ASEPTIC PROCESSING RISK MANAGEMENT: A REVIEWAbstract
Aseptic processing is a widely used technology in the field of pharmaceutical, biotech, and medical device industries for the preparation of sterile materials. The term aseptic processing as it is applied in the pharmaceutical industry refers to the assembly of sterilized components and product in a specialized clean environment. Aseptic processes are some of the most difficult processes to conduct in the pharmaceutical industry. Because of the nature of aseptic processes, sterile products produced aseptically present a significantly higher risk to the patient than terminally sterilized products. Because of the high level of risk, an effective quality risk management program is necessary to protect the patient. An effective risk-management program aids in the careful control of the process, reducing the risk of contamination as well as wasted effort in controlling insignificant risks.
E. Gopinath*, Raghvendra S. Bhadauria, Amit Mishra, Vinod Kumar Soan and D. P. Gupta
Shrinathji Institute of Pharmacy, upali oden Nathdwara, Rajasthan, India
23 May, 2010
14 August, 2010
16 September, 2010
01 October, 2010