Viral Safety of Cleaned Surfaces Using a Risk-Based Approach

Viral Safety of Cleaned Surfaces Using a Risk-Based Approach

04/04/2019, 10:00 AM - 10:45 AM

Javits Conventions Center - Stage 2, Booth 1577, Exhibit Hall
Viral cross-contamination of process equipment and small parts is a concern for pharmaceutical and medical device industries. Viral contamination leads to costly delays in production, product loss, and regulatory issues. Viral clearance studies focus on viral inactivation or removal steps within the process flow ensuring a theoretical viral log reduction and low viral risk. The viral clearance strategy often overlooks the potential of cross-contamination from equipment surfaces and small parts from one donor, batch or product to another. An effective clean-in-place, automated parts washer cycle, or manual cleaning procedure incorporating an alkaline detergent helps mitigate the risk of cross-contamination. Understanding critical cleaning parameters and viral inactivation parameters is paramount in assessing viral safety of cleaned surfaces. Depending on the assessed risk, cleaning procedures can be modified to address viral safety and segregation practices within facilities.


  • Paul Lopolito


    Technical Services Senior Manager

    STERIS Corporation

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

Type of Session

  1. Type of Session


  1. Track
    Managing the Interface with Risk Management and Quality Systems

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