STERILITY ASSURANCE

Radiation Sterilization Validation - AAMI/ISO 11137

Medical Device Sterilization Validation for Gamma and Electron Beam Dosing

Quarterly Dose Audit - Method 1 (AAMI/ISO 11137)

Routine Dose Audit Monitoring Program for Gamma or Ebeam irradiated products

Quarterly Dose Audit - Method 2 (AAMI/ISO 11137)

Routine Dose Audit Monitoring Program for Gamma or Ebeam irradiated products

Quarterly Dose Audit - VDmax (AAMI/ISO 11137)

Routine Dose Audit Monitoring Program for Gamma or Ebeam irradiated products

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Bioburden

Determine the viable microbial load of an environment or on a product.

USP Sterility

Sterility Testing performed under USP guidelines

Steam Sterilization Validation (USP)

Validation of Steam Steirlization Process with Biological Indicators

Endotoxin / Pyrogen (USP 85, AAMI ST72)

In accordance with a sterility program, endotoxin testing may be necessary as well for certain medical devices

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