The bioburden is a method that must be validated in order to assess the actual results of routine analysis. This determines a conversion factor indicative of the recovery of organisms of a particular device. The bioburden validation should be reviewed at regular intervals.
The routine determination of bioburden must be performed using a documented sampling plan defining the sample size and the sampling frequency. The application of statistical methods to determine the sample size, sampling frequency, and/ or acceptable limits can be advised by Medistri. It must be established and documented. This sampling plan is determined by factors such as the number of lots, the health risks associated with the use of products with a level of unacceptable contamination, product characteristics, and the degree of alleged contamination.
Medistri can also search germs specified by macroscopic characterisation (colony characteristics), microscopic (cell characteristics) by farming methods (biochemical characteristics), and colorations. Research specified germs allow at the end to get good information on the origin of the contamination and to act on the source of it.
In case of exceeding the limits of acceptance, Medistri offers its expertise in action at the source of the problem.