STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced the Bioburden and Sterility Testing services for medical devices under the guidance of the ISO 11731 method.
For medical device manufacturers, sterility assurance is a vital part in producing safe products. The FDA and other regulatory agencies require validation of sterilization processes, so Bioburden and Sterility Testing is often necessary. In addition, both tests are performed to check for microorganisms, while the latter has a deeper and broader significance.
Firstly, Bioburden Testing estimates the number of microorganisms on the surface of medical devices, containers, empty bottles or bulk products. For medical devices, bioburden levels are often employed for sterilization validation to calculate the dose of validation or sterilization that may be required for the device. Furthermore, bioburden levels are an essential part of ongoing quality control to determine if the microbial load on the device has changed.
There are three methods of Bioburden Testing, i.e., the membrane filtration methods, the pour plate methods, and the spread plate methods. Suitability testing is performed prior to Bioburden Testing of medical devices to ensure that the bioburden test method is effective in recovering microorganisms present on devices and to demonstrate that the test method allows for the growth of device microorganisms.
Second, Sterility Testing reveals whether medical devices are sterile. Similar to Bioburden Testing, Sterility Testing requires fitness for purpose testing, which is known as antimicrobial and fungal (B&F) testing, a strategy applied to avoid false negatives in sterility tests by measuring whether devices inhibit the growth of bacteria or fungi.
ISO 11731 specifies methods for verifying the sterilization process of medical devices. Typically, laboratory personnel employ a direct inoculation method to test the sterility of medical devices and utilize a common medium, called SCDM (Soy Casein Digestion Medium). Then if the medium becomes cloudy after 14 days, the sample fails the sterility test.
With extensive expertise in microbiology and sterility testing, STEMart can provide comprehensive services to support manufacturers in meeting regulatory goals and minimizing compliance risks. STEMart now provides Bioburden and Sterility Testing Services for medical devices under the guidance of ISO 11731 methods, and guarantees that all sterility testing is performed in its clean-room facilities.
If you have additional questions regarding these Bioburden and Sterility Testing Services for medical devices or would like to know more about STEMart's medical device development service, please visit https://www.ste-mart.com/.
*Please note that these products and services are for research use only and are not intended for therapeutic or diagnostic applications. This information is not a substitute for professional medical advice.
STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols in order to access better health worldwide.