Independent Testing and Consultation Services
Life Science Consumables and Medical Device Industries
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
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