The article published in the September-October 1993 issue of the Journal of Parenteral
Science and Technology, entitled “The Incubation Period in Sterility Testing” is a subject that …

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 …

The USP chapter titled “Sterility Tests” will be almost completely rewritten in USP XXI. Drafts
for comment will shortly appear in Pharmacopeial Forum and USP Comment Proofs.“Sterility …

Sterility test results gathered over a ten year period have been analysed to determine the
effects of the incubation period. Overall there was no difference between the membrane …

BACKGROUND The compendial Sterility Test is not a test for product sterility. This is not a
new, nor a particularly insightful observation. It has been frequently presented as a flawed …

BACKGROUND The compendial sterility test is frequently presented as a flawed test for its
stated purpose. This statement, of course, begs the question as to what exactly is the …

The administration of drugs by parenteral routes has required the development of
meaningful sterility tests to be used in the analytical control of these pharmaceuticals. Proom …

The development and use of effectwe sterility tests should be an essential part of the quality
control program of any industry engaged in production and marketing of parenteral drugs …

THE expanding use in medicine of drugs administered by parenteral routes has brought with
it an increase in application of aseptic techniques and consequently in the development of …

The need for sterility testing of antimicrobial-containing injectable solutions is discussed and
specific testing methods are described. Despite their antimicrobial activity, antimicrobial …