ENHANCED BIOSAFETY BSL3+ FACILITY DESIGN & PERFORMANCE QUALIFICATON
Keywords:Biosafety, BSL3+, Risk Assessment, Personnel Production, Product Production, Laboratory, BSC, Secondary Containment Barrier, Qualification, Design Principles
Abstract:This paper deals with biosafety change drivers, biosafety risk assessments, high containment biosafety design, secondary containment barrier design, commissioning & qualification as well as performance & verification testing of enhanced BSL3+ biosafety laboratories which are over and above the minimum requirements of the WHO BSL3 international biosafety standards.
While this paper is not intended to be a complete treatment of biosafety design particular attention is paid to biosafety facility design and construction issues including conflicts between personnel protection (biosafety) vs product protection (cleanroom), the importance of Risk Assessment in choosing the appropriate biosafety level and control measures, the critical linkage between design and a schedule of performance verification tests, common flaws and failures arising during commisioning & qualification and the importance of air leakage measurement in the verification of the Secondary Containment Barrier.
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