Producing safe products is a core goal of medical device Producers and sterility assurance is an integral component in achieving that objective. Many single use medical devices are sterilized by ethylene oxide or radiation techniques like gamma or e-beam. The FDA and other regulatory bodies requires the sterilization procedure be validated and these validations typically want a bioburden and sterility testing. Sterility testing and bioburden testing can also be performed on devices as part of routine quality control. A bioburden test determines how many germs are on the medical device. Before doing the test, a suitability test should first be performed. The objective of the bioburden suitability test also referred to as method validation will be to make certain that the bioburden test technique is effective in regaining microorganisms that are present on the device and also to demonstrate that the evaluation method will permit the rise of the apparatus microorganisms.
To do the method validation, a known low number of germs are put on a sterile device and then eliminated using the identical method that would be used for the true bioburden test. Dependent on the results of the method validation, a recovery factor is determined to account for the proportion of microorganisms which weren’t able to be removed from the device. After an acceptable method validation is complete, the device Will experience bioburden testing to find out their microbiological load. This apparatus bioburden level is frequently utilised in sterilization validations to figure out the confirmation or sterilization dose that a device may require. Additionally, as part of quality control, quarterly bioburden monitoring is done to ascertain whether the microbiological load onto a device has changed.
When doing a sterility test, it is imperative that the laboratory is Testing that the unit is really sterile instead of leaching out compounds that could inhibit the development, or even kill, microorganisms. Therefore, exactly like bioburden testing, sterility testing also includes a suitability test. The sterility suitability evaluation is known as bacteriostasis and fungi stasis testing. A bacteriostasis and fungi stasis Band test measures whether a system inhibits the growth of bacteria or fungi, which might result in false negatives during sterility testing. The test is done by adding the device to media and then inoculating the media with less than 100 CFU of three unique organisms. If the three organisms have the ability to turn the press turbid, the system passes the Band evaluation and sterility testing can start. Sterility testing of medical devices are normally conducted Using media known as SCDM Soybean-Casein Digest Medium.