strategies in commissioning for biosafety - bcxa · 2016-09-28 · strategies in commissioning for...
TRANSCRIPT
Strategies in Commissioning for
BiosafetyPresented by
G. Trevor [email protected]
WorkingBuildings, LLC
AgendaIdentify requirements of a BSL-3 laboratoryUnderstand how commissioning can be used as a tool to document these requirementsLearn how to apply the commissioning process to the biological safety laboratory
Laboratory SystemsArchitectural MechanicalElectrical Specialty Equipment
All systems are integral to a functioning biosafety laboratory
Laboratory Systems - Architectural
Laboratory Systems - Mechanical
Laboratory Systems - Electrical
Laboratory Systems - Specialty Equipment
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Biosafety Laboratory Requirements
Biosafety in Microbiological and Biomedical Laboratories (BMBL)
Specifies procedural, equipment and facility requirementsGroups biosafety laboratories into 8 levels
BSL-1, BSL-2, BSL-3 & BSL-4ABSL-1, ABSL-2, ABSL-3 & ABSL-4Level dependent on type of agent used
Containment BarriersPrimary - Biosafety cabinets & PPESecondary - Laboratory Facilities
Designed for easy cleaning & decontaminationMethod of decontaminating material leaving the spaceNon-recirculating exhaust systemVacuum lines protectedContainment penetration points must be sealed
Biosafety Level 3Agents with a potential for respiratory transmissionAgents may cause serious and potentially lethal infectionMore emphasis on primary and secondary containment barriers than BSL-1 or BSL-2
Biosafety Level 3 - BMBL Requirements
Annual verification & documentation of operational parameters & proceduresDocumentation of user training programLaboratory specific bio-safety manual
Requires knowledge of lab operation during all operating modes
Traditional Steps of Commissioning
Develop Owner’s Performance Requirements (OPR)Review Basis of DesignDrawing ReviewsContractor Submittal Reviews
Traditional Steps of Commissioning
Pre-functional ChecklistsSite Observation Visits During ConstructionFunctional TestingTraining VerificationWarranty ReviewFinal Report
All of these steps can be applied to the bio-safety laboratory
Owner’s Performance Requirements
Developed through workshops, interviews, questionnaires, ect. Defines success criteria for projectParticipants:Owner, O&M staff, Biosafety officer, Researchers
Basis of DesignTraditional commissioning reviews the MEP basis of designVerify that BOD meets OPR Should be coordinated with type of research being performed and method of decontamination
Design ReviewsFocused review of laboratory systems
Containment systemsMaintenance access to componentsRedundant systemsOperational sequences and alarmsOwner furnished equipment requirements
Submittal ReviewsReview product dataReview shop drawingsCompare to OPR and BODShould occur in parallel with designer reviewOwner furnished equipment
Pre-functional ChecklistsGoal is to do work right the first timeChecklists supplement the design, they do NOT replace the designNot intended to replace manufacturer’s instructions
Pre-functional ChecklistsUse the design drawings, specs, OPR, and BOD to createGet information to the contractor in simple, easy to understand languageConvey quality expectations to contractorHelps the Owner track construction progress
Pre-functional ChecklistsFormat:
Yes or No questionsYes is always the correct answerNo indicates a deficiencyKeep it simple
Site Observation VisitsPeriodic site visit to verify installationDocument deficienciesBe specific, take photosMeet with contractor to discuss findingsGenerate report quickly to minimize schedule impact
Functional TestingVerify installation meets OPRShould not be used strictly as a “punch-list”generating exerciseConsider challenge testing of laboratory systems
Functional TestingProgress from equipment to system levelPerform a BSL validation test
Tests & documents all aspects of lab with respect to OPR & BMBLTests & documents operation of the lab as a whole system during normal & emergency modes of operation
Functional Testing - Modes of Operation
Normal modeLoss of utility powerFire alarmSupply fan failureExhaust fan failureMaintenance modes
Training VerificationVerify & document training program meets owner’s needsProvides later documentation for lab audits
Warranty ReviewResponsibilities during first year of warranty include:
Review warranty requests Perform seasonal and/or deferred testingConduct lessons learned workshopReview warranty items with facility operations staff
Lessons Learned - Containment Envelope
Negatively pressured lab on exterior wallNo moisture barrierWater intrusion through gaps in pre-cast
Lessons Learned - HEPA Sizing
Redundant exhaust fans on VSDsBoth fans normally operatingRedundant HEPAsHEPAs sized for parallel operation
Lessons Learned - HEPA Sizing (2)
HEPAs selected Test section addedUnexpected increase in pressure drop due to test section addExhaust fans fell short
Lessons Learned - Access Panels
Partitions not to structureAccess panels in ceilingDirect path for air travel
Lessons Learned - Air Leakage
Penetration points at above ceiling areas not sealedIncreased air leakage through containment zone penetrations
Lessons Learned - Air LeakageDuct penetrating the ceiling - not sealed
Most often observed in difficult to reach areas
Lessons Learned - Air LeakageElectrical receptacles & data portsCommon failure pointsReview design detailsRequire a mock up
Lessons Learned - Emergency Power Ops.
System operated per OPR during emergency opsRoom pressurization issues during generator cooldown
Lessons Learned - Water Usage
Lab water system not sized to meet owners needsUnable to operate multiple washers and/or sterilizers
ConclusionIdentified BSL-3 requirementsCx can helpApplication of the Cx processObserved failures
Contact Information
Trevor PowersCommissioning AuthorityWorkingbuildings, LLC
www.workingbuildings.com