AGAWAM, Mass., Sept. 12 /PRNewswire/ -- Two new white papers detailing sterility testing essentials are now available for free download from Microtest (http://www.microtestlabs.com). The white papers, one which is customized for medical device manufacturers and one which is specialized for pharmaceutical manufacturers, presents the general concepts and problems associated with sterility testing and reviews different testing methodologies.
For medical device manufacturers, sterility testing of medical devices is required during the sterilization process as well as for routine quality control. Understanding sterility testing is essential when designing the validation process. The need to provide adequate and reliable test data is an important quality control issue. False positive results and test failures can have significant impact on production schedules and device time-to market. Medical device manufacturers can download the white paper at:
For pharmaceutical manufacturers, sterility testing of pharmaceutical articles is an essential element of the sterilization validation process as well as for routine release testing. USP requirements employ sterility testing as an official test to determine suitability of a lot. Understanding sterility testing is beneficial in terms of designing a validation process. In addition, the need to provide adequate and reliable test data is an important quality assurance issue. Pharmaceutical manufacturers can download the white paper at:
The author of the white papers is Steven Richter, Ph.D., President and
Scientific Founder of Microtest
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