Cleaning Considerations during Design, Start-up, and Commissioning of Biopharmaceutical Equipment

Extended Learning
Learning Level: Intermediate
Time: 1100 - 1200 ET
Session Length: 1 hour

Equipment cleaning concerns are often over-looked during design, startup, and commissioning of pharmaceutical facilities. This is often the case with newer technologies such as mRNA vaccines and cannabis derived products. Failures to link the manufacturing process to cleaning agent selection, physical properties of cleaning chemicals, storage and handling requirements, waste discharge restrictions, dispensing requirements, and material compatibility can lead to costly delays.

Technical transfer teams and regulatory agencies expect laboratory testing to support cleaning agent selection, cycle development, critical parameter selection, and a continuous monitoring strategy. Current industry trends also demand a sustainable cleaning approach which considers water consumption, energy requirements, carry-over concerns of active ingredients, and personnel safety. The presentation will focus on some steps to avoid common pitfalls in designing a new cleaning process through laboratory testing as well as leveraging a master soil to take full advantage of factory acceptance testing and commissioning events of new equipment. This valuable insight enables engineering and commissioning teams to dedicate resources on their manufacturing process.

Learning Objectives

  1. Start-up and commissioning concerns for cleaning production equipment
  2. Leveraging supplier’s information on cleaning cycle design and laboratory testing
  3. Sustainable cleaning approach
  4. Monitoring critical cleaning parameters and ensuring cleanliness

Speakers

Beth Kroeger
Technical Services Senior Manager
Steris Corp.
Paul T. Lopolito
Technical Services Senior Manager
Steris Corporation

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