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Validation of Sterile Processes and Concept of Barrier Isolators Mulay Sushruta*, Khale Anubha H.K. College of Pharmacy, Jogeshawari (W), Mumbai *Corresponding Author E-mail: sushruta.mulay@hkcollege.ac.in, scientific.cell@hkcollege.ac.in
Online published on 3 April, 2013. Abstract Current article reveals some of the important validation methods and the concept of Barrier Isolators which potentially control parenterals manufactured mainly by aseptic processing. Sterility in the absolute sense cannot be achieved even though greater levels of assurance can be achieved with current technology. All sterilization methods require validation and during validation they should demonstrate that products meet the required sterility assurance level, remain in function and are safe for use. Understanding the scope of this testing, the applicable standards and their application to the product produced with the designated sterilization methods are the essential requirements of validation. Thus Sound Validation Programme is an essential requirement of a company which affords a level of confidence in quality of products as there are fewer rejects, retests and reworks because of validation. Top Keywords validation, sterility assurance, class 100 area, barrier isolators, unidirectional airflow devices. Top | |
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