Cleaning of Dedicated Equipment: Why Validation is Needed.

Autor: Baccarelii, Cristina, Bernard, Paola, Cortellino, Teresa, Cruciani, Oscar, Pacello, Rita, Parisi, Chiara, Stoppa, Luisa, Marta, Isabella
Předmět:
Zdroj: Pharmaceutical Technology; 2015 Supplement API's, Excipients, & Manufacturing 2015, Vol. 39, ps48-s50, 3p
Abstrakt: The article discusses cleaning validation of equipment dedicated to the production of a single active pharmaceutical ingredients. Topics discussed include importance of cleaning pharmaceutical equipment to avoid the risk of product contamination. Topics discussed include the International Conference on Harmonization guidance, the factors such as clean hold time to be considered when performing validation and a chart depicting source of contamination such as microbiological or solvent induced.
Databáze: Complementary Index