Validation of Sterilizing Filters in the Biotechnology Industry.

Autor: Walker, John M., Desai, Mohamed A., Kalyanpur, Manohar
Zdroj: Downstream Processing of Proteins; 2000, p211-221, 11p
Abstrakt: Parenteral drugs have been manufactured on an industrial scale for many years and drugs that could resist heat were sterilized by terminal heat sterilization. However, some parenteral drugs were heat sensitive and could not be sterilized by heat. This was the beginning of the search for alternative methods of sterilization. Filtering out contaminating organisms from the drug product was obviously an excellent idea and filters made of a variety of materials such as porcelain, asbestos cellulose, and polymeric membranes have been developed over the years. Today, only the polymeric membrane filters are used as sterilizing grade filters. [ABSTRACT FROM AUTHOR]
Databáze: Supplemental Index