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MODULE #4MECHANICAL, ELECTRICAL, PLUMBING I
MICHAEL WALSH | PRINCIPAL, R.G. VANDERWEIL ENGINEERS, LLP
274 Summer Street, Boston, MA 02210(T) 617-423-7423 (F) 617-423-7401
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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Module 4 Agenda
1. Identify Biological Containment MEP Criteria
2. Pressurization and Airflow
3. Building Systems & Controls
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
MEP CRITERIA
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SARS Virus
Ebola Virus
Word Health Organization (WHO): Avian influenza is a threat to agricultural production and human health.
Bird Flu
Need for Biocontainment Facilities
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Protection of:
Researchers
Custodial Personnel
Public
Environment
Allows:
Diagnosis
Experimentation
Products (Vaccine)
Purpose of Biocontainment Facilities & Systems
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
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• All criteria must be identified by a project specific risk assessment• Assessment must identify project specific codes and standards• Assessment must identify types of agents to be used in the facility• Agent list will help determine required Biosafety Level
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Identify Design Criteria
US Department of Health & Human Services (CDC/NIH):Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition
Primary Containment for Biohazards - Selection, Installation and Use of Biological Safety Cabinets (CDC-NIH)
US Department of Agriculture:ARS P&P Manual 242.1M - Biosafety Level 2, 3, 4 & 3AG
National Institutes of Health:Design Requirement Manual
NIH Guidelines for Research Involving Recombinant DNA Molecules
Health Canada, Health Protection Branch – Lab Centre for Disease ControlLaboratory Biosafety Guidelines
National Academy PressBiosafety in the Laboratory - Prudent Practices for the Handling and Disposal of Infectious Materials
World Health OrganizationLaboratory Biosafety Manual
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Identify Codes & Standards
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National Select Agent Registry (CDC/APHIS):Federal Select Agent Program
http://www.selectagents.gov/SA_Gram.html
American Industrial Hygiene Association/ANSI:Standard Z9.5-2012 Laboratory Ventilation
Standard Z9.14 Testing and Performance Verification
Methodologies for BSL-3 and ABSL-3 Facilities - NEW
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Identify Regulations & Guidelines
Design Criteria
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
US Department of Health & Human Services:CDC BSL-2 & 3 Inspection Checklists
National Institutes of Health:CDC/NIH BSL-2 & 3 Inspection Checklists
National Research Council:Guide for Use and Care of Laboratory Animals
Building/Mechanical Codes:Current Applicable Version
National Fire Protection Agency:Standard 45-2012 Fire Protection for Laboratories Using Chemicals
General Design Guides:ASHRAE Laboratory Design Guide
American Biological Safety Association:High Containment Laboratory Accreditation Program
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Biosafety Level 1 (BSL-1). Agents of no known or minimal potential hazard to facility personnel, animals or the environment. No potential economic loss to the agricultural industries.
Biosafety Level 2 (BSL-2). Agents of moderate potential hazard to personnel, animals, and the environment, with minimal economic loss to the animal industries. Most research and diagnostics laboratories are at this level. (98% of all agents are BSL-2 Classified)
Biosafety Level 3 (BSL-3). Agents which may be indigenous or exotic to the United States that can be contracted by the respiratory route, and may cause serious or lethal diseases to man, animals, or cause moderate economic loss to the animal industries. (Tuberculosis)
Biosafety Level 3 Agriculture (BSL-3Ag). Pathogens that present a risk of causing infections of animals and plants and causing a great economic harm. (Foot and Mouth Disease).
Biosafety Level 4 (BSL-4). Used with highly lethal exotic agents which pose a high individual risk of life-threatening disease to man. Some of these viruses also infect food animals and have the potential to cause severe economic loss to animal industries. (Ebola)
Identify Biosafety Level Classification
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Sample CDC BMBL SECTION VII Agent Summary StatementsAgent: Bacillus Anthracis
Numerous cases of laboratory-associated anthrax, occurring primarily at facilities conducting anthrax research, have been reported. No laboratory-associated cases of anthrax have been reported in the United States since the late 1950s when human anthrax vaccine was introduced.
Laboratory Hazards: The agent may be present in blood, skin lesion exudates, cerebrospinal fluid, pleural fluid, sputum, and rarely, in urine and feces. Direct and indirect contact of the intact and broken skin with cultures and contaminated laboratory surfaces, accidental parenteral inoculation, and rarely, exposure to infectious aerosols are the primary hazards to laboratory personnel.
Recommended Precautions: Biosafety Level 2 recommended for activities using clinical materials and diagnostic quantities of infectious cultures. Animal Biosafety Level 2 recommended for studies utilizing experimentally
infected laboratory rodents. Biosafety Level 3 practices recommended for work involving production quantities or concentrations of cultures, and for activities with a high potential for aerosol production.
Transfer of Agent: For a permit to import this agent, contact CDC. Laboratory registration with CDC is required before sending or receiving this select agent.
Agent Summary Statements
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
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Containment Recommendations
Biosafety Level 2 facilities, practices and procedures are recommended for diagnostic, research and production activities utilizing contemporary, circulating human influenza strains (e.g., H1/H3/B) and low pathogenicity
avian influenza (LPAI) strains (e.g., H1-4, H6, H8-16), and equine and swine influenza viruses. Animal Biosafety Level 2 is appropriate for work with these viruses in animal models. All avian and swine influenza viruses require an APHIS permit. Based on economic ramifications and source of the virus, LPAI H5 and H7 and swine influenza viruses may have additional APHIS permit-driven containment requirements and personnel practices and/or restrictions.
Non-contemporary human influenza (H2N2) strains Non-contemporary, wild-type human influenza (H2N2) strains should be handled with increased caution. Important considerations in working with these strains are the number of years since an antigenically related virus last
circulated and the potential for presence of a susceptible population. Biosafety Level 3 and Animal Biosafety Level 3 practices, procedures and facilities are recommended with rigorous adherence to additional respiratory protection and clothing change protocols. Negative pressure, HEPA-filtered respirators or positive air-purifying respirators (PAPRs) are recommended for use. Cold-adapted, live attenuated H2N2 vaccine strains may continue to be worked with at BSL-2.
Agent Summary Statements – Changes Occur
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
BMBL 5TH Edition Requirement for BSL-3:
The laboratory building exhaust air should be dispersed away from
occupied areas and from building air intake locations OR the exhaust air must be HEPA filtered.
Example of Specific Direction from CDC for a specific Public Health Lab project:
“HEPA filtration is only needed with general exhaust when using viable Venezuelan equine encephalitis virus (VEE) and/or rift Valley Fever Virus as a select agent”.
Agent Summary Statements – Ask for Clarification
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
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Priority 1: Laboratory Work Practices & Protocols:Defined in the Laboratory Biosafety Manual (similar to Lab Chemical Safety Manual and Lab Fire Safety Manual)
Priority 2: Primary Containment (Biosafety Cabinets, Glove Boxes, BSL-3Ag and BSL-4 Containment Spaces)For BSL-3 and lower classification, the goal of primary containment is to minimize exposure to bio-hazardous material in the immediate lab environment.
Biological safety cabinets or glove boxes provide the primary containment barrier. HEPA filters in the BSC are intended to keep biohazards released during a procedure within the cabinet from escaping into the room or general exhaust system. Filters are decontaminated or contained in bags before they are taken out of the laboratory.
For BSL-3AG and BSL-4 Level Labs, facility and MEP systems are considered primary containment requiring decon of people and equipment leaving the space.
Priority 3: Secondary Containment (Facility & MEP Systems)Secondary containment is typically considered as the walls, floor and ceiling of the space in combination with the mechanical ventilation system.
How is Containment Provided?
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Class II Type A2 Class II Type B2 BSC (Hard-Ducted)
Primary Containment Devices
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Containment Caging
Understand primary containment performance during fan or power failures – Risk Assessment
NSF 49-2012:5.25.3 Type B exhaust alarmType B cabinets shall be exhausted by a remote fan. Once the cabinet is set or certified in its acceptable airflow range, audible and visual alarms shall be required to indicate a 20% loss of exhaust volume within 15 s. The internal cabinet fan(s) shall be interlocked to shut off at the same time the alarms are activated.
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Dirty Change
Clean Corridor
Containment Boundary
Legend:Dirty
Shower
Clean Change
BSL-3 Anteroom 1
BSL-3 Anteroom 2 –Infrequent Use
Equipment Path
BSL-3 Lab
Where is Containment Barrier?
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Select Agent Definition:The BSL-3 anteroom is considered to be within the containment envelope.
Consider Pressurized Corridor to Separate BSL-3 from Non-Containment Spaces
HVAC
Temperature
Humidity
Pressure
Directional Airflow/ Prevent Reversal
Exhaust
Filtration
Decontamination
Plumbing
Effluent Treatment
Water Supply
DI/RO Water
Fire Protection
Lab Gases
Breathing Air
Electrical
Lighting
Power
Emergency
Fuel
UPS
Security Systems
Telecommunications
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Is Redundancy Required?
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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Is Redundancy Required?
SA Grams - BSL-3/ABSL-3 Verification
Mechanical failure of exhaust fan or fan component(s):
If redundant fans are present, the ability to transition to the alternate fan without reversal of air flow from potentially contaminated laboratory space into “clean” areas surrounding the laboratory must be verified.
If no redundancy is present in the laboratory HVAC system, the capacity to transition from sustained inward air flow into the laboratory to a “static” condition, i.e., no air flow out of the laboratory must be verified.
NOTE: RISK ASSESSMENT MAYCONSIDER STATIC CONDITION AS ACCEPTABLE AFTER MULTIPLE FAILURES WHEN REDUNDANCY HAS BEEN INCLUDED IN THE DESIGN
System Redundancy Review
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
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MEP Biocontainment System Redundancy Options
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Enhancements are Project Specific
• Visible barrier inspection
• Double HEPA filtration
• Redundant HEPA filtration
• Directional airflow
• Pressure control or monitor
• Backward airflow prevention
Additional HVAC Criteria to Identify
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
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Plumbing Criteria
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Electrical Criteria
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
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For Containment Spaces Must Identify:
Required systems
Identify biocontainment barrier
Penetration seal details
Pressure relationships
MEP equipment redundancy
Control strategies
Maintenance of equipment outside containment
Failure Testing Per Risk Assessment –
Single Failure
Double Failure
Owner Project Requirements and Design Intent Document
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
PRESSURIZATION & AIRFLOW
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“A ducted air ventilation system is required. This system must provide sustained directional airflow by drawing air into the laboratory from “clean” areas toward “potentially contaminated” areas. The laboratory shall be designed such that under failure conditions the airflow will not be reversed.”
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Biocontainment Pressurization - Normal Operation
“Potentially Contaminated” Areas Can Be Neutral To Adjacent “Clean Areas” But NOT POSTITIVE.
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Biocontainment Pressurization - Failure Mode
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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Biocontainment Pressurization Concept
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Biocontainment Pressurization – Relative Pressure
No Consensus on Pressure Differential for Design:
Health Care Isolation Room Guidelines: 0.01” w.c. minimum
Typical Non-Containment Labs: 0.01” w.c. (Siemens Lab Design)
LEED IEQ: 0.02” w.c. average, 0.004” w.c. minimum (LEED 2009)
2011 ASHRAE: 0.03” w.c. minimum for Nuclear Secondary Confinement
2012 NIH DRM: 0.05” w.c. minimum each lab door
2012 USDA ARS 242.1M: 0.05” w.c. BSL-3 Labs
2012 IBC: 0.10” to 0.35” w.c. Stair Pressurization Systems
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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Biocontainment Pressurization Concept
BIOSEAL
Sealing light fixtures; Sealing all conduit penetrations; Sealing all penetrationsSealing outlet boxes; Sealing door bottoms, tops and frames
HOW TIGHT IS TOO TIGHT???
Mechanical System Details
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
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Mechanical System Details
Provide paths for transfer air if doors completely sealed (e.g. animal room vermin sealing).
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Engineer Transfers to Suite In Order to Minimize Pressure in Space During Failure Mode and Initial Testing
Mechanical System Details
Primary Containment Biosafety Cabinets Have Known Openings But Provide Containment
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Sealing and Inspection of Barrier Penetrations Eliminates UncontrolledLeakage Paths for Contaminants and Decontamination Gas
Engineered Transfers Are Sealed Similar to BSC Opening for Decon Process
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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Pressurization Monitor and Alarm
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Airflow Requirements
Standards and Guideline Recommendations Vary
Minimum Airflow Therefore Must Be Identified in Risk Assessment Based Criteria
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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
SYSTEMS AND CONTROLS I
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Mechanical Systems and Material Options
Only one system option for biocontainment HVAC main systems – All Air
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Penetration Seal Options:All seals accessible for visual inspectionBio-seal caulk at all penetrations into BSL-3Welded concrete in-bed penetrations sealed air tight BSL-3Ag/4
Space Leak Testing Options:Visual smoke or soap bubble pressure testing of all penetrations for BSL-3 (must define required test pressure and what is an acceptable test results - i.e. no visible leaks)Pressure decay testing @ 2 inches water column pressure for BSL-3Ag/4
Duct Testing Options:Standard SMACNA duct leakage test for BSL-2 - SMACNA defines acceptable leakage and test pressure for duct classification (not acceptable in biocontainment lab). Must define project requirements in specifications (seal class, duct pressure class, acceptable leakage)Pressure decay or helium leak testing may be required for BSL-3Helium leakage test for BSL-3Ag/4 (i.e. test at 4 inches water column pressure). Coordinate with ductwork specification.
Ventilation Control Options:Directional Air FlowActive Room Pressure control
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Mechanical Systems and Material Options
HEPA Filter Testing Options:Standard DOP Test (uses “average” efficiency)Filter Scan Testing - tests positive seal at filter/housing and test for large leaks recommended)
Monitor/Alarm Options:Monitor/alarm each space locally – CONSIDER AUDIBLE PER BMBLMonitor locally, alarm locally and centrallyMonitor locally, alarm locally, in all adjacent spaces and centrally
Redundancy Requirements:N+1 recommended for BSL-3N+1 required for BSL-3Ag/4
Zone Isolation Options:Individual room - allows each room to be decontaminatedSuite isolations - requires shut down of entire suite of spaces for decontamination
Source: Flanders Filters
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Mechanical Systems and Material Options
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Duct/Terminal Device Material Options:Standard galvanized steel construction may be applicable for lower containment (no gas decon - per ANSI Z9.5 only use standard construction for “light duty systems”)
Welded stainless steel recommended where gas decontamination, pressure decay or helium leak testing is required
Gas tight welded stainless steel ductwork required for BSL-3Ag/4 (helium leak testing may be a requirement)
Exhaust System Options:HEPA filtration at all primary containment devices is required
HEPA filtration of general room exhaust may be required may be required for BSL-3 (recommended for aerosolized work)
HEPA filtration of exhaust required for BSL-3Ag/4
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Mechanical Systems and Material Options
Supply System Layout Options:Dedicated Supply Air System for each containment level
Combined BSL-2/3 with system backflow prevention
Supply Backflow Prevention Options:HEPA Filtration (static protection not mechanical system). Filtration option on supply impacts system pressure requirements for all areas served
Bubble tight damper with automatic closing actuators
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Mechanical Systems and Material Options
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HVAC Room Isolation Strategy:
Electronic Isolation + Control Valves- $$$$
Manual Isolation + Control Valves - $$$
Shut-off Valves - $$
HEPA Filtration Strategy:
Parallel HEPA Caisson - $$$$
Single HEPA Caisson - $$$
Room Side Replaceable HEPA - $$
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Mechanical Systems and Material Options
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
System Layout Options
Top Floor with Interstitial
Lower Floor with Interstitial
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REMOTE HEPA FILTERS
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
System Layout Options
Lower Floor with Adjacent Mechanical Space
Lower Floor with Remote HEPA
• Coordinate equipment alarms with matrix
• Some labs require reports to comply with CDC, USDA, AAALACand other regulatory bodies
Mechanical System Details
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
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Supply Diffuser
Mechanical System Details
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Lab BSC Exhaust Connection
Mechanical System Details
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
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Mechanical System Details
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
• Clearly Identify All Applicable Codes, Standards & Criteria At Beginning of Design – Owners Project Specific Requirements
• MEP Systems & Controls Are Complex. Reduce Complexity Whenever Possible
• Definition of Secondary Containment Barrier is Critical For Design & Commissioning
MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Tradeline Takeaways
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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I
Questions?
MODULE #4 | MECHANICAL, ELECTRICAL, PLUMBING IMichael Walsh | Principal, R.G. Vanderweil Engineers, LLP
274 Summer Street, Boston, MA 02210(T) 617-423-7423 (F) 617-423-7401
Date:
Session:
Presenters:
Metrics
Tools
Resources
Innovative Ideas
Proofs
Date:
Session:
Presenters:
Metrics
Tools
Resources
Innovative Ideas
Proofs
Date:
Session:
Presenters:
Metrics
Tools
Resources
Innovative Ideas
Proofs