INSIGHT INTO THE PHARMACEUTICAL AND BIOTECH INDUSTRIES

VOL 16 | ISSUE 12 | JULY 2018 | MUMBAI | TOTAL PAGES 60 | ` 150

www.pharmabioworld.com PHARMA BIO WORLD VOL 16 ISSUE 12 JULY 2018 MUMBAI 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

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4 ◄ July 2018

Pharma Bio World

INTERVIEW 08.

“Burkert poised for a strong growth in India” -Sadiq Khan, General Manager Burkert

16.

“India’s rapidly growing capability is likely to position it as a leading player in Biosimilars” - Debayan Ghosh, President & Founder, Epygen Biotech FEATURES

08

22.

Primary desiccant packaging - No chance for moisture and odours in pharmaceutical packaging - Ursula Hahn, Head of Product Management, Sanner GmbH, Germany

26.

Biosimilars: Advancements, Future and the Role of Indian Pharma Market - Dr. Piyush Gupta, Associate Director, GNH, India

28.

Staying Compliant and Profitable in the Pharmaceutical Packaging Process with Checkweighing - Jana Meier, Marketing Team Leader, Product Inspection & Head of Marketing Checkweighing, MettlerToledo, Mettler-Toledo Garvens

3 1 . Contract Manufacturing Organizations: Navigating Serialization Implementation - Arthur Smith, Vertical Marketing Manager, Videojet Technologies MARKETING INITIATIVE

22

28

35

33.

Mass Flow Controlled Coating of Medical Devices

34.

Introduction to Flow Technology

35.

Mack Pharmatech Pvt Ltd

36.

Armacell’s ArmaFlex insulation materials offer proven performance on the mitigation of corrosion under insulation

37.

Speeded-Up Drug Approval Process Will Boost Biologics Market, The Business Research Company

39.

B&R organized a conference on next generation automation technologies in Mumbai

40.

B&R celebrates 20 years of growth & innovation with customers

41.

Powder Dryer End-Point Detection for Aqueous & Solventbased Drying

43.

NEWS UPDATE Press Release

44.

56.

CORPORATE AFFAIRS Products Events

57.

58.

BACKYARD Book Shelf Ad Index

Next Issue Focus: Intellectual Property

6 ◄ July 2018

Pharma Bio World

interview

Sadiq Khan

“Burkert poised for a strong growth in India�

India is expected to be among the top three pharmaceutical markets by incremental growth, by 2020 and sixth largest market globally in absolute size. The medical infrastructure has been continuously improving combined with increase in penetration of health insurance in the country, which are influence factors in the growth of the pharmaceutical sector.

To serve this local and export growth market the global drug manufacturing companies have strategically selected India for production. These companies can only rely on global leaders such as Burker t Fluid Control Systems, due to their experience in providing standard and customized components for pharmaceutical production equipment.

Sadiq Khan, General Manager, reveals more about Burker t with Pharma Bio World.

What will Burkert offer to the Indian market?

Wherever fluids and gases are used, there is always a need to measure, control and regulate. Burkert has an array of products under major segments like hygiene, water, gas and micro. We help customers right from the conceptual process drawings to select the correct blocks and instrumentation products to reduce the risk of crosscontamination and hold-up volume. Our goal is to increase productivity, yield, efficiency, and drug quality.

Our product range extends from sanitary diaphragm valves to instruments such as flow, temperature, level pressure, pH, ORP, dissolved oxygen, chlorine, and turbidity.

8 â—„ July 2018

We work closely with our customers to help in overcoming their fluid challenges by providing best solutions and optimizing processes. We offer products with different options based on the requirements with standard and fluctuating flow conditions. We also deliver product loop solutions to manage flow and de-stress immediate following processes. Apart from regular product-based solutions, we also build innovative application-oriented system solutions for complex processes to deliver maximum customer benefit. Whether it is a single component or a pioneering new system for a complete monitoring and regulation project, we offer an extensive range of services, from consultancy and the engineering of products or complex systems to installation, testing and after-sales service.

Pharma Bio World

interview

Figure 1: Type 8098 – FLOWave SAW flow meter How is Burkert technologically different from the current market products?

Burkert is the largest investor back in R&D in our industry, with 7.1 per cent of our profits being re-invested. This is why we are continuously inventing and launching new solutions for the Hygienic industry.

Our culture has always been to start with a solution where others stop. Our latest technology patents include the most sterile flow measurement principle, pneumatic actuator which will consume 35 per cent less air and a diaphragm valve body which allows for more production time.

10 ◄ July 2018

Why is Indian market key to Burket’s operations?

Indian pharma and equipment manufacturing sector is a diverse market. The whole sector is going through a period of radical change.

This transition phase is the growth driver for equipment manufacturers. With global and Indian drug and equipment manufacturers establishing a strong base in the country, valves and analytical equipment play a major role in process manufacturing technology. The industry is largely dependent on imports for advanced and quality products. The recent ACHEMA 2018, Frankfurt had very good

Figure 2: Type 8802 - ELEMENT continuous control valve systems number of footfalls of Indian customers. Year on year we are growing 20 per cent more, gaining new customers and taking a piece of share from our competitors. The Indian market is very aggressive and open to new products and application solutions, thus we see a lot of potential in India.

What are the challenges in the Indian Pharma equipment-manufacturing sector? How do you see them as opportunities?

The largest challenge for Pharma and Biotech companies located in India is to successfully complete the FDA audit.

Pharma Bio World

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Chemtech Hyderabad World Expo 2017

HYDERABAD - 2017

GUJARAT - 2018

13-15, December 2017 Venue: Hyderabad, India

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

MUMBAI - 2019

GUJARAT - 2018

MUMBAI - 2019

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

Dear Readers,

Figure 3: Tube valve body - Patent of Burkert - Patent DE 10 2010 023 855, US 8464566 This is an opportunity for Burkert because we are in a position to provide proven solutions, which will always exceed the US FDA regulations. The inspectors know the quality of our products and they feel there is no risk due to our product compliance with ISPE & ASME BPE guidelines.

Configuration of valves is the most critical task in any process operation. The need for awareness on new products and processes is the key challenge in the sector. Currently, the consultants, manufacturers and fabricators work independently and limiting the usage of product operation. The valves and analytical equipment manufacturers should be involved in conceptualization, design and implementation levels. More than just buying and selling, collaboration of teams at all verticals (including design, purchase, manufacturing and logistics) is the need of the hour. Knowledge on different usage of valves and application-based system solutions need to increase to reduce the process stages, cost reduction and weight reduction in equipment and plants.

How can Burkert add value to the complex and demanding process technologies? (eg, clean room, labs automation, etc) Our team has undergone intensive training to provide consulting for process related 12 â—„ July 2018

solutions using our products and systems.

This is unparalleled to any other component manufacturer, as they would normally understand the product details and not the process they are used in. We start right from water production to WFI or PW distribution, fermentation, chromatography, tangential flow filtration, clean utilities (CIP/SIP) and even the final filling of vials.

What are your business strategies and future plans for the Indian market?

We are growing in all verticals. We have gained considerable market share from our competitors through constantly being awarded projects. Currently, we are operating in major Tier-I cities, and planning to expand our operations in North and East Regions.

We are hiring and strengthening our service and supply-chain network. We are also planning to increase dealer network in TierII cities. Our major area of focus would be consulting, projects and application-based system solutions. We will introduce new and value added products and develop practical solutions specific to the Indian market. We would also increase product and servicetraining programs to customers for applicationbased system solutions.

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

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

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

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

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

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

Pharma Bio World

interview

Debayan Ghosh

“India’s rapidly growing capability is likely to position it as a leading player in Biosimilars”

16 ◄ July 2018

Debayan Ghosh Co-founded and built Epygen in the year 2006 with a vision to emerge as a leading biotech innovator enhancing human life. Epygen’s current focus area is to produce and launch Biosimilar Recombinant Streptokinase (rSK) for the cardiovascular segment under License and Technology support from CSIR Govt of India.

In an interview with Mr Debayan Ghosh who talks about biosimilar market in India, their process of completing the Regulatory Pathway of cardiovascular Thrombolytic Recombinant Protein drug for patients in Indian subcontinent and the underprivileged of the world and his aim to produce this LifeSaving drug to address the mid income strata and bottom of the pyramid.

Can you tell us about company’s journey till date?

Epygen group was conceived nearly a decade back outside India, in Dubai Science Park and Colorado USA, by two persons of Indian origin, me and my long time friend Ariyarathenam.

Our connecting thread was Biocon. While I was one of the first Biotech graduates in India who went on work for Biocon as a campus recruit, Ariyarathenam was running an agency for Biocon in south Asian countries for several years. After 5 years in Biocon and 7 years working for a US Biotechnology company based in south Florida, I started Epygen in 2006.

Ariyarathenam soon joined in, and a few years later, his son Ineeyan, a business graduate from the King’s college of London, joined the team. We started Epygen in India with the funds that we earned from our Biotech ventures abroad, as a 100% FDI setup. With our several years of experience of Fermentation, Protein expression and purification, we decided to focus completely on Biopharmaceuticals development and manufacturing in India and chose recombinant Streptokinase, a cardiovascular thrombolytic protein, as our entry product toBiosimilars. We quickly tied up with CSIR-IMTECH in Chandigarh India to license in its Recombinant Streptokinase technology, from lab scale technology transfer to scaling up and expression of proteins up to pre clinical and clinical scales.

Under the able guidance of the then director of CSIRIMTECH, who was also and the leader of Streptokinase research in the world, we went on cracking the puzzles of a newer version of streptokinase. Our aim was to make it safer for patients, produced it more efficiently and also utilize our skills in process optimization and protein engineering to enhance the expression levels, making this critical life saving protein more affordable to the masses in India and the region. Department of Biotechnology agency BIRAC acknowledged our efforts to improve this technology for the unmet needs in India, where 15 Lakh people dye of heart attack every year.

They extended financial assistance for our research, injecting a big boost to our enthusiasm and purpose. We went on to construct a state of art Recombinant Biotech and Protein Purification lab in Navi Mumbai, employing top Biotech scientists experienced in USA and India, whose the focus was to imbibe the technology that was being transferred and continue further development and fine tune. Subsequently, we started the work to construct a 60,000 square feet Biopharmaceutical facility in Patalganga, Maharashtra, to expand our research activity by several folds and further produce these Biosimilar proteins in commercial scales. Epygen’s recombinant Pharma Bio World

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interview proteins are in regulatory stages of Pre-clinical Trials with the recombinant Streptokinase to be launched by 2019 and an exciting pipeline of other e-coli based technologies e.g PEG GCSF (a Chemo Induced Neutropenia protein drug) and Monoclonal Antibodies for Oncology, making steady progress.

across the globe, especially in Asia, African and Latin American countries, each of which market Epygen is going to target. Our pipeline products like GCSF, PEG GCSF, Recombinant Hormones and Monoclonal Antibodies project billions of dollars biosimilar market in the regulated and semi-regulated markets.

How is the company positioned in the Indian and global market?

How does the company keep abreast with the ever-changing trends in biopharmaceutical market?

Let me talk about our stepping stone protein Recombinant Streptokinase. Epygen is amongst very few companies in the world to produce Recombinant Streptokinase, the only affordable thrombolytic injection for STEMI (ST Elevated Myocardial infarction patients).

Amongst Cardiovascular disease patients and number of people suffering strokes in urban and rural part of India, at least 0.5% of Indian population is at risk of suffering from myocardial infarction Cardiac stroke. This gives a potential of 6.0 million cases of thrombolytic treatment in India. Though for urban patients with higher economic capabilities, the top preferences would be tPA, 60% of urban population and nearly 100% of the rural population would be potential candidates for streptokinase treatment in our country. From the market figure on number of vials sold per year by the major brands, the current usage covers a miniscule portion of the potential.

This indicates a huge influx of undocumented and spurious/unreliable thrombolytics being used in the country. Streptokinase is by far the most economic Thrombolytic agent available, costing approximately Rs. 2,000-3,500 for a full dose of 1.5 million units. Mainly because of its cost, it remains the most used agent in clinical practice in the country. In addition, the recombinant version is free from streptolysin/ streptodornase associated with natural Streptokinasem making it safer for use. tPA based innovator drugs on the other hand, are the most expensive agents available for this treatment segment, costing approximately Rs 40,000 per full dose. Another available tPA Biosimilar agent in India costs approximately Rs 25,000 per dose. This comparison shows that for a cost sensitive Indian market, affordability still remains a limiting factor for most of these Thrombolytic agents except for Streptokinase. Streptokinase is widely used as a first line of treatment for STEMI patients 18 â—„ July 2018

Epygen engages continuously in conducting market intelligence exercise employing agencies like IMS etc., in addition to its Biotech network worldwide, which provides access to all the exciting scientific and commercial developments in the field of Biopharmaceuticals.

We participate in global conferences, where we often contribute scholastically and our scientists are encouraged to continuously update their outlook through such events.

How do you see the biopharma market in India maturing?

The Indian biotech market seems to have doubled in size in the past few years! This is expected, since it was very negligible to start with. The industry grew by a whooping 30%, fueled by the rise in domestic business, exports, mergers and acquisitions and new product innovations. Over the past five years, the industry has reportedly grown steadily by a 30 % to 50 %. The sector at present, employs more than 30,000 Biotech scientists, who continue to drive growth. Even then, the Indian market currently accounts for a little over 1.1 % of the global biotech market.

However, its rapidly growing capability is likely to position it as a leading player in the years to come, especially in the area of Biosimilars, posing a triple digit growth in the next decade. India already ranks third in Asia-Pacific, after Japan and Korea and among the top 12 globally. The Central Drugs Standard Control Organization and the Department of Biotechnology constantly monitors and improves biosimilar drugs policy and regulatory pathway, for manufacturing processes that aims to deliver safety, efficacy and quality of international standards. This policy is expected to catapult the Indian biosimilars market size to the vicinity of US$50 billion by 2030!

How do you place India among the Asia-Pacific countries? Do you feel that India could be an important player in biopharmaceuticals?

At first glance, Asia undoubtedly appears to be an assured avenue of growth for pharmaceutical manufacturers on the whole. According to IMS Market Prognosis 2012, the pharmaceutical market in Asia is expected to reach USD 350 billion in 2016-17, comprising 30% of the global pharmaceutical market of USD 1.2 trillion and driving close to 50% of global, incremental growth. Taking a closer look at the top pharmaceuticals locatedin Asia-Pacific reconfirms the importance of China, Japan, and India whose companies make up 32.0 %, 42.0 %, and 14.0 % in terms of market capitalization by regional companies respectively. In addition, India pharma is expected to grow over 15 % per annum between 2015 and 2020, and outperform the global pharma industry benchmark. The market is expected to grow to USD 55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by absolute size, as stated by Mr Arun Singh, Indian Ambassador to the US. With a clear perspective that 75% of pipeline drugs globally are from Biopharmaceutical nature, and 8 out of 10 largest selling drugs in 2017 being from Biopharmaceutical basket, a total of 667 innovative biopharmaceuticals were launched in the U.S. over the past 20 years, bringing new treatment options to critical ailments. From a numerical perspective and anticipating the progress of drug candidates currently in the research and development pipeline, the state of biopharmaceutical innovation is robust. The source of the biopharmaceutical innovation that is successfully launched in the U.S. is highly diverse, with over 300 entities filing original patents to protect the intellectual property that became the basis for the 667 medicines that were launched.

Biologic agents will continue to outpace overall pharma spending growth and are expected to represent 19-20% of the total market value by 2017. The Asia Pacific biopharma market has exploded since the 1990s, with thousands of homegrown biopharma companies and major multinationals setting up shop across the region.

Pharma Bio World

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interview Can you explain more about Epygen’s Biotech incubation facility at Navi Mumbai?

Epygen’s incubation facility in Navi Mumbai is equipped with the state of art equipment for Recombinant Technology work, Fermentation, Protein Expression and Purification with a full fledged DSP line up. It can develop and express recombinant proteins based on a wide range of expression hosts and scale up process based on an array of molecular biology, protein engineering and bioprocess optimization techniques. It houses a strong team of scientists with experience in the United States and India specializing in the area of Bioprocess, Regulatory and Quality Assurance, apart from the core team of Molecular Biologists.

It is equipped to express proteins of interest at various levels, model, monitor and scale up manufacturing of these critical therapeutic proteins based on the needs of Indian patients.

Could you please elucidate more on Epygen’s Pegfilgrastim and Bevacizumab?

As stated earlier, 8 out of top 10 highest selling drugs in the world come from biotech origin, contributing sales of nearly $65 billion. While the worldwide sales of Bevacizumab and Pegfilgrastim contributes 7.2 Billion and 4.8 Billion USD respectively, sales of Bevacizumab and Pegfilgrastim from India are only INR 98 Cr and INR 84 Cr respectively, owing to the price barrier presented by the innovator.

Harnessing the tools of Proteomics and improved bioprocess, which Epygen had been consistently able to do for several years, we are aiming to bring about a sea change in these meager numbers, rendering these drugs more affordable for patients in the region. With the highest quality standards that Epygen practices for therapeutic proteins, we are aiming to cater to the semi regulated markets world wide with these Biosimilar drugs and bring about some parity with the global numbers.

What do you see as the big drivers of innovation occurring in Cardiovascular therapy and oncology drugs right now?

There has been an increase in the prevalence of cancer and heart disease as the population ages.Cardiovascular disease (CVD) and cancer 20 ◄ July 2018

are the 2 leading causes of death worldwide.

Modern treatment strategies have led to improvement in the chances of surviving a diagnosis of cancer; however, these treatments are expensive. Heart disease is the numberone cause of death in the US and in most high-income countries, followed by cancer, and for years deaths from both diseases have been on the decline.. A quick survey at new drug approvals over 2010 and the first half of 2011 shows that the cardiovascular sphere got just three new medications: Dabigatran etexilate (Pradaxa, Boehringer Ingelheim), Azilsartan medoxomil (Edarbi, Takeda Pharmaceutical), and ticagrelor (Brilinta, AstraZeneca). By contrast, 13 new drugs have been approved since January 2010 for different cancers.

Drugs still in development paint an even starker picture: while cancer has over 700 drugs in development, the number of cardiovascular drugs in the pipeline is just 147.

As a biosimilar manufacturer, how you think the industry should balance between protecting the rights of a patent holder and providing affordable health care for all?

The issue of intellectual property and in particular patents is a matter of debate.

The issue holds more significance with respect to pharmaceutical patents and the concerned stakeholders which has resulted in a fierce policy debate regarding patenting across the globe and especially in developing countries. It is widely believed that patients in developing countries are disadvantaged as newer medicines under patent are out of reach of millions either due to lack of access or due to exorbitant costs. The recent issue of compulsory license in India for Bayer’s anti-cancer drug Nexavar (SorefenibTosylate), ¬¬¬¬unveiled a host of issues. Since, multinational pharmaceutical companies may fear to introduce newer medical therapies in Indian market, it is important to repose their faith in the system so that new medicines are launched in India. Various measures such as monitoring of prices of patented medicines, negotiating the price of a patented medicine by the government before marketing, providing petty patents (utility patents) for minor innovations, procurement of patented medicines by government for public distribution,

encouraging healthcare insurance, fostering Industry-Institute partnerships etc. may help balance access to affordable medicines and incentive for innovators.

Can we have your take on patent cliff and its implications in generic market?

To avoid falling off the cliff, innovators often augment their patents by process patenting or somehow extend market exclusivity for their products utilizing some IP extension tools. for a One frequently used strategy is to procureadditional patents beyond the original patents that protect the drug’s primary active ingredient and disease targets. A key question is to what level these later-issued patents protect valid features or methods, instead of serving as a business strategy to delay generic competition, simply as a barrier to progress.

In some cases, the patent claim may be frail or largely duplicative of an already patented feature or product. These patents can amplify the cost for a manufacturer to bring a generic version of a drug to market and in effect delay approval of the generic drug after the patents on the underlying base compound expire.

It is well established that extending market exclusivity by extending or augmenting patents can have severe public health implications in our part of the world.

Please brief us on generic drug patent and FDA issues?

The average time for FDA approval has increased to nearly 8 years in recent times.

There is a huge risk of economic burden due to such lengthy regulatory time for Biopharma companies. If the drug shows unpromising or average results in its clinical trial, then this leads to low or unpredictable sales and companies have no way to recover the cost invested on that molecule. In addition, intellectual property has made the market penetration even more difficult for Biosimilar drugs. In the case of drugs where the patent has been extended for an additional five years, it has been impossible for Biosimilar drugs to get in at a lower price point. The anatomy of an exorbitant cost of drug development is primarily related to government policies, FDA long-approval and time-consuming complex trials, that the Biopharma faces.

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ADVANCING YOUR INNOVATION

Primary desiccant packaging - No chance for moisture and odours in pharmaceutical packaging While moisture in pharmaceutical packaging can have negative or even dangerous effects on its content, unpleasant odours are especially repellent to patients.

Both can be systematically prevented using suitable adsorbents – provided the right aspects are taken into account.

M

any pharmaceutical products such as tablets and capsules, but also test strips or inhalers are sensitive to moisture. The effects of moisture are manifold and often pose a high risk not only to the drug but also to patients. In the case of tablets, powders and effervescent tablets, the properties and texture may change, whereas gel capsules might dissolve due to moisture. Blood or urine test strips may produce false or misleading results if the test chemical is influenced by too much humidity.

In the worst case, the efficacy of drugs is reduced, or the analytical results are falsified, which can lead to an incorrect medication and impede successful therapy. In addition, many pharmaceuticals, especially analgesics such as acetylsalicylic acid, release specific molecules into the ambient air inside the packaging that can develop very unpleasant odours.

Only real data provides reliable results The amount of humidity that penetrates into the packaging is decisive for the stability of a moisture-sensitive drug.

Around 65% of humidity ingress can be attributed to the packaging. Weak spots can be the packaging wall, the sealing surfaces between containers and closures, as well as the sealing seams of blister packs. Hence the choice of the primary packaging depends mainly on maintaining the optimum climate inside the packaging in order to ensure the required shelf life.

Ursula Hahn Head of Product Management Sanner GmbH Germany 22 â—„ July 2018

A holistic approach that takes all aspects of moisture ingress into a pharmaceutical packaging into account is indispensable.

Relevant parameters such as material type, wall thickness, product moisture and production conditions, as well as differing climatic conditions in the target

markets and consumer behaviour must be taken into account when designing the packaging. To obtain reliable data, tests should always be conducted with the actual packaging. Material data-sheets or databases provide data determined under very specific and ideal conditions.

These cannot be transferred 1:1 to a specific packaging. Consequently, only real data and realistic analyses avoid unnecessary durability tests.

Desiccants: silica gel or molecular sieves Depending on the area of application, different desiccants such as silica gel or molecular sieves can be used. These hygroscopic desiccants attract moisture and keep it away from the packaging content. The most common desiccant is silica gel. It contains numerous small interconnected channels that open up into pores on the surface. Its structure resembles a sponge with a large inner surface, whose channels and pores adsorb water molecules. These pores can absorb up to 36% of their own weight without altering their structure. The higher the relative ambient humidity, the higher the adsorption capacity.

Molecular sieves, on the other hand, are synthetically produced zeolites with a uniform pore diameter and a crystalline structure. Molecular sieves adsorb moisture corresponding to between 20 and 22% of their own weight, almost independently of the relative ambient humidity. While silica gel brings moisture to a certain level, molecular sieves can achieve a climate of close to 0% relative humidity inside a closed packaging.

Activated carbon: far more than odor adsorption When it comes to odor adsorption, activated carbon is particularly efficient: Pharma Bio World

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the surface of just one kilogram of activated carbon equals a 160 kilometer two-line highway. Activated carbon is made of organic material with high carbon content such as peat, wood or coconut shell. This material is slowly heated in an oxygen-depleted or oxygenfree environment to remove water and impurities. The surface increases significantly through further physical and chemical processing and creates a submicroscopic network of pores.

The extremely hygroscopic surface molecules actively search for other molecules they can bind to. Activated carbon attracts numerous chemical compounds by adsorption and thus binds bad odours. Moreover, activated carbon can adsorb residual solvents as well as organic and inorganic impurities that reach the headspace of bottles by evaporation.

Drop-in sachets: eliminating risks right from the start There are many different ways to equip 24 â—„ July 2018

packaging with the right type and amount of desiccants and/or activated carbon.

The fundamental difference lies in the way the adsorbents are inserted into the packaging. More cost-intensive, integrated desiccants are attached to the packaging, for example within the cap of a tablet tube or as a desiccant chamber in the package bottom or in the wall. Drop-in desiccant solutions are added directly into bottles or containers in different forms. In general, a distinction is made between capsules or canisters and sachets.

The market for drop-in desiccants is estimated at 200 million U.S. dollars minimum; more than half of the turnover is attributed to sachets, the remainder to capsules and canisters. Desiccant sachets are particularly soft and flexible.

They can be placed anywhere in the container without any risk of damaging the drugs. Due to their shape, patients can easily distinguish the sachets from the drug, leading to a low risk of accidental ingestion. Sachet packs are ideally made

of Tyvek. The dust- and lint-free material has several advantages compared to other materials: since it consists of 100% highdensity polyethylene (HDPE), Tyvek offers an excellent combination of durability and breathability. It is also particularly tearresistant and puncture-proof, eliminating the risk of product contamination due to desiccant leakage during filling or usage.

Desiccant capsules for 360 degree moisture protection Desiccant capsules are small, cylindrical containers made of plastic and sealed with a cardboard disc. Desiccant canisters have a similar shape but are made entirely of plastic. Desiccant capsules that provide 360 degree moisture absorption are rarely to be found on the market. Their unique grid structure in the capsule wall combines the advantages of conventional capsules and canisters. Even if the capsule ends up on the cardboard side within the container after filling, moisture adsorption is ensured without loosing effectiveness.

Desiccant capsules with 360 degree Pharma Bio World

moisture absorption can thus adsorb up to 30% more moisture than conventional capsules. In addition, the tactile grid structure prevents confusion with drugs and thus accidental ingestion.

Drop-in capsules or canisters are available in different sizes and with different filling material. Depending on the moisture protection requirements of certain drugs, silica gel, molecular sieves or a combination of both can be used. A mixture of silica gel and activated carbon is the best choice for pharmaceuticals Pharma Bio World

that require both odor adsorption and comprehensive moisture protection.

Holistic approach for ultimate product protection A holistic view based on real data is crucial. It is the only way to implement all technical and regulatory aspects quickly and efficiently. At the same time, it must be possible to produce large numbers while maintaining consistently high quality. Individual, integrated or drop-in – all desiccant packaging solutions must be smoothly integrated into existing processes of pharmaceutical manufacturers.

Regardless whether a product is to be protected against moisture by using silica gel, molecular sieves or a combination of both, or whether additional activated carbon is used for odor adsorption: all solutions must always be tested regarding suitability and regulatory compliance.

Support is provided by partners with many years of experience and the required expertise in packaging production and in the application of different adsorbents.

July 2018 â–ş 25

Biosimilars: Advancements, Future and the Role of Indian Pharma Market Biosimilars is a fairly new area in pharma as the guidelines and procedures are yet to be set by FDA. Since, they are prepared with the help of living cells, just like biologics, it becomes important to understand the composition and if it is suited for the stated ailment.

B

iologics are drugs regulated by the Food and Drug Administration (FDA) used to treat chronic diseases.

These are large molecule drugs and made up of living cells which make them unique and more complex than a chemically synthesized drug that is made up of small molecules. Due to the complexity of large molecules, characterization of biologics becomes difficult. Slight differences in these products are normal and are accepted by the FDA within certain limits however, it becomes important to maintain and control within-product variations so as to maintain the right amount of active ingredients in the drug.

In order to reach a larger base of patients that need biologics, their identical copies are manufactured with similar bioactivity and structure. These drugs are called biosimilars. These are drugs that are highly similar to biologics in function and structure in addition to being inter-changeable with a FDA- approved biological product. High-end technological support is needed to compare characteristics of a reference product and a biosimilar that includes chemical identity, bioactivity and structure.

The existence of an alternative pathway paves way for providing more treatment options, extended access to important lifesaving medicines and fundamentally lower costs as a result of increased possibilities in front of pharmaceutical companies. Biosimilars are at a nascent stage today with an estimated market size of $2.2 billion out of the total $32 billion Indian pharma market.

Dr. Piyush Gupta Associate Director GNH India 26 ◄ July 2018

It is a fairly new area in pharma as the guidelines and procedures are not set by the FDA for biosimilars. Since, they are prepared with the help of living cells, just like biologics, it becomes important to understand the composition and if it is suited

for the stated ailment. A biological product might be different than a biosimilar in terms of application as the suitability matters for the patients. Hence, biosimilars when developed are clinically tested to test the suitability for a particular patient in question.

Role of Biosimilars Biological products are very complex in nature as they are produced in a living environment that could be yeast, bacteria or a cell. These products have transformed treatment methods for various serious diseases including cancer, dermatological conditions, rheumatoid arthritis, etc. In developing a biological product, vast amount of research and innovation is essential for the end-product. To solve this, biosimilar can play an important role.

Generic drugs are copies of small molecule drugs whereas biosimilars can be similar to or sometimes interchangeable with an FDA approved biological product.

They provide the following advantages in the long run: • More treatment options • Increased access to medication to save lives • Economies of scale FDA’s Abbreviated Pathway Biosimilars are safe and effective, approved by the FDA and cost-competitive.

Biosimilars could provide enormous savings to consumers through more product competition. Inherent variability in case of biosimilars can exist because of their biological nature. The molecules are bigger than that of a chemically synthesized product. Biological products did not have an abbreviated approval pathway that made it difficult for them to be manufactured at low costs as the requirement was of a full data package. This gets reflected in the cost of these products in the marketplace. Data packages between a biosimilar product and Pharma Bio World

the originator product are different and that is where abbreviated approval pathway comes into picture.

Steps to ensure usefulness of a Biosimilar A biosimilar has to be highly similar with no clinically meaningful differences as compared to a reference product in terms of structure and functions. Following are the two steps that a biosimilar goes through in the tests against reference or originator drug.

1 st Step: Analytical comparison for structural and functional usages-The biosimilar should have the same primary sequence and quaternary and tertiary structure that assists the functions 2 nd Step: To see for no clinically meaningful differences – Pharmacokinetics - Exposure in the body, release of drug in the body, its circulation in the body, if the transit is similar to that of the reference drug Safety profile of the drug also needs to be monitored to ensure it has the same profile between the products. Hence, conclusively it is determined if the product is safe and effective and it will work the same way in the body whether it’s a biosimilar or a reference product. It also needs to be ensured that the same clinical result is achieved in any given patient; the application needs to include data or information that supports this. Also, medication given more than once and the impact of switching back and forth between the interchangeable products is evaluated with the switching study.

Indian Pharma market Indian pharma market holds a prominent position in the global market scenario dominating branded generics and making up around 80% of the retail market, according to a report by Mckinsey. Due to the intense competition present in this industry, the price levels tend to be low making it further favorable to the patients.

The pharmaceutical industry in India ranks 3 rd in the world in terms of volume and 10 th in terms of value. The industry has given Pharma Bio World

rise to numerous innovations in products, infrastructure and processes. India’s indigenous manufacturing methods have paved way for the development of another set of generics, this time biogenerics or biosimilars.

According to an Assocham report in 2017, the domestic biosimilars market is expected to reach $40 billion by 2030.

With a CAGR of approximately 30%, biosimilars are slated to become popular very soon, as the more affordable version of biologics. Development of a biosimilar might take approximately 5-9 years to be fully developed with a cost that is only 1/26 th the cost of developing a biologic. Hence, it has the potential of providing treatment options at a significantly lower cost.

Open Market Sourcing for clinical trials Biosimilars face stringent clinical timelines and it becomes important for companies to fast-track the development process of a biosimilar for a release that is well before the market gets crowded. Open market sourcing is considered as an effective strategy to support the growth of the biosimilars market. Open market strategy proves beneficial to the biosimilar makers as the clinical trial data can be kept discreet.

In addition to this, the biologics are made available at shorter lead times due to the availability of stock with the wholesaler or at a known manufacturing site.

Further, to support these clinical trials, a greater emphasis needs to be given in choosing the appropriate Comparator Sourcing Organization (CSO). The requirements range from the ability to source and transport products worldwide to validated storage/shipping systems.

GNH India is an organization with industry experience of over 12 years in comparator sourcing with exports to close to 180 countries around the world. Their validated shipping and storage shipments account for more than 135,000 products in their portfolio that present a great opportunity domestically in front of the market.

Future of Biosimilars in the Indian pharma market With the rising acceptance of this biogeneric, it is fast gaining popularity among pharmaceutical companies in India and abroad. The guidelines and procedures are moving towards providing biosimilars with the status that the industry has been waiting to attain. Adding to the catalysts is the recent USFDA approvals to various pharmaceutical organizations like Pfizer, Biocon, etc. With these progressions, the industry is fast striding forward. Biosimilars are drugs aimed at the treatment of serious and life-threatening diseases.

The Indian pharma companies are focusing all their efforts in developing their portfolio in this segment with the country’s large pharma players investing in huge numbers for the Research and Development of Biosimilars.

As patents of many biologics are expiring in the next few years, this aspect presents a great opportunity for the companies in India to focus their resources on the development of biosimilars.

India has a robust pipeline for biosimilar drugs that is in line with the Indian government’s plans to offer grants to Indian biosimilar manufacturers. According to Decision Resources Group’s analysis, more than 40 biosimilars are in the clinical development phase in India; a number higher than that in the US and almost similar to those in development in the European Economic Area (EEA). Another trick of the trade lies in strategic partnerships with companies outside of the Indian market to uplift their profiles in the world markets.

Differential pricing strategies present another set of opportunity in market expansion. This could work by targeting different economical sections of consumers with differentiated pricing strategies.

July 2018 ► 27

Staying Compliant and Profitable in the Pharmaceutical Packaging Process with Checkweighing This article highlights use of checkweighing technology in pharma packaging and how it can help manufacturers improve their productivity through lowering changeover downtime and greater traceability.

H

igh demand in the pharmaceutical industry is a constant.

Manufacturers both large and small must look to optimize their production lines in order to ensure production quotas are met in a timely, profitable and above all safe manner. Larger producers running single product batches seek outstanding reliability and accuracy in checkweighing, whilst smaller contract packagers - who are likely servicing multiple clients - need the flexibility to effect quick changeovers in order to keep throughput to a maximum.

As manufacturers need to remain certified in order to produce pharmaceutical products, compliance is also critical.

Products entering the supply chain that do not meet the required standard threaten patient safety, retailer confidence and in the worst case scenario a company's ability to continue production.

All are damaging to profit margins to varying degrees and the risks can be mitigated with a well executed product inspection programme.

Automation is a given in these environments and it is universally recognized that checkweighers play an instrumental role in day to day production.

A checkweigher's main function in a pharmaceutical environment is to check the package for missing components such as the leaflet or complete blisters. This is a vital part of the package, as a box of tablets for example will not be considered safe or compliant without it.

Jana Meier Marketing Team Leader Product Inspection & Head of Marketing Checkweighing Mettler-Toledo, Mettler-Toledo Garvens 28 â—„ July 2018

End of line applications are also commonplace, where systems are used to check the completeness of secondary and tertiary packaging, ensuring that what is sent into the supply chain is exactly what is expected.

Checkweighers automatically inspect 100 per cent of products on the line - which is highly recommended compared with random off-line sampling, as the latter gives a sample size that is now considered to be of little statistical significance.

Checkweighing solutions can help pharmaceutical manufacturers to maximize productivity Downtime is the enemy of any manufacturer, therefore identifying areas that affect this directly is important when looking at Overall Equipment Effectiveness (OEE). System setup is one such area that can be optimized, and checkweighing features such as digital position control help to verify this is carried out correctly - otherwise the batch cannot be run at all. Running a batch with incorrect inputs can be very costly to correct due to the wastage involved.

Also, should these products enter the supply chain it could have significant consequences, both in terms of consumer safety and brand reputation.

Another feature that increases OEE is In-Process-Testing. The test procedure, to be followed step by step, is normally written down on a separate instruction document and the results are manually entered on separate documents. Such testing procedures are very labour intensive, cause operational downtime and rely heavily on the operator consistently testing for reliable results.

In-Process Tests significantly reduce the risk of errors during test procedures and are highly flexible - so are able to adapt Pharma Bio World

to customers' specific requirements.

They are easy to operate, generate automatic reports for each test scenario, and - most importantly of all - require no shutdown of production.

In-Process Tests are carried out with the help of special screen prompts, which guide the operator through the complete procedure and automatically record the results, which can then be saved and printed. Clear guidance during testing reduces labour time and possible operator errors and manufacturers benefit from more consistent, reliable results and higher operational uptime. In-Process Tests enable several configurable test scenarios.

In addition, there is an easy to operate, intuitive Graphical User Interface (GUI), that helps the user to make changes easily. Mettler-Toledo also offers ProdX, a product inspection data management software application, which can significantly increase OEE as it enables nearly all processes on the line to be monitored from a central point.

Compliance with Good Manufacturing Practice (GMP) guidelines

Minimizing changeover downtime with checkweighing technology

Pharmaceutical checkweighers in particular are designed to meet the regulatory requirements of the pharmaceutical industry. First of all, GMP offers a broad guidance, although GMP regulations are not prescriptive instructions but consist of guidelines based on general principles.

Minimizing changeover downtime is critical.

Advanced checkweighing systems offer useful features such as digital positioning control. Due to a plausibility check the system does not allow users to enter false parameters. Users are immediatley alerted if settings are entered incorrectly and the system will not start if the parameters are wrong - another factor that influences the usability of the GUI also helps users to save time and therefore minimize changeover times - key factors when looking to increase productivity.

These include, for example, the validation of processes, record keeping, operator training or prevention of cross-contamination.

It is always up to the manufacturer to design the production process and quality programs in accordance with GMP principles, to interpret the guidelines and asseses process risks accurately. MettlerToledo, in order to maintain process safety, offers equipment qualification, which is a huge benefit to users as it reduces the qualification and validation time in order to comply with FDA or CGMP (Current Good Manufacturing Practice) requirements.

Equipment qualification comprises all aspects of design, installation, operational and performance qualification.

Statistical Process Control (SPC), in addition, is possible via software functions that can be utilised to predict issues on the line. SPC measures and refers to industry standard values of process capability CP and CPK. Standalone or integrated systems allow users access to the statistical data needed to understand, document and control profitability and production efficiency.

This way, early detection of problems can be achieved ahead of any major issues that may have a significant impact on uptime. The ability to monitor performance is directly linked to OEE, and the net effect of reduced machine downtime is that higher production levels can be achieved using the same amount of resources. This leads to a faster return on investment with regard to capital purchases such as checkweighers.

Tracebility of Process Changes Individual boxes, for blister packs of pills for example, are lightweight, therefore the load cell of a checkweigher has to be very precise. The checkweigher helps to check for product completeness, to reject falsely produced products and ensure the safety of the processes comply with FDA requirements.

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July 2018 â–ş 29

Manufacturers generally deal with multiple facilities, that will all have to be enhanced with hardened serialization software to comply with these regulations.

Overall serialization is the key to success here and the EUFDM will require a unique serialization number on every salable unit of drug product intended for dispensation to a patient.

So, for instance, a batch of 60 boxes of blister pack pills will have 60 different identifiers, not just one at the lot level.

During production every aggregation level will have to be integrated into the serialization process and can be supported by checkweighing technology. Added value can be generated either by checkweighers with integrated serialization functionality, tamper evident sealing or aggregation solutions for the secondary and tertiary packaging at the end of the line.

Another demand is the legal compliance with CFR 21 Part 11, which describes the way access to information is managed and changes made to the checkweigher.

Everything has to be traceable and logged. This is integrated into the audit trail feature that the pharmaceutical checkweigher offers and a local audit trail operates completely automatically in the background and usually requires no user intervention.

Another useful feature is the domain login server, which enables the manufacturer to use accounts, passwords and rules issued and administered by the company's IT department for the checkweighers.

Operators, maintenance personnel, supervisors and quality managers can 30 â—„ July 2018

use their normal network log-in name and password for tasks at the checkweigher just as they would with a network PC. This is not an FDA requirement but is a very valuable addition to the system.

Regulations: Looking to the Future A challenge for pharmaceutical manufacturers will be the European Falsified Medicine Directive (EUFMD), that is expected to be implemented by the first half of 2018. Two years may sound like a long time, but depending on how many products the manufacturer has, how they are produced and whether they are produced using internally owned facilities or with external partners, it really isn't a great deal of time at all.

If a pharmaceutical manufacturer works together with contract packagers, which is quite common in Europe, it should keep in mind that those contractors may not be ready for serialization when it needs them to be.

In addition to upcoming regulatory requirements, the US Drug Supply Chain Security Act (DSCSA) is in development for the pharmaceutical industry, which is to be applied in three phases for the US market up until 2023. First is to ensure lot traceability, followed by unique serialization and last, but not least, a combination of the two.

Like the EUFMD, this act will involve an increase in work, and systems such as checkweighers will be instrumental in helping manufacturers to remain both compliant and profitable as the regulatory landscape continues to evolve.

Contact: Jana.Meier@mt.com Pharma Bio World

Contract Manufacturing Organizations: Navigating Serialization Implementation This article looks at the importance of getting serialization right for Contract Manufacturing Organizations (CMOs)

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n recent years the pharmaceutical industry has seen a significant change to the way its manufacturers and supply chains operate, due to the establishment of several serialization and track and trace regulations mandated globally.

The prominent driving force behind such regulations is the issue of counterfeit medications and supply chain diversion.

It is estimated that in the developed world around 1 per cent of all medications sold are counterfeit. In developing countries that percentage rises as far as 30 per cent 1. Governments around the world have recognised the severity of this issue, and as a result are beginning to put in place several major serialization regulations.

Deadlines for implementation in key markets such as the US and EU are close, while in countries such as Turkey, Brazil and Argentina, regulations have been commonplace for many years now.

In Europe, the Falsified Medicine Directive (FMD) was published in February 2016 and gives the industry three years to comply from that date.

In the US, the Drug Supply Chain Security Act (DSCSA) has three key deadlines; lot-level management was already established in January 2015, item-level serialization on each individual single product will be required by November 2017, and by 2023 electric pedigree and full aggregation of products throughout the supply will be mandated.

Challenges of Implementing Serialization Regulations for CMOs

Arthur Smith Vertical Marketing Manager Videojet Technologies Pharma Bio World

For Contract Manufacturing Organizations (CMOs) the process of implementing

serialization is complicated, mainly due to the lack of certainty among their customer base as to their requirements.

This can cause delays for the CMOs and pose a real concern now that deadlines are approaching.

For CMOs there are two key considerations to address when implementing serialization into existing packaging lines; understanding what is required from them as a company and also understanding what their customers need. Furthermore, CMOs need to understand what markets their customers sell in, be it globally or locally, as regulatory requirements can differ.

Similar to traditional manufacturing operations, CMOs must also be conscious of the fact that, as they implement more complex processes to their packaging lines, the Overall Equipment Efficiency (OEE) of their systems may be negatively affected.

It is important to understand that good preparation, the right equipment and a focus on operator training can significantly reduce the negative impacts on operations.

Ensuring that code formatting is correct and lead times on key equipment are accounted for are other important factors to overcoming challenges.

Operational Framework Undertaking a serialization programme requires a comprehensive understanding of the stages of implementation. The typical framework for implementing a serialization programme consists of six phases.

• • The initial phase involves defining the strategy, identifying what needs to be done in terms of serialization, which stakeholders need to be involved and what the goals of implementation are.

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•• Once the strategy has been established, an organization must undertake an indepth analysis of each system, as well as the IT infrastructure, and identify what needs to be replaced and what new systems are required. At this point, stakeholders and others involved in the project going forward should also commence the training process.

•• Next follows the design phase; based on a clear definition of what needs to be achieved the contract manufacturer starts to design the solution, examining the hardware and process facets, as well as the IT and qualification, testing and validation features. Now is the time to start preparing what is called the organizational change management identifying how the program affects how people work within the company. This is vital, as serialization implementation will impact both processes at the manufacturing line and also at the warehouse stage when it comes to shipping and receiving goods.

•• The forth phase involves the building of the solution based on individual, well defined user requirements. Changing and testing of the individual equipment commences and customers start to look at how the systems will be integrated from an IT point of view.

•• The penultimate phase is where the final solution is built and the project goes live.

•• The final phase involves dealing with issues which arise as a result of the implementation, such as temporary reduction of efficiency on the packaging line, and also measuring whether the benefits of implementation are being realized once the process is underway.

If an organization engages in a structured framework of serialization implementation there is an opportunity to create real business value from a programme.

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Preferred Equipment

Conclusion

As packaging standards continue to grow in complexity due to regulatory developments, both manufacturers and contract manufacturers are faced with the challenge of how to gain a return on the investments they make in their packaging lines. Improperly selected printer technologies can seriously impede the speed and productivity of packaging lines, which can have a detrimental effect on profit margins. Selecting the correct printing technology from a dependable supplier is one of the most important considerations manufacturers need to make when implementing a serialization program.

Serialization and trace and trace regulations are becoming commonplace within the pharmaceutical packaging industry, and interpreting how to implement serialization practices within existing packaging lines does not come without its challenges for manufacturers across the board. However, understanding how to structure a serialization programme, being conscious of key regulatory deadlines and understanding customer requirements are keys to success for CMOs in the pharmaceutical industry.

Along with regulatory factors, the need for high resolution printing and printer cleanliness have also been driving forces behind the innovation of existing and new printing technologies in recent years.

Consequently, packaging engineers now have a varied selection of printing technologies from which to pick, the most popular being Thermal Inkjet (TIJ) and Laser.

Finding a partner who is able to support that process from start to finish has significant benefits, as the smoother the transition, the less downtime will be experienced. Having the backing of a global service network is something to be mindful of, as is finding a partner who has significant experience in implementing serialization solutions and the structure in place to deliver to requirements - from a single coding unit to a turnkey project.

TIJ coding and marking systems are inkbased, non-contact printers generally used to print traceability information, including 2D DataMatrix codes, onto commonly used packaging. The printer uses small resistors to propel ink drops onto packaging as it passes by the printhead. This system is used for high-resolution printing, utilizing heat and surface tension to move ink onto a package surface.

Laser printing systems use a beam of infrared light focused and steered with a series of carefully controlled small mirrors to create marks where the heat of the beam interacts with the packaging surface. Laser marking can be used to print 2D bar codes as well as human readable codes.

Contact : itan@abipr.com

Pharma Bio World

marketing initiative

Mass Flow Controlled Coating of Medical Devices

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he medical market - including health and personal care - is a very demanding market when it comes to the specification of instrumentation. Research and development activities are mainly geared to the demands of the market and many new products result from close co-operation with our customers. As an example, in the field of Medical equipment, our low flow liquid flow meters/controllers are being applied for artificial kidney production (hollow fibres). At healthcare institutions (eg, hospitals), our gas mass flow meters are used for monitoring anesthetic gas consumption.

the spraying of liquids using various types of nozzles, in all these applications the control of flow is vital to the accuracy of the coating applied. By using traditional flow metering and pump control techniques flow-rates can be controlled to 5-10% of the target rate. This may be acceptable in some applications, however, where active drug substances are being applied a variation of 10% in drug coating leads to an unacceptable rate of failures and losses at the QC stage. Responding to the need to improve flow control technology in low flow coating applications.

Advances in the design of medical devices such as catheters, guide wires and stents have greatly improved the quality of medical care.

However, these devices are often made with materials that bring undesirable complications, such as bacterial infection, blood clots and tissue trauma caused by device insertion. It is common to apply specialist coatings to alleviate these difficulties. Coatings must be applied in a repeatable verifiable manner especially when the coating is an active drug product as for example, in the case of a drug eluting stent. Traditional coating technology involves

Cori-Tech has developed a unique mini CORIFLOW controlled pumping system which uses the Coriolis principle to accurately measure true mass flow rate. Flow rates as low as 0.2 grams/hour can be controlled to an accuracy of 0.5% of target. The mini CORI-FLOW controller uses its integral fast PID control system to adjust the speed of a closed loop coupled pump resulting in a typical dosing accuracy of 0.5-1%. This represents a 10-fold improvement in what is achievable using a traditional volume flow metering system. The mini CORI-FLOW measures mass flow directly and there is no

need for the system to be calibrated for each liquid being pumped. It is not susceptible to errors caused by variations in density or temperature and is capable of controlling the flow of volatile fluids with low boiling points. The system is configurable to your individual needs and is available with a wide variety of pumps, communication and control options.

Some applications where this technology can be of benefit include: • Cardiac, peripheral and arterial stent coatings.

• Drug eluting balloon coatings.

• Pacemaker coatings.

• Coatings on to sutures and surgical instruments.

• Orthopaedic implant coatings.

• Bio-absorbable and biocompatible coatings.

• Hydrophilic or hydrophobic coatings on to medical devices such as catheters.

• Guide wire coatings.

• Heparin and silicon coatings for blood collection tubes and syringes.

• Silver Silane coating on to bandages.

• Anti-microbial coatings on to medical textiles such as bandages, surgical gauze, gloves and masks.

• Micro-encapsulation of pharmaceuticals.

• Pharmaceutical spray drying.

• Coatings for diagnostic test kits.

• Protein, enzyme, and reagent coatings.

• Supercritical CO2 for creating drug-loaded nanophase material.

For details contact : Toshniwal Hyvac Pvt Ltd

267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26445626, 26448983 Email: sales@toshniwal.net Website: www.toshniwal.net Pharma Bio World

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Introduction to Flow Technology

U

se this guide to evaluate the flow technology positive displacement flowmeter performance on your application. It provides the flow rate range, pressure drop information and typical calibration curves for each flowmeter size.

The following steps illustrate how to specify a flowmeter using these charts: 1) Collect Application Information - Complete a Flow Technology Application Form.

Information about flow rates, fluid viscosity and available pressure is required when reviewing the charts.

2) Convert Units (if necessary). It is necessary to convert the application information to

the same units as those on the operating range and pressure drop charts.

3) Choose the Flowmeter Size - Using the operating range and pressure drop charts, select a flowmeter size with a recommended flow rate range that covers the application’s flow rate requirements.

4) Check the Pressure Drop - Once a flowmeter size has been chosen; use the fluid viscosity to determine the maximum pressure drop across the meter. The pressure drop can be approximated by looking at the graph or calculated more closely by using the pressure drop equations adjacent to the graph. If the pressure drop is too high for the application, choose the next larger flowmeter size and re-evaluate the pressure drop.

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5) Evaluate the Flowmeter Performance- The square waves emanating from the After a flowmeter size with an acceptable preamplifier can be processed by any pressure drop has been selected, review the suitable electronic system for the indication typical calibration curves for that flowmeter. and totalisation of flow-rate including volume Review the individual flow technology batching, mixing and proportioning. flowmeter product sheets to determine which type of flowmeter is appropriate for The meter bodies may be constructed in stainless steel, grey cast iron or aluminium, the application The Toshniwal oval-gear-type positive with each material to suit fluid compatibility displacement flowmeters are designed for use with and process pressures and temperatures up to 100 bar and 180°C respectively. fluids having lubricity and viscosities up to 100 000 cSt. Performance characteristics that surround Installation of the meters on a sub-plate these meters include an excellent rangeability of assembly supplied with each meter for within a ±0.03% of rate measurement accuracy incorporation into the process piping facilitates for simplicity in mounting, servicing and a repeatability of ±0.05% of flow rate.

Based on the meshing gear-principle, two specially designed gear wheels developed by Toshniwal are precisely matched and enclosed in a very accurately machined housing.

Fluid flow initiates rotation of the almost frictionless gears and the measuring chambers that are constituted by the space between the gear teeth and the housing, define a known discrete volume of liquid that pass through the meters. The rotation of the gear wheels is such that exactly one tooth pitch defines that volume.

This rotation is detected by a system of two non-contacting magnetic field coils that are offset by a quarter of a tooth pitch. This phase shift in gear rotation recognizes the flow direction as well as provides for doubling of impulses that lends the meter an excellent capability for resolution of the generated flow signals.

and the periodic flushing of the process where necessary. The precision gear meters are available for supply voltages of 12 or 24 V DC and are also available in explosion-proof and intrinsically safe models for location within hazardous areas.

For details contact : Toshniwal Hyvac Pvt Ltd

267Kilpauk Garden Road Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshniwal.net Website: www.toshniwal.net Pharma Bio World

marketing initiative

Mack Pharmatech Pvt Ltd

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ack Pharmatech, a renowned lab equipment manufacturing company, was started in 1999 by two young technocrats – Mr Manoj Chaudhari, Managing Director and Dr Kiran Badgujar, Director. Since the time of its inception the company has focused on offering internationally accredited and globally compliant equipment to the industry, which has helped the company gain an edge above its competitors. Initially, the company took some time to come up with the final product and all the efforts paid off with the very positive response it received from domestic as well as international pharmaceutical industry.

Mack Pharmatech is the 1 Indian company to have CE Certified lab equipment. It is also an ISO 9001:2015 certified company and manufactures equipment as per the ICH and GMP guidelines. Today, Mack Pharmatech has positioned itself as one of the preferred suppliers of Stability Chambers in India and across various overseas markets. Both the partners attribute the growth of the company to a well-established marketing team, a strong network of dealers who represent the company across the country and a strong after sales services team which enables Mack Pharmatech to respond quickly to the customers’ queries and requirement and after sales support. All the equipment is made in compliance with US-FDA as well as UK-MHRA norms. The Directors along with their marketing team and st

engineers frequently visit exhibitions in India and overseas to keep themselves abreast with the latest technologies. Company conducts in-house training sessions at regular intervals to educate employees about the latest trends and their implementation, which has helped the company to produce highly innovative products for the industry. The team reviews customer feedback on monthly basis to address them and plan the next line of action. High quality of products + latest technology + prompt after sales service differentiates the company from its competitors and grows at faster pace.

Mack Pharmatech is the only company who gives all equipment with 1) PLC-based control system 2) 21 CFR software 3) Touch-screen display (HMI) 4) Standby refrigeration system 5) Standby humidity system 6) Imported standby Hygroflex sensor 7) GSM technology and hooter system

8) Password-protected door system Mack Pharmatech offers cost-effective PLCbased lab equipment’s like stability chambers, 9) Full view glass door and GMP Model walk-in stability chamber, BOD incubator, 10) Bullet feet levelling legs photostability chamber, cold chamber and deep freezer with European standard “CE” in 11) Tray spacing every ½” adjustable and more. different capacities.

Mack Pharmatech’s strong engineering Our Humidity Chambers Temp Range is base with in-house Engineering, R&D is the 20°C to 60°C, Humidity Range: 40%RH to backbone of the quality manufacturing. Its main 95%RH, Accuracy: ±0.2°C and ±2.0% RH, strength lies in its very quick development of Uniformity: ±1.0°C and ±3.0%RH, Control new products and its flexibility and adaptability System: PLC (Allen Bradly) and Stability to a changing environment. The main focus of chambers are suitable for different ICH test the company is to design and manufacture of conditions like 25°C and 60%RH, 30°C and high quality pharmaceutical equipment.

65%RH, 40°C and 75%RH, 30°C and 75%RH. The highly experienced and dedicated teams Also providing specially designed chambers have put in several hours of manpower to come for low humidity conditions such as 25°C and up with truly unique and innovative feature.

40%RH, 40°C and 25%RH and 30°C and We envisage the realization of these goals in near future, as our system evolves and surges 35%RH. forward in servicing age.

Our company shares a set of five core values: integrity, understanding, excellence, unity and responsibility. These values, which have been part of our company’s beliefs and convictions from its earliest days, continue to guide and drive our business decision. We continue to acquire and develop core technologies through continuous R&D and through alliances with renowned suppliers and partners.

For details contact: Mack Pharmatech Pvt Ltd

Figure 1: Walk-in Chamber Pharma Bio World

Figure 2: Photostability chamber.

B-48, MIDC Malegaon, Sinnar Dist: Nashik, Maharashtra 422 113 E-mail: sales@mackpharmatech.com Website: www.mackpharmatech.com July 2018 ► 35

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Armacell’s ArmaFlex insulation materials offer proven performance on the mitigation of corrosion under insulation

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rmacell, a global leader in flexible foam for the equipment insulation market and a leading provider of engineered foams, announced that ArmaFlex has successfully passed an independent corrosion under insulation test conducted by InnCoa, a widely-renowned corrosion institute. ArmaFlex was proven to have best-in-class performance and was the only material in the test not to exhibit any sign of corrosion.

Corrosion under insulation (CUI) refers to the external corrosion of metal piping and vessels, that occurs underneath externally clad or jacketed thermal or acoustic insulation, primarily due to the penetration of water. The choice of insulation system is

a critical factor in the mitigation of corrosion under insulation and can actively contribute to reduced operational costs.

To assess the capabilities of commonly used insulation systems with respect to the ingress of water vapour and the onset and spread of corrosion in a high humidity environment, an accelerated, 65-day test was conducted in Germany in March 2016

by InnCoa. The insulation systems tested included flexible elastomeric foams, glass fibre, polyurethane and stone wool insulation systems. The institute conducted daily visual inspections and took photographs of the insulation systems at regular intervals.

Corrosion was measured by way of visual inspection of the pipe surface following the removal of the insulation systems at the end of the test period and assessed with respect to the extent to which corrosion had occurred on the pipe surface.

As Nick Wiley, Managing Director, Armacell Engineered Systems, points out, “Corrosion under insulation is a major safety and performance issue for oil, gas and chemical process industries. It is estimated that up to 10% of annual maintenance costs in these industries are caused by this issue, with severe cases causing reputational risk. We

36 ◄ July 2018

are delighted with the superior performance of our materials in this assessment, which confirms the excellent results that have been achieved with our closed cell flexible elastomeric insulation solutions all over the world for decades.”

A white paper published by Armacell gives a detailed insight into the applied simulation methodology and the assessment of the insulation systems tested.

To download the white paper, please visit: www.armacell.com/oilandgas.

As the inventors of flexible foam for equipment insulation and a leading provider of engineered foams, Armacell develops innovative and safe thermal, acoustic and mechanical solutions that create sustainable value for its customers. Armacell’s products significantly contribute to global energy efficiency making a difference around the world every day. With 3,000 employees and 25 production plants in 16 countries, the company operates two main businesses, Advanced Insulation and Engineered Foams, and generated net sales of approx. EUR 560 million and adjusted EBITDA of approx. EUR 100 million in 2016. Armacell focuses on insulation materials for technical equipment, high-performance foams for high-tech and lightweight applications and next generation aerogel blanket technology. For more information, © Armacell, 2018. ArmaFlex is a trademark of the Armacell Group and is registered in the European Union, United States of America, and other countries. please visit:www.armacell.in.

For details Contact : Armacell Group

Manasi Bagde manasi.bagde@armacell.com Pharma Bio World

marketing initiative

Speeded-Up Drug Approval Process Will Boost Biologics Market, The Business Research Company

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he US Federal Drug Administration is aiming to cut the time-to-market and the development costs for new drugs.

This will help drive growth in the market for biologics, where over 1000 drugs are currently under development, to 9.6% year-on-year from its recent rate of 5.4%. Unlike small-molecule drugs that are manufactured through organic or inorganic chemical synthesis, biologics are manufactured by living cells. Biologics are more complex, fragile and difficult to manufacture than small molecules. They cost more to bring to market than the $2 billion average to develop a new drug, despite a trend to outsource development to contract research organizations.

The changes being implemented or considered by the FDA include allowing organ-on-chip trials to be substituted for animal trials in the early stages of the process, allowing the inclusion of non-trial data from patients, and changing the end-point benchmark from proving that the drug extends overall survival to showing that it prolongs the time a patient lives without the disease getting worse. Other changes include allowing biologics license applicants to obtain standard preparations for biologics (standard

Pharma Bio World

mAbs, chimeric mAbs, human and humanized mAbs; humanized source mAbs are currently the largest segment. Therapeutic proteins are engineered in the laboratory and work by targeting the therapeutic process which compensates for the deficiency of an essential protein. Therapeutic proteins include cytokines, peptide hormones and enzymes. Vaccines are biological preparations that stimulate the immune system and prepare it to fight future infections caused by pathogens. Biologic vaccines hold out hope for better treatment of viral infections and replacement of anti-biotics.

Biologics are very large complex molecules The therapeutic areas where the largest manufactured in living systems such as micro- number of biologics are being developed are organisms, animal cells or plant cells. They are cancer, rare diseases, neurological disorders, produced using recombinant DNA technology autoimmune disorders, heart disease and and are composed of sugars, proteins, nucleic stroke, diabetes, mental health disorders and acids or a combination of these substances.

Alzheimer’s, in that order.

solutions containing a precisely known concentration of an element) from sources other than the FDA’s Center for Biologics Evaluation and Research, or to develop them internally.

The FDA has also removed a rule (Section 610.21 of the FDA code) which specifies minimal potency limits to be met for certain antibodies and antigens. These changes will increase the rate of approvals in the world’s largest biologics market, the USA, from its 2017 level of 12 new biolics. Furthermore, where the FDA leads, other regulators often follow.

Monoclonal anti-bodies (mAbs) are the largest segment of the biologics market, followed by therapeutic proteins and vaccines. All three segments are growing at over 9% year-on-year. mAbs recognize and bind to a specific antigen that causes a chronic health conditions such as arthritis, cancer or multiple sclerosis. mAbs can be further segmented by source into murine

North America is the leading region for both biologic and other pharma sales but the story is different in second and third place. Asia Pacific has overtaken Western Europe in small-molecule drug sales but in biologics, Western Europe is still ahead of Asia Pacific.

The high cost of biologics, making them more affordable in affluent Western Europe, the

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greater prevalence there of the age-related diseases that many current biologics are designed to treat, and the more rapid growth of the biosimilars market in Asia Pacific account for this difference.

The USA’s biologics market is by far the world’s largest, worth seven times that of the second largest, Japan. Growth, however is widespread, with the BRICs (Brazil, Russia, India and China) in the lead. For instance, growth in India’s tiny market has surged recently, from the 12.4% CAGR it was achieving up to 2017, to 21%.

Growth has also accelerated in the European markets - the UK, France, Spain, German and Italy are all now seeing double-digit growth. as is the otherwise often somnolent market of Japan.

Growth in the US market, though a little slower in percentages, is of course worth most in dollars.

The global biologics market is fairly concentrated, with ten companies accounting for over 80% of sales. The US’s Johnson & Johnson is in the lead, closely followed by Swiss company Hoffman-La Raoche. BristolMyers Squibb, Glaxo Smith-Kline and AbbVie Inc are other key players.

to enable GSK to develop vaccines in-house; CSL acquired the influenza vaccine business of Novartis, a much bigger company; and in November 2016, Eagle Pharmaceuticals acquired Arsia Therapeutics, another relatively small pharma business, for $30 million.

Where To Learn More Read the Biologics Global Market Report 2018 from The Business Research Company for information on the following: Markets Covered: Biologics, healthcare services, pharmaceutical drugs, medical equipment.

Biologics Market Companies Covered: Johnson & Johnson, F. Hoffmann-La Roche Ltd., Bristol-Myers Squibb Company, GlaxoSmithKline Plc., AbbVie, Amgen, Sanofi S.A., Eli Lilly and Company, Merck & Co., Pfizer Regions: North America, Asia Pacific, Western Europe, South America, Eastern Europe, Middle East, Africa.

Countries: USA, China, UK, Japan, France, Germany, Australia, India, Spain, Russia, Italy, Brazil

Consolidation, rationalisation and developmentdriven M&A are taking place, particularly in the vaccine segment.

For example, GlaxoSmithKline acquired Swiss company Time Series: Five years historic (2013-17) and Okairos AG for 250 million euros ($325 million), forecast (2017-21).

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Data Segmentations: Biologics market historic and forecast size and growth rates for the world, 7 regions and 12 countries, therapeutic proteins, monoclonal antibodies (MAbS), and vaccines segments historic and forecast size, segment share, and growth rates for the world, 7 regions and 12 countries, global competitor sales and market shares.

Healthcare market segment shares for the world, 7 regions and 12 countries.

Other Data: Per capita average biologics expenditure, global and by country, biologics market size as a percentage of GDP across countries, biologics and biosimilars drugs sales proportion, number of general practitioners for 12 countries.

Other Information: Drivers and restraints of the global biologics market, PESTEL analysis, company profiles including products, strategy and financial performance for 10 biologics companies, biologics market trends and strategies, biologics market key mergers and acquisitions Sourcing and Referencing: Data and analysis throughout the report are sourced using end notes. Sources include primary as well as extensive secondary research.

Pharma Bio World

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B&R organized a conference on next generation automation technologies in Mumbai

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&R Industrial Automation has reached centre at B&R headquarters in Eggelsberg plans.” He opined that B&R aspire to be one an exciting milestone as the company as well as expanded production capacity of the most customer-oriented company, not celebrates 20 years of delivering a few kilometers away in Gilgenberg.” only with innovative approach but also with innovative technology and solutions to the Adding further on ABB, B&R synergy, he the dedicated support. “We have always Indian manufacturing industry. To mark this, mentioned, “ABB is investing `100 million been close to our customers and trust in long B&R recently organised a daylong technology in global innovation and training campus in term partnerships. To maintain this close conference in Mumbai. The primary objective Egglesberg. This ‘factory of future’ will be cooperation with customers B&R India has of this conference was to showcase next new high-tech innovation and technology launched World-Class Customer Support with a dedicated number. It will also help us in generation automation technologies and center and will be fully operational in 2020.” our endeavour to be close to customers and innovations to customers in Mumbai While discussing ambitious plans for company enabling them to reach us at all times,” he and nearby region. Technology focused doubling business in next three years, Jhankar elaborated. presentations and live demos of automation Dutta, Managing Director, B&R India averred, solutions were displayed to extend an avenue “Since last 20 years, many manufacturers Providing customers a competitive edge to connect with customers and to help them have placed their trust in B&R’s world class Dheeraj Taneja, Director, PET PLAST India, map their future technology requirements. The spoke at the conference on a topic focusing products and technologies.” event brought together over 100 experts from on benefits of technology for building efficient machine manufacturers, system integrators Jhankar further deliberated on what Industrial machines, which was of great help to and end users from a wide variety of industries. IoT means to our Indian ecosystem and delegates in understanding the importance of more importantly how it influences the way efficiency, quality and productivity. Speaking Global and innovative automation partner we run businesses. He further appreciated about collaboration and partnerships he said, Peter Gucher, Chairman B&R India and the government’s proactive initiatives and “Collaborating with B&R has given us access Member of Management, B&R Austria, stressed, “With government’s ‘Make in to latest technology and made our machines provided a global perspective on automation India’ initiatives, Indian machine builders competitive on the global market. Our trends and its impact on industries along and factories are becoming aware about partnership has already led to great success, with ground-breaking innovations by B&R, the requirement and benefits of technology and we look forward to achieving even more which help customers become ready for the and are willing to invest in same. B&R is in the future.” future. He spoke on B&R Austria becoming an innovative company, and we ready with the new global centre for machine and factory innovative products and solutions to be part The subsequent speakers at the conference automation for the ABB Group. “ABB and B&R of our customers Industrial IoT story.” He presented various topics such as, Integration are united in their innovation and customer stressed the importance of equipping B&R of long-stator linear motors in packaging lines, focus. These will be central factors as we to handle the market growth, and informed, efficiency in machine development, Edge evolve together going forward. Ensuring “To strengthen our market position we are architecture enabling IT / OT convergence its ability to handle the steadily increasing expanding our office space to 16000 sq. and importance of uniform, open and secure demand for B&R's advanced automation ft. in Pune at the same time investing on shop floor communications. The presentations solutions, ABB is investing in a new R&D manpower across India to match our growth showcased that building a digital enterprise will bring about operational excellence and cut costs across the value chain, giving diverse perspective on building smarter machines and factories.

With around 100+ delegates including customers and journalists, the conference provided the know-how and an easy path for successful implementation of Industrial IoT for machine builder and factories.

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

Website: www.br-automation.com Pharma Bio World

July 2018 ► 39

marketing initiative

B&R celebrates 20 years of growth & innovation with customers

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o mark a glorious milestone of 20 years strong and solid partnership with customers. Innovations : Making the difference in India, B&R Industrial Automation, Commenting on ABB- B&R synergy he stated, Delegates gained an inspiration for personal recently organised ‘CEO summit “B&R has closed the historic gap within ABB’s and business growth with insights from 2018’, which bought together CEOs from automation offering. This is a perfect fit and renowned speaker R. Gopalkrishnan, who leading companies in machine building for an will make ABB Group the only industrial is a senior corporate leader and an author evening of business presentations, talk from automation provider offering customers the of several books. He has led businesses at renowned leadership speaker and candid entire spectrum of technology and industrial Hindustan Unilever Limited; and is a former Executive Director, Tata Sons. By giving conversations. This summit focused on taking automation solutions.” examples of teashops, blue jays and colloidal advantage of the expertise of its attendees Speaking on the occasion, Jhankar Dutta, science, he distinguished between fulfilment with opportunities for participants to share Managing Director, B&R India spoke at length and success. their knowledge and learn from each other. on B&Rs focus on innovation, partnerships and collaboration enabling customers to join The summit also witnessed the launch of Joining hands for a successful tomorrow B&R management from Austria and India hands for a successful tomorrow. He mentioned, the 3rd edition of “Automotion INDIA”, a B&R shared their perspectives on industry trends, “Since last 20 years, many machine builders technology magazine, comprising of customer business growth with delegates. Peter have placed their trust in B&R’s world class success stories from various industries as Gucher, Chairman B&R India and Member of products and technologies. We are in pole plastics, automotive, printing, packaging Management, B&R Austria set the tone of the position today to get the maximum benefit out of and pharmaceuticals. The launch took event and thanked customers and partners for technology evolutions and adoption, which are place at the hands of B&R management being part of 20 years journey of B&R India. supported by policies of Indian government. We and customers who contributed towards the He focused on the importance of long-term aim at doubling business in coming three years.” articles published in the magazine.

Conference concluded with two pleasant entertainment acts specially organised for delegates. Artist portrayed B&R’s 20 years journey of growth and success through sand and UV light art. He highlighted B&R’s strength in terms of company’s global presence, world-class integrated manufacturing facility, high-tech products, long-term partnerships, and up-to-date technology which helps Indian manufacturers to gain a competitive advantage in global market.

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

Website: www.br-automation.com 40 ◄ July 2018

Pharma Bio World

marketing initiative

Powder Dryer End-Point Detection for Aqueous & Solvent-based Drying

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METEK Process Instruments offers powder manufacturers across a variety of industries a system for continuous, real-time monitoring and control of the powder drying process, whether it is aqueous- or solvent-based.

For years, drug manufacturers have relied on AMETEK ProMaxion mass spectrometers to monitor their pharmaceutical solvent drying processes.

Better suited for aqueous-based systems is AMETEK’s 5100 analyzer, which utilizes advanced tunable diode laser absorption spectroscopic technology to quickly and accurately measure water vapour concentrations during the drying process.

must be repeated until the LOD achieves a predetermined value.

On-line, real-time detection avoids the need to stop, analyze and then restart the drying process. Large-scale drying operations involving thousands of pounds of product can take upwards of 24 hours or more to complete. The repeated interruption of that process to accommodate manual analysis can add hours. In addition, many of the solvents used are flammable or pose other hazards, so there are added risks to manual analysis as well.

AMETEK’s on-line, real-time solution affords manufacturers the ability to pinpoint, without operator intervention, the exact moment Manufacturers across industries currently when a product has dried as much as rely on a combination of approaches involving possible. It works by monitoring moisture heat, pressure and vacuum to remove water and solvent vapours in the dryer exhaust line. and solvents from their products. The most- The amount measured is directly proportional common methods require that the process to the amount remaining in the product. be stopped and a sample removed for Loss of Drying (LOD) or Gas Chromatography In addition, data from the ProMaxion and (GC) analysis. This time-consuming process 5100 can be used to better understand

the drying process. Common off-line tests measure only the final LOD and provide little detail about internal processes. The ProMaxion and 5100 not only provide the data needed to confirm dryness at the end point but can be used to control all aspects of the drying cycle from product entry to removal.

The ProMaxion process mass spectrometer from AMETEK Process Instruments provides fast on-line monitoring of Volatile Organic Compounds (VOCs) with a reliable, easyto-use instrument. It comes equipped with a membrane inlet mass spectrometer (MIMS) that provides data at 10 to 15 seconds per sample stream and is between 10 and 50 times faster than most gas chromatography methods that require separation prior to analysis.

Mass spectrometry offers direct quantification of the species of interest, as well as a total reading. A single mass ion can be chosen specific to each compound and these masses can be continuously monitored. If a total concentration is required, the mass spectrometer can survey all VOCs, total them within the software, and output realtime concentration. This technique also avoids sounding false alarms.

AMETEK is experienced in designing complete systems with the ability to automatically control single or multiple dryers. The ProMaxion has multiple sample inlets, so a single unit can monitor multiple dryers, with each assigned its own individual configuration. The analyzer comes packaged in an explosion-proof housing and is certified Class I, Div. 1 for hazardous environments.

AMETEK 5100 TDLAS Analyser Pharma Bio World

The analyzer can periodically scan for mass intensities across the operating range and can detect abnormal conditions such as leaks or other problems. Another advantage of the ProMaxion is its ability to provide rapid measurement of multiple components on the same sample stream. Different calibration July 2018 ► 41

marketing initiative Modbus and Ethernet analog and digital connectivity.

In recent years, near-infrared tunable diode laser absorption spectroscopy has gained significant attention from its use in a range of industrial applications. The advantages and effectiveness of TDLAS techniques have been well proven in a number of challenging online applications.

TDLAS has three key attributes that have contributed to its success.

They are excellent specificity, high sensitivity and fast response speed. Tunable diode lasers have emission bandwidths that are on the order of 10-4 to 10-5 cm-1. That allows them to achieve extremely high spectral resolutions, such that a TDLAS analyzer can isolate a particular analyte species from a single rotational-vibrational transition.

AMETEK ProMaxion Process Mass Spectrometer

and analysis methods can be assigned to each inlet port.

AMETEK Process Instruments has broadened its line of 5100 Series gas analysers to include a portable version. The Model 5100P provides simple, easy-to-use moisture analysis using tunable diode laser absorption spectroscopy (TDLAS).

The durable, lightweight natural gas analyser is the tool-of-choice for users needing to perform water vapour measurements in remote locations or to verify fixed analyser installations.

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In addition, analyzer’s laser can be tuned rapidly, making it easy to implement such techniques as wavelength modulation spectroscopy, which yields dramatic enhancements to sensitivity over a direct absorption approach. And, because the TDLAS is a non-contact optical technique, it offers very fast response speeds, which can mean substantial savings in both time and cost for such applications as powder drying among others.

The speed of the ProMaxion facilitates the analysis of multiple streams. Its proprietary software provides for easy set-up, operation The ProMaxion draws on AMETEK’s more and calibration together with advanced than 30 years of experience in mass alarm and automation capabilities. Self- spectrometer design and manufacture diagnostics and a modular design ensure and the 5100 more than 40 years of ease of maintenance, and modem support is experience in the design and development available for additional factory diagnosis and of sophisticated process analyzers. AMETEK troubleshooting. offers the industry’s most extensive product line, offering analyzers based upon eleven Data can be exported using all common differentiated technology platforms. industrial protocols as well as dedicated analogue lines to bring the data to a common AMETEK Process Instruments is a point for collection. Alarms are available for unit of AMETEK, Inc, a leading global every stream, and a mathematical package manufacturer of electronic instruments and allows data to be presented in various ways. electromechanical devices.

The laser-based 5100 analyzer has a moisture detection limit in the ppm range.

It features compact, fully enclosed optics and sample conditioning, on-board moisture verification and all digital signal processing.

The rugged, compact unit is available in an IP-65 and NEMA 4 enclosure with both

For details Contact : AMETEK Process Instruments India

Plot 148, EPIP Zone, Phase 2 Featherlite Tech Park, 1st Floor Whitefield, Bengaluru, Karnataka 560 066 Tel: 080-67823200 Fax: 91-080-67803232 Website: www.ametek.in Pharma Bio World

press release Filling and closing machine from Bosch honored with Red Dot Award

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he filling and closing machine AFG 5000 from Bosch Packaging Technology recently received the internationally renowned “Red Dot Award” from the Design Zentrum Nordrhein-Westfalen in the category product design. The assessment was carried out by a 40-member international expert jury based on criteria such as degree of innovation, functionality, formal quality, ergonomics and durability. Designers and manufacturers from 59 nations submitted more than 6,300 objects.

The filling and closing machine from Bosch was awarded in the category product design.

“We are very happy to receive this award. The independent jury verdict shows that our approach to focus on the customer right from the beginning proves successful,” said Dieter Bandtel, product manager at Bosch Packaging Technology, during the award ceremony at the Red Dot Gala in Essen, Germany. “The AFG 5000 was developed and designed according to customer requirements. The result is a machine with a compact and space-saving design, easy handling and a small number of format parts.”

via transfer lock and then mounted with the aid of gloves. “Parts handling is usually a complicated process,” Bandtel explained. “This is why the product-handling parts of the AFG 5000 are light-weighted and easy to handle, so employees can install them with little effort.

Thanks to the vertical, ergonomically accessible design, the system can be operated completely from one side.” Alternatively, operators can exchange parts when the RABS is open and then sterilize the assembled essential parts with a CIP/SIP process.

Successful market introduction and ongoing development In autumn 2017, the AFG 5000 was first presented to a selected audience. The flexible machine platform allows the exact dosing of both small and large amounts of powder with an output of up to 480 vials per minute. Customers can choose between statistical or 100% in-process control of dosing weights. While the vials are continuously fed into the filling machine, the transport system adjusts the feed rate to precisely match the rhythm of the individual workstations.

Shuttle carrier systems, which can quickly switch between infeed and outfeed, prevent bottlenecks and idle times. “Since its introduction, the machine has been successfully established on the market within a very short time,” said Bandtel.

Continuous gas flushing reduces residual oxygen To increase pharmaceutical products’ durability, manufacturers must keep the residual oxygen content in the vial as low as possible.

Hence the glass containers are gassed with nitrogen prior to closing.

“However, when nitrogen is rapidly and forcefully blown into the vial, there is a risk of powder particles whirling up and out of the vial,” Bandtel explained. “We prevent this risk by integrating the gassing channels of the AFG 5000 directly into the stoppering wheel.” The rotation of the wheel creates a continuous flow of nitrogen at the bottle opening right up to closing and ensures consistently low residual oxygen levels. “The continuous transportation of the vials within the gassing area optimally supports this process,” said Bandtel. “This way, the functionalities of the machine complement each other even more effectively.”

Flexible aseptic parts changeover The close exchange with customers, as well as their feedback made it possible to add new features to the AFG. For instance, pharmaceutical manufacturers can now also aseptically incorporate powder-handling parts before the start of production with closed RABS (Restricted Access Barrier System). The parts are introduced Pharma Bio World

July 2018 ► 43

Manual Top Discharge Centrifuge Manual top discharge machines are available with full mouth body open lid, full lip mouth open lid and ¾ lip mouth open lid. The washing and feeding is designed to meet product requirements. The manual top discharge machines are available from as small as 8” dia to as large as 72” dia.

ACE Industries have made as large as 72” dia basket size of their STD Model 180-4 centrifuge machine giving cake load of 1,000 litre/1,200 kg per batch.

Lid available in three options: full mouth, D-type and full body open lids.

For more information, please contact: ACE Industries (India) Pvt Ltd 113 Alpine Indl Estate Marol Military Road Andheri (E) Mumbai 400 059 Tel: 022-42258000, 29201763, 66919449 Fax: 91-022-29204939 E-mail: ace_centrifuges@yahoo.co.in

Inlet Distributor The FXIntSep is a simple, dual vane inlet device used in horizontal separators where there is a requirement for reasonable flow distribution with low shear and pressure drop. In horizontal vessels this is suited to top entry.

Benefits of this compared with simpler deflectors such as deflector

device

plates or dishes include reduced agitation and hence improved 2 and 3 phase operational performance, more stable level control and reduced foaming.

For more information, please contact:

Fenix Process Technologies Pvt Ltd K 6/1 Malini, Erandwane Co-op Hsg Scty Nr Mangeshkar Hospital Opp: Sevasadan School Erandwane, Pune, Maharashtra 411 004 Tel: 020-65008772, 65008773, Fax: 91-020-25458454 E-mail: info@fenix.in

Dome Open Lifting Bag Type Centrifuge The latest trend in solid/liquid separation is to go in for greater ease in cake handling. Filter cloth is available in the desired strength and micron size. The fabric with polypropylene woven/non-woven polyester, nylon, cotton, etc, with strengthening strips and hook up arrangement are easily available.

The ACE lifting bag system supports such filter bags. Quick and easy fixing arrangement helps in the centrifuging. The time factor for the various operations is studied and this is passed on to the user at the time of installation and commissioning.

The filter bag setting is precisely done so that the entire assembly is as fool-proof as the simple top discharge centrifuge. Hence 100 per cent solid liquid separation without loss of a single solid particle in filtrate is achieved by the instant cake lifting type centrifuge.

For more information, please contact: ACE Industries (India) Pvt Ltd 113 Alpine Indl Estate Marol Military Road Andheri (E), Mumbai 400 059 Tel: 022-42258000, 29201763, 66919449 Fax: 91-022-29204939 E-mail: ace_centrifuges@yahoo.co.in

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Pharma Bio World

Batch Concentrators Omega-Kemix batch concentration system is a comprehensively engineered package for concentration of solutions, with effective recovery of solvents.

The system comprises of a holding vessel, with a calandria type thermosyphon reboiler fitted to the bottom of the vessel. An inline condenser-subcooler is mounted above the vessel and a secondary cooler is downstream of the condenser-subcooler.

The reboiler is a vertical heat exchanger with a central downcomer and a bottom conical jacketed outlet.

The vessel is filled to the desired level with the feed solution. The system is designed to evaporate the solvent from the solution, condense and cooled solvent to suitable storage by gravity flow. Volatile solvents are further cooled by chilled water to minimise evaporation losses. At the end of the operation, concentrated solution or slurry is discharged through the bottom cone of the vaporiser for further processing.

For more information, please contact: Omega-Kemix Pvt Ltd R-333, TTC, MIDC Rabale, Navi Mumbai 400 701 Tel: 022-27696614, 27696615 Fax: 91-022-27696642 E-mail: sales@okpl.com

Multi-tube Filter Subodh multi-tube filter consists of elements made up of multi-tubes and dressed with seamless filter hoses to obtain clear filtrate.

The number of elements housed in a pressure vessel on tube sheets and various registers are externally fitted to avoid complexity and corrosion due to deposition of solids on pipes if located inside the vessel.

Pressure vessel designed under ASME Code filtration is done with moderate pump pressure and initial circulation of slurry to obtain the clear filtrate.

As soon as the filtrate is clear the clear liquid is collected in the receiver. Soon the slurry exhausts in the tank, pumping is stopped and compressed nitrogen supply is restored in the filter vessel which filters the hold up till the end; the heel volume is filtered through single cartridge sintered metal filter fixed in inlet line.

In order to effectively discharge the cake in solid form the deposited cake is further blown with compressed nitrogen and dried to permissible limit. Special system is designed to collect the solids in closed bin through chute fixed with cloth sleeve to dissipate the clean air while solids are received by the bin. Special actuated butterfly valve is fixed at the drain point.

In case of catalysts applications the same candles after drying the cake is back-flushed with clean liquid being hydrogenated in subsequent batch so that entire catalyst is re-slurried and collected in the reactor.

For more information, please contact: Subodh Engg Pvt Ltd Plot No: A-314, Road No: 34 Wagle Indl Estate, Thane Maharashtra 400 604 Tel: 022-25810403, 25837791 Telefax: 022-25821392 E-mail: subodh314@vsnl.net subodhfilters@hatway.com

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July 2018 â–ş 45

Trace Elemental Analysis Solutions Simplify your CHNS/O analysis with the Thermo Scientific FLASH 2000 Organic Elemental Analyser (OEA) and discover how it solves your laboratory challenges, improves workflow and minimises downtime. The FLASH 2000 Elemental Analyser delivers the ultimate performance in simplicity, precision and costeffectiveness for any laboratory requiring the quantification from few ppm to 100 per cent of carbon, hydrogen, nitrogen, sulphur and oxygen. Providing a reliable, high speed accurate 24/7 analytical solution to a range of industries, the flexible, configurable organic elemental analyser uses a globally recognised technique, endorsed by official organisations worldwide.

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: 91-022-67429495 E-mail: sagar.chavan@thermofisher.com

VHP Pass Box SteriTransfer is designed for the material transfer from lower grade to higher critical grade. It can transfer and sterilise all kinds of materials, electricals and packages at low temperature. It follows standards and regulations: cGMP, FDA2003: sterile drug products produced by AsepticProcessing.GMP requirements of EU. GAMP guide for validation of automated systems.

For more information, please contact: Shreedhar Instruments 16 Shreeji Krupa Scty Opp: MGVCL Circle Office Next to GMERS Medical College Gotri Road, Vadodara, Gujarat 390 023 Telefax: 91-0265-2323041 E-mail: sales@shreedhargroup.com

46 ◄ July 2018

Trace Elemental Analysis Solutions Defining quality standards for the analysis of solid samples, the Thermo Scientific ELEMENT GD PLUS Glow Discharge Mass Spectrometer (GD-MS) redefines the analysis of advanced high purity materials directly from the solid. Extra-low detection limits are provided with minimum calibration and sample preparation effort, making bulk metal analysis and depth profiling applications the domain for GDMS. Ceramics and other non-conductive powders are analysed by using a pulsed source approach, providing the same level of sensitivity and data quality. This makes GD-MS the reliable standard method for metal analysis.

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: 91-022-67429495 E-mail: sagar.chavan@thermofisher.com

Glove Integrity Tester HTY-GIT01 glove integrity tester is designed to check the integrity of isolator/RABS system gloves/ sleeve or long gloves. It is in compliance with ISO 1464407 Standard. It is artistic and efficient.

It is housed in a SS enclosure with large touch screen panel which is compatible with clean rooms and it is very easy to operate. It works in positive pressure and result is displayed, based on which the operator can determine the integrity.

For more information, please contact: Shreedhar Instruments 16 Shreeji Krupa Scty Opp: MGVCL Circle Office Next to GMERS Medical College Gotri Road, Vadodara, Gujarat 390 023 Telefax: 91-0265-2323041 E-mail: sales@shreedhargroup.com

Pharma Bio World

Electropure EDI The Electropure EDI is manufactured by SnowPure LLC, USA, makers of high purity water modules.

The EDI module replaces the conventional mixed bed DI unit which produces high purity water up to 18.2 Meg-Ohms-cm resistivity unlike mixed bed unit, which requires regeneration. Electropure EDI does not require regeneration.

The Electropure EDI design combines two well-established water purification technologies – electrodialysis and ion-exchange resin deionization.

Electropure’s EDI removes ions by forcing them out of the feed streams via an electric potential. This process uses a combination of ionselective membranes and ion exchange resins sandwiched between two electrodes (anode (+) and cathode (-) under a DC voltage potential) to remove ions from RO pre-treated water. Result is very low conductivity ultrapure water which can be produced continuously up to 18.2 MegOhms-cm resistivity, It finds application in pharma industries, purified water, water for injection (WFI), automobile industries, power stations, boiler feed water, process industries, laboratories for process water, etc.

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

Spray Dryers SAKA’s spray dryers are designed to serve your specific process needs to deliver best output efficiency, with optimum operational costs and no product wastage.

The spray dryers are designed based on inputs derived from in-depth analysis of your process parameters, available space and the application. Engineering and automation in SAKA’s spray dryers provide you with complete control on configuring key process characteristics such as moisture content, particle size, bulk density, flow patterns, etc, to manufacture the desired product.

SAKA employs highly advanced methodology of computational fluid dynamics (CFD) analysis, to deliver guaranteed results for your business, process reliability and system performance. CFD simulation helps to foresee performance before actual execution of the systems, without actual installation of the system. It also helps understand the most vital parameters for improving performance.

SAKA is also credited with successful installation of one of the biggest spray drying plant in India at Bhavnagar, Gujarat. It has a strong process expertise with world class quality, experienced team of service engineers to provide you continuous support and is highly energyefficient with lesser cleaning and maintenance. Capability to design, manufacture and commission dryer for any capacity.

For more information, please contact: SAKA Engg Systems (P) Ltd Plot No: W45, T-Block, MIDC Bhosari Pune, Maharashtra 411 026 Tel: 020-27110011 Fax: 91-020- 27110013 E-mail: sales@sakaindia.com

Pharma Bio World

July 2018 ► 47

Trace Elemental Analysis Solutions The Thermo Scientific ELEMENT 2 and XR high resolution (magnetic sector) ICP-MS systems cover the sub-ppq to ppm concentration range. They provide class-leading elimination of interferences for accurate and reliable quantitative multi-element analysis at trace levels. Even without sample preparation. This makes them especially suitable for the metrology and analytical standards industry as well as semiconductor, geological and material science laboratories. The Jet Interface for the ELEMENT 2/XR HR-ICP-MS set a new standard in sensitivity for ultratrace elemental analysis.

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: 91-022-67429495 E-mail: sagar.chavan@thermofisher.com

Cyclone Inlet Distributors The FXIntSep is a cyclonic inlet device used in horizontal and some vertical separators where there is a requirement for high momentum dissipation, foam reduction and high capacity.

A characteristic of the FXIntSap is its high flow capacity, meaning that more throughput is possible through any given size separator.

For more information, please contact: Fenix Process Technologies Pvt Ltd K 6/1 Malini Erandwane Co-op Hsg Scty Nr Mangeshkar Hospital Opp: Sevasadan School Erandwane, Pune, Maharashtra 411 004 Tel: 020-65008772, 65008773 Fax: 91-020-25458454

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Sectional Overhead Doors Porto doors are built to ensure the highest ease and flexibility of use, which also allows quick, hassle-free and accurate replacement of old doors.

Porto door design is optional who need robust, well-insulated and space saving door in compliance with safety requirements.

The panels are sturdy and consist of double skinned pre-painted galvanised steel, thickness 40 mm. The door panels are available in two heights: 500 mm and 610 mm.

The core insulated with high-density (45 kg/m3), CFC-free polyurethane foam offers high protection from outside temperatures and soundproofing.

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

Tray Dryer The tray dryer is drying equipment developed for drying granules, powders, pellets, tablets, etc.

The design and geometry of the tray drier ensures that the moisture content of the product is removed in optimum time. They are available in R&D Models TD 6 and TD 12, and Production Models TD 24, TD 48, TD 96 and TD 200.

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

Pharma Bio World

High Speed Clean Room Doors Clean room doors are well suited to clean room isolation environment. They provide high air-tightness and controls the inside pressure. Fast opening and closing of clean room doors ensures very low air loss and minimize air exchange, which results in increased clean room cost-effectiveness. The entire door (side frame, motor and roll cover, and bottom profile) is made from SS. The smooth SS surface facilitates easy cleaning and prevents particle deposits.

The extremely small gap of the clean room doors curtain guide ensures minimal pressure loss.

The clean room doors are equipped with an optical safety contact edge.

In clean room door frequency converter control system are located in a compact sealed compartment under the top roll cover.

These doors are designed to ensure smooth and noiseless operation.

Various safety features are incorporated as per EN Standards.

Advanced drives and controls are incorporated to achieve any safety and operational requirement.

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

Membrane Contactors Liqui-Cel membrane contactors are offered by Membrana, USA, makers of liquid degasification contactors. Liqui-Cel membrane contactors are widely used for removal of dissolved gases such as oxygen, carbon dioxide, nitrogen and ammonia in aqueous solution. Membrane contactors are typically shell-and-tube device containing microporous hydrophobic, hollow fibres. The MoC of hollow-fibre is polypropylene having internal dia 200-220 microns, outer dia 300 microns and having an average pore size of 0.03 microns. Water is passed on outside of the membrane (shell side) and a gas is passed inside of the membrane (lumen side). Since the membrane is manufactured using a hydrophobic material and the pores are small, water does not easily pass through the pores. The membrane essentially acts as a support between the gas and liquid phases and allows them to interface at the pores. Gases, however, freely pass through the pores on a molecular level, sweep gas as air or nitrogen and either/or vacuum is applied inside the fiber which results in reducing the partial pressure of the gas to be removed. The water leaving the membrane contactor will be degassed.

It finds application in boiler feed water (oxygen removal); pharma (carbon dioxide removal); removal of non-condensable gases in pure steam generator; power and microelectronics (oxygen and carbon dioxide removal); beverage (carbon dioxide injection and oxygen removal); humidification of gases in pharma and process industries; and printing (degassing of inks and coatings).

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

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Ultra High Shear Inline Models Ultra High Shear Models include the Quad, X Series or MegaShear designs. The units include four stage or greater rotors that turn at speeds to 15,000 feet per minute within a stationary stator. As the rotating blades pass the stator, they mechanically shear the contents.

This Series is a good choice for process lines that require frequent changeover from one product to another. A simple valve can divert finished product downstream or switch instantly from one vessel to another. The Inline Models are supplied in many sizes and MoC from 10 through 250 HP. For more information, please contact: Ross Process Equipment Pvt Ltd Plot No: D-233/3, Chakan Indl Area Phase II, Village: Bhamboli Tal: Khed, Dist: Pune Maharashtra 410 501 Tel: 02135-628400, 628401, 628402, 628403 E-mail: mail@rossmixers

Silicone Rubber Sheet

Cold Chamber Mack Pharmatech offers cost-effective PLC-based cold chambers with European Standard “CE” in different capacities.

Their cold chambers have temperature range: 2°C to 8°C, accuracy: ±1.5°C, uniformity: ±2°C and control system: PLC (Allen Bradley) Mack Pharmatech is the only company who gives all equipment with PLC-based control system, 21 CFR software, HMI (Touch Screen Display), standby refrigeration system, GSM technology, hooter system, GMP Model, full view glass door, bullet feet levelling legs, tray spacing every ½“ adjustable and many more features.

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

Spheroniser Shree Gaurav’s silicone rubber sheets are available from sizes 1 x 1 ft up to max 1 x 2 metres. Thickness ranges from 2 to 12 mm.

Transparent silicone sheet is also available in compliance with FDA 21CFR 177.2600 requirements.

Models SPH500 and SPH700.

For more information, please contact: Shree Gaurav Rubber Products 112-B Marudhar Indl Estate Opp: Old Sydicate Bank Goddev Road, Bhayandar (E) Dist: Thane, Maharashtra 401 105 Telefax: 91-022-28197355 E-mail: Gaurav_rubber@rediffmail.com

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The spheroniser is a self-contained compact machine for the special purpose of making pellets. The extrudes are dropped axially from the feed hopper into the spheroniser to get exposed to rotating checker plate to get sized; further exposure to the surface of checker plate results in conversion of the extrudes into the shape of sphere, ie, pellets. They are available in R&D Models SPH75, SPH150 and SPH250 and Production

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

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Deep Freezer Mack Pharmatech offers cost-effective PLC-based deep freezer with European Standard “CE” in different capacities. Their deep freezer have temperature range: up to -40°C, accuracy: ±3°C, uniformity: ±3°C and control system: PLC (Allen Bradley).

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

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

High Speed Fold Up Doors When it comes to the external doorway openings, for medium and large dimension openings, fold up doors are the best alternative. Avians doors are characterized by their well-conceived design and highquality components to withstand extreme climate conditions and wind loads.

Moving speed of fold up doors is 1 to 1.5 m/sec and wind carrying capacity is up to 110 km/hr specially designed stiffeners in the curtain give high stability and a good wind load.

Incorporated with optical safety edge sensors with auto-opening feature to avoid damages arising from accidents. Rapid action doors have advanced feature control to integrate a variety of safety features.

Their drives are inbuilt with special anti-drop device and additional electromagnetic brake to prohibit free-fall of the door in any worst scenario.

Lifting belts are used to guarantee the opening and closing of high speed PVC doors, which are directly connected to the winding tubular shaft and are powered by side mounted motor.

The lowered curtain is completely extended down; while at open door the curtain is folded up in sections parallel to each other that safeguard the wear and tear of components. The door curtain is fitted with horizontal reinforcements at a regular interval.

Used for controlling environmental conditions inside the factory.

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

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Horizontal Plate Closed Pressure Filter The plate pack assembly consists of plates with interlocking cups, plate rings, perforated screens and filter media.

Interlocking cups arranged one above other forms single pipeline. The unfiltered liquid is centrally fed under pressure from bottom inlet. The liquid spreads out equally on each plate fitted with filter media. Solids remain on the filter media and clear filtrate flows through gaps on the supporting ring and collects in the shell, which is led out through outlet pipeline. In this process, solids are evenly distributed on each plate. At the end of the cycle the cake can be dried maximum by applying air or inert gas.

For more information, please contact:

Subodh Engg Pvt Ltd Plot No: A-314, Road No: 34 Wagle Indl Estate, Thane, Maharashtra 400 604 Tel: 022-25810403, 25837791 Telefax: 022-25821392 E-mail: subodh314@vsnl.net / subodhfilters@hatway.com

Compact Sieve

Carboxy Methyl Starch Carboxy Methyl Starch is a water soluble polysaccharide which is widely employed as an additive; it is biodegradable and non-toxic product that find increasing number of applications.

Sodium carboxy methyl startch referred to as SNS is a starch either derivative derived from starch. It is soluble in water under room temperature and forms a colourless, transparent and viscous liquid.

CMS is extensively applied in many fields of industrial production with its unique performance and higher economic benefits as a kind of important chemical auxiliary. CMS can be used as thicker, binder and emulsifying agent in various applications.

For more information, please contact: Patel Chem Specialities P Ltd Plot No: 272/4-5, Phase II, GIDC Estate Vatva, Ahmedabad, Gujarat 382 445 Tel: 079-25832974 Fax: 91-079-25895830 E-mail: info@pcspl.net

Deblinding System The Russell compact sieve is ideal for the high capacity safety screening of powders and liquid slurries, especially where space is restricted. All oversized contamination is removed from your product, giving total peace of mind. They are available in 250, 400, 600, 900, 1,200 and 1,500 mm size.

The vibrasonic deblinding system improves product quality further by allowing accurate separation down to 20 um. By applying an ultrasonic frequency directly to the separator mesh, the stainless steel wires effectively become friction-free. Without surface tension there are no mesh blinding, increasing capacities.

Features higher throughput per unit mesh area compared to conventional screeners; reduces downtime with easy strip-down and clean without the need for tools; and improves operator safety by eliminating harmful dust and fumes.

It increases production rates by eliminating mesh blockage and reducing downtime for cleaning; improves product quality by allowing screening on finer meshes; reduces costs by lengthening the mesh life; and can be retrofitted to any sifter or screener up to 1,800 mm.

For more information, please contact: Russell Finex Pvt Ltd A/1201 Rustomjee Adarsh Regal Adarsh Vihar Complex Off Marve Road, Malad (W) Mumbai 400 064 E-mail: sales.rfsf@russellfinex.com

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For more information, please contact: Russell Finex Pvt Ltd A/1201 Rustomjee Adarsh Regal Adarsh Vihar Complex Off Marve Road, Malad (W) Mumbai 400 064 E-mail: sales.rfsf@russellfinex.com

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Cap Sealing Machine Pharma Chem Machineries offers single head automatic cap sealing machine with SS belt conveyor to connect in line with automatic filling machine. It is also having cap orientation unit for automatic cap replacement on the bottle.

Features output up to 2,400 to 3,600 container per hour as per the bottle size; OHNS sealing rollers for trouble-free long life of rollers; easy height adjustment of sealing unit and cap orientation unit; and variable speed drive ensuring speed alignment with filling machine.

For more information, please contact:

Pharma Chem Machineries 311/2484 Motilal Nagar No: 2 M G Road, Goregaon (W) Mumbai 400 090 Telefax: 022-28735321 E-mail: pharmach@gmail.com / pharmachem79@gmail.com

Open Head Drums with Clamping Ring Lids An open head drum with clamping ring lids is a versatile system in a variety of sizes with or without rolled beads.

Various types of closures: clamping ring with toggle latch suitable for tamperevident sealing, jet-ring closure for fully automatic drum closing, also available as pharma version.

A versatile system from 2 to 220 litres; stackable empty or filled; recycling by easy separation or materials; internal and external surface coatings, powder coatings; UN Certified; FDA/BGA/BAGcompliant versions on request.

For more information, please contact: Vinisa E I Pvt Ltd 6 Himalaya House Palon Road Mumbai 400 001 Tel: 022-22614088, 22622391 E-mail: vinisa@vsnl.net

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Vaporised Hydrogen Peroxide Generator Hydrogen peroxide has better sporicidal efficacy in gas state than the liquid state at room temperature and that the generated free hydroxyl groups are able to attack cell components including lipids, proteins and DNA organisation, which achieves the requirement of complete sterilisation.

It finds application in sterilisation in isolation room, isolator, lyophilizor transfer passageway, blending machine, biosafety cabinets, small clean room, large clean rooms; etc.

For more information, please contact: Shreedhar Instruments 16 Shreeji Krupa Scty Opp: MGVCL Circle Office Next to GMERS Medical College Gotri Road, Vadodara, Gujarat 390 023 Telefax: 91-0265-2323041 E-mail: sales@shreedhargroup.com

Q Exactive HF Benchtop Orbitrap Mass Spectrometer Thermo Fisher Scientific India Pvt Ltd offers Q Exactive HF Benchtop OrbitrapMass Spectrometer The Thermo Scientific Q Exactive HF mass spectrometer is the next generation HRAM benchtop system with an ultra high-field Orbitrap detector, providing greater speed, productivity and confidence for both qualitative and quantitative omics workflows.

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

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Compact Coriolis Mass Flow Meters & Controllers for Liquids & Gases Coriolis mass flow meters are highly 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 CORL-FLOW 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); excellent price/ performance ratio For more information, please contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26448558, 26448983 E-mail: sales@toshniwal.net

High Vacuum Pump Over three decades of expertise in vacuum technology, Toshniwal Instruments (Madras) Pvt Ltd offer customized solutions ranging from individual products to a complete system. New customer requirements have given rise to further development in Toshniwal direct driven vacuum pumps, the 72-D Series.Beyond usual quality and reliability of Toshniwal pumps the 72-D Series pump offers improvement in the areas of quieter operation, smaller size and easy maintenance. Pumping capacities available are 120 to 900 litres/min.

Beyond usual quality and reliability of Toshniwal pumps the 72-D Series pump offers improvement in the areas of quieter operation, smaller size and easy maintenance.Pumping capacities available are 120 to 900 litres/min.

For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26448983, 26448558 E-mail: sales@toshniwal.net

54 â—„ July 2018

Fluidized Bed Granulation & Pellet Coating Prism fluid bed processing i n v o l v e s drying, cooling, agglomeration, granulation and pellets coating of particular materials. It is ideal for heat sensitive and non-heat sensitive products in pharma, biotech, nutraceuticals, chemicals and other industries.

They are available in 2 to 1,200 litre working capacity; wurster coater – bottom spraying system for pellets and granules coating; single pot technology for mixing, granulating, drying and pellet coating; precise flow rate spray system with atomised spray gun and peristaltic pump; easy mechanism to change from process of granulation to coating; sophisticated PLC controls with HMI touch screen; top spraying system for granulation; etc.

For more information, please contact: Prism Pharma Machinery Plot No: 3713, Phase IV, GIDC, Vatva Ahmedabad, Gujarat 382 445 Tel: 079-29096204, Fax: 91-079-25841623 E-mail: mkt@prismpharmamachinery.com

Compact Vacuum Packages Toshniwal Instruments (Madras) Pvt Ltd provide solution to your vacuum application. It replaces multi-stage water/liquid ring pumps, steam jet ejectors with high performance compact vacuum packages.

The volume flow from 180 to 97,000 m 3/hr. There is energy savings resulting from low motor rating. Integral pipe work allows easier installation. Constant vacuum is in the range 0.1 to 400 mbar (absolute). Booster and rotary pump may be started at the same time. Built-in bypass value to protect from overloads.

For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshniwal.net

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Integrated Wet Granulation Line Prism integrated granulation lines as per current GMP requirements is fully contained during processing to protect operators and environment.

Also improves productivity through closed materials transfer, automation, increase yields and efficient cleaning procedures. An integrated granulation line for solid dosages is available from 2 to 1,200 litre working capacity; closed process technology for grading, mixing, granulating, drying, milling, blending and tabletting; reduced amount of transfer operation; better containment for highly potent materials; materials transfer by vacuum transfer system; and sophisticated PLC controls with HMI touch screen.

For more information, please contact:

Prism Pharma Machinery Plot No: 3713, Phase IV, GIDC, Vatva, Ahmedabad, Gujarat 382 445 Tel: 079-29096204 Fax: 91-079-25841623 E-mail: mkt@prismpharmamachinery.com

Safe Area Oxygen Monitor Safe area monitor utilises advanced non-depleting paramagnetic technology to accurately monitor O 2 levels without sensor deterioration that affects outmoded electrochemical sensors used in competitor detectors. Features latest Hummingbird Paracube sensor never needs replacing; independent auto calibration of all measurements with up to 8 isolated analogue outputs and up to 12 relays with follow or freeze option; and alarm, fault and calibration history logs.

For more information, please contact: Spectris Technologies Pvt Ltd Plot No: A-168 MIDC, Thane-Belapur Road Khairane, Navi Mumbai 400 710 Tel: 022-39342700 E-mail: MEI_Sales@servomex.com

High Shear Rotor-Stator Mixer The Batch Model high shear rotor-stator mixer design consists of a single stage rotor that turns at high speed within a stationary stator. As the rotating blades pass the stator, they mechanically shear the contents.

The batch model can be either permanently mounted to a vessel or suspended over a vessel on a portable lift. The mobile configuration offers the flexibility to use a single mixer in multiple vessels. It also allows the user to vary the position of the stator to process a variety of materials.

The rotor-stator of the batch model is generally positioned 2-3 head dia off the bottom of the vessel, and slightly off centre. To ensure adequate suspension of heavier solids, the rotor-stator generator may be positioned in the centre of the vessel.

Interchangeable rotor-stator combinations provide unlimited flexibility to adapt to a variety of product formulations.

The Inline Models are supplied in many sizes and MoC from 1/2 through 100 HP..

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

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events diary   

   

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

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

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

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



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

Date: 2 nd - 4 th October 2018 Venue: Doubletree Suites by Hilton Hotel Boston Cambridge, Boston, U.S.A.

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

Ensuring safer drugs to market by analyzing latest developments in drug safety and risk management. Pharmacovigilance will bring together top pharma, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. The entire program will cover the detection, analysis and prevention of adverse drug reactions. It will be studied with the help of case studies and industry experiences. This conference will help the drug safety representatives from the pharma industry and academic and quality research organizations who wish to understand how to avoid common deficiencies in inspections by learning from the experiences of others; to gain a greater understanding of new and existing PV requirements, and to improve their organizations’ compliance with PV requirements.

Also it can help you control your product’s lifecycle, your patient’s trust, and your revenue. Hence, this conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting PV development.

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

 Virtue Insight 40 Alwarthirunagar, 2 nd Street, Lakshmi Nagar Chennai

56 ◄ July 2018

Pharma Bio World

bookshelf The Organic Chemistry of Drug Design and Drug Action Authors: Richard B Silverman and Mark W Holladay Price: $78.73 No of pages: 536 pages (Hardcover) Publisher: Academic Press (3rd Edition) About the book: This book represents a unique approach to medicinal chemistry based on physical organic chemical principles and reaction mechanisms that rationalize drug action, which allows reader to extrapolate those core principles and mechanisms to many related classes of drug molecules. This new edition includes updates to all chapters, including new examples and references. It reflects significant changes in the process of drug design over the last decade and preserves the successful approach of the previous editions while including significant changes in format and coverage.This text is designed for undergraduate and graduate students in chemistry studying medicinal chemistry or pharmaceutical chemistry; research chemists and biochemists working in pharmaceutical and biotechnology industries.

Basic Concepts in Medicinal Chemistry Authors: Dr Marc Harrold and Dr Robin Zavod Price: $46.30 No of pages: 460 pages (Paperback) Publisher: American Society of Health-System Pharmacists (1st Edition) About the book: Basic Concepts in Medicinal Chemistry focuses on the fundamental concepts that govern the discipline of medicinal chemistry as well as how and why these concepts are essential to therapeutic decisions.

The book emphasizes functional group analysis and the basics of drug structure evaluation.

In a systematic fashion, learn how to identify and evaluate the functional groups that comprise the structure of a drug molecule and their influences on solubility, absorption, acid/base character, binding interactions, and stereochemical orientation. Relevant Phase I and Phase II metabolic transformations are also discussed for each functional group. Discussions on the roles and characteristics of organic functional groups, including the identification of acidic and basic functional groups. How to solve problems involving pH, pKa, and ionization; salts and solubility; drug binding interactions; stereochemistry; and drug metabolism. Numerous examples and expanded discussions for complex concepts. Therapeutic examples that link the importance of medicinal chemistry to pharmacy and healthcare practice. An overview of structure activity relationships (SARs) and concepts that govern drug design. Review questions and practice problems at the end of each chapter that allow readers to test their understanding, with the answers provided in an appendix. Whether you are just starting your education toward a career in a healthcare field or need to brush up on your organic chemistry concepts, this book is here to help you navigate medicinal chemistry.

Applied Pharmaceutics in Contemporary Compounding

Author: Robert Shrewsbury Price: $95.78 No of pages: 464 pages (Paperback) Publisher: Morton Publishing Company (3rd Edition) About the book: This book is designed to convey a fundamental understanding of the principles and practices involved in both the development and the production of compounded dosage forms by applying pharmaceutical principles. Updated edition includes addition of formulation records from compounding laboratory, a new chapter about aerosols and foams, and student data results from compounding laboratory. Loose-leaf, 3-hole drilled, Black and White.

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ad index Sr.No

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HRS Process Systems Ltd

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Mack Pharmatech Pvt Ltd

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Ravel Hiteks Pvt Ltd

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Schenker India Pvt Ltd

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Suresh Enterprise

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Technofour Electronics Pvt Ltd

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Toshvin Analytical

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Pharma World Expo 2019

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