Filter validation

 

The product filters used during filling of parenterals have to be validated for the process of filtration (bioburden reduction filtration and final sterile filtration). Multiple parameters need to be checked during this process. The filter supplier has provided certain information and documents, but the filter user assumes the responsibility for product-specific filter validation. To support you, we offer different services tailored to your request. For example, this can be a consultation regarding the extent or the complete preparation of the necessary documentation.

 

Our services in the field of filter validation include:

  • Reviewing the existing documentation for completeness based on the PDA 26 recommendations
  • Comparing the manufacturer’s documentation to current requirements
  • Checking chemical compatibility
  • Reviewing the MBR for validated filter integrity test results that need to be met
  • Conceptualizing studies that need to be set up from scratch
  • Creating SOPs / best practice documents in order to determine the studies‘ implementation in-house
  • Supporting the selection of a suitable test laboratory for performance of the studies
  • Supporting, reviewing and / or the complete creation of test plans and reports for the studies
  • Compiling all studies in a summarizing overview document
  • Evaluating the extractables / leachables regarding their toxicological concern with the collaboration of a toxicologist or as a provisional evaluation for a further assessment by a toxicologist