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Drug Product Validation
This paper addresses how to qualify a Biological Safety Cabinet(BSC) and includes a description for Installation and Operational Tests that should be included as part of the Qualification process.
Despite having robust design and environmental monitoring, cleanrooms are at risk for several sources of contamination. In this case, BSCs, if purchased with much consideration, are the first line of defense in providing personnel, environmental, and/or product protection against biohazards and harmful agents in a range of laboratory, research, clinical, and pharmaceutical settings. As much as selecting the right BSC is important, it is more important to ensure that the BSC is functioning correctly at a high safety level. This white paper provides a template/ description of various Installation Qualification (IQ) and Operational Qualification (OQ) tests that should be included at a minimum when qualifying BSCs to ensure it helps facilitate an optimum working environment.
Wamika Vohra is an experienced Commissioning and Qualification Engineer and an ISPE member who received her BS degree in Physical Therapy from India and MS degree in Kinesiology and Exercise Science from California State University, Fullerton. She always had a penchant for life sciences and pharmaceuticals and thus decided to gravitate towards these industries. She has spent the last few years utilizing her diverse background to work passionately in this field. She has worked on a wide range of projects from Gene Therapy, QC Laboratories, to Pharmaceutical Manufacturing Facilities. Wamika is currently working at Commissioning Agents Inc. and has experience working in the pharmaceutical and biopharmaceutical industries.