About EBSA20 - Course D - Commissioning and validation of containment laboratories − Why? What needs to be verified and how to proceed?

Instructors: Philippe Stroot and Felix Gmünder

Short description of the course:

Commissioning and validation are terms that are used in various settings and circumstances. What do they exactly mean in the context of the design, construction, and startup of a biological facility, such as a containment laboratory? Why are they needed and what is their purpose? And what needs to be verified accordingly?

This workshop intends to answer these questions and many others, in order to allow biosafety professionals to understand commissioning and validation, and become able to fulfil their role efficiently and effectively during the design, construction and early operation phases of a containment facility such as a BSL3 laboratory. So, the course is designed for biosafety professionals with some knowledge and experience in design, construction, and management of containment facilities. Facility managers and vendors of services and equipment involved in the verification process are also welcome.

After an introduction to the current concepts, participants will be actively involved in discussing and developing possible approaches and solutions. They will work on the development of a verification plan, mostly from the perspective of what needs to be checked from a biorisk management perspective, and when and how it can be done. More to the point, participants will work by way of examples on the development of commissioning and validation plans and criteria for selected features, processes and equipment items such as room air tightness, room decontamination, or an autoclave. For the whole duration of the course, participants are welcome to ask questions and share experiences.

Main topics:

• Needs and rationale of verification (commissioning and validation) in the context of the design and construction of biological facilities
• Roles of the biosafety professional in the verification process
• Current terminology and approaches used in different settings
• Development and implementation of a verification plan
• Development of example commissioning and validation plans and criteria for selected features (e.g., air tightness), processes (e.g., room decontamination), or equipment (e.g., an autoclave)
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CWA 16335:2011 Biosafety professional competence reference

The topic refers to some sections of competence 7.2. and training specifications C.2.1.2.7 Facility design, construction, commissioning, decommissioning, validation, operation and maintenance