Monthly Archives: July 2017

Recipe control in manufacturing system

Now a day’s regulators looking for control on the product /system recipe. Recipes  are very critical part of process. Because process are control through validated recipe. If firm calming that their system complying 21 CFR par 11/EU annex 11, in … Continue reading

Posted in Pharmaceutical and Biotechnological | 1 Comment

Design, Operation, Qualification and maintenance of Isolator

Isolators have been around the Pharmaceutical Industry since the early 1980s and in the Nuclear Industry (glovebox technology) since the 1950s. The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process … Continue reading

Posted in Pharmaceutical and Biotechnological | 2 Comments