Bioburden and Sterility Analysis in Medical Products
The main purpose of medical device manufacturers is to produce safe products. The main key to producing safe medical devices is producing sterile products. In particular, disposable medical devices are sterilized by ethylene oxide or radiation methods such as gamma or e-ray. It is necessary to verify the suitability and adequacy of sterilization processes applied to medical devices.It is carried out with biological load (from bioburden) and sterility test to verify the adequacy of the sterilization process applied to medical devices. Bioburden and sterility tests are part of the routine quality control system in medical device production.
Bioburden Test in Medical Devices
The bioburden (from bioburden) test basically refers to the number of microorganisms present in the medicinal product. The biological load of medical products is affected by raw materials, production, packaging and storage processes. Insufficient processing controls and sterility claims of the product can be supported by the determination of the bioburden.
Sterility Tests in Medical Devices
In order for medical devices to be accepted as a microorganism load in the process until they reach the consumer, they must undergo appropriate sterilization processes. Sterility tests should be performed to determine whether the applied sterilization process is sufficient.
Bioburden and sterility tests are carried out within the scope of the Medical Device Regulation.
