[Cleaning validation of the prefermentation-fermentation group for production of biomedical products].
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.
Lencioni
E
E
Dipartimento Farmaco Chimico Tecnologico, Facoltà di Farmacia Università degli Studi di Siena.
Mecatti
F
F
Travagli
V
V
Valeri
A
A
D001709:Biotechnology / Q000379:methods* / Q000592:standards; D005285:Fermentation; D015203:Reproducibility of Results