Sterility Assurance

Bacteriostasis/Fungistasis  – USP or EP (6 Organisms Test)

• Direct Transfer – Immersion
• Membrane Filtration by Vacuum Method
• Membrane Filtration by Millipore SteritestÔ Method

For Bacteriostasis/Fungistasis tests by membrane filtration, 60 product samples are normally required. This test includes performing three filtration sterility tests of 20 samples each. For each simulated sterility test, one test organism is inoculated into the final 100 mL rinse of the membrane filter. The USP/EP combination test requires 8 organisms..

Bioburden Method Validation – Recovery Study

• Liquids (per organism, in triplicate: 3 organisms recommended)
• Powders (per organism, in triplicate: 3 organisms recommended)

Bioburden Analyses

• Bioburden – Containers, Closures, Packaging Materials
• Total Aerobic Bacteria and Fungi by Membrane Filtration Method
• Bioburden – Process Fluids
• Total Aerobic Bacteria and Fungi by Membrane Filtration Method
• Bioburden – Powders (Total Aerobic Bacteria and Fungi)
• Bioburden – Total Anaerobic (with Total Aerobic Bacteria and Fungi)
• Bioburden – Total Aerobic Spores (with Total Aerobic Bacteria and Fungi)
• Biological Indicator Population Verification (3 spore strips)

Sterility Audits

• 10 Spore Strips and 1 or 2 positive controls – 15 mL SCDM
• Extra Spore Strips – 15 mL SCDM
• Product Only – Direct Transfer (Immersion) –  < 120 mL media
• (20 products in SCDM, 20 products in FTM, 14 days incubation)

Membrane Filtration Sterility Tests*

• Vacuum Filtration (Liquid)
• Vacuum Filtration (Powder)
• Millipore Steritest Filtration (Liquid)
• Millipore Sterisolutest Filtration (Powder)
• Extra Samples for Filtration Test (per sample)
• Extra 100 mL Filter Rinses (per rinse beyond 3)
• Steritest Filtration – Subsequent Subtest**
• Vacuum Filtration – Subsequent Subtest**
• Filtration Test – Exact Reconstitution (per sample)
• Filtration Test – Exact Pooling – Dilution (per sample)

*All standard fees for sterility tests by membrane filtration are based on testing 20 samples, using one vacuum or Millipore filter unit, three 100 mL filter rinses, and culturing of the filter in FTM and SCDM. Samples which require extraordinary preparation or filtration time will incur a surcharge.

**For some products, it may not be possible, or desirable due to bacteriostasis or fungistasis properties, to run 20 samples through one filter unit. A subtest consists of using an additional vacuum or Millipore filter unit for a portion of the samples, three 100 mL filter rinses, and culturing of the filter in FTM and SCDM. For tests requiring subtests, one standard test fee will be billed, plus one subtest fee for each subsequent subtest that is required.

Contact our Sterility Assurance Specialists for more information or complete the form to request for quotation.