Abstract
Bioburden is measure of microbial contamination or #microbialload;
the amount of #microorganisms contaminating an object. Each lot
of a component, drug product container, or closure with potential for
#microbiologicalcontamination that is frightful in perspective of its
planned utilize might be subjected to microbiological tests before
utilize. Appropriate written procedures, designed to prevent
objectionable
microorganisms in drug products not required to be sterile, shall be
established and followed. Microbiological monitoring of the
manufacturing
environment can serve as an adjunct to control and generally is a
qualitative assessment tool in a properly implemented formal risk-based
microbiological control program. A monitoring program corresponding with
the product bioburden risk can help confirm the effectiveness of
microbiological controls and may facilitate early detection of potential
problems. The techniques utilized for microbial monitoring should be
capable of isolating the numbers and types of organisms that have been
deemed significant relative to in-process system control and product
impact for each individual system.
#Sterilization Validation of #Pharmaceuticals by Shaziya Yasmeen Sayeed in BJSTR
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