Speakers and topics
 Hilton J. Klein, M.S., V.M.D.
– Overview and introduction
 Kathryn A. L. Bayne, M.S., Ph.D., D.V.M.
– Review of commonly cited facility problems
 James F. Taylor, D.V.M., M.S.
– Design of facilities - the AAALAC perspective
 Stephen T. Kelley, M.S., D.V.M.
– Performance standards and facility design and operation
Hilton J. Klein, M.S., V.M.D.
Overview and introduction
What is a program?
Rising costs of research
and research trends …
Rapidly increasing R&D costs
New targets from genomics
Flexibility and adaptability
 Research trends of animal use
– Dog and monkey use - USDA reports show decline
– Rodent use
– Institution dependent
– Academic vs. industry
– NIH/PHS funding increases
– Overall/general animal use
 Animal regulations
– Dog, monkey space and care - U. S.; Europe
Flexibility and adaptability
 Future
– Regulation of rats, mice, birds - space?
– Operational issues
– Energy
– Maintenance
– New technologies
– Transgenics and new species
– Genomics and proteomics
– Other drivers for the way animals are used
– Social
(Cont’d)
Facilities operation and design
 Scientific programs
 Laboratory animals
 Veterinarians
 Engineers
 Community
Building considerations







Research objectives
New construction
Renovation
Flexibility and adaptability
Utilities use
Adjacencies
Operational costs
Operation and design tools
(Some examples)
 Information sharing - network
 Computer aided design
 Computational fluid dynamics
Information and management
 An Integrated Database for Managing Animal Study Proposals and
Animal Inventory for the Small Animal Facility. T. Calzone, J. S.
Montijo, M. B. St.Claire, and E. Lamoreaux. 2001. Lab Animal
30(2):28-31.
 A Comprehensive, Bar Coded System for the Management of Animal
Information in a Research Facility. C. Pryor, D. Frankenfield, H. Klein,
W. Terpeluk, S. Washington, N. T. Mourad. 2001. Lab Animal
30(2):36-38.
 Software for Lab Animal Facilities. G. Novak and T. Schub. 2001 Lab
Animal 30(2):39-43.
Conclusion: renovations or construction will require systems for
information management access and retrieval for effective colony and
facility management.
Design and
operational considerations
Qualification
 Performance standards approach
 Factory acceptance testing (FAT)
 Dirty cage set up
 Microbiology tests
 Physical testing
 Installation qualification (IQ)
 Operational qualification (OQ)
Performance standards
"Performance standards define an outcome in
detail and provide criteria for assessing that
outcome, but do not limit the methods by
which to achieve that outcome."
Standards used
 Guide for the Care and Use
of Laboratory Animals (NRC 1996)
 EEC 86/609
 CoE Convention
 National legislation
 Reference resources (“Ag Guide,”
AVMA Panel on Euthanasia, etc...)
Hager Hauler
Summary and conclusions
 As demand for animal space changes, we must
design, construct, and operate facilities in a
flexible and adaptable manner.
 The use of R&D resources is rising as new
therapeutic targets are identified.
Summary and conclusions
(Cont’d)
 Animal research resources are coupled to R&D
and we must determine strategies to address
operational issues through facility design and
automation-performance standards.
 Team approaches are highly effective for
scientists, administration, engineers, lab animal to
address and solve space and operational issues.
Summary and conclusions
 Certain future areas in lab animal facilities
opportune for change include:
–
–
–
–
Room design and layout
Facility design and layout
New technological advances
Automation
(cont’d)
Kathryn A. L. Bayne, M.S., Ph.D., D.V.M.
Review of commonly
cited facility problems
Over 640 accredited institutions ...
… in 18 countries
10
,0
00
25 24,
9
,0
00 99
50 49,
9
,0
00 99
10
-9
9,
0,
99
00
9
020
19
0,
00 9,99
09
49
9,
99
9
>5
00
,0
00
99
9
00
09,
1,
00
0
<1
Proportion of accredited units
By facility size (sq. feet)
100
90
80
70
60
50
40
30
20
10
0
Percent of
Total
Animal care and use
program deficiencies
13%
Institutional Policies
12%
Laboratory Animal
Medicine
Veterinary Care
5%
70%
Physical Plant
Facilities
mandatory deficiencies
1. Facility HVAC
2. Facility safety
3. Facility maintenance
4. Facility sanitation
5. Facility design
6. Facility illumination
7. Facility storage
8. Facility security
The top three deficiencies
 IACUC function
 Occupational health and safety program
 Heating, ventilation and air conditioning
system performance
HVAC mandatories
(Ranked in order of most common)
1. Data not available at site visit
2. Not maintaining temperature range
3. Not maintaining air changes (ventilation)
4. Not maintaining humidity range
5. Not meeting recirculated air standards
6. Animal room temperature and humidity
not monitored
Common HVAC findings




Air exchange rate (10-15 ach)
Relative humidity levels
Air recirculation/filtration
Air pressure differentials
HVAC purposes
(Guide)





Supply adequate oxygen
Remove thermal loads
Dilute gaseous and particulate contaminants
Adjust moisture content
Create static-pressure differentials
Space, temperature
and humidity criteria
 Dry bulb temperature
– Adjustable +/- 2°
– Fixed, minimum 66°F or 68°F
– Individual room or zone
Space, temperature
and humidity criteria
 Relative humidity
– Adjustable or fixed, 30-70% RH
– Individual room or zone
HVAC purposes
(NIH Ventilation Design Handbook)
 Balance air quality, animal comfort and energy
efficiency to provide cage environments that
optimize animal welfare and research efficiency.
 Provide a healthy and comfortable environment
for researchers and animal caregivers.
Factors





Room size
Air change rates
Pressurization
Type and location of diffusers
Type and location of racks/cages
Factors
 Species
 Bedding type
 Cage change frequency
www.aaalac.org/connection_1su1998.htm
Contains:
 Details on codes,
regulations and standards.
 Laboratory animal
facilities planning and
design including
architectural finishes and
costs issues.
 Overview of equipment
and mechanical systems.
Available in CD ROM or
Spiral Bound book.
James F. Taylor, D.V.M., M.S.
Design of facilities –
the AAALAC perspective
Critical elements for success
 Define what the facility needs to accomplish
 Provide flexibility to accommodate future needs
 Knowledgeable users and A&E/planners:
•
•
•
•
Plan, program, design, and construct
Define decision making matrix
Consider operational and life-cycle costs
Review, review, review!
 Constantly focus on ‘Achilles heels’
 Include commissioning/validation
Program needs








Animal procedures - vivarium or laboratories
Surgical or diagnostic radiography suites
In-house diagnostic needs
Need for floor drains
Containment/contamination control
Imaging requirements
Sizing major installed equipment
Impact of design on labor costs
Separation of functions




Animal ops from personnel areas
Disease-status separation
Species conflicts/incompatibilities
Noise
Operational adjacencies







Established colonies vs. new arrivals
Cage sanitation
Cage storage/cage staging
Procedure rooms
Surgical suite and associated support spaces
Loading dock and associated in/out functions
Indirect adjacencies requiring accommodation
Horizontal vs. vertical design







Elevators
Stairways
Security
Windows/external light
Mechanical systems distribution
Support columns
Security
Traffic flow vs.
efficiency of design








System of corridors
Containment/contamination control
Safety and security (emergency egress)
Personnel entering or using facility
Animal resource staff; research staff
Maintenance/service staff; Visitors
Access to support spaces (offices, training)
Horizontal versus vertical construction
Facility integrity
considerations






Seismic
Vibration
External water - vertical & horizontal
Inherent insulation
Acoustic control
Floor loading considerations
Institutional infrastructure





Electrical
Central steam & chilled water
Water and sewage systems
Communications
Security
Facility maintenance
 Interstitial space = max. flexibility
 Avoid maintenance devices above animal room
drop ceilings
 Consider space/access for repair of all
installed equipment!
Mechanical systems






Design HVAC for worst case
Dedicate to animal facility
Provide component redundancy
Ductwork integrity (minimal leakage)
Air pressure differential control needs
RH control (none, zone, room-by-room)
 Additional exhaust needs
Floor drains
 Drain diameter/grating critical
 Location
– Center vs. side; trench vs. surface
 Obviously should be low point of room
 Cap drains in infrequently used rooms
– Consider installed but capped as contingency
Ventilation characteristics






Computational fluid dynamics
Air supply diffusers
Exhaust grilles - number and location
Room exhaust filters to protect HVAC
Pressure differentials
Stability of temp and RH control
Floors






Chemical and wear resistance
Life cycle cost - maintenance burden
Epoxy, seamless vinyl, MMA, terrazzo, tile
Surface preparation and cure times!
Provide continuous cove
Installer expertise is paramount
Walls





Structural requirements (caging systems)
Space (and renovation) costs of CMU versus RFP
Noise control
Life cycle cost - maintenance burden
Epoxy, tile, RFP
 Surface preparation and cure times!
Ceilings




Bottom of floor above or suspended
Access requirement
Sanitizability
Integrity – impact upon pest control program
Fit and finish protection




Wall guards - bumpers
Door jamb guards
Corner guards
Interior curbs
Critical dimensions





Door heights and widths (net clearances)
Cage wash equipment chamber (H&W)
Elevator door heights
Autoclave height, width and depth
Corridor widths + turning radiuses at corners,
elevator lobbies, etc.
 Corridor devices & other protuberances (signs,
fire extinguishers, telephones, etc.)
Doors







Avoid hollow doors (pest management)
Door hardware - long-term integrity is critical
Hinges
Door closures
Door handle design
Security (electric strike)
Metal versus fiberglass versus wooden
Electrical system








Early identification of high-demand equipment
Emergency (stand-by power) needs
HVAC
Emergency lighting
Emergency egress; surgery/ICU areas
Animal holding; outlets for equipment
Perimeter and internal security
Assure sufficient distribution, placement and
number of outlets
Illumination
 Dual light levels
 Fixture placement relative to rack positions
to maximize cage level illumination
 Light-cycle automation minimizes inadvertent
lighting errors
Cage wash
 Consider automation for large facilities
 Consider equipment throughput capacities versus
manpower costs
 Solid waste management - soiled bedding
 Ergonomics of cage wash tasks deserve priority
treatment
 Personnel safety and comfort deserve priority
consideration
 Assure adequate space around machines for
maintenance and repair!
Critical elements for success
 Define what the facility needs to accomplish
 Provide flexibility to accommodate future needs
 Knowledgeable users and A&E/planners
–
–
–
–
Plan, program, design, and construct
Define decision making matrix
Consider operational and life-cycle costs
Review, review, review!
 Constantly focus on ‘Achilles heels’
 Include commissioning/validation
Stephen T. Kelley, M.S., D.V.M.
Performance standards and
facility design and operation
AAALAC International uses recognized
references for performance standards…
www.aaalac.org/resources
Examples of references which
address facility design and operation
 Guide for the Care and Use of Laboratory Animals, 1996,
National Research Council, National Academy of
Sciences.
 Animal Welfare Act - 9 CFR Chapter 1, Subchapter A,
Animal Welfare.
 Biosafety in microbiological
and biomedical laboratories, 4th Ed., 1999, HHS
Publication No. (CDC) 93-8395.
References
(Continued)
 Occupational Health and Safety in the Care and
Use of Research Animals, 1997. National Research
Council, National Academy of Sciences.
 Guide for the Care and Use of Agricultural
Animals in Agricultural Research and Teaching,
Federation of Animal Science Societies, First
Revised Edition, January 1999.
References
(Continued)
 Guide to the Care and Use of Experimental
Animals, Canadian Council on Animal Care.
Vol. 1, 1993.
 Guide to the Care and Use of Experimental
Animals. Canadian Council on Animal Care.
Vol. 1, 1993.
References
(Continued)
 European Convention for the Protection
of Vertebrate Animals Used for Experimental
and Other Scientific Purposes. Council of Europe
(Convention ETS 123), 1985.
 Council Directive on the Approximation of Laws,
Regulations and Administrative Provisions of the Member
States Regarding the Protection of Animals Used for
Experimental and Other Scientific Purposes. European
Union (Directive 86/609/EEC), 1986.
Evaluation criteria
 Performance vs. engineering
Evaluation responsibility
 Institutional Animal Care and Use Committee
 Facility management
 Engineering
Operational considerations
 Size of the program
 Nature of animal use
– Species
– Flexibility requirements
 Geographical location & environment
 Facility type and construction
Facility location
and traffic patterns
Security
 Public access
 Signs
 Locks and other measures
Traffic reduce potential
for contamination
Personnel areas
 Clerical / office areas
 Rest rooms / locker rooms
 Eating areas
Animal species
 Species requirements
 Microbiological status
 Containment
Support functions
 Surgery
– Dedicated?





Procedure
Necropsy
Cage Wash
Receiving
Laboratories
Maintenance




Identification of deficiencies
Prioritization of repair
Conducting repairs
Documentation of the maintenance program
Surfaces
 Walls, ceilings, floors
– Frequency
– Space
– Materials and methods
Heating ventilation
and air conditioning
 Monitoring
–
–
–
–
–
Personnel
Manual / automatic
Temperature & humidity
Air flow direction
Evidence of animal abnormalities
 Frequency
 Maintenance
 Operational aspects
Heating ventilation
and air conditioning
Special requirements
 Biosafety and fume hood
maintenance and certification
 Necropsy
 Inhalant anesthetics
Plumbing
 Monitoring
– Drinking water systems
– Sanitation water systems
– Drains
Illumination




Light timers (timer overrides)
Light intensity
Natural light
Observational conditions
Noise
 Animal issues
 Personnel safety issues
 Operational issues
Storage facilities
 Adequacy
 Appropriate for use or separation
–
–
–
–
Food
Bedding
Clean cages
Chemicals
Sanitation facilities






Prevent cross contamination
Control aerosols - personnel protection
Monitoring effectiveness
Maintenance
Use of vacuums
Use of chemicals
Standard operating
procedures and training
The key element necessary
to assure high levels of performance standards:
Well trained
and dedicated personnel
Case studies
Case Study #1
HVAC
Observation
Site visitors conducted a site visit at a respected,
small research institute conducting infectious disease
studies involving Biosafety Level 2 agents. There
were a total of six (6) animal rooms housing either
rats or mice. The HVAC report below was provided
as an attachment to the program description.
Room No.
Filtration
Air Exchanges
Air Pressure
Differential
1101
HEPA
11.8/hr (fresh)
Negative
1202
HEPA
8.2/hr (fresh)
Negative
1303
HEPA
7.8/hr (fresh)
Negative
1404
HEPA
10.4/hr (fresh)
Negative
1505
HEPA
12.0 (fresh)
Negative
1606
HEPA
8.0 (fresh)
Negative
Surgery/Necropsy
HEPA
14.0/hr (fresh)
Negative
Follow up
All rooms were sanitized at weekly intervals by wetmopping the floor and wiping the walls down with an
appropriate mild quaternary ammonium disinfectant.
Cages were sanitized appropriately twice weekly.
Bedding was also changed once in a hood between
cage sanitation cycles. Upon entering the rooms, site
visitors observed the following cage and stocking
densities …
Follow up
 Room 1101 rats-4
plastic cages (2/box)
 Room 1202 rats-8
plastic cages (2/box)
 Room 1303 mice-15
plastic cages (3/box)
 Room 1404 mice-12
plastic cages (2/box)
 Room 1505 mice-10
plastic cages (4/box)
 Room 1606 rats-8
shoebox cages (2/box)
Suggestion for improvement …
Case Study #2
Elevator access
Observation
A site visit to a large university biomedical research program
indicated that a small colony (n=25 adults) of macaques was
housed in the top floor of a “satellite” building. The research
involved behavioral testing and brain imaging which was
conducted in separate laboratories within the same building.
The behavioral test lab and the imaging lab were accessible only
by an elevator which was also used to transport non-laboratory
personnel. Cage washing facilities were located in the basement
of the building.
Findings
 The macaques were specific pathogen free and were
known to be CHV-1 (Herpes “B” virus) negative by ELISA
and Western Blot.
 Cages were covered by Tyvek® shrouds for transport to
and from cage wash. Soiled cages were sprayed with
povidine-iodine solution prior to transport to the cage wash
area.
 Elevators were “locked out” to personnel when transport to
and from the labs was performed and the elevators were
sanitized after use. Review of documents revealed no
problems.
Suggestions for improvement
 Suggest a security review to assure the potential
for escaped animals is minimized in the elevator,
the behavioral testing lab, and the imaging lab.
Suggest the labs be evaluated for wearing
adequate PPE and whether human patients were
imaged in the imaging lab, as well as any health
risks to personnel and patients.
Case Study #3
After-hours monitoring
Upon careful review of the written Program Description, site
visitors concluded that after-hours monitoring of the animal
rooms in a 45 year old animal facility consisted of: a) recording
the high-low temperature readings in the room on a log sheet by
the animal caretaker, and b) the security guard making rounds to
ensure the corridor and hallway doors are closed. This process
was confirmed during the site visit.
more…
Case Study #3
After-hours monitoring
(cont’d)
Additional background information revealed a steam injector
valve in the room humidification control system had stuck in the
open position overnight six months prior to the site visit. This
room housed 50 rats on a respiratory/inhalation study at the
time. Animal care staff realized the room temperature had
reached 105ºF overnight because of the steam valve defect.
Fifteen animals were found dead the next morning. Within two
days, the study was terminated because of twenty (80%) percent
mortality in the controls and test animals. Excessive respiratory
problems were observed in the remaining animals which
invalidated the study.
Suggestions for improvement
 There were no after hours monitoring mechanism for
monitoring HVAC system performance in the facility and
for alerting responsible personnel for malfunctions. To
minimize the risk to animal health and control variables
that might confound research and testing data, a process
whereby appropriate personnel are notified when
environmental variables fall outside Guide recommended
ranges should be implemented.
Suggestions for improvement
 AAALAC International must be notified of such events
under the recent changes in the by-laws for accredited
institutions. The institution was reminded of the
requirement to notify OLAW as well as AAALAC.