Regulatory Requirements for Filter Integrity Testing

Addressing Regulatory Requirements for Filter Integrity Testing

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Filter integrity is a fundamental element of sterility assurance during production of biopharmaceutical and vaccine products. Integrity test results are a key foundation for drug lot release, so any external element that could affect their reliability must be viewed as a critical issue. But when should a filter integrity test be performed?

In this article, you will find the following:

  • An overview of the legal requirements for Filter Integrity Testing (FIT)
  • Background for data integrity, quality risk management and HSE related to FIT
  • Insights on how the Sartocheck® 5 Plus Filter Tester can help you comply with regulations

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