Understanding Sterility Testing Services
Sterility testing is central to all sterility assurance programs. Sterility testing exposes medical devices and/or biological indicator spore strips (BIs) exposed to a sterilization process. The purpose of product sterility testing is to confirm medical devices, pharmaceuticals, and therapeutic cell preparations are free from viable microorganisms. Sterility tests may be carried out via direct transfer method (solid products) or via membrane filtration method (liquid products and extracts from solid products).
Testing Capabilities
- Biological Indicator Sterilization Validations
- Bacteriostasis/Fungistasis (B/F)
- Membrane Filtration Sterility
- Direct Transfer Sterility
- Biological Indicator Strip Population Verification
Testing Categories and Specifications
| Test Name & Method | Sample Needed | Turn-Around Time |
|---|---|---|
| Bacteriostasis & Fungistasis (B&F) Sterility Validation Membrane Filtration Method per USP Direct Transfer Method per USP Membrane Filtration Method per AAMI Direct Transfer Method per AAMI | 3-6 Units | 2 weeks |
| Product Sterility Testing USP Sterility by Direct Transfer Method USP Sterility by Membrane Filtration Method AAMI Sterility by Direct Transfer Method AAMI Sterility by Membrane Filtration Method | Lot size dependent, recommended 10 minimum | 3 weeks |
| Inoculated Product Sterility USP Sterility by Direct Transfer Method USP Sterility by Membrane Filtration Method AAMI Sterility by Direct Transfer Method AAMI Sterility by Membrane Filtration Method | Lot size dependent, recommended 10 minimum | 3 weeks |
| USP Biological Indicator (BI) Strip Sterility | 10 to 20 spore strips to monitor a cycle (ISO 11135) | 3 weeks |
| AAMI Biological Indicator (BI) Strip Sterility | 10 to 20 spore strips to monitor a cycle (ISO 11135) | 3 weeks |
| Biological Indicator Strip Population Verification | 4 biological indicator strips | 2-3 weeks |