Bioburden- Membrane Filtration
The Bioburden test determines the total number of viable microorganisms in or on a medical device, container or component. It is performed on any product that requires control and/or monitoring of bioburden counts, usually as part of a sterilization program. This test acts as an early warning system for possible production problems that could lead to inadequate sterilization. It is also used to calculate the necessary dose for effective radiation sterilization and to monitor product routinely as part of quarterly dose audits.
Nelson Laboratories performs this test in accordance with ANSI/AAMI/ISO 11737-1 and is most commonly referenced in the Radiation Sterilization standard (ANSI/AAMI/ISO 11137-2) and the EO Sterilization standard (ANSIAAMI/ISO 11135).
- ANSI/AAMI/ISO 11737
- ISO 11135
- EN 1174
Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.
|BIO815||Bioburden: Standard MPN Method||Add|
BIO815 - Bioburden: Standard MPN Method
Study OutlineRoutine bioburden testing should be performed by all manufacturers of medical devices to demonstrate that the manufacturing process 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.
The AAMI Radiation Sterilization guideline (ANSI/AAMI/ISO 11137) mandates testing 10 samples for bioburden with each quarterly audit. Monthly bioburden testing may be required depending on the validated sterilization dose.
For products validated using the Industrial Ethylene Oxide Sterilization Guideline (AAMI/ANSI/ISO 11135), the type and frequency of bioburden tests performed will also vary with the method used in the initial validation. Most products are validated using the overkill method, where performing bioburden testing of 3 – 10 samples quarterly is sufficient. Products validated using the absolute bioburden method require frequent and significant bioburden testing. Even products validated with the BI/bioburden method should be tested periodically (at least quarterly) for bioburden.
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.
We’re happy to help you create a Bioburden testing schedule and identify the right tests for your product.
The method of obtaining samples for bioburden and sterility tests can influence the test results. The preferred method for evaluating products or processes is to obtain random samples. These samples may be selected from routine production, which should include products produced at different times during the production of a single lot. The selected production lot needs to be representative of typical processing and conditions. Samples may be obtained from in-process rejected materials if those materials have been subjected to the same processing conditions used for the remainder of the lot.
Please be as clean as possible when sampling. Samples intended to receive a verification dose of radiation and undergo a test of sterility should be double bagged before they are sent to be dosed. This provides an extra barrier to take into the cleanroom and can reduce the potential for false positives.