Actylis launches a New cGMP WFI Generation, Storage, and Distribution System with Additional ISO Class 7 manufacturing space as Part of its continued Commitment to Supporting Biopharmaceutical Manufacturing

— Qualified to Meet ISO 14644-1 Requirements for Class 7 Clean Environment —
 
— Capable of Generating & Maintaining Water as per Required USP & PhEur/BP Specifications for Water for Injection —

MONTREAL, CANADA – September 21, 2023— Actylis, a leading global manufacturer of critical raw materials and performance ingredients for the life sciences and specialty chemicals markets, today announced the launch of Water for Injection (WFI) and additional ISO Class 7 manufacturing space at its Baie d’Urfé site in Montreal, Canada. Used for the preparation of media, buffers, and other aqueous solutions, Actylis’ WFI meets monographs for pharmacopoeias worldwide, and can be provided in both custom and standard packaging configurations. 

Gilles Cottier, CEO at Actylis, said: “Today we are delighted to announce the opening of this new WFI system at our Baie d’Urfé site. Investment in this new WFI generation, storage, and distribution system reflects our ongoing commitment to support our customers, and to continuously develop our range of products and services. The new system positions us to be a preferred outsource partner for our customers’ buffer solutions.  We understand that capacity is often a pinch-point for our customers, and we are delighted to be able to propose this option to them.”

Damien O’Rourke, SVP Manufacturing Operations at Actylis added: “Our new WFI system, redundant with our Limerick, Ireland WFI capabilities, incorporates the latest advancements in water purification technology, adhering to Good Manufacturing Practices (cGMP) that guarantees the production of WFI that meets or exceeds the most rigorous quality standards. In addition to the services this enables for our customers, the investment provides Actylis and our customers with a robust multi-site business continuity plan to ensure dependable supply.”
 
Jean-Francois Raymond, Site Director, elaborated on some of the specifics of the system: “We are excited to have this new system here at Baie d’Urfé come on stream.  The WFI system is fully qualified with all supporting validation documents, and is capable of generating and maintaining water as per required USP and PhEur/BP specifications of Water for Injection.”

The new system’s strategic location in Montreal positions it as a pivotal hub for biopharmaceutical companies across North America and beyond. Its proximity to major transportation networks ensures timely distribution of WFI to manufacturers, enabling them to streamline their production processes and meet growing market demands. 

For more information on our Water for Injection offering, click here

To explore Actylis' entire portfolio for the Biopharmaceutical market, visit the dedicated page here