Pharmaceutical Technology - March 2021

Pharmaceutical Technology - Regulatory Sourcebook - March 2021

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10 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 P h a r mTe c h . c o m Operations C ontrolling the contamination generated by human opera- tors and their clothing during manufacturing and other activities is a major concern for cleanrooms and con- trolled environments. People disperse large numbers of particles (i.e., skin fragments, bacteria, and hair), with the total number varying over time and depending on the individual operator. Cleanroom garments must be designed to protect the environment and the process by containing any particles shed by the operator without becoming a source of further contamination. In addition to managing the particulate load, cleanroom gowns may also need to contain any microbes shed by operators that could pose a risk to the product and process. Cleanroom managers are charged with selecting the best clean- room garments and related systems for their specific environments. This article will present a new testing approach designed to assess conditions during operations. It is based on the following important considerations, which are not always included in the typical clean- room garment selection process: • Particulate shedding over time during routine operations, shown by comparing the performance of two different types of garments • Life cycle of a garment (determined by studying the perfor- mance of a garment after repeated laundry cycles) • Assessing the overall heat load of the operator during routine cleanroom operations. A Real-World Approach to Evaluating Cleanroom Garments Anne Marie Dixon-Heathman Traditional methods fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garment life cycle. Anne Marie Dixon- Heathman, annemarie@, is principal of Cleanroom Management Associates, Inc. MANTINOV - STOCK.ADOBE.COM

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