Sterility Testing

Confirm medical devices, pharmaceuticals, and therapeutic cell preparations are free from viable microorganisms.

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 & MethodSample NeededTurn-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 Units2 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 minimum3 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 minimum3 weeks
USP Biological Indicator (BI) Strip Sterility10 to 20 spore strips to monitor a cycle (ISO 11135)3 weeks
AAMI Biological Indicator (BI) Strip Sterility10 to 20 spore strips to monitor a cycle (ISO 11135)3 weeks
Biological Indicator Strip Population Verification4 biological indicator strips2-3 weeks