[Microbiologic validation in the production of sterile pharmaceuticals]

Some microbiological validation procedures for sterile drug production are described. There concern the environmental microbial and particle "self-decontamination" time specified in the English "Guide to Good Pharmaceutical Manufacturing Practice 1983" and the EEC "Guide to Good Manufacturing Practice for Medical Products", the various methods for evaluating that sealing of sterile drugs is intact and the validation methods for aseptic filling of sterile powders and solutions. For these, the limits laid down in FDA regulations are indicated.