Total Organic Carbon for Enhanced Verification of Bioprocess System Cleaning CQA’s

Total Organic Carbon for Enhanced Verification of Bioprocess System Cleaning CQA’s

04/18/2018, 3:15 PM - 4:00 PM

Technical Conference Stage 3, Booth 1376, Exhibit Hall


In the manufacture of therapeutic and biocommodity products, contamination control is of paramount importance to product quality, efficacy, patient safety, and GMP compliance. Equipment cleaning is the primary line of defense in preventing adulteration by contaminants. Yet the control and monitoring of effective cleaning processes can be difficult. A survey of FDA warning letters found that 60 percent cited 21 CFR 211.67 (equipment cleaning and maintenance) deficiencies relating to inadequate equipment cleaning procedures, monitoring, and documentation (European Compliance Academy, 2006). While the industry has begun to integrate continuous monitoring technologies into manufacturing systems, cleaning systems are often overlooked in that effort. However, online TOC systems can be extremely useful not only for enhancing the control of critical cleaning process parameters but actually measuring forward processing criteria with the end goals of real-time release and continual verification. This presentation reviews the fundamentals of the cleaning process, important process parameters, and how appropriate instrumentation and control strategy can improve cleaning process control. Two case studies are also entertained in which TOC analyzers were implemented on CIP systems as well as the underlying philosophies that best fit the particular analyzers chosen.


  • Clare Hogan


    Marketing Coordinator

    Hyde Engineering + Consulting

  • Keith Bader


    Sr. Director Technology

    Hyde Engineering + Consulting

Type of Session

  1. Type of Session

Learning Objectives

  1. Learning Objectives 1. Basic capabilities of online TOC for cleaning systems. 2. Basic considerations for physical Integration of online TOC for reliable and representative sample collection. 3. How continual monitoring can data provide value by reducing revalidation workloads through data review and requalification.


  1. Track
    Manufacturing Efficiencies & Improvements

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