We are here to alleviate the challenges associated with regulatory compliance through comprehensive bioburden testing. Don’t let the performance of your medical equipment decline. Rely on our team of skilled and experienced microbiologists to provide the testing services you need.
Bioburden Testing of Medical Devices
Bioburden testing determines the presence of microorganisms on a medical device. The process involves two essential steps: a suitability examination followed by the actual test. The goal of the bioburden appropriateness test, also known as method validation, is to ensure the effectiveness of the bioburden test technique in eliminating microorganisms from the device. It also demonstrates that the test method supports the device’s microbial development.
During method validation, a known low concentration of bacteria is placed on a sterile device and removed using the same procedure that will be used for the actual bioburden test. The percentage of microbes that cannot be eliminated from the device is calculated using a recovery factor based on technique validation results.
After a successful technique validation, the device undergoes bioburden testing to establish its microbiological load. This information is frequently crucial for sterilization validations, determining the necessary sterilization dose for a specific device. Additionally, quarterly bioburden monitoring is conducted as part of quality control to track changes in the microbial load on a device.
Sterility Testing of Medical Devices
Sterility testing is a critical process to ensure that medical devices are truly sterile and do not release substances that can inhibit or kill microbial growth. Similar to bioburden testing, sterility testing includes a suitability test known as bacteriostasis and fungistasis testing (B&F). This test determines whether a device prevents the growth of bacteria or fungi, which could lead to false negatives during sterility testing.
To conduct the B&F test, the device is introduced into media and injected with less than 100CFU of each of three separate organisms. Sterility testing is often performed using SCDM (Soybean-Casein Digest Medium) and requires an incubation period of 14 days. If the media becomes turbid during this period, the sample fails the sterility test.