Cleaning validation of the prefermentation-fermentation group for production of biomedical products
Lencioni, E.; Mecatti, F.; Travagli, V.; Valeri, A.
Bollettino Chimico Farmaceutico 139(1): 8-13
2000
ISSN/ISBN: 0006-6648 PMID: 10829546 Document Number: 524678
The fermentation-group is largely employed to produce pharmaceuticals by means of biotechnology techniques. The operative functions of these plants are surely kept under control by the validation process, while its cleaning is less investigated. The aim of this work is the cleaning validation of a fermentation-group. Furthermore, Standard Operative Procedures (SOPs) have been validated relating to the production necessities and to the allowed safety limits.