Bioburden Testing – Medical Devices
Bioburden testing measures the number and type of microorganisms present on a sample and constitutes an important part of quality control for all medical devices. This test is done before the device undergoes any type of sterilization and is necessary as no regulatory submissions can be completed without it.
Bioburden testing acts as an early warning system for possible manufacturing problems that could lead to inadequate sterilization processes.
Applicable Standards
Embryotech Laboratories perform this test in accordance with ANSI/AAMI/ISO 11737-1 standards.
Bioburden Testing Outline
Routine Bioburden testing of medical devices should be performed to demonstrate raw materials quality and proper manufacturing procedures. The appropriate frequency and number of samples depend upon the sterility assurance level (SAL), type of product, type of sterilization used, environmental control and manufacturer.
Bioburden sample collection method impacts the results. The most recommended method for evaluating products or processes is to obtain random samples. Samples may be selected aseptically from routine production, which should include products 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.
Method
Samples are incubated in an extraction solution which is vacuum filtered through a .45-micron filter membrane, trapping all microorganisms present. The membrane is transferred to culture media and incubated to observe microorganism colony formation. Results are available approximately one week from receipt of sample.
Bioburden extraction technique can be adjusted based on sample composition for optimal recovery. Methodology is validated by a recovery efficiency assay.
Parallel culturing in three conditions allows detection of fungi and both aerobic and anaerobic bacteria, covering the full range of potential microorganism contamination.
If microorganisms are detected, further characterization can be conducted through Gram staining and colony analysis. Allowing manufacturers to identify likely sources of contamination.
All reagents used are pretested for growth potential and sterility, ensuring accurate and reliable results.
Documentation
We provide comprehensive and accurate documentation that helps streamline the regulatory submission process. We also stay on top of changes and updated standards to help clients stay proactive and well-documented.
Testing Request
Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing complete the Sample Submission Form below.
Contact Us
If you have additional questions about Bioburden test services for medical devices or would like to consult with the experts at Embryotech laboratories, just send us a request or call us at +1 978-373-7300 Our highly skilled team is on standby to provide you with the assistance that you need.