There are so many medical devices manufactured and used around the world and they are required medical devices to be sterile, that is they have to be free of viable microorganisms. To make sure that the medical devices are free from microorganisms nation and international quality assurance systems have laid down the requirements of correct validation and control of sterilization processes and bio burden testing of medical devices.
To adopting the standards for minimizing the microbiological contamination of the medical devices prior to the sterilization, we can achieved by controlling the process, raw materials, and environment during the manufacturing. Even though taking care of the controlling the process it might be small numbers of microorganisms can be found on the medical devices before sterilization making them non-sterile.
Bioburden is the population of viable microorganisms on a product. D10 is the radiation dose required to kill 90% (1 Log) of a homogeneous microbial population. Dose is the calculated level of radiation absorbed by the product which are present on or in a product or a sterile barrier system. It is important isssue to understand the bio burden as it.
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