C.G. Laboratories, Inc. is a leader in the field of medical device sterilization validation and testing. Sterile medical devices require extensive microbiological testing to ensure the sterility of the device and comply with FDA regulations.

Trained microbiologists will be handling your device under a laminar flow hood to ensure that your device is being tested by the best personnel and in the best environment. All the microbiological testing required is performed no matter the sterilization method used (Gamma Radiation, E-Beam, Ethylene Oxide, or steam). Finally, we can provide consulting to help you comply with FDA requirements or sterilization and what sterilization method would be best suited for your device.

  • AAMI 11137 Method 1 for VD Max-Gamma or E-Beam Radiation Validations
    • Bioburden (3 Lots of product) — AAMI/ANSI/ISO 11737-1
    • Bioburden Recovery — AAMI/ANSI/ISO 11737-1
    • Verification dose (Gamma or E-beam)
    • Product Sterility Testing — AAMI/ANSI/ISO 11737-2
    • Bacteriostasis/Fungistasis Sterility Validations — AAMI/ANSI/ISO 11737-2
  • AAMI Quarterly Dose Audits — AAMI/ANSI/ISO 11737
    • Bioburden/Bioburden Validation –AAMI/ANSI/ISO 11737-1
    • Verification dose (Gamma or E-beam)
    • Product Sterility Testing — AAMI/ANSI/ISO 11737-2
  • Sterility testing of Biological indicators
  • Biological Indicator Population Verification
  • Ethylene Oxide Sterilization Validation — AAMI/ANSI/ISO 11135
  • Steam Sterilization Validation — AAMI/ANSI/ISO 17665
Request Sterilization Validation Information

Dorie Tucker, Chief Laboratory Scientist
C.G. Laboratories, Inc.
1410 Southtown Dr.
Granbury, TX 76048
P: (817) 279-1945 Ext. 4

Email Dorie