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VOL 16 | ISSUE 11 | JUNE 2018 | MUMBAI | TOTAL PAGES 56 | ` 150

www.pharmabioworld.com PHARMA BIO WORLD VOL 16 ISSUE 11 JUNE 2018 MUMBAI

Pharma Innovation

TOTAL PAGES 60 ` 150 BioPharma World Expo 2019 20-23, February 2019

Venue: Bombay Exhibition Centre, Goregaon (East), Mumbai, India

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INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES

VOL. 16 | NO. 11 | JUNE 2018 | MUMBAI | ` 150

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4 ◄ June 2018

Pharma Bio World

FEATURES 08.

Sustainability in processing and packaging technology; Technological solutions for ecological challenges -Dr. Ing. Carsten Weiß, Vice President Engineering, Bosch Packaging Technology

18.

Ethics in Clinical Trials: Its Role and Importance -Dr. Ashok Peepliwal, Associate Professor IIHMR University, Jaipur

21.

Pharma 4.0 – Impact of IIoT in Pharmaceutical Manufacturing

MARKETING INITIATIVE

08 24.

B&R India launches enhanced customer support

27.

B&R joins Huawei’s OPC UA TSN testbed

28.

Digitalization influences the pharmaceutical industry

30.

More efficiency, more communication

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Resistotech Industries Private Limited

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Improved Dosing Applications using Coriolis Instruments with CORI-FILL Technology

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The Vacuum Pump Unique in Reliability, Performance and Consumption

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NEWS UPDATE 37.

Press Release

CORPORATE AFFAIRS 41.

52.

Products Events

28 BACKYARD 53.

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Book Shelf Ad Index

30 Next Issue Focus: Anniversary Issue

6 ◄ June 2018

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Sustainability in processing and packaging technology; Technological solutions for ecological challenges The article analyses current ways of the pharma industry to make for more sustainable packaging and manufacturing processes, from utilising biodegradable plastics and fibre-based packaging to integrating energy-saving process equipment into their manufacturing lines. Further, the article takes a deep dive into how connected industry solutions can help reduce and optimize energy consumption.

Dr. Ing. Carsten Weiß Vice President Engineering Bosch Packaging Technology 8 ◄ June 2018

I

ncreasing urbanization, smaller household sizes and an ageing population are fundamentally changing the expectations for food and pharmaceutical packaging. At the same time, there is a growing need for more sustainable packaging solutions and processes. But according to Carsten Weiß, Vice President Engineering at Bosch Packaging Technology, no single company can rise to this challenge alone.

In order to develop packaging concepts that are both truly sustainable and appealing to consumers, manufacturers, material and packaging suppliers, as well as mechanical engineering and waste management companies need to join forces.

the circular economy. There is a greater demand for packages that are “designed for recycling”, for example by using easily separable materials, mono-material packaging, and renewable materials. But what good does the most environmentally friendly packaging design do if it is not compatible with processing and packaging machinery? Or if the process steps involved in its manufacturing, filling, packaging and disposal involve much higher energy consumption? All parties involved in the production and supply chain have to work together to devise more sustainable solutions. The outcomes of key initiatives like Save Food, CEFLEX and European Bioplastics can offer valuable insights into future needs.

In the majority of industrialized nations, the “Supersize Me” mentality is now a thing of the past. Given the demographic change and more responsible consumer behavior, the current trend is toward smaller portions. This can also be seen in the growing demand for convenience and on-the-go products. In many growth markets, small portions are also the number one choice due to consumers’ limited financial resources. As a result, packaging sizes are becoming smaller, yet the number of individual packages is constantly on the rise. Although the sense of environmental responsibility among the general public is improving, every year more than eight million metric tons of plastic litter find their way into the ocean, due in part to insufficiently established or poorly implemented waste disposal processes. According to figures from the UN, this amounts to roughly one garbage-truck load per minute. In parallel, more and more effort is being put into the development of sustainable packaging and environmentally friendlier manufacturing processes.

On the lookout for new packaging concepts

In the future, there will be a greater focus on fulfilling the requirements of

Some of the most important trends on the packaging market include the further development of conventional materials, research into new combinations of materials, and the introduction of more efficient processes. In this regard, various parties are already working hand in hand to find new solutions that reflect the spirit of sustainability. When it comes to achieving these goals, expertise from disparate, not directly related fields can be vital. For example, the automotive industry has been investing heavily in optimizing materials and processes for the past several years.

With regard to products with extremely high barrier requirements, like battery cells, the spotlight is on optimizing flexible packaging materials. Lessons learned from these efforts can – provided they are available – be directly applied to the development of new packaging solutions and production concepts for food and pharmaceuticals.

Many research activities focus on the development of bio-based or biodegradable plastics that satisfy the requirements for food packaging. BioPharma Bio World

Figure 1: Bosch Packaging Technology is investing in new technical solutions to ensure more sustainability in processing and packaging engineering. based plastics often offer a better CO 2 balance than conventional plastics.

Biodegradable plastics are particularly advantageous if they can easily be broken down by microorganisms. Compostable materials are an especially good choice for food packaging where the product and its packaging often enter the waste disposal cycle together – as is the case with coffee capsules or teabags.

Nonetheless, biodegradable plastics do not represent a cure-all for the pollution of our environment and oceans: as they break down, carbon dioxide, water and methane are released. Methane has a much more higher effect on global warming than CO 2, which is why it is burned to CO 2 and H 2O at managed waste disposal plants. Biodegradable plastics that are additionally bio-based offer a much better CO 2 balance, while those that are based on renewable raw materials can produce other negative environmental impacts, including eutrophication, increased soil acidity, and air pollutants.

Generally speaking, rapidly degradable plastics are particularly advantageous for the environment when they are “marine degradable,” that is when they break down in seawater. Needless to say, it should 10 ◄ June 2018

still be our goal to reduce the amount of marine litter to a minimum; in this context, good recycling solutions and smoothly running disposal systems are elementary.

First concepts already put into practice Companies are also working intensively on new concepts in the area of fiber-based packages, so as to satisfy the circular economy’s criteria for recyclability and the use of renewable materials without compromising product protection. For example, the first sealed paper packaging consists of mono-material paper instead of polymer film, making it completely recyclable. It is suitable for dry food like sugar, pasta, cereal or powder. Until recently, packaging products in monomaterial paper was only possible with glued, premanufactured bags or with glued paper packaging produced by mandrelwheel systems. With the new solution, food products can now also be packaged and sealed with vertical form fill seal (VFFS) machines, which translates into higher flexibility concerning the choice of format and packing style. Moreover, VFFS sealing delivers improved product protection and dust tightness. Thanks to

the use of FSC- or PEFC-certified paper, this approach is truly sustainable – from the raw material to recycling – and offers a viable alternative to plastic for products with low barrier requirements.

In addition to mono-material packaging and compatibility with VFFS machines, additional future applications are imaginable. By suitably modifying current packages, the number of different materials needed could be reduced.

Also, the increasingly stringent barrier requirements for product protection could be satisfied. However, a good deal of further development work will be needed to keep costs low while achieving a high degree of product protection and environmental protection, as a recent analysis (see graphic 1) shows. While the majority of materials are out of the question for use in the pharmaceutical industry due to the extremely high standards for product protection, the food segment also often has to sacrifice shelf life for the sake of higher sustainability. Accordingly, all parties involved will continue to have their hands full trying to optimally reconcile packaging requirements, cost efficiency and environmental protection.

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Figure 2: The first sealed paper packaging consists of mono-material paper instead of polymer film, making it completely recyclable.

Although the pharmaceutical industry faces more complex challenges given the high barrier requirements for its products, some secondary packaging concepts are already available that may prove to be visionary. When it comes to fragile products like syringes, vials and ampoules, as well as applicators such as insulin pens, conventionally a mix of materials has been used to ensure their safety. However, a new, tray folding carton made entirely of cardboard and featuring variable inlays could offer an alternative solution. Thanks to the use of a single packaging material, there is no more need for plastic trays.

Consequently, there is also no need to separate different classes of materials during recycling, which translates into better sorting and more efficient recycling outcomes.

12 â—„ June 2018

Energy recovery during ongoing processes Conserving resources is another key aspect of sustainability in the processing and packaging industry. In the energyintensive pharmaceutical industry, for example, innovative energy recovery concepts are yielding significant savings.

In the sterilization process, heating and cooling energy are recovered, which can mean up to 40 percent lower heating costs and 60 percent lower cooling costs. When it comes to ultra pure steam generation and distillation, the latestgeneration systems use a preheater to reduce hot steam consumption by roughly 30 percent. In cleanroom production, up to 65 percent lower energy costs in connection with hot and cold water, steam and electricity can be achieved with the help of cutting-edge isolator

technology depending on the air supply system used.

Similar concepts can now be found in the food sector: thanks to heat recovery, new systems used, for instance, to separate masses in the manufacture of jelly products consume only half as much energy. In addition to lower overall operating costs through reduced energy consumption, reducing the steam pressure in the separation process by 0.3 bar subjects the product to less thermal strain, helping preserve both quality and taste.

Keeping an eye on resource consumption with industry 4.0 The latest software solutions in the area of digitization show how manufacturers can conserve resources with their existing machines and lines, by asking questions Pharma Bio World

Pharma Bio World

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Figure 3: arious packaging materials are used in the food industry, depending on the specific product and barrier requirements. like: which machines consume the most electricity? At which point in which process step do we use most energy?

Thanks to the progressive connectivity of production, we now enjoy access to more and more data, which can also be used for consumption analysis: sensors provide data, for instance on energy and compressed-air consumption, allowing us to analyze these parameters over a given timeframe. These often very different types of data can be bundled and analyzed on a single platform, and displayed in real-time on the Human Machine Interface (HMI) of a given machine or line. In this way, fluctuations, peak loads and irregularities can be identified – and effectively remedied.

Thanks to industry 4.0, we will soon be able to use increasingly detailed data, paving the way for more fundamental analyses ranging from individual machines to entire plants. In turn, predictive analytics will help us spot potential sources of higher consumption and errors in advance – and identify corresponding potentials for optimization, leading to more efficient and resourceconserving production processes.

16 ◄ June 2018

Trinity of design, material and machine Several different aspects are important in the context of selecting suitable packages and processes: in addition to cost efficiency, more attention is being paid to barrier properties, processability, mechanical requirements, quality, and compliance with regulations. In this regard, sustainability will become more and more important in the future. When it comes to developing new packaging concepts and systems, factors like recycling, energy and resource efficiency have already become an integral part of performance specifications. Leading processing and packaging machinery providers are already working closely together with their customers in various pilot projects to develop comprehensive solutions based on a trinity of design, material and machine.

This can best be achieved by getting material manufacturers, brand owners and their customers on board at an early stage. As part of the UX (User Experience) approach, feedback is collected on various parties’ expectations and needs, and is then directly integrated into further

developments. In addition to individual customer needs, regional specifications like legal requirements, consumer mentality and the degree of automation in production also have to be kept in mind. Only then can solutions be found that will allow the emerging markets to establish ecologically sound production, packaging and disposal concepts in their own regions. And this can only succeed if producers and materials developers, packaging manufacturers and mechanical engineering firms, as well as logistics, waste management and recycling companies act in concert, so that the entire packaging industry actively contributes to more sustainability.

Contact: Carsten.Weiss@bosch.com Pharma Bio World

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Ethics in Clinical Trials: Its Role and Importance Clinical trial ethics are the set of relevant ethics considered in the conduct of a clinical trial in the field of clinical research. It borrows from the broader fields of research ethics and medical ethics. This article discusses the role and importance of ethics in clinical trials.

C

linical trials are a necessary practice in drug development to certify the safety and efficacy of a new drug and involve the participation of human subjects. Healthy volunteers and patients of specific diseases are considered legitimate trial units provided their free and informed consent is obtained under the law.

Exploitation in the Clinical Testing arena Low and middle-income countries provide easy test subjects for clinical trials because in many cases, participating in a trial is the only way for the poor or needy to access expensive healthcare. However, this exposes them to the risk of exploitation.

Experience has shown that unregulated practices in drug development can lead to unhealthy consequences for the people involved. In the 1960s, a chemical called Thalidomide was administered to pregnant women who had complained of morning sickness. The drug was marketed as a mild sleeping pill that was projected as being safe even for pregnant women.

However, babies born to the mothers who took the pills were born with congenital deformities as a result. This spurred authorities and pharmaceutical companies to employ more rigorous testing standards before the introduction of a drug for human consumption.

Guidelines and Frameworks for Clinical Trials in India

Dr. Ashok Peepliwal Associate Professor IIHMR University, Jaipur 18 ◄ June 2018

Ethical concerns are to be addressed responsibly by all the stakeholders involved including doctors, pharmaceutical companies, ethics committees, regulatory agencies, CROs, patients and drug testing laboratories. Patients can help by honestly describing symptoms and therapeutic progression during testing. ICH-GCP (E6 guidelines) unequivocally declares that the rights of the individual, safety and well-being shall prevail over the interests of both science and society. The safety of the trial subject is an inalienable right to be protected at any cost. To ensure that

this happens, stakeholders are required to undergo periodic training in order to comply with requirements of the Indian Council of Medical Research (ICMR) and the World Medical Association’s (WMA) Declaration of Helsinki on the ethical guidelines for biomedical research on human participants.

These principles themselves stem from the Declaration of Geneva, one of which binds the physician with the words, “A physician shall act in the patient’s best interest when providing medical care”.

The central concern of medical research is to study and understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Evaluation should continue beyond preliminary stages to as long as the tested molecule resides within the human subject. Nor does this declaration stop at lofty ephemeral ideals.

Comprehensive guidelines include the compulsory performance of medical research/ clinical trial by appropriately trained and qualified personnel with the requisite scientific and ethical bent of mind.

Clinical trials should also minimize harm to the environment. Known adverse effects should act as a breach of preliminary conditions before subjecting humans to trials. Suitable compensation and treatment in case of subjects who have been harmed should be available.

The Ethics Committee (EC) in Clinical Trials ICMR guidelines (2006) require the establishment of and oversight by an ethics committee. An EC is to be registered with the Central Drugs Standard Control Organization (CDSCO). Approval or disapproval of a clinical trial is in the hands of the EC. The EC examines the pros and cons of a clinical trial protocol before approval. The committee members including the Chairman, Member Secretary, Clinician, Pharmacologist, Lawyer, Layperson, etc, must scrutinize protocols, Pharma Bio World

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investigate brochures, informed consent forms and other relevant documents thoroughly to ensure that the patient does not undergo any suffering due to negligence of document oversight.

Once the Ethics Committee nod is acquired, the principal investigator and her team members can begin recruiting patients according to inclusion and exclusion criteria. These criteria are to be strictly followed even if the numbers are low so as not to endanger the patient’s life. All queries of a patient must be satisfied even after the informed consent form has been signed and received. All the benefits and adverse effects of the Investigational Medicinal Product (IMP) ought to be disclosed beforehand. Only when the patient or his/her relatives agree to all conditions should the participation in

the clinical trial begin. The patient should have the freedom to discontinue with the experiment should she so desire.

Role of the Principal Investigator It is the job of the PI to ensure that deprivation and vulnerability of the subject is not taken undue advantage of. An official report says that India serves 1.4% of the world’s clinical trial needs while holding 16% of the world’s population and 20% of its burden of disease. In the past, thousands of trials have been conducted here and several cases of death due to negligence or other serious accidents have come to light. Compensation to the victims has been a persistent bone of contention.

of India as per the Drugs and Cosmetics Rules, 1945. GSR 53(E) dated 30-012013 inserted a new rule, 122-DAB and Appendix XII in Schedule Y to arrive at the compensation due to aggrieved patients and their relatives. Rule 12-DD of the DCR, 1945 mandating compulsory registration of ECs with it has enabled more transparency in the drug development regime. About 1200 ECs are currently registered. They are empowered to approve and implement ethics in clinical testing in India. Ethical measures have the ability to define and increase the reliability and authenticity of clinical research while at the same time pushing the limits of human understanding of disease.

Recent Amendments The CDSCO has been assigned the task of clinical trials regulator by the government

NOVEMBER 2017 MUMBAI TOTAL PAGES 60

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20 ◄ June 2018

Pharma Bio World

Pharma 4.0 – Impact of IIoT in Pharmaceutical Manufacturing

W

ith the growing number of medical ailments across the globe, the pharmaceutical industry will undoubtedly become more important than ever in the near future. There is a paradigm shift from the mass production of drugs to offering more customized and specialized drugs to a smaller group of patients and this is greatly expected to improve the effectiveness of treatments.

The Pharma 4.0 initiative is expected to not only address productivity issues but also provide the industry with smarter tools that can help ensure drug safety.

Everyday factory equipment, people, and processes are thus getting increasingly smarter with the advent of digitization.

The introduction of digitization in pharmaceutical manufacturing will also be instrumental in enabling a seamless data exchange across the pharmaceutical supply chain. The connectivity of product, people and process is what constitutes the Industrial Internet of Things (IIoT).

Manufacturing will undoubtedly be the biggest beneficiary of IIoT. Thus, industries such as pharma and healthcare will certainly stand a good chance to continue to benefit from IIoT. Analyticsenabled data management vis-Ă -vis traditional paper-centric approaches will come a long way in being crucial enablers for important management decisions. The pharmaceutical industry should consider making investments in IIoT technologies, most of which are already mature in other industries and have proven effective in improving the efficiency of complex manufacturing operations. Leveraging lessons from this should help companies improve their financial and operational performances.

integrating the different manufacturing departments that are otherwise not adequately connected. IIoT technologies will enable manufacturers gain a 360-degree view of their plant operations with the ability to drill down to any level of detail at any stage of product development. This essentially would mean that data would be made available at just a tap of the screen. Manufacturing companies will transform from being small local hubs to global market places with the introduction of IIoT. The pharmaceutical industry has been among the forerunners in adopting these digital technologies that can help improve process efficiencies, reduce efforts, and increase profits. Within the industry there has always been an impetus to manage manufacturing processes more effectively.

However, the pharmaceutical industry faces several challenges in being one of the most regulated manufacturing industries. The industry demands a good understanding of manufacturing processes and strict adherence to stringent regulatory standards that guide these processes. Due to regulatory

compliance issues in this sector, it has become mandatory for companies in the pharma industry to implement digital technologies. As is the case with any other industry, pharmaceutical manufacturing is faced with challenges, such as the need to enhance product quality, improve process efficiencies, reduce cycle times, reduce scrap and rework, track products, ensure adherence to regulatory guidelines, reduce downtime, and connect the supply chain among several others. This wall of challenges will however crumble eventually, thanks to the advancing benefits of digitization.

With emerging benefits of industrial IoT and its increased applications in manufacturing, the dynamics of the industry is changing considerably. All information about machines, people, and materials involved in pharmaceutical manufacturing is required to be recorded according to mandatory requirements set down by government agencies such as the Food and Drug Administration (FDA). There is also an increasing demand for real-time reporting within the industry and IIoT plays a crucial role

Digital technologies have thus become a quintessential component of the manufacturing industry in automating operations, streamlining processes, and

Pharma Bio World

June 2018 â–ş 21

in making the requisite data available.

Connectivity ensures management and monitoring of manufacturing operations on the factory floor. Digital initiatives can by large provide a strong foundation for initiatives, such as Industry 4.0 to take over factory management. Manufacturers will be required to constantly upgrade their digital systems until such time when Industry 4.0 can be implemented in a fullfledged manner.

Factory machines may already be connected and controlled by systems such as Supervisory Control and Data Acquisition (SCADA) or Manufacturing Execution Systems (MES) or even Distributed Control systems (DCS).

Industrial IoT is an added perk that brings along with it the power of data and computational prowess. This could now imply bringing in the power of analytics to generate valuable insights that can help oversee plant workflows and track and maintain machine activities much ahead of a breakdown. The benefits of IIoT in pharma manufacturing will pretty much be the same as is the case with several other industry verticals. The 22 â—„ June 2018

distinguishing advantage, however, could be in the fact that IIoT can go a long way in helping pharma manufacturers ensure a proper documentation during production for compliance reasons. Industry 4.0 could also help steer the pharma industry towards a paperless environment with lesser human intervention involved. This could involve terabytes of data being stored and processed on the cloud, as traditional methods of data storage get completely phased out. Introduction of IIoT in pharma would also mean making a fundamental shift towards outcome-based targeted therapies characterised by a more individualized production method.

Pharma is also an industry that has extremely sensitive storage conditions.

The manufactured products typically are of high value and have a short storage life.

They also mostly need to be stored under prescribed storage temperatures, which cannot be monitored if not for critical components of IIoT such as sensors and connectivity. IIoT has become an integral part of manufacturing and therefore it is only natural that the pharma industry should look to adopting it at the earliest.

This would involve manufacturing companies taking important decisions such as phasing out legacy systems and transforming business models.

IIoT plays an important role in the continuous monitoring of connected factory equipment and personnel. This real-time tracking of equipment can help improve effectiveness of factory processes by enabling informed decisions through data resultant of connectivity.

The other important benefit of IIoT in pharma manufacturing is the modular automation of pharma production plants, which enables a faster time-to-market for pharma products.

The IIoT may be at its nascent stages of development, but its impact on pharmaceutical manufacturing is certainly indisputable. Only those market participants able to see the potential gains and start taking those small baby steps will be the ones who will eventually be able to reap benefits from IIoT.

Article courtesy: Frost & Sullivan Pharma Bio World

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marketing initiative

B&R India launches enhanced customer support Dedicated hotline ensures high quality support and accelerated response times

B&R India has launched World Class Support – a dedicated support hotline that will serve as a single point of contact for its customers nationwide. Customers served by B&R India headquarters in Pune and its six branch offices will now have a single number to call, ensuring that they receive a consistently high level of support with the fastest possible response times. “We are proud of the best-in-class service and support we offer our customers,” says Jhankar Dutta, Managing Director of B&R India. “Our World Class Support hotline will further enhance our customers’ experience, in turn enabling them to offer their customers faster service and reduced machine downtime.”

B&R’s online Support Portal allows customers worldwide to create and track support requests and share support documentation via the B&R website.

With the new hotline, customers of B&R India also benefit from streamlined

telephone support from a local team of experts. “Our highly qualified support team is committed to our customers’ success and has the expertise it takes to help them gain a competitive edge in their market,” says Ravishankar Gawhade, head of national support, B&R India.

About B&R B&R is an innovative automation company with headquarters in Austria and offices all around the world. On July 6, 2017, B&R became a business unit of the ABB Group. As a global leader in industrial automation, B&R combines state-of-the-art technol-ogy with advanced engineering to provide customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI and integrated safety technology. With Industrial IoT communication standards like OPC UA, POWERLINK and openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industrial automation is driven by a commitment to simplifying processes and exceeding customer expectations.

For details Contact : B&R Industrial Automation Pvt. Ltd.

World Class Support hotline to enhance customer experience 24 ◄ June 2018

tel: +91 / 20 4147 - 8999 E-mail: office.in@br-automation.com 8, Tara Heights, Mumbai - Pune Road, Wakdewadi, Pune 411003 Website: www.br-automation.com Pharma Bio World

marketing initiative

B&R joins Huawei’s OPC UA TSN testbed Practical testing for seamless smart factory communication

B&R has joined the OPC UA TSN testbed of Chinese network equipment vendor Huawei. The Austrian automation specialist is now participating in all three of the world’s most significant platforms for practical testing of the new communication technology. The two other testbeds are those organized by the Industrial Internet Con-sortium (IIC) in the USA and Labs Network Industrie 4.0 (LNI) in Europe.

The new OPC UA TSN testbed was introduced at the Hannover Messe. Source: Huawei

“Huawei’s testbed gives us the opportunity to advance the standardization of OPC UA TSN in Asia,” explained B&R Marketing Manager Stefan Schönegger during the presentation of the testbed at the Hannover Messe. “In doing so, we’re making another important contribution toward globally harmonized industrial communication.”

From the sensor to the cloud Huawei’s testbed will feature an OPC UA TSN network simulating all aspects of smart factory communication – from individual sensors to the ERP system and on into the cloud. Data will be transmitted exclusively via OPC UA TSN – regardless of whether it is real-time motion control data or aggregated performance metrics for executive management. There is Pharma Bio World

no need for communication interfaces of any kind.

About B&R B&R is an innovative automation company with headquarters in Austria and offices all around the world. On July 6, 2017, B&R became a business unit of the ABB Group.

As a global leader in industrial automation, B&R combines state-of-the-art technology with advanced engineering to provide customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI and integrated safety technology.

With Industrial IoT communication standards like OPC UA, POWERLINK and openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining

the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industrial automation is driven by a commitment to simplifying processes and exceeding customer expectations.

For details Contact : B&R Industrial Automation

Corporate Communications Tel: +43 7748 6586-0 E-Mail: press@br-automation.com B&R-Strasse 1, 5142 Eggelsberg, Austria Website: www.br-automation.com June 2018 ► 27

marketing initiative

Digitalization influences the pharmaceutical industry

I

ndustry 4.0 is all about creating seamless connectivity in between machines, processes, and people within and beyond manufacturing facilities to increase quality, productivity and profit by using the power of advanced data analytics. By using IoT solutions, pharma manufacturing companies can digitize and connect their various operations, increase efficiencies, enhance product quality and fulfil regulatory compliances. Pharma companies are tasked with examining data at every stage of the manufacturing process, right from the time raw materials arrives until the final product is packed and sent to distribution. In the traditional pharmaceutical facilities, the references and information about drug formulation, production and equipment and data of QA-QC are manually entered in data sheets, which are prone to human errors and can even be manipulated. However, with connected plant and IoT - solutions, manufacturers can access data in real time to monitor production, quality, OEE and condition of equipment. Mass customization and batch size one with cost-effective production is also possible with Industrial IoT. Improved operational efficiencies

With IoT implementation in manufacturing facilities, data from sensors can be monitored

to a minimum. These results also provide detailed insight into the system mechanics, allowing existing processes to be optimized with maximum efficiency.

in real-time to enhance process efficiency.

In pharma industry, appropriate quality assurance is important. Without it, companies cannot guarantee that the product conforms to necessary quality and safety standards.

Many a times quality of the product suffers because of machine downtime. In such cases, condition monitoring data in real time data can be utilized to increase the equipment availability to prevent unplanned downtime. Condition Monitoring solutions are able to predict device failures using real time data, which helps plan service and enables the maximum life cycle usage of a product, maximizing machine uptime resulting in improved OEE. Management can make faster and smarter business decisions with the use of real-time data of operational insights. IoT helps prioritize business decisions to reduce operating costs.

Indian Pharma OEM’s are selling the equipment and systems in all corners of the world. Modern communication and transportation is helping to bring distant locations closer together. But for OEMs, having customers around the world also comes with its share of new challenges.

The situation becomes more difficult when it comes time for more extensive maintenance. To avoid the cost of flying service technicians and engineers halfway around the world, OEMs are increasingly relying on remote maintenance.

Condition monitoring modules from B&R precisely detect cases when service work may be needed and are also extremely easy to configure. All of these modules are part of the X20 control system series and can therefore be used in any control topology with no limitations. A special feature of these modules is that they perform vibration analysis locally, right on the module. The availability of fully processed results reduces the time and cost of integration

Connected devices enables real-time monitoring of equipment, so engineers can remotely identify faults quickly and improve after sales service. Remote maintenance makes diagnosis and maintenance of machinery and equipment easier than ever.

Service technicians can access machines from anywhere in the world. The secure remote maintenance solution utilizes the latest IT and security standards and allows for significant savings with low investment costs.

Digital remote access

The new remote maintenance solution from B&R makes diagnosing and maintaining machinery and equipment easier than ever. The solution utilizes the latest IT and security standards and allows for significant savings with low investment costs.

Figure 1: 3D simulation of transport system shows the behaviour of all shuttles in combination with synchronised subsystems like robotics and CNC 28 ◄ June 2018

With B&R’s remote maintenance solution, a service technician can access machines from anywhere in the world to retrieve logbook entries, application data and much more. This is done via a certificate-secured and encrypted VPN connection between the SiteManager on the machine and the GateManager at the machine manufacturer’s service center. When a customer’s equipment or machine isn’t working, every minute counts.

If a service technician isn’t available on-site, it can be hours or days before expert assistance Pharma Bio World

marketing initiative

Figure 2: ACOPOStrak boosts the overall equipment effectiveness (OEE), multiplies return on investment (ROI) and accelerates the time to market (TTM)

is available. With the B&R remote maintenance solution, a technician can connect, run diagnostics, adjust parameters and resolve the error – all in a matter of moments.

while simultaneously improving product quality. This makes the production line more economical and effective at any volume from mass production down to batch size one.

Enabling mass customization

B&R’s versatile industrial transport systems, SuperTrak and ACOPOStrak helps to achieve the increased demand effectively and efficiently. Based on long-stator linear motors, B&R’s next – generation industrial transport systems are constructed with IP65 dust and water protection and smooth surfaces that are easy to clean. The hygienic design certifies operation in food grade environment. The industrial-grade design ensures high availability and reliability with 24/7 operation. Dependable, precise and remarkably low maintenance –ACOPOStrak

Demand for individualization is creating new business opportunities for everyone. However, while executing this, high ratio of setup costs to unit production costs act as a bottleneck in the manufacturing process. With latest industrial transport system manufacturers can eliminate this challenge. Next generation industrial transport technology delivers key advantages for advanced manufacturing solutions. The flexible, operator-friendly conveyors make production more efficient

melds seamlessly with robotics and CNC systems to create integrated production lines.

The flexible tracks used in the system make production more efficient, simultaneously improving product quality. This helps in making the production and packaging lines economical and effective at any volume from mass production down to batch size one. By eliminating the need for buffer zones, they allow for a substantial reduction in track length compared to conventional belt conveyors. They also make much more efficient use of the remaining space by utilising curve sections and incorporating reverse movements. Products can be transported flexibly and independently and then grouped together at a station to be processed as a batch. Overall, the production process can be accelerated by up to 50 per cent for a significant boost in productivity.

B&R’s smart-factory motion control used in the transport technology helps to achieve key advantages as maximum availability, high-speed transport and positioning, rapid changeover and fault-tolerant high quality.

ACOPOStrak boosts the overall equipment effectiveness (OEE), multiplies return on investment (ROI) and accelerates the time to market (TTM).

IoT might be in its nascent stages of adoptions, but its eventual impact across the global pharma sector is indisputable. IoT helps in the standardization of the manufacturing process along with data integrity. By systematically monitoring and analyzing large volumes of data, manufacturers can be benefit in terms of improved production efficiency, productivity, reliability and quality.

IoT provides manufacturers with a holistic view of production, raw materials and distribution, leading to better and feasible analysis of the processes thereby increasing operational efficiency.

For details Contact : B&R Industrial Automation Figure 3: Mass customization and batch size one with cost-effective production is also possible with Industrial IoT. Pharma Bio World

Corporate Communications E-mail: pooja.patil@br-automation.com June 2018 ► 29

marketing initiative

More efficiency, more communication Process and factory automation: APROL R 4.2 offers numerous new software functions

B&R has published a new major release of its APROL process control system. APROL R 4.2 contains numerous new software functions, including improved cloud communication via OPC UA and MQTT. It also offers a modern new “Dark style” interface design option.

A

PROL R 4.2 includes additional process in a convenient radar chart.

SSL/TLS communication options, Key process variables are displayed in as well as numerous new functions a pattern that makes the plant operator’s for optimizing the efficiency of plants job considerably easier. and processes. These include asset performance monitoring, new condi- Redundancy at every level tion monitoring features, an extensive business intelligence solution and The full range of redundancy options optimized alarm management. B&R has are now integrated as standard APROL also expanded its advanced process features. This makes high-availability control solution with new features such systems an attractive option, even for as a PID tuning block based on the finite smaller applications. APROL supports redundancy at every level. Operator frequency method. bus, process bus, runtime server and controllers can all be laid out redundantly Plant status at a glance using standard components. No expensive The new “Dark style” design gives special hardware is required. the operator station a clean, modern interface and makes operation easi- The new “Dark style” interface design and er and more intuitive. It is now also convenient radar chart ensure operators a possible to view the overall state of a quick and clear overview of plant status.

About B&R B&R is an innovative automation company with headquarters in Austria and offices all around the world. On July 6, 2017, B&R became a business unit of the ABB Group.

As a global leader in industrial automation, B&R combines state-of-the-art technology with advanced engineering to provide customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI and integrated safety technology.

With Industrial IoT communication standards like OPC UA, POWERLINK and openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining the future of automation engineering.

The innovative spirit that keeps B&R at the forefront of industri-al automation is driven by a commitment to simplifying processes and exceeding customer expectations.

For details Contact : B&R Industrial Automation

The new “Dark style” interface design and convenient radar chart ensure operators a quick and clear overview of plant status.

30 ◄ June 2018

Corporate Communications Tel: +43 7748 6586-0 E-mail: press@br-automation.com B&R-Strasse 1, 5142 Eggelsberg, Austria Website: www.br-automation.com Pharma Bio World

marketing initiative

Resistotech Industries Private Limited Eliminate your leakages in lined columns, tank vessels with seamless paste extruded PTFE liner.

C

hemical process industry commonly uses PTFE lined piping however non-availability of large bore diameter seamless liners chemical industry and processor go for other alternative like Glass lining, PVDF / PFA melt process / PTFE sheet welded or exotic metals like titanium / tantalum / Hastelloy, etc.

Glass lining - being fragile and can break due to mechanical shocks come under maintenance quickly, with temperature and chemical applications limits it cannot be used widely.

PTFE sheet welding / fusion with PFA rod can qualify testing of strength sometime however its weld joint, even at single drop leakage not allowing same to run for longer life.

PVDF / PFA lining have introduced due to its little better weldable properties than PTFE sheets.

It was industry needs to get developed seamless paste extruded PTFE liners in large bore diameter for column, tank and vessels with maximum lengths to avoid flange joints as source of leakage, theses columns, tanks and vessels can be used under full vacuum application with different technology like as heavy-duty thickness liners of 10 – 12 mm or mechanically extracted nozzles which holds liner from getting it buckle or inserting graphite / ceramic sleeve inside.

Construction: - seamless PTFE-lined column is with single piece without any weld joint of liners, lining of shell is done as normal lined piping with flare at both ends, nozzles are mechanically extracted having uniform thickness all over neck and flare areas, single piece construction of nozzles helps for zero leakage chances.

Pharma Bio World

June 2018 â–ş 31

marketing initiative

Comparative analysis of PTFE paste extruded seamless liners VS other techniques: -

Specifications

Paste extruded Liner D 4895

Sheet Lining PTFE / PFA / PVDF

PFA moulding

Liner Properties

As per ASTM F 1545,

PTFE with PFA rod have poor weld joints due to no parent material welds, PVDF / PFA sheet has better welds

Degrades polymer due to long hours heating at high temperatures (more than melt temperature), hard in sealing which increase chance of leakage, as per ASTM F 1545 melt grades recommended up to 10”,

Nozzle

Mechanically extracted as single piece from liner without affecting liner thickness

Welded to sheet welded liner, minimal strength at weld areas,

Moulded single piece, may have thickness variation,

A n t i - Va c u u m Protection

Mechanical extracted nozzles or higher thickness liners to be used or Graphite / ceramic sleeve can be used,

No anti-vacuum protection

Steel net of 1.5 -2 mm used inside of lining which gets damage during some operation due to permeability creating big failure of lining as swelling and blistering,

Specification: Steel Housing:- A106 Gr.B Sch.40/A516 Gr.60/70 / IS2062.

Flanges:- IS2062 / A105 /A516 Gr 60/70, SOFF/SORF dimensions as per ANSI / DIN/JIS, Welding:- As per ASME Section IX. Surface Preparation:- Surface prepared by shot blasting SA 2.5 to all steel parts.

32 ◄ June 2018

Painting:- 30 µm Zinc base primer or Epoxy or PU based primer.

Lining:- Paste extruded PTFE seamless liners as per ASTM D 4895 with liner thickness 4 – 12 mm depending on applications, maximum length of segments 3 meter in large bore.

Distributor:- PTFE. Support Plate:- PTFE, sandwich type

For details Contact : Resistotech Industries Private Limited

C-11, MIDC, Sinnar, Nashik, Maharashtra - 422113 M:- 0091 9820429054 E:- sales@ressitotech.com w:- www.resistotech.com Pharma Bio World

marketing initiative

Improved Dosing Applications using Coriolis Instruments with CORI-FILL Technology How to overcome the disadvantages of using weighing scales? How to shorten production time whilst improving the quality of the final product? The integration of (mini) CORI-FLOW instruments in your production line offers unprecedented improvement to process efficiency.

C

ORI-FILL technology features an integrated batch counter function together with the facility to directly control shut-off valves, proportional valves or (gear) pumps. Due to this technology, Cori-Tech can offer compact assemblies of (mini) CORI-FLOW instruments combined with a valve or pump, capable of dosing the exact desired amount of fluid.

In contrast to the gravimetric method (weighing scales), multiple fluids can be dosed simultaneously. Furthermore, the scales need to be re-zeroed when switching from one fluid to another, whereas instruments with CORI-FILL technology just require a short reset command to start the next batch. The amount to be dosed can be easily preset by programming the batch counter via a fieldbus connection.

This batching method is faster and more compact than the gravimetric method, and highly accurate.

As a result of their small footprint it is possible to mount the (mini) CORI-FLOW

instruments directly to the shut-off valves, thereby minimizing the internal volume, resulting in a fast response time and the highest accuracy (minimum delay-effects in the piping).

Benefits •

Reduced production time due to simultaneous dosing of compounds.

•

Improved product quality due to less evaporation of volatile fluids.

•

Compact solution due to small footprint, without extended tubing between flow meter and valve or pump.

•

Reduced risk of gas inclusion that can cause delay effects.

•

High accuracy due to Coriolis technique and compact assembly.

•

Automatic overrun correction.

•

Fast response times (to less than 0.5 sec).

•

Mass and volume dosage possible (using density information).

•

Less overhead for PLC/operating system thanks to CORI-FILL technology using integrated batch counter and direct actuator control.

Markets They are suitable for pharma, chemical, food and beverage industries.

Pharma Bio World

Applications They find application in dosage of additives, fragrances, flavours, colorants, H 2O 2 (for sterilization) in continuous or batch blending processes.

For details Contact : Toshniwal Hyvac Pvt Ltd

267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshniwal.net Website: www.toshniwal.net June 2018 ► 33

marketing initiative

The Vacuum Pump Unique in Reliability, Performance and Consumption When Others Stop, Saurus939 Carries On!

S

aurus939 has all the Italvacuum experience, a vacuum pump that is particularly suitable for the main chemical and pharmaceutical processes.

A simply designed machine, that combines traditional robustness and reliability with the most evolved technology.

Saurus939 has always been the core business of Italvacuum, one of the leading manufacturers of vacuum pumps as well as a worldwide reference point in the design and manufacture of vacuum dryers.

Resistance, strength and consumption of oil virtually eliminated thanks to the innovative LubriZero® system, a solution which guarantees perfect operation and optimum results with total respect for the environment.

Designed to work with both the most common and the most aggressive solvents, Saurus939 guarantees:

Figure 1: Saurus939 front view 34 ◄ June 2018

• Absolute safety for both operators and the process • Easy round-the-clock operation • Unrivalled performance • Nominal flowrate up to 3,800 m 3/h • Vacuum level up to 0,03 mbar • Minimum operating costs, thanks to: • Low energy consumption motors • Innovative LubriZero system, with negligible oil consumption • Easy and economical maintenance.

Saurus939 vacuum pump is particularly suitable for the most demanding applications, ensuring constant vacuum level and flow rate over time.

Powerful, efficient, but absolutely safe: Saurus939 guarantees optimum safety through the whole process and complete purity of the final product. In other words, ensures an uncontaminated vacuum.

Use in the Fine Chemicals Industry Fine chemicals, which are used as raw materials in the pharmaceutical, biopharmaceutical and agrochemical sectors, differ from basic chemical products because of their high purity.

Producing fine chemicals involves many processes of synthesis and purification employing vacuum technology. These processes include reaction, drying, distillation and crystallization.

Reaction Processes Chemical reactions are widely used in synthesizing compounds, where vacuum is required to avoid high temperatures and to remove oxygen and secondary products. Reactions normally take place at temperatures around 10/20 mbara. Vacuum reactors generally have a volume between 1 m3 and 10 m3. For these applications, it is often sufficient to use a vacuum pump with a nominal output between 80e 380 m3/h. Here, the double stage Saurus939 is the ideal solution, thanks to its resistance to corrosive solvents and reliability in the most demanding work environments.

Examples of areas where the Italvacuum vacuum pump has been used include the synthesis of: • Compounds for the agrochemical sector, where the ATEX Zone 0 version of the Saurus939 is used • Performance additives for the lubrication market, where the Saurus939 piston pump is the only technology that can be used because of the aggressive solvents and significant amount of powdered materials involved.

Drying Processes Vacuum drying takes place immediately after centrifugation or filtration. It is a process that removes the moisture from a wet solid by introducing heat. This operation is performed under vacuum in order to dry heat-sensitive substances at temperatures that are lower Pharma Bio World

marketing initiative near absolute vacuum up to 30 mbara.

Vacuum crystallizers generally have a volume between 1 m3 and 4 m3. For these applications, it is often essential to employ the Saurus939 vacuum pump in combination with a Roots compressor.

Thanks to uncontaminated vacuum and continuous recovery of extracted solvents, the Italvacuum vacuum pump maintains total finished product purity.

Figure 2: Saurus939 use in the chemicals industry

than would otherwise be possible. In the fine chemical industry, vacuum drying is a batch operation and can be carried out using a variety of technologies, depending on the product involved.

Applications for the Italvacuum vacuum pump include drying: • Raw materials for the pharmaceutical industry, where the double stage roots compressor version of the Saurus939 piston pump is used • Raw materials for the biopharmaceutical industry, where the basic double stage version of the Saurus939 vacuum pump is used.

Distillation Processes Vacuum distillation is a process in which the pressure above a liquid mixture is reduced to less than the latter’s vapour pressure, thus causing the more volatile liquid to evaporate. This process is used when the liquids to be distilled have low volatility (Teb > 150°C) or can undergo chemical decomposition at temperatures near their atmospheric boiling point. Vacuum distillation is also used to remove impurities from temperature sensitive materials such as flavorings. The pressure at which distillation is carried out may vary according to the compounds to be separated, ranging from values near absolute vacuum up to 60 mbara. Vacuum distillation columns generally have a volume between 5 m3 and 20 m3. For these applications, it is advisable to combine the Saurus939 vacuum pump with a Roots compressor in order to increase nominal output and reduce limit pressure.

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Applications of the Italvacuum vacuum pump include distillation of plant-based fragrances and flavorings for the cosmetics and food industries.

Crystallization Processes This is a process in which a solid compound is precipitated from a solution. Crystallization is employed in cases calling for extremely low operating pressures, obtained under very low absolute pressures, and for applications that involve relatively small amounts of high value-added material. It is thus usually a batch operation. Crystallization cycles last from 2 to 8 hours. The pressure at which crystallization is carried out can vary from

Use in the Pharmaceutical Industry Vacuum pumps are among the most widely used types of equipment in the pharmaceutical industry. They are employed at all scales, from pilot to industrial production, and by all sectors, from manufacturers of intermediates to producers of Active Pharmaceutical Ingredients (APIs).

A typical process calling for vacuum technology is drying, which is a crucial step in the pharmaceutical production sequence.

Drying takes place immediately after centrifugation or filtration. It is a process that removes the moisture from a wet solid by introducing heat. This operation is performed under vacuum in order to dry heat-sensitive or hygroscopic substances at temperatures that are lower than would otherwise be possible.

In the pharmaceutical industry, drying is a batch operation and can be carried out using a variety of technologies, depending on the product involved.

Figure 3: Saurus939 use in the chemicals industry June 2018 ► 35

marketing initiative these circumstances, the condenser which is always mounted upstream of the Saurus939 vacuum unit is bypassed and the positivedisplacement compressor is activated. With the compressor’s help, it is possible to reach very high vacuums – at least an order of magnitude below the levels that could be reached with the vacuum pump alone – together with extremely high output (here again, the output increases by around one order of magnitude).

Figure 4: Saurus939 use in the pharmaceutical industry

Crystalline products produced by synthesis (reactors) are chiefly processed using dynamic dryers (ie, rotary and horizontal paddle dryers). These products, in fact, must have a very specific particle size and very low humidity.

Amorphous or plant and animal based products, on the other hand, are normally processed in static dryers. Particle size is not usually a determining factor for these products, since they are subsequently ground, and the moisture content is never as strictly controlled.

Dynamic Drying In a dynamic system, the drying process’s effectiveness depends not only on the system itself, but also on the vacuum unit. This is

the typical case found in the production of Active Pharmaceutical Ingredients (APIs) using rotary dryers and horizontal paddle dryers. Here, the vacuum pump must cope at the same time with aggressive organic solvents such as acetone, toluene and so forth, and the potential interaction with solid powder particles (especially if they are not adequately removed by the filter systems).

The Italvacuum vacuum pump can deal with both these issues.

Where very low final moisture content is required, dynamic dryers are often combined with pumps coupled with roots compressors.

For processing purposes, these compressors must be activated at the final stage of drying in order to extract the last traces of solvent retained in pharmaceutical powders. Under

In drying APIs, other vacuum technologies are less effective than the Saurus939 pump.

Rotary vane pumps and liquid-ring pumps have a number of shortcomings when used with aggressive solvents, including a short life cycle and limited application in severe operating conditions. Dry pumps, on the other hand, have difficulty dealing with processes involving a great deal of interaction with solid particles, as they are particularly susceptible to damage by minimum quantities of dust.

Static Drying By contrast with dynamic dryers, static dryers, which are universal systems capable of drying any product, rarely need roots compressors. In addition, this technology only sporadically requires a filter between the dryer and the vacuum unit.

An example of application consists of drying plant extracts, a typical process used in today’s booming herbal industry. This sector combines the most modern extraction technologies with the vacuum drying techniques that the pharmaceutical industry has used from its beginnings. Natural and plant-based products are subjected to solvent extraction. The batch resulting from this process is then dried in order to retain all its heat-sensitive properties without change.

The vacuum pump and the condenser unit are activated during this process. Both remain active for the entire duration of the process.

The double stage version of the Saurus939 vacuum pump is used with or without a roots compressor. ◘

Your vacuum drying specialist

Figure 5: Saurus939 use in the pharmaceutical industry 36 ◄ June 2018

For more info, please visit: www.italvacuum.com Pharma Bio World

press release Agilent to Showcase Latest Analytical Solutions at Two Scientific Symposiums in India Agilent Technologies Inc. will be hosting two scientific symposiums in India this summer, both featuring industry speakers, interactive workshops, and Agilent’s latest analytical solutions.

The first edition of the Total Agilent Experience, held in Mumbai last year, drew 300 scientists and researchers from across the country.

This year’s symposiums took place in Ahmedabad, 13th June, and Hyderabad, 20th June.

“The Total Agilent Experience offers unparalleled opportunities for scientists and industry leaders to talk about new ways to solve problems and make their laboratories more efficient,” said Bharat Bhardwaj, country manager for Agilent in India.

On display at the two symposiums was Agilent’s latest chromatography, mass spectrometry, and spectroscopy platforms, including: • The Agilent Intuvo 9000 GC system, which features click-andrun connections that eliminate ferrules, guard-chip technology that extends column life, and a trim-free column that eliminates retention time shifts due to trimming.

• The Agilent Ultivo Triple Quadrupole LC/MS system, which delivers robust performance, superior uptime, and easier serviceability, in a footprint that is 70% smaller than previous instruments.

• A suite of innovative Raman spectroscopy instruments, acquired last year when Agilent bought Cobalt Light Systems, a UK-based developer of innovative technologies for non-invasive, throughbarrier chemical analysis for use in pharmaceutical and publicsafety applications.

Using the sophisticated, user-friendly technologies offered by these platforms, scientists are now able to work on a wider range of challenging applications with improved performance and ease of use, while also increasing laboratory productivity and economic value.

Metropolis Healthcare launches new test to screen and diagnose Preeclampsia Metropolis Healthcare has launched sFlt-1/PlGF ratio, a new tool for the diagnosis of preeclampsia by discriminating between preeclamptic pregnancies and other forms of pregnancy-related hypertensive disorders. Its uniqueness lies in the fact that it has been conceptualized as a simple blood test to deliver clear, reliable results with a specificity of 95% and a sensitivity of 82% to help identify patients at risk for potentially life threatening complications.

It is believed that Preeclampsia may be caused by an imbalance of angiogenic factors. It has been demonstrated that high serum levels of sFlt-1, an anti-angiogenic protein (inhibits growth of new blood vessels) and low levels of PlGF, a pro-angiogenic protein (promotes Pharma Bio World

growth of new blood vessels) predict subsequent development of preeclampsia.

Speaking on the launch of this new test, Dr Sushil Shah, Founder & Chairman, Metropolis Healthcare said “Metropolis is proud to launch this test to diagnose preeclampsia and we truly believe that this will greatly help clinicians manage their patients accordingly. This new test could be a life saver for moms at risk.”

Adding to it, Dr Deepak Sanghavi, Head of Department, Clinical Chemistry said “Clinical criteria alone (blood pressure and proteinuria) may be inadequate to predict adverse outcomes. This test for preeclampsia allows for early and precise diagnosis leading to effective clinical management and improving the outcome for mother and child.”

Though it may sound complicated, Indians have been aware of preeclampsia over several decades. The need for developing high-accuracy diagnostic pathways have prompted doctors to start monitoring blood pressure from early pregnancy periods to ensure the close monitoring of high-risk pregnancies.

Senior Marketing Director - Biocon, Vasudev Tribhuvan, joins Wellthy Therapeutics Wellthy Therapeutics (Wellthy) has announced the appointment of Vasudev V. Tribhuvan as Vice President, Partnerships & Alliances effective May 2018.

Commenting on the appointment, Abhishek Shah, Co-Founder and CEO of Wellthy Therapeutics said, “We have reached a point where digital pills greatly augment conventional drugs to target outcomes which were previously unheard of. Wellthy has already been pioneering outcomes beyond the pill in India. Vasudev's rich experience in understanding of healthcare stakeholder problems, coupled with Wellthy’s world-class platform to solve for them has incredible potential to accelerate our impact goals, both in India and in Asia”.

Vasudev’s previous role was at Biocon, where he was the Senior Director, Marketing and led strategic initiatives for the metabolic unit while guiding the team on patient programs. Prior to Biocon, Vasudev held sales and marketing leadership roles with AstraZeneca, Boehringer Ingelheim and Novo Nordisk, and is an alumni of the University of California, Los Angeles.

Commenting on his new role, Vasudev V. Tribhuvan said, “For years, there has been a push within the pharmaceutical industry to move ‘beyond the pill’, to improve outcomes in chronic metabolic disorders. The impetus to move beyond the pill typically arises from the realizations that drugs alone do not suffice for patients to achieve optimal clinical outcomes. Pharma companies should consider integrating beyond-the-pill solutions as a differentiated package offering in chronic disease categories, also ensuring better outcomes.”

June 2018 ► 37

press release Lupin Gets FDA approval for generic Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram Pharma major Lupin announced that it has received final approval for its Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram, from the United States Food and Drug Administration (FDA) to market a generic version of Delcor Asset Corporation’s (Delcor) Mycolog®-II Cream.

Lupin’s Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1mg/gram, is the generic equivalent of Delcor’s Mycolog®-II Cream. It is indicated for the treatment of cutaneous candidiasis.

Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/ gram and 1mg/gram, had annual sales of approximately USD 62.2 million in the US (IQVIA MAT April 2018).

US FDA Approves Mylan and Biocon’s Fulphila, the First Biosimilar to Neulasta Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) has announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Fulphila (pegfilgrastimjmbd), a biosimilar to Neulasta (pegfilgrastim), co-developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer.

Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon’s joint portfolio approved in the U.S. Mylan anticipates launching Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients. A suite of patient services also will be available at launch to further support patients and caregivers with treatment.

As a global leader in the development and manufacturing of complex products, Mylan has a portfolio of 20 biosimilar and insulin analog products – one of the industry’s largest and most diverse portfolios – and deep experience with more than 60 marketing authorizations for biosimilar products worldwide.

Mylan was the first company to receive FDA approval of Ogivri, a biosimilar to Herceptin (trastuzumab), in late 2017 and has continued to obtain regulatory approvals for biosimilar trastuzumab in nearly 30 additional countries around the world.

The approval for Fulphila was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that the product is highly similar to Neulasta. The data demonstrated that there were no clinically meaningful differences between the biosimilar product and Neulasta in terms of safety, purity and potency.

38 ◄ June 2018

Neulasta had U.S. sales of $4.2 billion for the 12 months ending March 31, 2018, according to IQVIA. Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Do not administer Fulphila to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. Splenic rupture and sickle cell crisis, including fatal cases, can occur following the administration of Fulphila. Discontinue Fulphila in patients with Acute Respiratory Distress Syndrome and consider dose reduction or interruption in patients with glomerulonephritis. The most common adverse reactions are bone pain and pain in extremity.

2018 China International Pharma 4.0 Summit Successfully Ended At the Longemont Shanghai During May 17-18, 2018, 2018 China International Pharma 4.0 Summit held by Borscon Group was ceremoniously convened in The Longemont Shanghai. This summit was strongly supported by important institutions at home and abroad such as Ministry of industry and information technology, China Chemical Pharmaceutical Industry Association, ISPE member unit -Lachman Consultants, Fraunhofer IPK Research Institute, China Pharmaceutical City, Optics Valley Bio City, etc. and related leaders.

Mr. Wu Haidong, deputy director of the consumer products division of the Ministry of industry and information technology, Mr. Pan Guangcheng, executive chairman of China Chemical Pharmaceutical Industry Association came to the meeting, taking a deep interpretation of the nineteen largest party of the party and the strategic planning of manufacturing in China for the high quality development of the pharmaceutical industry in 2025; the summit also successfully invited the experts and scholars of Pfizer, GSK, Yang Sen, Sanofi, and Tian Shi Li, separately taking a discussion of multi angle and deep level for the application and development of advanced pharmaceutical technology such as continuous manufacturing, PCMM system, innovation driven, virtualization, modularization, informatization and digitalization and so on, as well as the intelligent upgrading and transformation of Chinese traditional medicine. In addition, many top smart technology suppliers such as Cheng Yi Tong, CHIEFTAIN, SIEMENS, Swisslog, Rockwell Automation and so on brought solutions of Landing and realizing the customization, efficiency, flexibility and precision of pharmaceutical 4.0 and actual cases.

The thematic sharing that unusually brilliant -- with high lights of the above made the 153 representatives present have receive a great deal of outstanding especially 80 executives, directors and managers from the pharmaceutical development, manufacturing, and quality control departments of the pharmaceutical factory. In addition to the topic speech in the field, the site was also integrated into a variety of communication links such as round table discussion, tea break and outdoor display and so on, for providing the possibility of more opportunities for cooperation for the participants.

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press release AstraZeneca expands its GMD Centre in India Global science-led biopharmaceutical company AstraZeneca officially opened its new Global Medicines Development (GMD) Centre in Bengaluru, India. This unit is one of AstraZeneca’s nine GMD centres around the world that transform breakthrough molecules into medicines and monitor their use and safety. With this opening, India will now play an even bigger role in AstraZeneca’s global operations.

Globally, GMD works with AstraZeneca’s two biotech units – Innovative Medicines and Early Development (IMED) and MedImmune – and the Global Portfolio and Product Strategy (GPPS) organisation to understand where there is unmet medical need, to shape AstraZeneca’s therapy area strategies from early development through to commercialisation.

The GMD Bengaluru team will focus on supporting AstraZeneca’s medicines, which covers treatments across a range of therapy areas, including oncology, respiratory and cardiovascular and metabolic diseases. GMD Bengaluru plays a key role supporting 51 of AstraZeneca’s mature brands which are used by patients around the world. During the last year, the team has recruited scientific experts in the fields of regulatory science, clinical, and patient safety, and has grown from 30 to 70 people. The expansion will see a further increase to more than 100 specialists.

LifeCell launches “Pentastic” LifeCell, India’s premier mother & baby diagnostics company and stem cell bank, has launched “Pentastic” - an ultrasound and biochemistry based blood test undertaken in the first trimester of pregnancy between 11 to 13 weeks 6 days to screen for genetic abnormalities, structural malformations in the fetus and serious high blood pressure in pregnancy.

Compared to conventional screening tests that use only 2 analytes [PAPP-A + free hCGß], the new Pentastic test incorporates 5 analytes [PAPP-A + free hCGß + AFP + Inhibin-A + PIGF] to predict the risk. Addition of these new analytes can significantly improve the detection of these abnormalities whilst simultaneously lowering the number of false alarms raised. This would lead to substantial improvements in health outcomes whilst providing a higher level of reassurance for expectant parents.

The screening will be performed on a platform accredited by Fetal Medical Foundation (FMF), the flagship international organisation for fetal diagnostics.

Sanofi Genzyme partners with MSSI to support the multiple sclerosis community in the country Sanofi Genzyme, the specialty care global business unit of Sanofi, and Multiple Sclerosis Society of India (MSSI) join hands to raise Pharma Bio World

awareness and to provide better treatment solutions for the 130,000 people living with Multiple Sclerosis (MS) in India.

Sanofi Genzyme and MSSI are working together to ensure that people affected with multiple sclerosis can continue to live fuller lives through support programs that enhance their quality of life.

The eight MSSI chapters in - Delhi, Mumbai, Bengaluru, Chennai, Hyderabad, Kolkata, Indore and Pune, along with Sanofi Genzyme are rolling out this year’s campaign #bringinguscloser, through various awareness programs such as symposiums, MS camps, MS walks, medical seminars, photo exhibitions, and laughter & music therapy sessions. These programs will help bring the multiple sclerosis (MS) community together to share stories and raise awareness about the condition.

Sanofi Genzyme in India is focused on treatment for multiple sclerosis, rare diseases, and immunology. Through its partnership with the MSSI in India, Sanofi Genzyme is playing a critical role in enabling and empowering the lives of people with multiple sclerosis.

Globally, Sanofi Genzyme is continuously working to advance multiple sclerosis treatment and care with therapies, portfolio of research and development-stage programs, and MS research collaborations.

Syngene International Announces Partnership with Zumutor Biologics for Biotherapeutic Antibody Discovery Services Syngene International, a leading global Contract Research Services Company, has entered into a non-exclusive partnering agreement with Zumutor Biologics, an emerging immuno-oncology Company, to access Zumutor’s proprietary naïve human phage/yeast display library. This collaboration further enhances Syngene’s marketleading capabilities in Discovery Biology, providing its scientists with additional tools to help solve complex biology problems in biotherapeutic drug discovery.

Under the terms of the agreement, Syngene will screen target antigens against Zumutor’s proprietary human antibody libraries to identify and characterize novel antibody clones, which will be further developed by Syngene towards novel biotherapeutics programs for its partners.

Kavitha Iyer Rodrigues, Founder-CEO, Zumutor Biologics said, “Zumutor will use its proprietary antibody display platform to enhance Syngene’s discovery programmes. Our antibody engineering expertise and experience enables us to optimize any lead to evolve into a best-in-class differentiated molecule”.

Commenting on the collaboration, Dr. Manoj Nerurkar, Chief Operating Officer, Syngene International, said, “Syngene has been a pioneer in discovery research and we see Discovery Biology as one of our growth drivers. This partnership will expand our existing portfolio of therapeutic antibody discovery platforms for our clients”.

June 2018 ► 39

press release ZIM Laboratories Limited to List on BSE Main Board ZIM Laboratories Limited (ZIM) – is a unique R&D centered pharmaceutical company focused on developing and supply of complex generics products based on proprietary Novel Drug Delivery Solutions (NDDS).

ZIM got listed on OTC Exchange of India in 1994, following the SEBI guidelines the company will be listing on BSE and will have a price discovery as per trading on the bourses.

Promoted by Technocrat Dr. Anwar Daud, the company has a Unique R&D focused business model helping customers with product development, co-development, out licensing, manufacturing, supplies and marketing support with a strong IP base – 26 inventions with 53 patent filings and 174 clients across 45 countries.

Incepted in 1989, ZIM has made a significant mark as a pharma innovator. Throughout all these years constantly penetrating newer areas of pharmaceutical technology and business, ZIM has established itself as a preferred healthcare solution provider in the field of New Drug Delivery Systems.

Dr Rajiv Kovil, Consultant Diabetologist, commented “It is really great to see a tool that not just stresses on the importance of SMBG, but is effectively improving the adherence of and value to patients. SMBG is an essential tool in the optimal management of diabetes, and am glad to see clinically validated real time responses helping patients manage their blood sugar levels better”.

Stressing on the importance of improved SMBG among people with diabetes, Dr. Banshi Saboo (MD. PhD), Chairman, DiaCare Ahmedabad, Hon. Sec of Diabetes India said, “In-spite of the advice given by physicians to patients with Type 2 diabetes, compliance with SMBG in patients living in India is very low.

There is a need to help, encourage and empower patients beyond the test, to enable better compliance and better glycaemic variability. Digital Therapeutics like Wellthy Care provides data that is acquired, integrated, analysed, and presented in a self‐ explanatory manner to patients, while highlighting important trends that require attention for physicians, and am glad to see such encouraging results.”

Dr. Cyrus Poonawalla conferred with “Doctor of Science Hon.” By the University Digital therapeutics improves self-monitoring of Massachusetts of blood glucose adherence in India The University of Massachusetts conferred Dr. Cyrus Poonawalla, Clinical data published in the latest edition of Endocrine Practice, the AACE Journal established the role of Wellthy Care, a digital therapeutic platform by Wellthy Therapeutics, in improving self-monitoring of blood glucose (SMBG) for patients with Type II Diabetes.

As per clinical guidelines, a Type 2 diabetic patient should check his blood glucose daily. Real World studies in India indicate, that the average educated diabetes patient checks blood glucose less than once a month.

The data reported from 104 patients that recorded a total of 1288 blood glucose readings (12.38 measurements per patient on average) shows how Wellthy Care can potentially help physicians and HCPs personalize care for their patients by knowing the glycaemic variability. On completion of the 16 weeks program, 56% and 50% of patients reported a reduction in their fasting blood sugar and post prandial blood sugar values respectively, with significantly more readings than average at the time of the next physician appointment.

“There is an unmet need for personalised care in between doctor visits.

In emerging markets like India, SMBG still remains relatively affordable versus other blood sugar measuring diagnostic tools. Real time feedback and guidance plays a crucial role for SMBG adherence and value creation, which needs tools like chat bots and self learning logic systems like those that Wellthy Therapeutics provides for patients.

Better and more data leads to personalised decision support for both the doctor and the patient, which is of utmost importance to enable the respective stakeholder to action decisions leading to better outcomes, and enables patients to unlock more value from their device” said Abhishek Shah, Co-Founder and CEO, Wellthy Therapeutics.

40 ◄ June 2018

with the Honorary Degree of “Doctor of Science Hon” for his commendable work in the field of vaccines. Known as one of the ‘seven vaccine heroes of the world’ by Bill & Melinda Gates Foundation, Dr. Poonawalla is the Founder of Serum Institute of India, world’s largest vaccine manufacturer producing 1.5 billion doses annually that are administered in 170 countries.

Dr. Poonawalla said, “I am grateful to the University of Massachusetts for recognising our work. I strongly feel that we need to treat the field of vaccination with the respect it deserves. It’s not just another field related to medical science. But one of the most important ones.

We need more precautionary measures than cures for betterment of human life and vaccination is one such measure”.

In the past, this degree has been awarded to Barack Obama, in the year 2006, Anthony S. Fauci, Director of National Institute of Allergy and Infectious Disease in the year 2008 and Her Excellency Ellen Johnson Sirleaf, President of Liberia and the 2011 co-recipient of the Nobel Peace Prize in 2012.

Along with Dr. Poonawallah, physician-scientist Huda Y. Zoghbi and Duke University nursing leader Marion E. Broome were conferred with the Honorary Degree if "Doctor of Science Hon." for their accomplishments as well.

Dr. Poonawalla is also the first Indian to receive the award for “Excellence in Inter-American Public Health” by the Pan American Health Organization (PAHO) and the Pan American Health and Education Foundation (PAHEF).

Pharma Bio World

Oil-lubricated Vacuum Pumps Toshniwal supplies oillubricated vacuum pumps.

These oil lubricated vacuum pumps of the TMS Series are single stage, oil-lubricated rotary vane vacuum pumps with oil re-circulation system. The lubricant system is rated for continuous operation of high intake pressures so that the pump may be used in a versatile manner in most rough vacuum applications. The pumps are used for suction of air also in presence of water vapour and for continuous industrial use. TMS Series pumps are made from high quality materials, has economical features which matches together to achieve: high pumping speed over the range of absolute pressure 1,000-0.5 mbar; high water vapour tolerance and low noise level; no pollution; air-cooled: builtin anti-suck-back system. The pumping capacities available are: 17 m3/hr, 35 m3/hr, 65 m3/hr, 100 m3/hr and 150 m3/hr 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

Liquid Ring Vacuum Pump POMPETRAVAINI is one of the leading worldwide manufacturers of liquid ring vacuum pumps with single stage (TRS) and two-stage (TRH) pump series.

With the experience acquired through decades of engineering research. Continual investments in the latest technological advanced machinery and sound mechanical know-how, POMPETRAVAVINI’s product is today synonymous with high quality, high efficiency, robust construction and maximum reliability.It finds application in central vacuum system, deaeration, impregnation, boiling processes, vacuum condensing, distillation, drying, sterilization, filtration, solvent recovery, etc.

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

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Mass Flow Controller Coriolis mass flow meters are appreciated for their accuracy and independence of fluid properties. The direct coriolis mass flow measuring principle is generally used for higher flow rates. Moreover, mini CORLFLOW instruments have an integrated PID-controller and a batch counter to control the fluid flow. Features direct flow measurement, independent of fluid properties; fast response time; high accuracy, excellent repeatability; additional density and temperature output; compact design (same footprint as CORI-FLOW M50 Series); and excellent price/performance ratio.

For more information, please contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044-2644 8558, 26448983 Fax: 91-044-26441820 E-mail: sales@toshniwal.net

Oval Wheel Meters The oval wheels (Type OI), displaces precisely known volume of liquid through the meter, from inlet to outlet. The number of revolutions therefore is directly proportional to the measured volume.For the protection of oval wheel meters and turbine meters against foreign matter and solids contained in the liquids, measured with these meters. These strainers may also be used for protection of piping systems for contamination. Strainers, Type N.... without heating jacket are available in sizes 15-100 mm (1/2” to 4”). Features include: high flow capacity with little space requirement; high accuracy with low pressure drops; pulse and current output for remote transmission; safe operation and long service life; approved by Weights and Measures Authorities; etc.

For more information, please contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Te: 044-26445626, 26448983 E-mail: sales@toshnwial.net

June 2018 ► 41

High-resolution MS

Ribbon/Paddle Vacuum Mixer Dryer

Orbitrap technology has become the recognised standard for routinely achievable ultra-high resolution (>250,000) mass spectrometry with reliable accurate mass. Combined with superior dynamic range and unsurpassed sensitivity, orbitrapbased platforms are the only LC-MS and MS/MS systems capable of providing all four benefits at the same time, without compromise. The addition of an ion trap mass analyser to an Orbitrap detector enables multiple levels of fragmentation (MSn) as well as multiple fragmentation modes (CID, HCD and ETD) for the elucidation of analyte structures.

Coupling with continuous ionization sources such as atmospheric pressure chemical ionization source (APCI), electrospray (ESI) or nanoelectrospray (NSI), provides increased analytical flexibility and power.

For more information, please contact: Thermo Fisher Scientific India Pvt Ltd 102, 104, Delphi ‘C’ Wing Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-67420404 Fax: 91-022-67429495 E-mail: sagar.chavan@thermofisher.com

The ribbon paddle vacuum mixer dryer is suitable for mixing and drying the material which cannot operate at high temperature easily oxidised, poisonous in nature. It operates at low temperature under vacuum and used for drying and mixing powder.

They are available in models 10 to 10,000 litre working capacity. U-shape jacketed and vacuumized container is available with ribbon or paddle stirrer. Vacuumized closed system with condenser, receiver for solvent recovery. Uniform mixing and drying process under vacuumizer is at low temperature.

For more information, please contact: Prism Pharma Machinery Plot No: 3713, Phase IV, GIDC Vatva, Ahmedabad, Gujarat 383 445 Tel: 079-29095204 Fax: 91-079-25841623 E-mail: mkt@prismpharmamachinery.com sales@prismpharmamachinery.com

Contra Rotary Mixer Contta rotary mixer available in standard cGMP and customised models with SS-304/316/316L contact parts designed exclusively for mixing of ointments, pastes, creams as highly applicable in pharma and cosmetic industries.

Double contra rotary blades creating a laminar thinning of materials ensure uniform mixing. Precision design favours intensive mixing, dispersing and kneading of products of any level of viscosity.

Supplied as a complete unit, only requires levelling and connection to electrical and air supply. It is perfectly designed to withstand the vacuum created during the mixing process.

Contra rotary mixer is provided with jacket for cooling or heating as per the application.

Enriched with vacuum operation, agitation and jacket it is suitable for steam heating.

They are available in batch capacities ranging from 50 to 5,000 kg as per client’s requirements.

For more information, please contact:

IPEC Engg Pvt Ltd Plot No: 5175, GIDC, Ankleshwar Gujarat 398 002 Tel: 02646-221175 Telefax: 91-02646-225175 E-mail: md@ipecengg.com / marketing@ipecengg.com

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Analytical Solutions Depending on the measuring task in question, Endress+Hauser offers customer-specific analytical solutions such as monitoring panels, cabinets or stations as well as automation systems.

Their monitoring stations are supplied in turnkey condition and contain all of the components required from sample preparation right through to the transfer of data to higher level systems. This guarantees easy installation, operation and calibration. These monitoring solutions are individually adapted to the customer’s specific ambient conditions as well as communication and service requirements.

Their automation solutions support you in optimizing your processes, be this aeration control or phosphate dosing in a wastewater treatment plant or the automatic cleaning and calibration of pH measuring stations in the chemical or life science industries.

For more information, please contact:

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

Vial and Bottle Labeller LSS, a subsidiary of German Logopak from Denmark developed a standard Vial and Bottle Labeller and a Tamper Evident Labeller.

Both machines are designed with high attention to simple and safe operation, precision in labelling as well as safe and secure product handling. Easy function overview, inspection and control, easy line clearance and ergonomics are also significant features of both labellers.

The new Tamper Evident Labeller from LSS complies with the Falsified Medicines Directive (FMD) 2011/62/EU mandatory for the pharma industry within the EU directive and ensures tamper-proof security of cartons. As an option, a laser or inkjet printer and a vision system of any brand can be integrated to provide each carton with a unique identification for track and trace, and serialisation.

The machine is operated with a user-friendly HMI. The flexible solution handles cartons ranging from 50 to 220 mm in width, 15 to 120 mm in height and 40 to 120 mm in length. A small foot-print allows the machine to fit into any production area easily.

The LSS Vial and Bottle Labeller can be used for labelling a wide variety of smaller cylindrical products made of glass or plastic with a product dia between 14 and 35 mm and a min height of 30 mm. The efficient machine labels up to 250 vials or bottles per minute and runs both as an off-line or in-line unit. Thanks to its small footprint and modular design, it is the right solution for both new and already existing production environments. Vision inspection of both the label and the vial or bottle ensures max safety.

For more information, please contact: LSS Etikettering A/S Labelling Systems Scandinavia Normansvej 8 DK-8920 Randers NV Denmark Tel: +45 7020 2500 E-mail: ul@lss-dk.com

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Planetary Mixer

Microbial Enumeration Test System Planetary mixers are available in standard cGMP and customised models with SS-304/316/316L contact parts. They are designed exclusively for mixing of ointments, pastes, creams, dry powders and wet mass.

designed agitator profile.

Precision design favours intensive mixing, dispersing and kneading of products of any level of viscosity. They are specially

Supplied as a complete unit, only requires levelling and connection to electrical and air supply. They are applicable in pharma and cosmetic industries and available in batch capacities ranging from 50 to 1,000 kg, as per client’s requirements.

For more information, please contact: IPEC Engg Pvt Ltd Plot No: 5175, GIDC, Ankleshwar Gujarat 398 002 Tel: 02646-221175 Telefax: 91-02646-225175 E-mail: md@ipecengg.com marketing@ipecengg.com

HTY micro-organism limit test systems adopt membrane filtration method composed

by HTY-100 microorganism test device and S60 incubation kits. HTY-100 microorganism test device has equipped an in-built vacuum pump, which makes inside and outside vacuum power available.

It can be directly poured with solid medium and cultured without transferring membrane; relieve the operations of preparing dishing and sticking membrane. Larger diameter with a 60 mm membrane is more convenient for counting the bacterial colony of samples with more of them. The whole machine is anti-rust and easy to clean.

For more information, please contact: Shreedhar Instruments 16 Shreeji Krupa Society Opp: MGVCL Circle Office Next to GMERS Medical College Gotri Road, Vadodara, Gujarat 390 023 Telefax: 91-0265-232041 E-mail: sales@shreeedhargroup.com

Industrial Sliding Doors Doors are constructed of 100 per cent CFC-free polyurethane high density insulated steel sliding doors of 80, 120 or 150 mm thickness with protection against corrosion or corrugated PEB cladding sheet.

Minimum headroom required and is best suited for temperature controlled areas.

Top rollers made of self-lubricating nylon which ensures smooth and noise-free movement of the door. Hot galvanised material treated with primer and polyester resin offer optimum protection against adverse effects of the environment.

It is equipped with CE Certified rugged and powerful drive unit, integral electronic control unit and built-in contact-less magnetic limit-switch.

For more information, please contact: Gandhi Automations Pvt Ltd Chawda Commercial Centre, Link Road Malad (W), Mumbai 400 064 Tel: 022-66720200, 66720300 Fax: 91-022-66720201 E-mail: sales@geapl.co.in

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Orbitrap Fusion Lumos Tribrid Mass Spectrometer The new Thermo Scientific Orbitrap Fusion Lumos Tribrid Mass spectrometer expands performance in advanced proteomics, biopharma and metabolomics applications, including quatitation using isobaric tags, low level PTM analysis, data independent acquisition (DIA), and top down proteomics. The new instrument features enhanced sensitivity resulting in improved analyte detection, characterisation and quantitation, enabling scientists to perform more comprehensive sample analysis faster and with better accuracy than ever before.

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 Fax: 91-022-67429405 E-mail: sagar.chavan@thermofisher.com

Production of Injection Solutions Bosch offers flexible processing system for an economic production of injection solutions.

The seamless transport of the product from the processing machine to the ALF filling machine can be tracked using LED visualization. Further, Bosch shows how data from the processing and filling machines is fed into a single system and visually displayed in an Industry 4.0 application.

The SVP250 LF processing system is designed for injection solutions (Small Volume Parenterals, SVPs) with small batches ranging from 15 to 250 liters. The system includes both a preparation and a storage vessel. Depending on the desired volume, these process vessels can be expanded to four each, in a range of different sizes.

The preconfigured architecture allows processing modules to be easily and flexibly installed or exchanged, for instance for different temperature-control concepts or the feeding of different media like powders, liquids or gases. Since the process vessels are equipped with a gassing module for nitrogen, production can also take place under low-oxygen conditions.

In addition to its suitability for Industry 4.0 applications, the ALF 5000 filling and closing machine delivers a high degree of process reliability and flexibility. In the combi configuration, the machine not only processes ampoules but also injection bottles. It can be equipped with all standard filling systems and four, six, eight, ten or twelve filling heads. A carrying walking beam system can be used for especially gentle handling. Here, the glass containers are lifted slightly so as to ensure they are not damaged by rubbing along the machine guides. Without sacrificing product quality, the ALF 5000 delivers output rates of up to 600 containers per minute. According to Bosch’s pharma line competence, the system can easily be combined with upstream or downstream machines. Customers who order both their preparation and filling machines from Bosch receive a coherent overall concept and a number of further advantages: during project implementation, Bosch attends to the complete coordination of interfaces between systems, which fosters efficient planning and smooth processes.

For more information, please contact: Commha Consulting GmbH & Co. KG Poststraße 48 D-69115 Heidelberg. Germany Tel: +49 6221 18779-32 E-mail: bosch@commhaconsulting.com

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Vacuum Shelf Tray Dryer The vacuum tray dryers are used to heat and dry material under vacuum, where difficulties in drying materials due to high toxic contents, hygroscopic in nature, heat sensitive.

They are available in models 6, 12, 24, 36 and 48 tray loading capacities; vacuumize shelves drying on low temperature system for high toxic, hygroscopic and heat sensitive materials; vacuumized closed system with condenser, receiver for solvent recovery; very low value of final moisture even at low drying temperatures; etc.

For more information, please contact: Prism Pharma Machinery Plot No: 3713, Phase IV, GIDC Vatva, Ahmedabad, Gujarat 383 445 Tel: 079-29095204 Fax: 91-079-25841623 E-mail: mkt@prismpharmamachinery.com sales@prismpharmamachinery.com

Extruder The extruder is a self-contained compact machine for the special purpose of making pallets. The raw material is introduced axially from the feed hopper into screw housing where it is exposed to rotating screw which conveys the material towards rotor. Rotor forces the material to pass through the mesh with the effect of scraping impact resulting in formation of cylindrical extruders - R&D Models: single screw EXT-20, EXT-30, EXT 60; and Production Models: twin screw TSEXT-100, TSEXT-130.

For more information, please contact:

Sunsai Pharma Equipments Pvt Ltd Plot No: 1, Survey No: 77, Nr Laxmi Indl Estate Sativali Road, Vasai (E), Thane Maharashtra 401 208 Tel: 0250-3200130 E-mail: sunsai.pharma@rediffmail.com sunsaipharma@gmail.com

Hotmelt Coating System Romaco Innojet offers GMP compliant hot melt coating device specifically for use in the pharma industry.

The IHD Series for processing hot melt coatings can be supplied as a laboratory or pilot scale machine.

The IHD Series was specially designed for coating and granulating pharma products with hot greases and waxes. The hot melt coating flows through straight tubes to prevent any build-up of product residues. The IHD Series successfully avoids cross-contamination thanks to the hygienic design with no dead spaces.

The Innojet IHD was designed as a heatable monobloc integrating all functional components. The melting container, dosing unit and valve block are all included in the same thermal cycle, which means they do not have to be heated and insulated separately. The compact hot melt coating devices are connected via a trace heated tube to the processing machines in the Romaco Innojet VENTILUS Series whenever this is required by the application. The Innojet IHD feeds the hot melt with a pulsation-free dosing piston as standard, so that the coating is applied to the product absolutely evenly. The central bottom spray nozzle on the Innojet machine enables both the temperature and the size of the droplets with which the product particles are coated to be precisely defined. The Romaco Innojet air flow bed technology ensures homogeneous and controllable flow conditions in the container of the processing machines. The laboratory scale version of the hot melt coating device (Innojet IHD 5) is designed to handle batches of up to 5 litres while the pilot scale machine (Innojet IHD 50) can process up to 50 litres.

For more information, please contact: 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

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Freeze Dryer Bosch Packaging Technology offers freeze dryer. The lyophilization system can be used to stabilize thermolabile and delicate active ingredients like oncological medications, vaccines or antibodies.

Its modular design makes the GMP-compliant freeze dryer suitable for the production of small batches for clinical trials, as well as for medium and large production batches.

During the freeze drying process, water is extracted from the drugs by means of sublimation without affecting its properties. The dry, porous lyo cake can be quickly and easily reconstituted shortly before use by adding sterile water.

Another advantage of the system is the homogenous temperature distribution in the shelves. The internal channeling and flow velocity were optimized on the especially developed test bed to ensure consistent heat exchange. The tilting shelves ensure rapid cleaning: the slight tilt enables water droplets to quickly drain from the surface, shortening the cleaning and drying time. The tilt angle also improves the performance of the CIP nozzles, reducing water consumption.

For more information, please contact: Commha Consulting GmbH & Co KG PoststraĂ&#x;e 48 D-69115 Heidelberg, Germany Tel: +49 6221 18779-32 E-mail: bosch@commhaconsulting.com

Capsule Filling Machine Bosch Packaging Technology offers a fast high-precision capsule filling machine for small batches. The new GKF 720 ensures efficient and resource-saving processing for all types of hard capsules. Building on many years of experience with the 702 ProTect and 1700 HiProTect Series, the GKF 720 completes the Bosch containment portfolio with an output of 720 capsules per minute.

In the first cleaning stage of the GKF 720, the components that come into contact with the product are automatically cleaned from above with 200 milli-liters of water, binding the highly potent residual dust. In the second stage, the processing area is manually flushed with ten liters of water max, quickly and completely ridding it of any product residue. The specially designed tabletop and the new dosing stations make sure that no water penetrates the machine room during cleaning.

The GKF 720 is designed for processing powders, pellets and tablets. For pellets and micro-dosed powders in particular, it features a patented, automatic height-adjusting pellet station and a manually height-adjustable dosing disk. Together with the Net Weight Detection System (NWDS) and the integrated gravimetric checkweigher, these features allow consistent in-process control (IPC).

The regular adjustment of dosed amounts via IPC ensures a stable, capacitive measuring process throughout the production cycle.

The GKF 720 is equipped with an extremely flexible plug-and-play station, which supports rapid switching, for instance from pellets to powders.

For more information, please contact: Commha Consulting GmbH & Co, KG PoststraĂ&#x;e 48 D-69115 Heidelberg, Germany Tel: +49 6221 18779-32 E-mail: bosch@commhaconsulting.com

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Water Purification System (Lab Scale) Water purification system (lab scale) generates Type III and Type I water. Output of RO water is 99 per cent micro-organismfree and 95 per cent ions are also removed.

It has an in-built 20 litre tank and requires less space for the installation of the system. Tank is pressurised and ensures impurities will not enter the tank to maintain the purity of water system. Recirculation feature avoids stagnancy of water. Conductivity cell used is of cell constant 0.01.

Easy to operate and maintain. Self-diagnostics ability in system (give appropriate alarms). Low capital consumable and maintenance cost as compared to all available brands in water purification system.

For more information, please contact:

Shreedhar Instruments 16 Shreeji Krupa Society Opp: MGVCL Circle Office, Next to GMERS Medical College Gotri Road, Vadodara, Gujarat 390 023 Telefax: 91-0265-232041 E-mail: sales@shreeedhargroup.com

Quantek Head Space Oxygen Analyser Quantek is an expert for analysing various gases especially oxygen in vials.

Model 905V is one of the most successful and robust models in the industry. Pharma preperations packaged in vials are often gas flushed to provide a specific atmosphere in the vial, with defined levels of oxygen, nitrogen or other gases.

Depending on the product, these vials can range in size from 1 to 250 ml or larger. Small vials present some difficulty for oxygen analysis because the sample volume available is often quite small. A 1-ml vial, eg, may have only 0.5-ml of headspace gas. For direct analysis with a pharma oxygen analyser, the instrument must be capable of analysing very small volumes.

Their pharma oxygen analyser is designed for this process.

Used for vials, blisters and bottles. It is ideal for IP QC or QC laboratory requirements and runs on battery.

For more information, please contact:

Shreedhar Instruments 16 Shreeji Krupa Society Opp: MGVCL Circle Office, Next to GMERS Medical College Gotri Road, Vadodara, Gujarat 390 023 Telefax: 91-0265-232041 E-mail: sales@shreeedhargroup.com

High-pressure Pumps HPP is a Cornet SpA brand specialised in the design and construction of plunger pumps for water, made even better thanks to its technological expertise and further boosted by modern day technologies. This means the company is able to offer a wide range of products to meet requirements that go from 50 to 400-KW with pressure up to 2,800-bar.

HPP pumps are manufactured using the most modern technologies both as regard to the materials used machining and mechanical operation and heat treatments. Comet is also able to provide a wide range of accessories, suitable for the specific need of the single user. Professionalism and research make it a dynamic modern company intent on tackling and resolving the problems of a fast-evolving market.

For more information, please contact:

Powerjet Engineering Gala No: 108, Building No: 7 Blue Mount Work Station Premises CSH Ltd Sativali Road, Village Waliv Nr Parle Global Technologies, Vasai (E) Dist: Thane, Maharashtra 401 208 Tel: 0250-6454169, 6580963 E-mail: info@powerjetengineering.com / sales@powerjetengineering.com

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BOD Incubator

Photostability Chamber Mack Pharmatech offers cost-effective PLC-based BOD incubator with European Standard “CE” in different capacities. Their BOD incubator temp range is 10°C to 60°C, accuracy: ±0.2°C, uniformity: ±1.0°C and control system: PLC (Allen Bradly).

Mack Pharmatech is the only company who gives all equipment withPLCbased control system, 21 CFR software, touch screen display (HMI), standby refrigeration system, PT 100 sensor, GSM technology, hooter system, password protected door 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 photo stability chambers with European Standard “CE” in different capacities. Photo stability chambers temp range is 20°C to 50°C, accuracy: ±0.2°C uniformity: ±1.0°C and control system: PLC (Allen Bradly).

Mack Pharmatech is the only company who gives all equipment with PLCbased control system, 21 CFR software, test samples on fluorescent light or UV lights separately as well as simultaneously, lights automatically shut-off after a specified exposure level or time duration, HMI (touch screen display), GSM technology, hooter system, full view glass door, bullet feet levelling legs, GMP Model 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

Air Cleaner Camfil offers CamCleaner 300 an energy efficient air cleaner. This CC300 can cater to an average air purification area of up to 1,000-sq ft, controlling 0-10V Potentiometer, with adjustable speed. CC300 is best suited to perform across varied indoor comfort requirements ranging from small or medium spaces.

CC300 is even well-suited to perform efficiently in an open ceiling environment offering clean ambiance at home and a healthier work environment. CC300 has an air flow capacity of 0-400 m 3/h, controlled by 6 stage controller-card, which ensures safety by controlling and reducing the impact of ambient air formaldehyde and VOC concentrations. With a reduced height of only 300 mm, this can be installed in the ceiling (built-in). Camfil CC300 also comes fitted with an electronically controlled motor that reduces the operational noise and also drives energy efficiency.

CC300’s smooth interior helps the filters to slide smoothly, with new simple side access. The hard-wearing and protective coating on CC300 ensures the long life of its filters, protecting them against corrosion. The unit also has inlet and outlet with standard Spiro connection with 250 mm, easing the operations and maintenance tasks.

For more information, please contact: Camfil Air Filteration India Pvt Ltd 62, IDC, Mehrauli Road Gurgaon, Haryana 122 001 Tel: 0124-4874101 Fax; 91-0124-4082405 E-mail: pksv.sagar@camfil.com

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Tank Vents Cipriani Harrison’s tank vents are made in SS304L and SS-316L are highly polished and have FDA EPDM O-rings and Delrin bushings. These tank vents are designed as breather valves to avoid vacuum or overpressurisation inside a tank or piping system. These valves are 3A authorised. The optional purge port version is available for purging the inert gas.

For more information, please contact: Cipriani Harrison Valves Pvt Ltd Sub Plot No: 2, B/s Margin Impex Ltd Nr Phase IV, GIDC Estate V U Nager, Anand Gujarat 388 121 Tel: 02692-235082, 235182 Fax: 91-02692-236385 E-mail: info@harrisonengineers.com

Sight Glasses & Level Gauges Cipriani Harrison’s sight glasses and level gauges are made from SS-304L and SS-316L and are highly polished. The sight glasses are used inline, come standard with clamp, Butt-weld or I-line end connections and have PTFE/Silicone seals as standard. An acrylic safety guard is available to prevent damaging the inner glass.

The upper and lower level gauges come with clamp or MNPT connections, FDA EPDM and silicone seats and they accommodate either 5/9” or 7/8” dia sight tubes.

For more information, please contact: Cipriani Harrison Valves Pvt Ltd Sub Plot No: 2, B/s Margin Impex Ltd Nr Phase IV, GIDC Estate V U Nager, Anand, Gujarat 388 121 Tel: 02692-235082, 235182 Fax: 91-02692-236385 E-mail: info@harrisonengineers.com

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Rapid Mixer Granulator The RMG is a rapid mixer and granulator with specially designed Z Type impeller and high shear chopper blades for efficient dry mixing and wet granulation enclosed bowl with GMP compliance - R&D Models: 1, 2, 3, 5, 10 and 15 litres; and Production Models 30, 60, 150, 250, 400, 600, 800, 1,200 and 1,600 litres.

For more information, please contact: Sunsai Pharma Equipments Pvt Ltd Plot No: 1, Survey No: 77 Nr Laxmi Indl Estate Sativali Road, Vasai (E) Thane, Maharashtra 401 208 Tel: 0250-3200130 E-mail: sunsai.pharma@rediffmail.com sunsaipharma@gmail.com

Q Exactive Plus Benchtop LC-MS/MS The Thermo Scientific Q Exactive Plus benchtop LC-MS/MS combines highperformance quadrupole precursor selection with high resolution, accurate-mass (HRAM) Orbitrap detection to deliver high performance and tremendous versatility.

From protein characterisation to targeted or DIA-based quantitation and confident DMPK qual/quan screening studies, this system enables you to screen, identify, and quantify compounds in complex samples rapidly.

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 Fax: 91-022-67429405 E-mail: sagar.chavan@thermofisher.com

Pharma Bio World

Automated Actuators

High Volume Test Instrumentation

Proveris’s patented Vereo automated actuators reliably replicate hand use of nasal and oral spray pumps, and metered dose inhalers. Vereo actuator MicroDrive technology provides pinpoint accuracy for single-device shot weight and dose content uniformity tests. Vereo actuators are available in configurations for all types of nasal sprays, including sideactuated and dual-actuated (squeeze bottle) devices. They are also available in configurations for oral sprays and metered dose inhalers For more information, please contact: Aimil Ltd Naimex House A-8 Mohan Co-operative Indl Estate Mathura Road New Delhi 110 044 Tel: 011-30810200 Fax: 91-011-26950011 E-mail: info@aimil.com

Indizo high volume test instrumentation automates dose content uniformity and shot weight testing of nasal sprays.

The robotic instrument provides pharma laboratories with the ability to conduct multiple high-throughput tests of routine nasal spray devices using a single platform. Indizo instrument radically improves productivity by fully automating routine dose content uniformity and shot weight tests.

For more information, please contact: Aimil Ltd Naimex House A-8 Mohan Co-operative Indl Estate Mathura Road New Delhi 110 044 Tel: 011-30810200 Fax: 91-011-26950011 E-mail: info@aimil.com

Heat Exchangers Kipp Umwelttechnik offers fast and gentle cleaning for all types of fin heat exchanger with its JetMaster+ system.

Made up of four combination devices, the JetMaster+ system is also successful where other cleaning systems cannot help. Kipp Umwelttechnik is now 100 per cent effective in cleaning spiral-finned tubes in tight spaces, even with extremely hard deposits. Stones have even been removed from the equipment. Many other companies had already tried and failed.

Kipp Umwelttechnik has been successful in cleaning tube bundle heat exchangers for many years. The TubeMaster process from its sister company mycon GmbH cleans tubes without residue and removes even the toughest deposits. The interior of the tubes can even be polished at the same time – significantly reducing energy costs and increasing production capacity.

Cleaning removable plate heat exchangers using the PowerMaster system has also long been part of Kipp Umwelttechnik’s work. Supported by a regional university in 2017 Kipp Umwelttechnik developed its own flushing technique for cleaning closed plate/tube bundle heat exchangers. Kipp Umwelttechnik based the new system primarily on green chemistry that cleans gently, can be reused and after multiple uses, can later be recycled or neutralised.

For the biogas plant sector, there is a fully-equipped vehicle that carries the necessary cleaning equipment at all times. In collaboration with the system’s manufacturer, sister company mycon GmbH, Kipp Umwelttechnik also offers the JetMaster system for cleaning all types of fin heat exchanger for hire, together with the compressor required if necessary. All heat exchangers can also be cleaned at their premises for a fixed price. If required, we can collect the equipment from your site and return it after.

For more information, please contact:

Kipp Umwelttechnik GmbH Lorenzstraße 29, 76135 Karlsruhe, Germany Tel: +49 (0) 721 98 77 93 17, Fax: +49 (0) 721 98 77 93 11 E-mail: m.kueppershaus@kipp-umwelttechnik.de / service@pressebox.de

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events diary  

   

Date: 6 th - 7 th July 2018 Venue: Chennai Trade Centre, Chennai

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

Pharmac South 2018 is highly focused on Pharma Marketing Companies and the only Convention happening in Tamil Nadu for Pharma Marketing Professionals. Pharmac South is all set to host Pharma professionals from all parts of the world at the South India city of Chennai. The exhibitions bring together a spectrum of vendors, business heads, Pharma brands, large corporates, contract manufacturers and more under one roof. Pharmac South is organized by premier association of Pharma Industry.

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

 Orbit Exhibitions Pvt Ltd 103 Navyug Indl Estate T J Road, Sewri (W) Mumbai 400 015

  

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

Date: 7 th - 9 th August 2018 Venue: Pragati Maidan, New Delhi

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

The Indian Pharma Expo is a pharmaceutical industry event that creates enormous space with the presence of pharmaceutical manufacturing services, pharmaceuticals wholesale and distribution services, software companies, pharmaceutical technologies, chemicals and compounds, packaging materials and goods, ayurvedic and herbal products, pharmaceutical franchises and other related services and products. The event brings together leading drug manufacturers and suppliers at a common platform and allows the exhibitors to enhance their business and networking. The event also presents latest trends of technologies and products of the industry.

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.

 CIMS Medica India E-mail: it@cims.co.in

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 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 Leading Pharmaceutical Innovation: How to Win the Life Science Race (Hardcover) Authors: Oliver Gassmann, Alexander Schuhmacher, Max von Zedtwitz, Gerrit Reepmeyer Price: USD 79.99 No of pages: 179 pages Pharmaceutical giants have been doubling their investments in drug development, only to see new drug approvals to remain constant for the past decade. This book investigates and highlights a set of proactive strategies, aimed at generating sustainable competitive advantage for its protagonists based on value-generating business practices. This book focus on three sources of pharmaceutical innovation: new management methods in the drug development pipeline, new technologies as enablers for cutting-edge R&D, and new forms of internationalisation, such as outside-in innovation in the early phases of R&D.

Pharmaceutical Innovation, Competition and Patent Law: A Trilateral Perspective (Hardcover) Authors: Josef Drexl, Nari Lee (Editors) Price: USD 154.00 No of pages: 352 pages Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals.Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care.

Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators.

Pharmaceutical Packaging Innovations (Paperback) Author: Sandeep Kumar Goyal Price: USD 41.80 No of pages: 132 pages Pharmaceutical Packaging is not a recent phenomenon. It is an activity closely associated with the evolution of society and, as such, can be tracked back to human beginnings. The nature, degree, and amount of Packaging at any stage of society’s growth reflect the needs, cultural patterns, material availability, and technology of that society. The pace of the technological change in Packaging field is bringing new innovative packaging ideas and Pharmaceutical Packaging is not an exception. Idea behind this book is to bring the innovations to wider group of professionals to meet the mission of packaging knowledge sharing and that too cost effectively. We feel that this publication will further fill the project pipelines of companies and improve the standards of packaging. Many professionals either do not have the access or time to go through so many innovations together. So we think this publication will fill that gap.

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