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Routine testing of tissue should be performed to demonstrate that the tissue processing remains in control. The appropriate frequency and number of samples depend upon the sterility assurance level (SAL), type of product, type of sterilization used, environmental control, and the process controls of the manufacturer or tissue processor.
In order to validate a bioburden test, a recovery efficiency needs to be performed. There are essentially two approaches available: repetitive treatment (also referred to as exhaustive recovery) or product inoculation. Ideally, a recovery efficiency should be established prior to the start of any bioburden test. It should be performed on a minimum of three samples. The recovery efficiency is then validated and can be applied to all future testing of that product. Due to the inhibitory nature of tissue samples, this can prove challenging at times and an initial consult with technical lab staff is recommended.
The AAMI Radiation Sterilization guideline (ANSI/AAMI/ISO 11137) tissue sample requirements for bioburden with each quarterly dose audit. Monthly bioburden testing may be required depending on the validated sterilization dose.
Bioburden tests may include aerobic bacteria, spores, aerobic fungi (yeasts and molds), and anaerobes. Many factors enter into the choice of the type of tests most appropriate for your product. Generally, one should test for aerobic bacteria and fungi.
For tissue products with low bioburden, the Most Probable Number (MPN) test may be utilized. This testing involves immersing the product directly in nutritive media and following a seven-day incubation, scoring the media for growth or no growth.
If you have additional questions about Bioburden Tissue testing, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.