Sterility assurance based on validation of the sterilization process using steam under pressure. Committee on "Microbial Purity". F.I.P. (International Federation of the Pharmaceutical Industries)
The F.I.P. has long been involved in the practical aspects of microbial quality in pharmaceuticals. This report deals with steam sterilization. A group of European experts from official laboratories and pharmaceutical industries has compiled this text which successively reviews the different pharmacopeias, defines some essential sterilization concepts and parameters, reviews the current approaches to steam sterilization and advises, for each of them, practices in validation and in-process control.
D005060:Europe; D010606:Pharmacy and Therapeutics Committee; D011312:Pressure; D011786:Quality Control; D012015:Reference Standards; D013227:Steam; D013242:Sterilization / Q000379:methods* / Q000592:standards
D013227:Steam