Bioburden Testing Level In Sterile Pharmaceutical Manufacturing

The term sterility refers to this Lack of workable any microorganism; bacteria, spores, and viruses in a product. Viable microorganisms proliferate from the item finally destroying it and making it unsafe for use. It is thus important to get sterility validated. Pharmaceutical manufacturers have to guarantee sterility of their goods especially those intended for parenteral or implant use. Assurance of sterility, therefore, guarantees that these products are of quality, efficacious and safe to use. Sterility Assurance Level is a ratio that permits the Sterile Pharmaceutical Manufacturers to provide an arbitrary number to demonstrate the amount of sterility in their merchandise.

As mentioned above, SAL is a ratio. It gives the probability of getting a viable microorganism at a product. As an example, the standard accepted sterility assurance level is 10-6. This implies that for each one million products which have undergone the sterilization procedure there is at least no more than one viable microorganism. However, there are various SAL determined by the intended final use of the product and the stability of the product to the sterilization. Standard level assurance 10-6 Also called pharmaceutical sterilization is meant for parenteral pharmaceutical products which are heat-resistant. Standard level assurance 10-4 known as high-level sterilization Meant for heat resistant bioburden testing apparatus. Standard level assurance 10-3 called non-invasive sterilization is meant for reusable medical devices which have a validated following use cleaning procedure.

Sterile Pharmaceutical Manufactures, however, face the problem of assessing the achievement of the sterilization procedure employed. A normal Level Assurance of 10-6 is just about impossible to document in an experiment. Thus, to overcome this restriction sterility assurance level of a sterilization is obtained from model experiments. Conclusions, drawn from such experiments, determine a specified standard level assurance. In this case, Sterility Assurance Level Can Be used to specify the number of microbes which are destroyed under specified sterilization conditions. In cases like this, a pre-determined number of microorganism is subjected to a sterilization procedure. Then the number of germs after the evaluation are then determined. The mosquito signs are contaminated with the maximum resistant microorganism into the specified sterilization procedure. This allows to encircle all germs susceptible to the sterilization.