Medical Device Sterilization Validation Testing

Sterilization Validation Testing
Sterilization Validation Testing

Medical Device Sterilization Validation  is imperative to invasive sterile medical products such as implants and reusable surgical instruments. routinely helps  manufacturers, distributors, and healthcare facilities with their  sterilization validation. There are many different  sterilization methods, the most common methods include steam, heat, radiation, irradiation, and ethylene oxide. Proper sterilization procedures follow predetermined protocols and focus on disinfection.

Proper medical device sterilization methods will remove or destroy any and all forms of microbes such as bacteria and other disease causing microorganisms. Choosing a method for sterilizing can depend on the type of material the device is made of, the number of potential microorganisms involved, the classification of the device, and the availability of each sterilization method.

Before sterilization of a device or instrument can occur it must be properly cleaned. Cleaning a device before sterilizing helps to remove any dirt, oil, or other substances that could block or shield any hidden microorganisms.  Proper packaging and storing is also important to the sterilization process as it ensures the integrity. Proper storage of sterilized equipment minimizes the chances of a product becoming contaminated from dust, moisture, or other factors after it has been sterilized.

Sterilization through steam and heat is done using an autoclave which works similar to a pressure cooker where high temperature steam is is forced inside destroying any microorganisms. This process can take anywhere between 15 and 60 minutes.

Using chemicals such as ethylene oxide for sterilization is generally done for any devices that cannot be autoclaved. Sterilization using this method requires objects be soaked in the solution. This process is more time consuming and can take days to complete.

Medical Device Sterilization by radiation is done by placing items to be sterilized on a conveyor belt where they are then transported to an area where they can be hit by strong gamma radiation. The radiation from the rays helps create free radicals which damage enzymes and DNA that result in cell death. One benefit of radiation is that it is faster than physical and chemical methods of sterilization.

Sterilization Test Request Projects

Contract Laboratory has helped numerous companies and manufacturers find laboratories for medical device sterilization validation testing such as the following:

  • ISO 17025 medical device laboratory needed for cleaning / sterilization validation testing on bone fixture medical devices.
  • Medical device laboratory needed for cleaning and steam sterilization validation testing of reusable medical implant completed on a Scan Adapter.
  • Laboratory needed for Transmittance Test for UTMB Hospital waste water UV light used for sterilization
  • Large Medical Device Company needs Microbiology laboratory for EP/USP Ethylene Oxide sterilization validation testing for 4 different products as per ISO 11737-2 as well as to validate the Ethylene Oxide sterilization process, EP/USP including validation of test methods (B&F)
  • Medical Device Product Safety Laboratory needed for all biological testing for latex based medical devices with colorants needed for CE mark, FDA, ISO 13485 and Japanese biological safety requirements. Our products contact mucosal surfaces for weeks. May also need microbiology testing for sterilization.
  • Medical Device Company needs laboratory for packaging/product/development of disposable medical cable. ABS plastic housing for connectors Silicone vs PVC for cable assembly
  • Canada microbiology laboratory needed for pharmaceutical sterilization validation and Sterility assurance testing
  • and many more   Sterilization Validation Test Requests !

Need help finding a third-party contract  laboratory to perform your medical device sterilization validation testing? Call us at 1-855-377-6821, or Submit Sterilization Validation Test Request !

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