Sterilization Validation

C.G. Laboratories, Inc. is a leader in the field of medical device sterilization 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. C.G. Laboratories, Inc. can perform all the microbiological testing required no matter the sterilization method used (Gamma Radiation, E-Beam, Ethylene Oxide, or steam). We can also 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 11735
  • Steam Sterilization Validation -- AAMI/ANSI/ISO 11735

Sterilization Validation for Reusable Devices

The validation of a reusable device is not only required by the FDA but also ensures that your instructions for use are appropriate with your device. C.G. Laboratories, Inc. follows the guidelines of AAMI TIR12 and AAMI TIR30 to validate reusable devices. The validation of a reusable device involves several factors to comply with these guidelines, sterility, cleaning, and repeated use.

Facility Process and Environmental Validations

Facility Process and Environmental Validations are an important part of a company's overall compliance. C.G. Laboratories is proficient in helping you, the customer, understand what is needed for these validations and how to implement baseline and routine testing.

  • Cleaning Validations of equipment and medical devices
  • Environmental Monitoring
    • Viable Air
    • Viable Surface
    • Non-Viable Particulates
  • High Quality Water Tests USP Guidelines for Purified Water and Water for Injection
    • Conductivity
    • Microbial Plate Count
    • pH
    • Total Organic Carbon
    • City Feed Water
      • Coliform
      • pH
      • Total Chlorine
  • Customer Specific Process Validations - Designed to your specific process

Equipment Validations (IQ/OQ/PQ)

  • Autoclave
  • Incubators
  • Aging Chambers
  • Refrigerators
  • Freezers
Additional Information

Sterilization Validation

Kayce Starnes, Senior Laboratory Contract Review
C.G. Laboratories, Inc.
1410 Southtown Dr.
Granbury, TX 76048
P: (817)279-1945 Ext. 5
Mail: sjacks@cg-labs.com

© 2017 - C.G. Laboratories, Inc.