Datwyler to supply first samples of new Pune production line in August

New Delhi: Datwyler, the Swiss-based industrial supplier of state-of-the-art solutions for drug packaging and medical devices, is currently expanding its state-of-the-art production facility in Pune, which is expected to supply first samples of the new First Line production line in August 2018.

With the expansion of its production facility in Pune, Datwyler has set a new milestone for cleanroom production in India and the region. The facility is now aligned with Datwyler’s highest manufacturing standard First Line, a concept dedicated to the production of high-quality elastomer components in a fully integrated state-of-the-art cleanroom environment.

“Incorporating First Line in our Pune facility underscores our commitment to India and the region. The Indian market is of strategic value to Datwyler and our market share is quite substantial”, says Rahul Dev, Vice President India at Datwyler. “The Pune facility is our first facility in Asia which is aligned with the First Line standard. This is not only a milestone in the history of Datwyler, but also for cleanroom production in the Asia Pacific region.”

The Pune facility has always played a substantial part in Datwyler’s efforts to cater to regional and global markets. The company is currently supplying to the top ten pharmaceutical companies and global players in the region. Up until now, the facility manufactured close to 4 billion components for vials, pre-filled syringes, and diagnostic devices per year. First samples of the new production line are expected to be supplied in August 2018.

Datwyler’s First Line manufacturing concept for high-quality elastomer components is based on ultra-modern cleanroom technology, automated production cells, fully automated camera inspection, and a unique validated washing process. Datwyler’s facilities aligned with the First Line manufacturing standard are specially designed and operated under a zero-defect philosophy. The process flow, gowning protocols, personnel and material flow, and state-of-the-art technology and automation all result in the lowest endotoxin, bioburden, particulate, and defect levels available in the industry. This innovative approach to manufacturing exceeds the most stringent quality standards of the European and US regulatory authorities and is certified to ISO 15378.

The Pune facility is Datwyler’s second facility aligned with the First Line standard. The first facility is located in Alken, Belgium, and a third facility is currently in the process of completion. For its third location, Datwyler has chosen Middletown in the US state of Delaware.