C.G. Laboratories 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.

Sterilization Validation Methods

  • 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
Sterilization Validation
WHY CHOOSE CG LABORATORIES?

C.G. Labs began in 1983 as a microbiology laboratory founded by Dr. Glenn Crum. In 1996, we relocated to Granbury, TX and expanded our services to include medical device contract manufacturing. We have grown into a multi-service company with three distinct divisions with 19,000 square feet spanning two sites. All our services are current, regulated and quality-driven. We are registered with the FDA and ISO accredited to 13485:2016 and MDSAP.

Our GET MORE objective gives you great customer service, guidance, quality management and access to experts. We strive to exceed your expectations, to meet government regulations and to make the world a safer place. With C.G. Laboratories, you always GET MORE.

Call us today! 817-279-1945

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
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