“Keeping them in or out?”...Summary & Conclusions Keeping them in or out? 25 • It has been...
Transcript of “Keeping them in or out?”...Summary & Conclusions Keeping them in or out? 25 • It has been...
“Keeping them in or out?”Control of aerosols in loose housed versus caged
laboratory research animals for HPAI studies
– a case study
Principal Consultant, Henriette Schubert
57th ABSA Conference 2014San Diego, California
Objective of the presentation
The main objective is to discuss the pros and cons of primary barrier caging
systems versus primary barrier facility design for HPAI research in ferrets in a
high containment laboratory
The discussion is based on a case study
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Case study overview
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The challenge: Choosing a housing principle for ferrets for HPAI studies
Conclusions
Authorities approach
Facility program intent
Pros and Cons
Regulatory compliance& Housing options
ABSA San Diego 2014, "Keeping them in or out?", Henriette Schubert
Undisclosed Facility in Scandinavia
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• Vision / Mission of containment animal facility
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Program intentHigh containment multi purpose facility
ABSA San Diego 2014, "Keeping them in or out?", Henriette Schubert
Key factors & Design Drivers
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• Scientific vision & mission
• Flexibility & Multi use facility
• Regulatory compliance
• Workflow operations
• Biosafety / PPE
ABSA San Diego 2014, "Keeping them in or out?", Henriette Schubert
High containment facility for HPAI researchNew Facility for research studies – the immune system
studies of the efficiency of vaccines
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Housing of ferrets?ABSA San Diego 2014, "Keeping them in or out?", Henriette Schubert
”Keeping them in or out”? Animal housing and barrier principles
Primary barrier CAGE principle
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Primary barrier ROOM principle
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Regulations on ContainmentAnimal research work with HPAI
“Infected material including any animal is to be handled in asafety cabinet or isolation or other suitable containment”DIRECTIVE 2000/54/EC ,Annex V
“Loose-housed animals infected with HPAI strains must be contained within BSL-3-Ag facilities”BMBL, Section VIII-E: Viral Agents
ABSA San Diego 2014, "Keeping them in or out?", Henriette Schubert
The starting Point principleAnimal holding in IVC caging systems
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Ferret containment system / CageModified Ferret Cage
Transport module
The starting pointCage system evaluations for ferrets
ABSA San Diego 2014, "Keeping them in or out?", Henriette Schubert
Cage system evaluations for ferretsWorkflows & operations studies
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Bedding change activities, work flow & Operations
Waste handling
Research activities, work flow & Operations
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Minimum3000 cm2 per animal
Minimum1400 cm2 per animal
>600g
Animal welfareEuropean vs US housing standards
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Comparison of US and EU animal housing standards & sizes
ABSA San Diego 2014, "Keeping them in or out?", Henriette Schubert
SpaceErgonomicsWelfareENTRY / EXITPPE & Risk
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24m2 / 258 sq.ft.
ChallengesCage systems vs loose housed animals
75m2 / 807 sq.ft.
ABSA San Diego 2014, "Keeping them in or out?", Henriette Schubert
ChallengesCage systems vs loose housed animals• Studies of ergonomics & work operations
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ca. 30 cm
ca. 90 cm
ca. 150 cm
ABSA San Diego 2014, "Keeping them in or out?", Henriette Schubert
ChallengesCage systems vs loose housed animals
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Authorities approach & positionWe may approve a principle where the room provides the primary containmentfor your facility....
BUT we may require a more comprehensive level of PPE and respiratory protection, perhaps even a fresh air supplied system……
ABSA San Diego 2014, "Keeping them in or out?", Henriette Schubert
ChallengesPrinciple diagrams for entry and exit of facility
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ENTRY
EXIT
ABSA San Diego 2014, "Keeping them in or out?", Henriette Schubert
ChallengesPrinciple functional relation diagram
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Animal holding & procedureBSL3AG
Laboratory spaceBSL3 enhanced
Show
er
Cleanchange
Dirtychange
Deconarea / PPE
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Reference facilities – large animal rooms – primary containment
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Reference facilities animal welfareCage systems vs loose housed animals
ABSA San Diego 2014, "Keeping them in or out?", Henriette Schubert
Summing upPros and Cons
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Spac
e ne
ed
Ergo
nom
ics
Wel
fare
Primary containmentcaging
primary barrier facilitydesign
PPE
Entr
y/Ex
it
??
?
Wor
kflo
w&
op
erar
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?ABSA San Diego 2014, "Keeping them in or out?", Henriette Schubert
Summary & ConclusionsKeeping them in or out?
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• It has been essential to perform a thorough, holistic risk evaluation of all relevant parameters (workersaftety, PPE, animal welfare, work operations)
• A high number of single caged / isolated ferrets tendto be a challenge in work load and time consumption– and the animal welfare requirements in Europe arenot really compatible with the system
• In cases with a high number of research animals a primary barrier facility approach may be a more transparent principle
• However – it may consequently require a more extensive level of PPE – depending on the country specific regulations and the interpretations of them
ABSA San Diego 2014, "Keeping them in or out?", Henriette Schubert
Thank you for your attention!Acknowledgements
Jan Pravsgaard Christensen, Professor in Immunology of Infectious Diseases, University of Copenhagen, PhD
Dr. Vibeke Halkjaer-Knudsen, PhD, Sandia National LaboratoriesSandia National LaboratoriesNNE Pharmaplan colleagues:Karin Hedebo Wassard, Flemming Kjaergaard Nielsen, Jesper Schufri Meyer
Contact details:
Principal Consultant, Laboratory OperationsHenriette Schubert
NNE Pharmaplan, [email protected] phone: +45 30 79 42 93
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