Towards a Rapid Sterility Test?
نویسنده
چکیده
Sterility test is an established method for detecting the presence of viable forms of microorganisms in or on finished pharmaceutical products. Sterility, in this sense, means that a product is free from viable microorganisms (although not necessarily metabolic by-products or toxins). The classic form sterility test examines a pharmaceutical product in contact a culture medium, as a way of detecting the possible presence of viable microorganisms. The test is mandatory for all aseptically filled products.
منابع مشابه
Evaluation of the ScanRDI(R) as a Rapid Alternative to the Pharmacopoeial Sterility Test Method: Comparison of the Limits of Detection.
Two sterility test methods, the ScanRDI® rapid sterility test and the United States Pharmacopeia/European Pharmacopoeia/Japanese Pharmacopoeia (USP/EP/JP) compendial sterility test, were compared with respect to the limits of detection for the presence of viable microorganisms in aqueous solutions at low inoculation levels. The ScanRDI® system employs a combination of direct fluorescent labelin...
متن کاملTowards an improved sterility test.
The sterility test is generally recognized as a flawed test for its stated purpose. Since the original description in 1932, this test has generated controversy as to its role in product quality testing and in terms of means to improve the assay. As early as 1956 Bryce published an article describing the two critical limitations of this test (1). He put forward that the test was limited in that ...
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Currently Available Rapid Microbial Tests for Translational Medicine
Rapid microbial tests ensure testing in rapid and accurate manners at reasonable costs. The ideal test should achieve detection of certain types of microorganisms that are undetected by the pharmacopoeia-defined sterility tests and its accuracy should be confirmed by regulatory authorities. The use of pharmacopoeia sterility tests is limited since they can detect only microorganisms that are vi...
متن کاملValidity of a rapid assay for antisperm antibodies in semen.
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