Datwyler, the Swiss-based specialist supplier of drug packaging solutions and medical devices has expanded its plant in Pune, India
In the FirstLine production the elastomeric components are manufactured in clean room conditions according to ISO 15378 quality standards
Completion is expected by the end of 2017 and first samples will be supplied to market by July 2018.
The facility underlines the company’s commitment to India and acknowledges the country’s role in the global pharmaceutical market.
The expanded facility will manufacture according to the First Line concept, making India the first market in APAC region to incorporate this standard.
The facility plays a substantial part in Datwyler’s efforts to cater to regional and global markets. Once the production site is fully operational, the facility will cover approximately 58,000 sq ft and will create up to 500 jobs, which will be staffed by members of the local community.
Set against the background of the ever-evolving requirements for drug packaging, Datwyler provides a unique range of future-proof health care sealing solutions and services for primary and secondary packaging.
This includes the most advanced elastomer formulations, proprietary coatings, sterilisation options and aluminium seals for high-efficiency production lines, which not only meet the demands of current pharma trends, but go beyond them.
In India, Datwyler’s core business consists of container closures. Manufacturing close to four billion components for vials, pre-filled syringes, and diagnostic devices per year, the Pune facility plays an increasingly strategic role for the company.
In recent years, the Indian pharma and healthcare market has become increasingly important for global manufacturers, suppliers and customers.
Rahul Dev, Vice President India, Datwyler, said, “The Indian market is of strategic value to Datwyler and our market share is quite substantial. We are currently supplying to the top ten pharmaceutical companies and global players in the region. For this reason, we are expanding our presence in India. We invest in growth and believe it is one of the core strengths of the Indian market – and of Datwyler.”
During November 27 – 30, Datwyler will present its new health care offering and product portfolio at this year’s CPhI India 2017 in Mumbai. CPhI India brings together the Indian pharmaceutical and manufacturing technology industries, and presents the latest trends and innovations the market has to offer. Datwyler will be presenting its product portfolio at booth G73 in hall 1.
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.