ABSTRACT
A ‘‘necessary evil’’ is something that one does not like to do, or perhaps does not understand the need to do, but which one realizes must be done. Sterility testing falls into this category. It must be done because the Code of Federal Regulations (CFR) requires that a sterility test be performed on each lot of product labeled ‘‘sterile’’ (21 CFR 211.167(a); 21 CFR 610.12). Unfortunately, given the statistical limitations of the current test method, the result of a sterility test really gives little, if any, indication about the sterility of a batch (Appendix 1) (1,2).
