Sterility testing of products or biological indicators (BIs) are necessary for medical devices, pharmaceuticals, or other articles claiming to be sterile.  LexaMed conducts sterility testing in accordance to USP <71> and ANSI/AAMI/ISO 11737.  Per the USP, prior to routine sterility testing, a bacteriostasis/fengistasis test validation must be conducted in our laboratory.

Biological indicator testing is common practice to monitor the efficiency of sterilization modality.  Common sterilization processes monitored are steam, ethylene oxide (EO), dry heat, and other client specific sterilization modalities.  BI steriliy testing can be completed for lot release, or, as part of a sterilization validation.  LexaMed can assist you with your  sterilization validation.

All sterility tests are began on the date the test article(s) are received.  Published results are available with 15 days from receipt.

Biological Indicator Sterility Testing, USP/ISO

Bacteriostasis/Fungistasis

(All products should be initially validated with a B/F test, which is also a USP requirement)

  • USP – SCD and FTM (6 Organisms)
  • AAMI/ISO – SCD only (3 Organisms)

Product Sterility Testing

Product Immersion Testing

  • <200 mL media
  • 200-500 mL media
  • 600-900 mL media

Membrane Filtration

Media Fill Sterility