PRE-STERILIZATION TESTS

Bacteriostasis/Fungistasis (Sterility test and dose audit method validation)
Immersion (Direct Transfer)

• 3 organisms – SCDM (Dose Audits)
• 6 organisms – 3 in FTM and 3 in SCDM (USP)

Membrane Filtration
Growth Promotion of Media (per organism, in duplicate)

Bioburden Method Validation – Recovery Study
Exhaustive Recovery (3 – 5 extractions per sample)
Simulated Recovery (spore inoculation, per sample)
Screening for the Release of Substances Adversely Affecting Bioburden Estimates (from AAMI/ISO 11737-1: 3 organisms, in triplicate)

Bioburden Analyses
Total Aerobic Bacteria and Fungi by Membrane Filtration Method

• Small Devices
• Medium Size Devices, Small Kits
• Large Devices, Large Kits, Papers, Fabrics

Bioburden – Total Aerobic Bacteria by Plate Count Method

Total Aerobes Only by Membrane Filtration Method

• Small Devices
• Medium Size Devices, Small Kits
• Large Devices, Large Kits, Papers, Fabrics

Bioburden – Total Anaerobic
(with Total Aerobic Bacteria and Fungi)

Bioburden – Total Aerobic Spores
(with Total Aerobic Bacteria and Fungi)

*Bioburden fees apply when five or more samples are submitted together for testing. If fewer than five samples are submitted, there will be an additional charge per sample. The total anaerobic and aerobic spore fees apply when tests are performed in conjunction with total aerobic bacteria and fungi bioburden tests. Additionally, there is a per isolate charge for differentiation of strict vs. facultative anaerobes. Unless otherwise requested, the membrane filtration method will be used for all samples with filterable extracts.

• Bioburden – Packaging (Contact Plate)
• Bioburden – Packaging (Swab/Membrane Filtration)
• Bioburden – Process Fluids (Membrane Filtration)
• Bioburden – Water (Aerobic Bacteria by Membrane Filtration)