Bio-containment. Michael C. Connor, PE Principal Atlanta, Georgia

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1 Bio-containment Michael C. Connor, PE Principal Atlanta, Georgia

2 Differences in BSL-2, BSL-3, BSL-3Ag and BSL-4 Labs and Animal Facilities

3 Biosafety Level 2 (BSL-2)*. Used with agents of moderate potential hazard to personnel, animals, and the environment, with minimal economic loss to the animal industries *CDC-NIH Biosafety in Microbiology and Biomedical Laboratories, 5th edition

4 Wall Construction: Gypsum Board or Masonry

5 Ceiling Construction: Lay-in acoustic tile with vinyl surface

7 Biosafety Level 3 (BSL-3)* is applicable to clinical, diagnostic, teaching, research or production facilities In which work is done with indigenous or exotic agents which may cause serious or potentially lethal disease as a result of exposure by the inhalation route. *CDC-NIH Biosafety in Microbiology and Biomedical Laboratories, 5th edition

8 Wall Construction: Clean Room panel (BSL-3), Masonry (BSL-3+) or Poured Concrete (BSL-3++)

9 Ceiling Construction: Clean Room Gasketed Panel System (BSL-3) or Exposed Structure (BSL-3+) or Coated Structure (BSL-3++)

10 Example of Panel System

11 Wall Construction: Masonry

13 Biosafety Level 3 Agriculture (BSL-3Ag). Used with pathogens that present a risk of causing infections of animals and plants and causing a great economic harm. (Foot and Mouth Disease is the premier example.) ZOONOTIC DISEASES are diseases caused by infectious agents that can be transmitted between (or are shared by) animals and humans. USDA-ARS and APHIS

14 Wall Construction: Poured Concrete with Coating

16 Ceiling Construction: Exposed Structure with Coating

20 POWERED AIR PURIFYING RESPIRATOR (PAPR)

22 BSL-4 WATER SHOWER CHEMICAL SHOWER

23 CHEMICAL TANK

24 BSL - 4

25 BSL - 4

28 Information resources: American Biological Safety Association web site CDC-NIH Biosafety in Microbiology and Biomedical Laboratories, 5th edition NIH Design and Policy Guidelines USDA/ ARS/ APHIS

29 Break

30 BSL-2 Laboratory

31 BSL-2 Laboratory Design commissioning verify designed access to various commissioning points of measurement Volume Control Boxes don t conflict with cable trays, etc. Verify air flows in accordance with air flow schedules. Verify space pressurization. Verify access to critical components Pressure and air flow transmitters. Verify labeling of all components requiring maintenance.

32 BSL-3 Laboratory

33 BSL-3 Laboratory

34 BSL-3 Laboratory All of the items covered in BSL-2. Autoclave qualification. Inspect room penetrations and seals smoke test. Verify VHP effectiveness. Calibrate local pressure indicators Security system qualification NSF test of BSC s cabinets

35 BSL-3ag Laboratory

37 BSL-3ag Laboratory

39 BSL-3ag Laboratory All of the requirements for BSL-2 and BSL-3 Autoclave temperature profile. Place typical load in autoclave Thermocouple mapping of chamber with multi channel recorder. Air Pressure Resistant (APR) door verification. Air Compressor Air Quality Wall Coating Testing Pull-off testing Spark Testing Inspect utility penetrations Visually inspect BOTH sides of penetrations.

40 BSL-3ag Laboratory Space Pressure Decay Testing Room must hold 500 Pa (+/-) with a maximum decay to 250 Pa in 20 minutes. Epoxy Seal conduits with wiring. Impervious wall surfaces. HEPA Filter challenges per BSL-3. Helium leak testing of Ducts and HEPA housings Outboard test 1 x 10 5 cc/sec acceptance criteria. 1 x 10-6 cc/sec atmospheric background level requires mass spectrometer NOT thermal conductivity equipment to sense at this level.

41 BSL-3ag Laboratory Pressure decay testing of double wall plumbing drain pipe Test Annular space Hold negative pressure limit to 5 psi MAX Waste treatment plant endotoxin challenge 6 log reduction of Colony Forming Units (CFU), heat resistant bacteria (Bacillus Steareothermophillus) used for challenge.

42 BSL-4 Same as BSL-3ag Commissioning Breathing Air System Commissioning Chemical Shower System

43 Large Animal BSL-3 Facilities NCFAD,Winnipeg ARS, Ames IAH,Pirbright PIADC,Greenport CISA,Valdeolmos AHRC, Athens DVIV, Lindholm CVI,Lelystad FRCVDA,Tubingen IVI,Mittelhausern CISRO,Geelong CISA Valdeolmos.

44 Case Study #1: BSL-3Ag Construction Project 1991 First edition of ARS Guideline for BSL-3Ag released 1998 Second edition of ARS Guideline for BSL-3Ag released 2002 Third edition of ARS Guideline for BSL-3Ag released 1978 Dean of CVM proposes Bio- Containment Facility 1986 $8 Million secured from USDA 1990 First Design Completed 1991 Project Shelved for lack of State Funding 1996 Start Construction 1999 Law Suit Filed by Contractor 2003 Lost RBL Grant Money

45 Case Study #1: BSL-3Ag Project Financial Performance $16,000,000 Construction Contract $4,000,000 in Change Orders $11,700,000 in Damages Sought by Contractor $2,400,000 spent by State in Defense of law suit $3,000,000 paid to Contractor to settle suit $47,000,000 to bring building up to current ARS standards (includes soft costs)

PI s Name Date Bldg./Rm# CDC Biosafety Level 3 (BSL-3)

PI s Name Date Bldg./Rm# CDC Biosafety Level 3 (BSL-3) Yes No 1. Is access to the laboratory limited or restricted at the discretion of the laboratory director when experiments are in progress? Yes No