MODULE #4 MECHANICAL, 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 [email protected]

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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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Need for Biocontainment Facilities

SARS Virus

Bird Flu Word Health Organization (WHO): Avian influenza is a threat to agricultural production and human health.

Ebola Virus

MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Purpose of Biocontainment Facilities & Systems Protection of: Researchers Custodial Personnel Public Environment Allows: Diagnosis Experimentation Products (Vaccine)

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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Identify Design Criteria • 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 Codes & Standards 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 Control Laboratory Biosafety Guidelines National Academy Press Biosafety in the Laboratory - Prudent Practices for the Handling and Disposal of Infectious Materials World Health Organization Laboratory Biosafety Manual

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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Identify Regulations & Guidelines 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

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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Design Criteria 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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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Identify Biosafety Level Classification 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)

MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Agent Summary Statements Sample CDC BMBL SECTION VII Agent Summary Statements Agent: Bacillus Anthracis Numerous cases of laboratory-associated anthrax, occurring primarily at facilities conducting anthrax research, have been reported. No laboratoryassociated 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.

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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Agent Summary Statements – Changes Occur

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

Biosafety Level 3 and Animal Biosafety Level 3 practices, procedures and facilities are

circulated and the potential for presence of a susceptible population.

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. Coldadapted, live attenuated H2N2 vaccine strains may continue to be worked with at BSL-2.

MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Agent Summary Statements – Ask for Clarification 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”.

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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I How is Containment Provided? 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.

MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Primary Containment Devices

Class II Type A2

Class II Type B2 BSC (Hard-Ducted)

Understand primary containment performance during fan or power failures – Risk Assessment NSF 49-2012:

Containment Caging

5.25.3 Type B exhaust alarm Type 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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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Where is Containment Barrier? Dirty Change BSL-3 Lab

BSL-3 Anteroom 1 Dirty Shower

Consider Pressurized Corridor to Separate BSL-3 from NonContainment Spaces

Legend: Containment Boundary

Clean Change

BSL-3 Anteroom 2 – Infrequent Use Equipment Path

Clean Corridor

Select Agent Definition: The BSL-3 anteroom is considered to be within the containment envelope.

MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Is Redundancy Required? HVAC

Temperature Humidity Pressure Directional Airflow/ Prevent Reversal Exhaust Filtration Decontamination

Electrical

Lighting Power Emergency Fuel UPS Security Systems Telecommunications

Plumbing

Effluent Treatment Water Supply DI/RO Water Fire Protection Lab Gases Breathing Air

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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

MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I System Redundancy Review

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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I MEP Biocontainment System Redundancy Options

MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Additional HVAC Criteria to Identify Enhancements are Project Specific •

Visible barrier inspection

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Double HEPA filtration

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Redundant HEPA filtration

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Directional airflow

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Pressure control or monitor

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Backward airflow prevention

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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Plumbing Criteria

MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Electrical Criteria

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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Owner Project Requirements and Design Intent Document 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

MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I

PRESSURIZATION & AIRFLOW

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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Biocontainment Pressurization - Normal Operation

“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 - Failure Mode

“Potentially Contaminated” Areas Can Be Neutral To Adjacent “Clean Areas” But NOT POSTITIVE.

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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

MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Mechanical System Details Sealing light fixtures; Sealing all conduit penetrations; Sealing all penetrations Sealing outlet boxes; Sealing door bottoms, tops and frames

HOW TIGHT IS TOO TIGHT???

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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Mechanical System Details Provide paths for transfer air if doors completely sealed (e.g. animal room vermin sealing).

Engineer Transfers to Suite In Order to Minimize Pressure in Space During Failure Mode and Initial Testing

MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Mechanical System Details Primary Containment Biosafety Cabinets Have Known Openings But Provide Containment Sealing and Inspection of Barrier Penetrations Eliminates Uncontrolled Leakage 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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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Mechanical Systems and Material Options Penetration Seal Options: All seals accessible for visual inspection Bio-seal caulk at all penetrations into BSL-3 Welded 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-3 Helium leakage test for BSL-3Ag/4 (i.e. test at 4 inches water column pressure). Coordinate with ductwork specification. Ventilation Control Options: Directional Air Flow Active 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)

Source: Flanders Filters

Monitor/Alarm Options: Monitor/alarm each space locally – CONSIDER AUDIBLE PER BMBL Monitor locally, alarm locally and centrally Monitor locally, alarm locally, in all adjacent spaces and centrally Redundancy Requirements: N+1 recommended for BSL-3 N+1 required for BSL-3Ag/4 Zone Isolation Options: Individual room - allows each room to be decontaminated Suite isolations - requires shut down of entire suite of spaces for decontamination

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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Mechanical Systems and Material Options 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

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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Mechanical Systems and Material Options 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 System Layout Options Top Floor with Interstitial

Lower Floor with Interstitial

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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I System Layout Options Lower Floor with Adjacent Mechanical Space

Lower Floor with Remote HEPA

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REMOTE HEPA FILTERS

MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Mechanical System Details • Coordinate equipment alarms with matrix • Some labs require reports to comply with CDC, USDA, AAALAC and other regulatory bodies

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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Mechanical System Details

Supply Diffuser

MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Mechanical System Details

Lab BSC Exhaust Connection

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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Mechanical System Details

MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I Tradeline Takeaways • 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

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MODULE 4 | MECHANICAL, ELECTRICAL, PLUMBING CONSIDERATIONS I

Questions?

MODULE #4 | MECHANICAL, 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 [email protected]

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