Pune, India – Datwyler Sealing Solutions is preparing to start production of pharmaceutical rubber components at a new facility on its Satara site in Pune.
Product manufacture is scheduled to start in the second quarter of 2018 and samples to reach customers by the yearend.
In correspondence with ERJ, Datwyler said the investment – the amount was not disclosed – was intended to strengthen its position in the Indian pharma and healthcare market.
The project will increase manufacturing volume at the site to five billion components per year, and more than double its production area to 58,000 sq. feet.
The Swiss company is currently producing close to four billion components for vials, pre-filled syringes, and diagnostic devices at Satara.
The site operates to Datwyler’s ‘first line’ standard, based on advanced cleanroom technology, automated production, camera inspection and special cleaning processes.
The new unit is specially designed to manufacture pharmaceutical rubber components in a fully integrated GMP environment.
As part of Datwyler Sealing Solutions, the original plant has been delivering commercial supplies to customers worldwide since 2010.
The new facility will produce complex rubber vial and syringe components, for the company’s Omni Flex product range.
“These complex products have a total fluoropolymer coating which prevents any interaction with the drugs,” Rahul Dev, Datwyler’s India VP previously told ERJ.
In addition to Omni Flex, the Pune site will also be focusing on “high-end rubber formulations” for products such as plunger stoppers, serum stoppers and customised stoppers.
The Indian market, said Datwyler, has become “increasingly important” for global pharma manufacturers in recent years.
The country, it added, is rapidly becoming “one of the most important global manufacturing destinations, particularly in generics and biotech.”