Viral inactivation (ISO 22442-3)

A publicly listed world’s largest medical technology company with over $ 57 Billion in market cap offering wide varieties of innovative therapies. Client operates in over 140 countries offering medical therapies in Cardiac, Vascular, Diabetic, Neurological and Musculoskeletal treatments.

Client was manufacturing multiple structural heart valve products, each with different chemical treatments specifications for viral inactivation. The client was preparing multiple chemical solutions with different specifications. Since each product line’s viral inactivation (ISO 22442-3) was already established for specific chemical solution used in production, client was not sure whether changing the chemical solution was an option.

BridgeMed solutions consultant analyzed this project, compared the chemical solutions used for impacted product lines, provided strategy regarding as to how to go about this project. In addition wrote a viral inactivation rationale in compliance with ISO 22442-3 for three heart valve products for which chemical solution change can be implemented without impacting the products.