Medical Device Bioburden and Sterility Testing

For medical device manufacturers, sterility assurance is a key component to achieve producing safe product. The FDA and other regulatory agencies require verification of the sterilization process, and these verifications usually require bioburden and sterility testing. Bioburden testing and sterility testing performed on medical devices are also as part of routine quality control. Both bioburden and sterility tests are intended to check for microorganisms, while sterility test has a deeper and wider implication.

Bioburden Testing of Medical Devices

Bioburden Testing is used to estimate the population of microorganisms in a product or on the surface of medical devices, containers, empty vials or bulk products. For medical device, the bioburden level is usually used in sterilization validations to calculate the verification or sterilization dose a device may need. In addition, the bioburden level is an important part of ongoing quality control to determine whether the microbiological load on a device has changed.

There are three methods for bioburden testing: membrane filtration, pour plates and spread plate methods. Before performing bioburden test on a medical device, a suitability test is required to ensure that the bioburden test method is effective in recovering microorganisms that are present on the device and to show that the test method will allow the growth of the device microorganisms. More details about Bioburden Testing methods, please read our Bioburden Tissue Testing Services.

Sterility Testing of Medical Devices

Medical Device Sterility Testing is used to prove that equipment is actually sterile. Like bioburden test, sterility test also requires suitability test, which is called the antibacterial and fungal (B&F) test. B&F tests are used to avoid false negatives in the sterility test through measuring whether the device inhibits the growth of bacteria or fungi.

ISO 11731 provides the method of verifying the sterilization process of medical equipment. Generally, a direct inoculation method is used to test the sterility of medical device, and a medium culture call SCDM (Soy Casein Digestion Medium) is commonly used. If the medium becomes turbid after an incubation time of 14 days, the sample has failed the sterility test.

STEMart offers Bioburden and Sterility Testing services of medical devices following the ISO 11731 method. All sterility tests are performed in our clean-room facility.

If you have additional questions about Bioburden and Sterility Testing or would like to find out more about our services, please feel free to contact us.