In todayâ&#x20AC;&#x2122;s water parched world, it has become strenuous for local water bodies to be able to provide a steady supply of water. The concept of rainwater harvesting in buildings has been the need of the hour.

To help buildings with their rainwater delivery systems Grundfos has excellent dewatering Systems.

One of the prime examples would be the DWK and the DPK pumps. Grundfos DWK and DPK are submersible pumps designed for dewatering and drainage applications. The cast-iron construction and the hydraulic design contribute durability and high efficiency. The differences between the DWK and DPK pump ranges lie in the discharge arrangement and the installation type.

The DPK range of submersible drainage pumps provides surface water drainage, combining installation flexibility and high-pressure capabilities with reliability and ease of service. The DPK range presents a surprisingly compact design, considering the pressure capabilities on offer. Together with the solid cast-iron construction and available installation options, the DPK range is perfect for drainage pit applications. DPK pumps has an in-house motor protection that provides protection against overheating; double mechanical seal provided in the oil chamber of this pump ensures a trouble-free operation; auto coupling/ring stand aids in easy installation of the pump in submerged conditions

For more information, please contact: Grundfos Pumps India Pvt Ltd 118 Rajiv Gandhi Salai, Thoraipakkam Chennai 600 097 Tel: 044-45966800 Fax: 91-044-45966969

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Pharma Bio World

Blister Packaging Machine The Promatic PTT, which can be flexibly connected to any standard cartoner, checkweigher or transfer system, was developed by Romaco to enable tamper-evident identification of cartons. This new track and trace machine provides numerous functions for seamless monitoring all along the supply chain, eg, the cartons can be laser or inkjet printed with 2D Data Matrix or QR codes. The data can then be read out using OCR/OCV. The packs can additionally be closed with various seals or labels for even better protection against counterfeiting. A vignette applied to the top of the carton provides further proof of originality.

An interface to special serialisation software rounds off the Romaco Promatic PTT. The Promatic PAK 130, too, is shipped ready for integrating aggregation and serialisation solutions. Up to five shipping cases per minute can be filled with this semi-automatic machine.

For more information, please contact: The Romaco Group Am Heegwald 11 76227 Karlsruhe Germany Tel: +49 (0)721 4804 0 Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

High Resolution Isotope Ratio MS Discover a new world of mass spectrometry. The Thermo Scientific 253 Ultra high resolution isotope ratio mass spectrometer (IRMS) revolutionises the measurement of sitespecific and clumpedisotope-ratio analysis of intact molecules. Analysts now get direct access to the conditions under which molecules were formed and how they were transported, stored and degraded. This will enable new discoveries in climate research, biochemistry, forensics, and oil and gas exploration.

For more information, please contact: Thermo Fisher Scientific India Pvt Ltd 102, 104, Delphi ‘C’ Wing Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-67429494 E-mail: sagar.chavan@thermofisher.com

Blister Packaging Machine Romaco’s new Unity 500 blister packaging line is set to make its public debut. This monobloc machine will be in line with the Promatic PTT for seamless track and trace, and the new Promatic PAK 130 case packer. Romaco specialises in singlesource turnkey concepts – with the primary, secondary and final packaging all in one line. A compact, GMP compliant design was a key priority for the fully integrated blister packaging line. With a max output of 500 blisters and 150 cartons per minute, the Romaco Unity 500 is mainly intended for high-performance jobs at medium speeds. The Romaco Unity 500 will be teamed up with a Combo v2.0 feeder from Elizabeth Europe. This patented system gives Romaco increased flexibility for feeding pharma solids in numerous different shapes and sizes. The finished blisters are passed directly to the cartoner’s bucket chain by means of a vacuum assisted overhead conveyor and QuickTransfer, which works according to the positive transfer principle. Separate servo drives ensure safe operation at the individual stations. The Romaco Unity 500 also offers excellent opportunities for improving overall equipment effectiveness (OEE). The optimal access to all components speeds up and simplifies cleaning of the blister line. The fast product changes add up to significantly less downtime for the Romaco Unity 500. Reproducible format parameters and QuickAdjust, the automatic station control system, simultaneously reduce the run-in times to almost zero.

For more information, please contact: The Romaco Group Am Heegwald 11 76227 Karlsruhe Germany Tel: +49 (0)721 4804 0 Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

Pharma Bio World

October 2018 ► 51

Cold Chamber

Deep Freezer

Mack Pharmatech offers costeffective PLC-based cold chambers with European Standard “CE” in different capacities. Their cold chambers have temperature range: 2°C to 8°C, accuracy: ±1.5°C, uniformity: ±2°C and control system: PLC (Allen Bradley).

Mack Pharmatech is the only company who gives all equipment with PLCbased control system, 21 CFR software, HMI (Touch Screen Display), standby refrigeration system, GSM technology, hooter system, GMP Model, full view glass door, bullet feet levelling legs, tray spacing every ½” adjustable and many more features.

For more information, please contact: Mack Pharmatech Pvt Ltd B-48 Malegaon MIDC, Sinnar Dist: Nashik, Maharashtra 422 113 Telefax: 91-02551-230877 E-mail: sales@mackpharmatech.com

Mack Pharmatech offers cost-effective PLC-based deep freezer with European Standard “CE” in different capacities.

Their deep freezer have temperature range: up to -40°C, accuracy: ±3°C, uniformity: ±3°C and control system: PLC (Allen Bradley).

Mack Pharmatech is the only company who gives all equipment with PLCbased control system, 21 CFR software, HMI (touch screen display), standby refrigeration system, GSM technology, hooter system, GMP Model, bullet feet levelling legs, tray spacing every ½” adjustable and many more features.

For more information, please contact: Mack Pharmatech Pvt Ltd B-48 Malegaon MIDC, Sinnar Dist: Nashik, Maharashtra 422 113 Telefax: 91-02551-230877 E-mail: sales@mackpharmatech.com

Kneader Extruder Kneader extruder combines the efficiency of a double arm - sigma blade mixer with the convenience of an extrusion screw for the mixing and discharging of heavy viscous materials.

The kneader extruder includes a set of counter-rotating kneading blades and a discharge screw. The blades are mounted on a horizontal axis in a U-shaped trough. Below the blades in a separate cavity is the discharge screw. During the mixing cycle the blades rotate towards each other while the mixing screw rotates in a reverse direction, constantly feeding new materials into the mixing blades. After the mixing/kneading cycle is complete, the screw is reversed and it transports the mixed materials from the mix zone out through a discharge die and on to further processing or packaging.

The kneader extruder has several advantages over conventional non-screw discharge kneaders.

Many sizes and designs are available to meet the most stringent process needs. Kneader extruders are manufactured in many sizes from 1 through 1,000 gallon capacity.

For more information, please contact: Ross Process Equipment Pvt Ltd Plot No: D-233/3, Chakan Indl Area Phase II, Village: Bhamboli, Tal: Khed Dist: Pune, Maharashtra 410 501 Tel: 02135-628400, 628401, 628402, 628403 E-mail: mail@rossmixers

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V Blenders V-Blenders designs are most often used for the intimate dry blending of free flowing solids.

The solids being blended in these units can vary in bulk density and in percentage of the total mixture. Materials being blended are constantly being split and inter-mixed as the shell rotates. Normal cycle times are typically in the range of 15 minutes, however can be less depending on the difficulty of blending.

V-Blenders are stocked in 5, 10 and 15 cu ft capacity. Each is constructed of type SS-316 and is internally polished to a 240 grit sanitary finish. The exterior is polished to an easily cleaned 150-grit finish.

All Ross V-Blenders are supplied with intensifier bars to permit de-agglomeration as needed. Discharge is accomplished through a manually operated butterfly valve. The valve is positioned 24â&#x20AC;? from the floor when in the bottom position. All units are provided with appropriate safety railings and appropriately interlocked. Stop-Start and E-Stop Pushbuttons are included with all blenders.

For more information, please contact: Ross Process Equipment Pvt Ltd Plot No: D-233/3, Chakan Indl Area Phase II, Village: Bhamboli, Tal: Khed Dist: Pune, Maharashtra 410 501 Tel: 02135-628400, 628401, 628402, 628403 E-mail: mail@rossmixers

Industrial Sectional Overhead Doors Avians industrial door systems guarantee max security and reliability as they are made of steel panels. The double-skinned PUF core design is heat insulating and particularly suitable for heated halls.

Doors are specifically designed to suit the modern industrial architecture. Avians offer a complete range of overhead sectional doors; either insulated sandwich panel doors or glazed doors. They can also be supplied as fully covered or semi-glazed versions for optimal daylight exposure. They provide good air tightness and insulation.

In industrial sectional doors complete sealing on the door prevents dust, air and water.

High precision hinges made of galvanized steel, roller guide with adjustable ball bearing rollers are provided for smooth movement of the door. Easy-to-integrate side and wicket doors ensure that pedestrian movement can be diversified. Intelligent safety edge mechanism stops the door if it comes into contact with an obstacle.

All doors are incorporated with EN safety standards. Industrial doors are attractive, robust and durable with different types of textures.

For more information, please contact: Avians Innovations Technology Pvt Ltd Gat No: 60/61, Dehu-Moshi Road, Chikhali Pune, Maharashtra 412 114 Tel: 020-71400600 Fax: 91-020-71400654

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3 Magnetic Level Switch Magnetic level switch consists of non-abrasive float carrying permanent magnet and nonferrous stem carrying one, two or multiple reed switches. The float glides along the stem and when the float nears the vicinity of reed switch, the magnetic field of permanent magnet forces the reed contact to close. The reed switch output is potential-free contacts.

It finds application in water, cooling towers, hydraulic oil, diesel, edible oil, chemicals and pharma.

For more information, please contact:

Filpro Sensors Pvt Ltd No: 130, 10th Cross, Petechennappa Indl Estate Kamakshipalya Magadi Main Road Bengaluru, Karnataka 560 079 Tel: 080-23286463 E-mail: sales@filprosensors.com

4 Miniature Float Switch Miniature float switch is suitable for single level sensing. It consists of a reed switch housed inside the SS housing and a permanent magnet inside the float assembly. The float moving with the liquid level makes (NC) and breaks (NO) the reed switch contact. It is used for sensing low, high or point level in tank. The mounting is through a M10 male thread. It finds application in hydraulic oil, water boilers, chemicals and pharma For more information, please contact: Filpro Sensors Pvt Ltd No: 130, 10th Cross, Petechennappa Indl Estate Kamakshipalya, Magadi Main Road Bengaluru, Karnataka 560 079 Tel: 080-23286463 E-mail: sales@filprosensors.com

Indexing Plungers Corrosion resistance, hygiene and material quality are properties which are highly appreciated in the pharma and food industry, in hospital engineering, fresh water supply and waste-water engineering, the aerospace industry, conveyor engineering and in machine and plant construction.

For these industries ELESA+GANTER’s standard machine elements has added to its product range of index plunger models GN 613 / GN 617 and GN 617.1 the design variant with stainless steel knob - the first all stainless steel index plunger. The GN 613 indexing plungers have no collar and boast extremely small dimensions, designed to absorb axial forces in their end position.

The GN 617 and GN 617.1 indexing plungers are each fitted with a collar, with the GN 617.1 indexing plunger featuring an additional indexing lock. These are used if the index pin is temporarily not allowed to protrude. To engage, the knob is turned by 90° after pulling out. An index notch prevents the disengaged knob inadvertently turning back under the impact of vibrations.

All stainless steel indexing plungers are made in consistently high quality and feature a long service life.

Options - Ganter offer include the holding fixtures GN 612.1 and GN 412.1 as mounting aids for indexing plungers, cam action-indexing plungers and positioning bushings (GN 412.2).

For more information, please contact: Elesa and Ganter India Pvt Ltd A-54, Sector-83 Noida, Uttar Pradesh 201 305 Tel: 0120-4726666 Fax: 91-0120-4726600 E-mail: info@elesaganter-india.com

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Pharma Bio World

Electrostatic Spray Dryer P o l a r D r y Electrostatic Spray Dryer utilizes electrostatic t e c h n o l o g y that lowers the evaporation temperature and helps in eliminating active ingredient loss, degradation and denaturalization. PolarDry feature all-in-one modular equipment design features, which means a small footprint reducing maintenance and installation costs. The product is also scalable from R&D to production. PolarDry system operates at low temperature, which allows for temperature efficiency and reduces heat degradation of molecules and other components. Recycled process gas with negligible emissions makes it environmentfriendly and eliminates regulatory issues.

For more information, please contact:

Spraying Systems (India) Pvt Ltd Plot No: 303 & 304, 2 nd Cross, 5 th Main, 4 th Phase Peenya Indl Area, Bengaluru, Karnataka 560 058 Tel: 080-39853200, 39853201 E-mail: ashwath@sprayindia.com / ssipl@sprayindia.com

Tilt Type Kneader The sigma blade mixer includes two blades that rotate toward each other at differential speeds.

Each blade moves the material in opposite directions thereby providing excellent cross-mixing of all raw materials. The blades pass the trough walls and each other at close clearances. This close clearance action provides a shearing and tearing action that is beneficial to the size reduction of solids such as rubber and plastic pellets. Once the mix cycle is complete the trough of the mixer is tilted and the mixture is discharged to a secondary container for transfer to packaging or to downstream operations.

For more information, please contact: Ross Process Equipment Pvt Ltd Plot No: D-233/3, Chakan Indl Area Phase II, Village: Bhamboli, Tal: Khed Dist: Pune, Maharashtra 410 501 Tel: 02135-628400, 628401, 628402, 628403 E-mail: mail@rossmixers

Ultrafiltration Membranes Liqui-Flux ultrafiltration membranes are manufactured by Membrana, Wuppertal, Germany market leader in membrane technology.

Liqui-Flux ultrafiltration membranes are microporous, hollow fibre, polyethersulfone membrane which are used to filter separate micro-organisms down to macromolecules from water. The ultrafiltration membranes are typically engineered provide large membrane separation area in a housing well designed to allow uniform flow of the feed liquid on one side the membrane and the permeate/filtrate on the other side. The fluid flows from the inside of the hollow fibre membrane the outside of the membrane.

or to of to

It finds application in RO pre-treatment, waste water reuse, drinking water, process water, swimming pool and beverage filtration.

For more information, please contact: Evergreen Technologies Pvt Ltd 3-D, Maker Bhavan-2 18 New Marine Lines Mumbai 400 020 Tel: 022-22012461, 22012706, 61566969 Fax: 91-022-22010024 E-mail: info@evergreenindia.com

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events diary  

   

Dates: 31 October-02 November 2018 Venue: Shanghai New International Expo Centre (SNIEC), Shanghai, China

Date: 20 th – 23 rd February 2019 Venue: Bombay Exhibition Center, Mumbai

This event is involved with various laboratory technologies which are used in the medical and health labs all over the world. The event is involved in displaying the modern equipment which aims to benefit the visitors with its application.

BioPharma World Expo 2019 will be a perfect destination for Bioprocess Solution Providers, CROs/CMOs, Clinical Trial Supply Chain Providers, Cold Chain Packaging & Cargo, Global Pharma, Regulatory Consultants, Analytical Instrument Manufacturers, Local Biotechs & Start-ups, Quality Control Consultants, Academics, and Regulators to showcase and promote their product and services as well as offer unique opportunity to meet, network and discuss current industry trends, establish business partnerships and be updated on investment opportunities in India.

The concurrent conference tracks will explore areas like biosimilars and vaccines development, antibodies, orphan drugs, stem cells, innovations in biologics manufacturing and regulatory compliance; growing issues in generic drug manufacturing and more.  Amrita Patkar Event Coordinator Tel: 91-22- 4037 3617 Email: amrita_patil@jasubhai.com

Many industrialists who have gained success in the respective fields are present in this event and provide information and solution to the issues of the visitors. The show is strongly supported by the Chinese government and other leading institutions. The location also adds to the popularity of the event as Shanghai is known as the most economical state of China  Messe Munchen GmbH Messegelaende Muenchen, Germany Tel: +(49)-(89)-94920720 Fax: +(49)-(89)-94920119

    

      Expo

Dates: 14-15 November 2018 Venue: Palais des Congres de Montreal, Montreal, Canada

Date: 16 th - 17 th April 2019 Venue: Mumbai Exhibition Centre, Mumbai

Event: The event will showcase wide variety of automation related services associated with this field. Thus event like this will organize wide variety of workshops, seminar presentation and open forum questionnaires with the help of it the exhibitors will showcase products and services like accessories, components, automation, instrumentation, controls, conveyers, feeders, dryers, dust collection, scrubbers and material handling equipment associated with this field. Beside this the event will cordially invite all the eminent and distinguished experts associated with this field.

Analytica Anacon India and India Lab Expo are together the biggest show in laboratory technology, analysis and biotechnology in India. The international trade fair is the most important industry gathering in India. Get to know the entire range of topics that pertain to laboratories in research and industry. This is a trade fair which showcases chromatographies, spectroscopes, microscopes and imaging, bioinformatics, medicine and diagnostics, life sciences, analytical instrumentation systems, instruments for physical and chemical analysis, laboratory furniture, equipment, machines, laboratory diagnostics, etc.

 UBM UBM plc, Ludgate House 245 Blackfriars Road London, U.K. Tel: +44- 0-20-7921-50 00

56 ◄ October 2018

 Messe Muenchen India Pvt Ltd INIZIO 507 & 508, 5th Floor Cardinal Gracias Road Opp: P&G Bldg Chakala, Andheri (E) Mumbai 400 099

Pharma Bio World

bookshelf Phytopharmaceuticals for Brain Health Editors: Shahnaz Subhan and Manashi Bagchi Price: $114.11 No of pages: 464 pages (Hardcover) Publisher: CRC Press (1st Edition) About the book: Research studies demonstrate diet and proper nutrition in conjunction with cognitive, mental, social, and physical activities can significantly help in improving brain health with advancing age, and potentially reduce the risk of cognitive decline. These studies of phytopharmaceuticals and medicinal plants, demonstrate the efficacy of Huperzine A, berry anthocyanins, trans-resveratrol, Ginkgo biloba, Bacopa monniera, Centella asiatica, tocotrienols, and palm oil in boosting brain health and physical well-being.

In addition, consumption of marine fishes and general seafood is recommended for long-term nutritional intervention to preserve mental health, hinder neurodegenerative processes, and sustain cognitive capacities in humans. Omega-3 and omega-6 polyunsaturated fatty acids, n-3/n-6 PUFAs, flavonoids, and antioxidants prevent the initiation and progression of many neurological disorders.

This book is a comprehensive review of phytopharmaceuticals impacting brain health with emphasis on diverse applications in food and nutrition sciences, biomedicine, neurology and other scientific and medical fields. It details available methods and contains numerous references making this the perfect guide for scientists who want to explore the fascinating world of phytopharmaceuticals with relation to brain health.

This book appeals to a diverse range of readers in industry, medical doctors, research and academia, including biologists, biochemists, food scientists, nutritionists and health professionals. Overall, this book brings a classic scenario of neurological problems to possible amelioration using novel nutraceuticals and functional foods.

Phytopharmaceutical Analysis

Authors: Ramadoss Karthikeyan and Oruganti Sai Koushik Price: $78.00 No of pages: 236 pages (Paperback) Publisher: LAP LAMBERT Academic Publishing About the book: A variety of different plants have been reviewed. Based on brief review, the compounds have been isolated for assessment of their pharmacological activities, and it is believed that these compounds found to be the most active for their further studies. The objective of these findings is to systematically estimate and evaluate the outcome of various plant metabolites and collate these findings to be used as a guide for future biological-activity relationship and mode of action studies.

Intellectual Property Author: Deborah E Bouchoux Price: $128.43 No of pages: 576 pages (Paperback) Publisher: Cengage Learning (5th Edition) About the book: Master the complexities of modern intellectual property law with this comprehensive, reader-friendly text! Throughout the book, you will find sample agreements, forms, checklists of paralegal tasks, statutes, realistic case studies, and excerpts of real cases involving interesting issues (such as the copyright ability of the Batmobile, tattoos) that will help you prepare for a successful career as a paralegal.

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ad index Sr.No

Client's Name

Page No

1

Alpha Process Engineers

25

2

Ami Polymer Pvt Ltd

23

3

Bry-Air (Asia) Pvt Ltd

21

4

Cole-Parmer India

9

5

Domino Printech India LLP

7

6

Ekato India Pvt Ltd

17

7

HRS Process Systems Ltd

5

8

M K Silicone Products Pvt Ltd

27

9

Mack Pharmatech Pvt Ltd

25

10

Nichrome India Ltd

15

11

Ravel Hiteks Pvt Ltd

27

12

Shah Brothers

27

13

Spraying Systems (India) Pvt Ltd

3

14

Suresh Enterprise

19

15

Vacuum Drying Technology India LLP

23

16

Vega India Level & Pressure Measurement Pvt Ltd

17

Pharma World Expo 2019

58 â&#x2014;&#x201E; October 2018

11-14 Inside Cover

Pharma Bio World