Performance Survey and Comparison Between Rapid Sterility Testing Method and Pharmacopoeia Sterility Test
نویسندگان
چکیده
منابع مشابه
Towards a Rapid Sterility Test?
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 dete...
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15 صفحه اولTowards 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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ژورنال
عنوان ژورنال: Journal of Pharmaceutical Innovation
سال: 2017
ISSN: 1872-5120,1939-8042
DOI: 10.1007/s12247-017-9303-z