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By Steve LoCastro

April 16, 2014

A new regulatory guidance in the US has clarified expectations for pharmaceutical companies wishing to transition from an existing pharmaceutical component wash process to another, such as the Westar® Ready-to-Sterilize (RS) process.

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By West Technical Operations

March 12, 2014

Manufacturers of sterile drug products have a long history of receiving elastomeric plungers for use  in a prefilled syringe in a sterilized, ready-to-use (RU) condition. This trend has more recently evolved to include other container closure components including, glass or plastic vials, aluminum over seals and elastomeric stoppers. When accepting RU components into a new or existing manufacturing process, it is important to consider how sterility assurance of the components will be determined.