Pharmacopeial sterility test: The statistical limitations of sampling
نویسندگان
چکیده
For aseptically filled products, as well for many terminally the sterility test is a mandatory product release test. It is, however, statistically poor at detecting anything other than gross contamination (this limitation has been addressed in number of studies (1)). This relates to few numbers articles tested (2). batches excess 500 containers, pharmacopeia only require that twenty samples are included set. sample size appears have set arbitrarily, and it does not provide significant population with which estimate (3). Although unclear how this was derived, grounded, part, through being destructive (each article via available patient) therefore maximise availability batch by using units possible. remains, nonetheless, 20 provides no confidence pharmaceutical items compromised. In relation sampling, limitations apply low but also difficulties selecting representative all events during filling (4). important because unlikely be uniformly distributed throughout thus random sampling cannot detect absolute certainty. particular importance aseptic where specific can occur. possible certain captured, such interventions into core, vials exposed time activity incorporated (notwithstanding captured way).
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ژورنال
عنوان ژورنال: European journal of parenteral & pharmaceutical sciences
سال: 2023
ISSN: ['2633-6588', '1740-6277']
DOI: https://doi.org/10.37521/ejpps.28203