Mitigating Risks Associated With Aseptic Parenteral Filling

Summary: Recalls and warning letters are littering the news and don’t help those pharma and biopharm companies engaged in producing sterile dose forms. The issues that lead to unacceptable products may have a direct impact on product availability, and even patient safety, if they go undetected. Many of the negative headlines arise from problems that occurred in the aseptic parenteral filling process, and frequently they involve microbial contamination or contamination by foreign particulates.

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