Sample size of parenteral solutions for sterility testing*

Autor: Lila F. Knudsen
Rok vydání: 1949
Předmět:
Zdroj: Journal of the American Pharmaceutical Association (Scientific ed.). 38:332-337
ISSN: 0095-9553
DOI: 10.1002/jps.3030380613
Popis: Two questions have been asked in regard to sampling for sterility testing: “What size of representative sample should be taken?” and “How much should sample size vary with lot size?” Both of these questions can be answered by using some mathematical calculations together with a few assumptions. Recent developments in sampling theory have shown that sometimes tremendous variations in the quality of lots passed are due to chance alone involved in selecting the sample. It has been shown that it is possible to predict the variations and the frequency with which they will occur. The results of the mathematical calculations on a particular sample plan can be shown graphically by means of a curve called an “operating characteristic curve.” Much has been written on sampling; however, Grant (1) and the Statistical Research Group (2) summarize sampling developments quite well.
Databáze: OpenAIRE