CX Mission Critical Facilities for Safety and Resiliency Select Agent BSL-3 Lab. Dave Guberud QCxP, CxA Rachel Rueckert P.E., QCxP, CxA, LEED AP
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1 CX Mission Critical Facilities for Safety and Resiliency Select Agent BSL-3 Lab Dave Guberud QCxP, CxA Rachel Rueckert P.E., QCxP, CxA, LEED AP
2 AIA Quality Assurance The Building Commissioning Association is a Registered Provider with The American Institute of Architects Continuing Education Systems (AIA/CES). Credit(s) earned on completion of this program will be reported to AIA/CES for AIA members. Certificates of the Completion for both AIA members and non-aia members are available upon request. This program is registered with AIA/CES for continuing professional education. As such, it does not include content that may be deemed or construed to be an approval or endorsement by the AIA of any material of construction or any method or manner of handling, using, distributing, or dealing in any material or product. Questions related to specific materials, methods, and services will be addressed at the conclusion of this presentation. 2
3 Learning Objectives 1. Identify the threats and vulnerabilities of facilities to biological, weather-related, and other disaster events. 2. Recognize the principles of resiliency and how they compare with sustainability. 3. Design a space with the proper air balance to prohibit potential health, safety, and welfare disasters. 4. Identify what the Commissioning Provider does to support the Responsible Official. 3
4 Something so cute, small and/or unassuming can be so dangerous ebola ricin monkey pox bird flu 4
5 BSL Labs & associated terms BSL: Biological-Safety Level BSL s types are identified by both numbers and suffixes or prefixes: The higher the number between 1 and 4, the more stringent the standards are with which to comply ABSL - A indicates animal AgBSL Ag indicates agriculture BSL E E indicates enhanced BSL SA SA indicates select agent BSC: Biological Safety Cabinet (most popular Class II type A) RO: Responsible Officer BSL-4 BSL -3 High Risk Microbes BSL -2 BSL -1 Low Risk Microbes 5
6 BSL1 Labs What Defines 1 Risks are known (low and well characterized) No potential loss to Ag industry No special practices (other than good micro-biological techniques) Cleanable Hand Sinks Waste is segregated by hazard type No specific recommendation for isolating lab from others parts of building Labs typically within this category include the typical undergraduate / secondary education teaching labs 6
7 BSL2 Labs What Defines 2 Moderate potential hazard to animals Endemic in nature (people have been exposed to these before) Illness is treatable or preventable BSL1 micro-biological techniques are followed, plus: Higher level of PPE (gloves, lab jackets, etc.) Using BSCs when working with splatters or aerosols Restricted access by signage and closed doors Though no requirement for directional air flow, most are designed negative to adjacent spaces Labs typically within this category include most research and diagnostic labs that work with food-borne pathogens and domestic diseases 7
8 BSL2 Labs Biosafety Cabinet air flow Biosafety Cabinet 8
9 BSL3 Labs What Defines 3 Indigenous or exotic agents that can cause lethal infections or grave consequences to agriculture BSL1 and BSL2 micro-biological techniques are followed, plus: Separated from other areas (secondary barrier) Inward air flow (air moves from lesser contaminated areas to areas of greater contamination) Personnel must participate in medical surveillance program Double door entry & higher security measures Higher PPE protective clothing HEPA filtering Pressure measuring and monitoring Defined decontamination strategies 9
10 BSL3 Labs 10
11 BSL4 Labs What Defines 4" Research on dangerous and exotic agents that pose high individual risk of human life-threatening diseases which may be transmitted via aerosol route and for which there is no available vaccine or treatment BSL1, BSL2 and BSL3 micro-biological techniques are followed, plus: Cabinet Laboratory: Manipulation of agents must be performed in a Class III BSC Suite Laboratory: Personal must wear a positive pressure supplied protective suit 11
12 BSL4 Labs Protective Suit Class III BSC 12
13 Who is in control and who writes the standards? FSAP: Federal Select Agent Program BMBL: Biosafety in Microbiological and Biomedical Laboratory standards ANSI/ASSE Z
14 Select Agents 14
15 Commissioning a BSL3 SA Lab Two main topics where the RO needs Cx support: Why are we building this lab so tight (decontamination) and how do we prove it was built tight (ANSI/ASSE Testing Ductwork and Room Air Leakage)? How do we comply with the following statement from FSAP? Documentation provided to FSAP of verification of HVAC design functionality under failure conditions must demonstrate that under exhaust fan or normal power failure conditions, or during normal power start-up, there is no reversal of air which originates within the BSL-3 / ABSL-3 laboratory or vivarium room that travels all of the way outside the containment boundary. 15
16 Commissioning a BSL3 SA Lab Our reference space 16
17 Commissioning a BSL3 SA Lab Our reference space (the mechanical system) 17
18 Commissioning a BSL3 SA Lab Our reference space (the mechanical system) 18
19 The reason we are building the lab so tight Obvious reason: Prevent escape of airborne biohazards Less obvious reason: Decontamination Cleaning chemicals are virtually as dangerous as the SA Intent is to decontaminate a space while allowing other work to occur in adjacent areas Either a Leak Test or a Decay Test can be used Let s build it first. Tight Tight Tight 19
20 What level are we building the lab to To create a space where decontamination by fumigation can occur requires all penetrations in the barrier envelope to be sealed (or capable of being sealed) in order to prevent excessive migration of fumigants out of the space. This can be very challenging: Most constructors have never built anything this tight Many constructors do not fully grasp what it takes to be sufficiently tight at the conceptual stage of this process Think of building a pool for air that operates as a black hole nothing ever gets out past the walls that define the space 20
21 What are we building the lab to Specifications guides this sets the bar for acceptance criterion Following are 3 examples: Which test appears to be most stringent? A minimum of -0.5 WC (negative) differential pressure remaining after 20 minutes, from an initial (negative) pressure differential of -2.0 WC. A minimum of WC (negative) differential pressure remaining after 5 minutes, from an initial (negative) pressure differential of WC. A measured air leakage rate of 120 CFM into the suite when under a W.C. (negative) differential pressure to the surrounding area for a period of 10 minutes. 21
22 What are we building the lab to 22
23 What are we building the lab to 23
24 How are we zoning and why 24
25 Containment As described in the standards, the space needs to be cleanable and tight. How does this happen? Construction Documents - Provide details on how to install Standards - Indicate expected outcomes (though not means and methods!) Commissioning - Systematic processes How to get the contractors to use the details 25
26 Containment Provide Constructors a Lessons Learned Power Point of previously constructed facilities 26
27 Containment Construction: how do you get the contractor to use the design teams details: 27
28 Containment Construction: How do you get the contractors to use the design teams details? 28
29 Containment Discuss details Obtain buy-in of their use Change if necessary 29
30 Containment Discuss details Obtain buy-in of their use Change IS necessary AND CHANGE WE DID 30
31 Containment Penetration Tracking Log 31
32 Containment Specifications describe the testing method steps: Observation and Listening Soap Bubble Testing / Smoke Testing Final Testing (typically two consecutive successful tests) It has to ALWAYS be remembered that both the supply ducts and the exhaust ducts are part of the containment space Creates its own challenges Duct in no-mans space Duct in the penthouse 32
33 Containment The Duct 33
34 Containment Preparing the Space: Test Doors Vacuum Cleaner Calibrated Meters Bubble Gun Smoke Gun Dish Wash Liquid Painters Tape 34
35 Containment Observing and Listening: What might NOT be a leak early in the process might become a leak as other leaks are found and repaired the NEW path of least resistance! 35
36 Containment Soap Bubble and Smoke Testing: Door Frames Floor Duct Lights Shelves 36
37 Containment And then frustration sets in 37
38 Containment Success does come eventually 38
39 Containment Success does come eventually 39
40 Installation Construction verification and factory startup forms used 40
41 Installation 41
42 System Operation (No Reversals) As construction is proceeding, many other actions are ongoing: Vetting the sequence of operation (additional controls page turn meetings) Reviewing the control minutia Software simulation (if possible) User interface review (expose the hidden code) Setup trending immediately (trend everything) Graphics Dry run test Functional Test scripts Pre-Testing, Documenting, Learning, Re-Testing.. 42
43 Sequence of Operation SUBMITTAL SPECIFICATION 43
44 Control Drawings 44
45 Vetting and simulating software Use automation simulation to the fullest 45
46 Pre-Testing Exposing points buried in code, especially problematic when using (for example) a Tridium front end.typically only the general information is bought forward We NEED it all! 46
47 Utilizing Graphics to the Fullest 47
48 Direction of Air Flow NEG X1 NEG X4 NEG X3 NEG X2 NEG X1 48
49 Utilizing Trending to the Fullest Cascading Negativity Air-Lock BSL Bio-T Lab 49
50 RO - Documentation Support Needed to Provide to FSAP Verification of HVAC design functionality under failure conditions Demonstrate during exhaust fan or normal power failure or normal power start up, there is NO reversal of air (air from within the BSL-3 does not make it out of the containment boundary). Failure conditions that must be met: Mechanical failure of EF or fan components With redundant fans - Ability to transition to alternate fan with no reversal of airflow With no redundancy - Ability to transition from sustained inward flow to laboratory to a static condition (NO airflow out) 50
51 RO - Documentation Support Needed to Provide to FSAP Power failure of supply fan and exhaust fan components With emergency power - Ability to transition from normal power to backup power with no reversal of airflow With no backup power - Ability to transition to a static condition with no reversal of airflow (NO airflow out) Return to normal power With emergency power - Ability to transition from backup power to normal power with no reversal of airflow With no backup power - Ability to return to normal operating conditions with no reversal of airflow (NO airflow out) 51
52 RO - Documentation Support Needed to Provide to FSAP 52
53 RO - Documentation Support Needed to Provide to FSAP Snag it video tool demo 53
54 Lessons Learned Let us build a mock-up wall and test it Gives the contractors an early first hand experience on what M&M s they need Builds the team functions and dynamics early Simple to test with the bubble gun 54
55 Lessons Learned Dedicated Redundancy 55
56 Quiz: Which Level BSL Should be Utilized? Ricin Measles Ebola Bird Flu Monkey Pox HIV Tuberculosis Hepatitus B Canine Hepatitus Malaria Lassa BSL-3 BSL-2 BSL-4 BSL-3 BSL-2 BSL-3 BSL-3 BSL-2 BSL-1 BSL-3 BSL-4 56
57 Summary Understanding the level of BSL that is being designed, constructed and utilized. Understanding the HVAC design, the sequence of operation, equipment and components selection, the details of construction, installation strategies and more all play an important role in the completion of a successful BSL. Sharing lessons learned with all constructors on what it takes to create a tight environment. Demonstrating for the RO, that there is NO reversal of air (air from within the BSL-3 does not make it out of the containment boundary) during any failure events. Understanding that what is of most importance is the safety of the people those working within the lab, those working within the building, those breathing the air outside of the building. 57
58 Rachel Rueckert P.E., QCxP, CxA, LEED AP Commissioning Provider Dave Guberud QCxP, CxA Commissioning Provider Ring & DuChateau, LLP W Capitol Drive Brookfield, Wisconsin 53045
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