The Biological load test for tissue determines the total number of living microorganisms in or on a tissue product or solution. It is usually performed on any tissue product that requires control and / or monitoring of biological load counts as part of a sterilization program. This test acts as an early warning system for possible production problems that can lead to inadequate sterilization or disinfection. It is also used to calculate the dose required for effective radiation sterilization and to routinely monitor the product as part of quarterly dose checks.
EUROLAB performs this testing in accordance with ANSI/AAMI/ISO 11737-1 and implements Radiation Sterilization standards (ANSI/AAMI/ISO 11137-1 & 2) and EO Sterilization standard (ANSI/AAMI/ISO 11135).
Routine tissue testing should be done to demonstrate that tissue processing remains under control. The appropriate frequency and number of samples depend on the sterility assurance level (SAL), product type, type of sterilization used, environmental control, and process controls of the manufacturer or tissue processor.
A recovery efficiency must be performed to verify the biological load test. There are essentially two approaches: repetitive treatment (also called comprehensive healing) or product vaccination. Ideally, a recovery efficiency should be ensured before the start of any biological load test. It should be done on at least three samples. Recovery efficiency is then verified and can be applied to all future tests of that product. Due to the obstructive nature of the tissue samples, this can be challenging from time to time, and initial consultation with technical laboratory staff is recommended.
AAMI Radiation Sterilization guide (ANSI / AAMI / ISO 11137) tissue sample requirements for biological load with a quarterly dose check. Depending on the validated sterilization dose, a monthly biological load test may be required.
Biological load tests can include aerobic bacteria, spores, aerobic fungi (yeasts and molds) and anaerobes. There are many factors in choosing the most suitable test type for your product. Generally, it is necessary to test aerobic bacteria and fungi.
The Most Possible Number (MPN) test can be used for tissue products with low biological burden. This test involves immersing the product directly in the nutritious environment and following a seven-day incubation, scoring the media for growth or growth.
EUROLAB, with its highly expert team and internationally accredited laboratories, Tissue Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
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