How To Prevent Parenteral Drug Shortages As Sterilizer Capacity Tightens

Sterility assurance expert urges check-and-adjust approach as ethylene oxide and gamma radiation sterilization capacity tightens, pointing to Bio-Process Systems Alliance’s plan for single-use system sterilization as a model.

Parenteral drug supply
when sterile parenteral drugs must be available • Source: Shutterstock

 Firms can do much individually and even more collectively to prevent terminal sterilization capacity shortfalls from triggering parenteral drug shortages, a sterilization expert told the ISPE Aseptic Conference in March.

Emily Craven, Boston Scientific’s director, global sterility assurance, shared her advice on the eve of the Environmental Protection Agency’s 11 April proposal to require that commercial sterilizers reduce emissions...

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