Cleaning Validation Limit calculation, Cleanability Studies, Equipment Considerations

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  • เผยแพร่เมื่อ 11 มี.ค. 2021
  • About the Webinar
    Cleaning validation in non-sterile pharmaceutical manufacturing is an ongoing task for the industry. Over previous years, some topics were discussed more than others. This presentation will focus on the recent hot topics, such as moving from manual cleaning to an automated process, visual inspection and visual clean evaluations after cleaning. The often-questioned cleaning process development will also be discussed, as well as the requirements for cleaning agents, including a review of how to set scientific-based limits for detergents.
    The objective of this presentation is to understand why the subjects outlined above are reviewed and considered by many different companies, and the approaches that have been established to deal with them. This should give the participants a better understanding of the risk-based cleaning validation approach.
    About Thomas Altman
    Thomas is a cleaning chemistry, cleaning process, cleaning validation and regulatory compliance subject matter expert. He is an expert in cleaning validation for product contact surfaces across all types of pharmaceutical and personal care production equipment. He is experienced in addressing regulatory inspection findings related to cleaning processes - and with implementing CAPA plans to prevent re-occurrence. Thomas has developed more than 1500 cleaning programs/ recommendations for pharmaceutical and personal care industries. Thomas contributed significantly to the ASTM E55 WK15778 Cleaning Process Development and Validation standard and published related articles as a co-author in “Pharmaceutical Engineering” as well as “Pharmaceutical Online” and “Biotechnology Online”. Prior to joining Ecolab, Thomas worked in the pharmaceutical and food industries.
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