About Pre conference course B. Fundamentals for (re)design of a safe and compliant BSL3 facility (2 day)

Instructor

Karen van der Meulen and Toon De Kesel

Course description

The construction of high containment facilities is a complex business and there are many potential risks associated with translating the design intent into the finished and fully operational facility. The final goal is to construct a safe, secure and reliable containment facility, also in compliance with the regulatory requirements. This preconference course aims at providing an overview of the biosafety principles relevant for the (re)design of a safe and compliant BSL3 facility thereby starting from a risk-based approach.

The preconference course B is meant for biosafety professionals and other people that are directly or indirectly involved in the (re)design of a BSL3 facility. Based on classroom presentations, practical cases and interactive discussions, the participants will be invited to critically think about the basis of (re)design from a biosafety perspective. During the course, they will face the challenges rising during the (re)design of a BSL3 facility and the subsequent translation into the finished facility. Additionally, a (virtual) visit is scheduled to a BSL3 facility in Ghent with the opportunity to discuss about the design process with several people that were closely involved in the design.

At the end of the workshop, the participant should have a thorough understanding of the relevant biosafety critical infrastructural requirements, utilities and other issues, and should be able to apply his/her knowledge as part of a building design team, as well as during subsequent validation of the BSL3 facility. This includes the ability to:

• Understand the basic systems and (re)design features of a BSL3 facility
• Be familiar with a risk- and evidence-based approach of design
• Participate in a team involved in the planning and (re)design of a BSL3 facility and guide a needs-assessment
• Identify and describe specific biosafety and biosecurity issues when (re)designing a BSL3 facility
• Incorporate the user needs and legal requirements into a BSL-3 facility to ensure a safe and compliant BSL3 environment
• Ensure that facilities and associated installations and equipment are designed, operated, and maintained in a safe and secure way with respect to biorisk management

Learning objectives are in line with the CWA 16335 - Core requirement 7.2.9 (and informative annexes). Additionally, ISO 35001:2019 - Biorisk management for laboratories and other related organisations, paragraph 8.1 and 8.2, as well as the recently published 4th Edition of the WHO Laboratory Biosafety Manual and its Monograph ‘Laboratory design and maintenance’ are important guidance documents for this course.

Main topics

• Oversight regarding a BSL3 facility and infrastructure requirements
• User requirement specifications (URS) for the (re) design of a BSL3 facility
• Understanding and identifying the containment barrier integrity requirements, with respect to infrastructure, HVAC and routing (people, materials, equipment and waste)
• Need to perform a risk- needs assessment for a BSL3 facility

CWA 16335:2011, annex C reference

• C.2.1.2.7 Facility design (and re-design), construction, commissioning, decommissioning, validation, operation and maintenance
• C.2.1.3.1-2 National / International regulatory framework, standards, guidelines and conventions
• C 2.2.11 Containment Level 3 Facilities