Validation

It is widely recognized that filter validation studies must be performed for aseptic processing inorder to meet quality and safety compliances, stipulated by the respective GMP governance. The validation process is an inherent cost that is part of the aceptic manufacturing process. Masterfilter offer validation services to help you chose and conduct the appropriate validation tests, for your filters and assemblies.

Our validation services provide detailed knowledge of global and local regulations and industry best practices, to assist you in devloping and implementing an appropriate validation strategy. We can help you determine what, how and when to test; upstream, downstream, or final fill.

The validation services offered:

• Product and process filter validation

  • Compatibility studies
  • Extractables and leachables studies
  • Adsorption studies
  • Viability studies
  • Bacterial retention studies
  • Product wet integrity test

• Compativility studies of material in contact with drug product

• Toxicological evaluation and assessment