In the white paper titled “Sterility Testing: Essential Things You Must Know,” author Steven Richter, Ph.D., president and scientific founder of Microtest, presents the general concepts and problems associated with sterility testing and reviews different testing methodologies. Sterility testing of medical devices is required during the sterilization validation 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. Microtest is a leading provider of medical device services and analytical services for medical device designers and manufacturers. The firm recently expanded its facilities, resources, and technology in the delivery of medical device sterilization validations, package validations, microbiology and clean room services.
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