Verifiable Containment Performance of Isolator Technologies

Verifiable Containment Performance of Isolator Technologies

04/18/2018, 11:30 AM - 12:15 PM

Technical Conference Stage 4, Booth 1477, Exhibit Hall
Language:
English

With the advent of increasingly potent compounds such as HPAPIs, ADCs, etc within the pharmaceutical industry, the focus on containment solutions and their ability to offer the required exposure protection has never been greater. End users have several different technologies available to them ranging from flexible and hard wall isolator systems to containment valves, each with their own particular applications and accepted OEL range. Much discussion has taken place regarding the standard definition of Operator Exposure Limits (OELs) with varying client, industry and manufacturer interpretations. What is clear, however, is that the ability of isolator technology to achieve the required OEL limits through validated containment performance testing (CPT) is critical not only to personnel protection but to the end user's production, quality and EHS/OH functions. This presentation will outline, with proven project examples, best practices in the design and engineering of isolator technology to achieve OEB5/6(ng/m3) level containment. An approach to achieving an independent, validated containment performance test result will be described, with reference to past examples and review of current guidelines and future trends. Key considerations to achieve the required outcomes expressed in relevant equipment user specifications / CPT protocols will be shown in detail, allowing listeners to leave with a new viewpoint on managing risk with regards to OEL, production, quality and safety.

Contributors

  • Torsten Belger

    Speaker

    Technical Director

    ProSys Containment and Sampling

  • Michael Hennessy

    Speaker

    Head of Global Sales

    ProSys Containment and Sampling Technology

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. Best practice in containment design to achieve OEB5/6 containment 2. Realisable containment performance from different containment equipment 3. Approach needed to achieve validated CPT results

Categories

  1. Track
    Risk Management

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