Buoyed by rapidly growing India’s pharma and biotech markets, Switzerland-based Datwyler, a supplier of customised sealing solutions to manufacturers and companies operating in the healthcare and automotive industry, has announced that it will make 65 million Swiss franc (Rs. 453 crore) investment in India by 2017. The company located in Satara SEZ has been present in the country since 2010 and has been delivering diagnostics rubber stoppers, rubber stopper for vials, vaccines, plunger stoppers for prefilled syringes, etc to customers worldwide since 2013.

The company's most advanced manufacturing facility – FirstLine which will be integrated in Satara facility is in construction phase and is likely to become operational by next year. In 2015, the company had supplied products to 2.8 billion people worldwide. This year we are hopeful to deliver commercial supplies to 3 billion people globally, informed Rahul Dev, vice president, Datwyler India.

The new facility is specially designed to manufacture pharmaceutical rubber components in a fully integrated good manufacturing practice (GMP) environment using innovative automated processes, and conforming to the highest industry standards. Each zone has been meticulously designed and constructed in order to prevent bio-contamination and is equipped with material airlocks. State-of-the-art pass-through washing equipment has its automatic loading side in one zone and its automatic unloading side in a zone of even higher cleanliness. The new clean room also incorporates the latest generation of camera inspection techniques. The entire facility as a whole incorporates rational and lean production flows in accordance with the Six Sigma methodology.

The most complex rubber components produced at the FirstLine site belong to the Omniflex family of vial and syringe components. They prevent any interaction with the drugs due to their total fluoropolymer coating.

“We have been supplying products to Indian pharma injectable manufacturers over last 2 decades. Top 25 pharma companies in India and abroad are our trusted clients. Currently, we are doubling our existing capacity in India which will help us achieve revenue of Rs. 350-400 crore by 2018,” he opined.

Datwyler which supported Prime Minister Narendra Modi's Make in India initiative has invested heavily in R&D in order to expand its product range.

When asked how Datwyler ensures elastomeric closure compatibility with drugs, vaccines in a bid to ensure safety and efficacy of pharmaceutical products, Dev said “As a manufacturer of closures we place great emphasis on developing rubber compounds that have the lowest possible level of extractables to ensure drug compatibility. The lower the level of extractables, the lower the probability that there occurs an issue with drug compatibility. Datwyler has developed a concise set of low extractable materials which are capable of covering most of the drug applications.”

“The level of extractables can also further be minimized by applying a fluoropolymer coating on rubber products. Therefore, Datwyler offers a range of fluoropolymer coated products for vial stoppers and syringe plungers under the brand name Omniflex. The sole function of the fluoropolymer film coating is to provide an inert barrier between the rubber and the drug formulation, especially for sensitive biologic drugs. They ensure the integrity of the drug by preventing any absorption or interaction with the medical content. This is ensured by continuous tests of our materials against the requirements of various regulatory frameworks during and after the development stage. All Omniflex-coated products are produced in Datwyler’s state-of-the-art manufacturing facility known as FirstLine in Belgium and in the future facility in India,” he said.

Shedding light on recent pharmaceutical packaging trends, Dev said “One of the major global trends can definitely be seen in the fact that more and more drug products are packaged in prefilled syringes, and more recently, also in cartridges. An increasing number of these syringes are used in auto-injectors for self-administration of drugs.”