Leveraging Master Soil Selection: Cleaning Validation Design Phase Thru FAT of an Automated Parts Washer

Leveraging Master Soil Selection: Cleaning Validation Design Phase Thru FAT of an Automated Parts Washer

07/15/2020, 4:15 PM - 5:00 PM

Stage 4, Booth 2276, Exhibit Hall
One of the goals of the cleaning validation design phase is to define critical parameters (inputs) and critical quality attributes (outputs) of the cleaning process. Laboratory testing as well as on-site field trials are commonly used to achieve these goals and have been well documented in the literature. These laboratory studies can also be conducted in advance or in parallel to the design of the user requirement specification (URS) and functional requirement specification (FRS) of cleaning equipment, such as automated parts washers. The factory acceptance testing (FAT) may include a coverage and cleaning test. However, it is often the case that product or process residue may not be available during the FAT, due to restrictions from the manufacturer, production timing, environmental risks, health and safety concerns of the operators, shipping regulations, sample costs, or confidentiality precautions. This article explores the selection of a master soil as part of the cleaning validati


  • Paul Lopolito


    Technical Services Senior Manager

    STERIS Corporation

    Paul Lopolito is a technical services senior manager for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). He currently provides...

  • Mathieu LePage


    Associate Product Manager



  1. Objective 1. How identifying and selecting a master soil can help with the cleaning validation design phase. 2. How this master soil can be used during FAT to complement coverage testing and add robustness to the equipment validation process. 3. How this master soil can be leveraged during the on-site qualification to reduce time and cost of cleaning validation processes.

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    Facility Optimization

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