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PHARM/BIOPHARM QC STERILITY

Sterility testing is used to ensure that pharmaceutical and biopharmaceutical therapeutics are sterile and safe for human use.

Testing performed at Pacific BioLabs consists of three main categories:

Bioburden testing is performed on nonsterile products to determine the baseline microbiological level of products. Bioburden is performed as part of a sterilization validation, and may be done on a regular basis to measure whether the microbiological load on a product has changed over time.

Bacteriostasis/Fungistasis testing is performed to determine whether a product inhibits bacterial growth or fungal growth so as to ensure that false negatives do not occur during a sterility test.

Sterility testing determines whether a product is sterile and may often be used in the lot release process to verify that the sterilization process has been effective.

Pacific BioLabs offers sterility testing services in an ISO Class 5 Sterility Suite. We test to the standards specified in USP <71>, which has been harmonized for the European and Japanese markets.

Available Pharm/Biopharm QC Sterility Tests

• Bioburden Validation and Testing
• Bacteriostasis / Fungistasis Testing
• Sterility Testing
  • Direct Transfer
  • Closed-System Membrane Filtration
• Media Fill and Growth Promotion