PT  - JOURNAL ARTICLE
ED  - ,
TI  - Sterility Assurance Based on Validation of the Sterilization Process Using Steam Under Pressure
DP  - 1989 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 226--230
VI  - 43
IP  - 5
4099  - http://journal.pda.org/content/43/5/226.short
4100  - http://journal.pda.org/content/43/5/226.full
SO  - PDA J Pharm Sci Technol1989 Sep 01; 43
AB  - 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.