Attachment 12 Containment Definitions.docx

Definitions Facilities inside Containment: A space requiring access beyond the identified containment boundaries that includes areas designated as Bio-Safety Level (BSL) spaces: BSL-4, BSL-4AG, BSL-3, BSL-3AG, BSL-3E, BSL-2; Arthropod Containment Level (ACL) spaces: ACL-3, ACL-2; and a current Good Manufacturing Processes (cGMP), Cleanroom, and Biotechnology Development Module (BDM) utilizing Enhanced Construction methods subject to a Premium Level of Detail and Regulation as defined by the designated areas. Issued Task Orders will identify these designated areas if inclusive of the work being performed.

Facilities inside Containable: A space acting as a tertiary barrier to many of the spaces inside containment utilizing Increased Construction methods subject to a Higher Level of Detail and Regulation as defined by the designated area. Issued Task Orders will identify these designated areas if inclusive of the work being performed.

Other Facilities: A space outside of containment, containable or outside of the Main Lab Facility that is not subject to the same level of detail and regulation for spaces specifically identified as, Containable, Bio-Safety Level (BSL) spaces: BSL-4, BSL-4AG, BSL-3, BSL-3AG, BSL-3E, BSL-2; Arthropod Containment Level ACL-3, ACL-2; cGMP/Clean Room/BDM, would be considered standard or general construction.

Normal Working Hours: Normal working hours are defined as Monday through Friday, 8:00AM – 4:30PM CST, except Federal Holidays.

Other Than Normal Working Hours: Other than normal working hours are defined as Monday through Friday, 4:30PM – 8:00AM CST, except Federal Holidays. Any work performed on Saturday or Sunday will also be defined as Other Than Normal Working Hours.

BIOCONTAINMENT GENERAL NOTES

1. THE BSL DESIGNATIONS AND BARRIER DIRECTLY RELATE TO THE CONSTRUCTION REQUIREMENTS FOR EACH SPACE TYPE.

2. THE TYPICAL CONTAINMENT BARRIER INDICATED IS THE SECONDARY BARRIER, I.E. FACILITY CONSTRUCTION, WHICH SERVES TO ISOLATE THE AREAS INSIDE IN A MANNER THAT PROTECTS PEOPLE AND THE OUTSIDE ENVIRONMENT FROM THE WORK CARRIED OUT WITHIN.

3. GASEOUS DECONTAMINATION MAY BE CARRIED OUT ON INDIVIDUAL ROOMS WITHIN THE CONTAINABLE SPACES WHILE OTHER ROOMS REMAIN IN OPERATION. FOR THIS REASON, INDIVIDUAL ROOMS SHALL BE ISOLATED FROM ONE ANOTHER.

4. MDF, PLYWOOD, OR OTHER POROUS MATERIALS ARE NOT ALLOWED IN CONTAINABLE SPACES.

5. CLEAN AGENT FIRE EXTINGUISHERS SHALL BE UTILIZED IN ALL AREAS WITH HEPA-FILTERED EXHAUST OR EQUIPMENT TYP., UNO. PRIMARY BARRIERS TYPICALLY INCLUDE USE OF BIOSAFETY CABINETS, CONTAINMENT CAGING SYSTEMS, PERSONAL PROTECTIVE EQUIPMENT, AND OPERATIONAL PROTOCOLS. SEE BSL-4 AND BSL-3AG GENERAL NOTES FOR ADDITIONAL INFORMATION RELATED TO BSL-4 AND BSL-3AG SPACES WHICH SERVE AS PRIMARY CONTAINMENT BARRIERS.

6. THE FLOOR WALL AND CEILING FINISHES INSIDE A BSL-4/BSL-3AG/BSL-3E SPACE SHALL BE MONOLITHIC AND SEAMLESS TO FORM A SEALED "SHELL" INSIDE THE SPACE. WALL/CEILING/FLOOR FINISHES SHALL BE FREE OF PINHOLES OR OTHER SMALL PENETRATIONS THAT MAY COMPROMISE THE CONTAINMENT BARRIER. REFER TO BSL-4 AND BSL-3AG GENERAL NOTES FOR SPECIFIC CRITERIA FOR ROOM INTEGRITY TESTING.

7. ALL PENETRATIONS THROUGH BSL-4/BSL-3AG/BSL-3E ROOM FINISHES SHALL BE SEALED AS DETAILED OR NOTED TO MAINTAIN THE CONTAINMENT BARRIER. REFER TO MEP DWGS FOR FURTHER INFORMATION ON UTILITIES AND ROOM PENETRATIONS.

8. ALL JOINTS IN FLOORS/WALLS/CEILINGS SHALL BE SEALED.

9. SURFACE-MOUNTED ITEMS SHALL BE SEALED TO THE SURFACE ON WHICH THEY ARE MOUNTED UNLESS NOTED OTHERWISE.

10. ANY ITEMS RECESSED IN THE BSL-4/BSL-3AG/BSL-3E WALL/CEILING SHALL BE OF SEALED CONSTRUCTION SUCH THAT THEY MAINTAIN THE SAME SEALED BARRIER CONDITIONS AS THE WALL/CEILING THE ITEM IS RECESSED IN. MOUNTING OF SUCH ITEMS SHALL ALSO BE SUCH THAT THEY ARE SEALED TO THE WALL CONSTRUCTION.

11. GASEOUS DECONTAMINATION MAY BE CARRIED OUT ON INDIVIDUAL ROOMS WITHIN THE BSL-4/BSL-3AG/BSL-3E CONTAINMENT BARRIERS WHILE OTHER ROOMS REMAIN IN OPERATION. FOR THIS REASON, INDIVIDUAL ROOMS WITHIN THE OVERALL BSL-4/BSL-3AG/BSL-3E BARRIER SHALL BE ISOLATED FROM ONE ANOTHER AS WELL AS ISOLATED FROM SPACES OUTSIDE THE CONTAINMENT BARRIER.

12. SEAMS AND JOINTS BETWEEN DOOR HARDWARE AND DOORS/FRAMES IN BSL-4/BSL-3AG/BSL-3E SPACES SHALL BE SEALED.

13. DOORS AND FRAMES IN BSL-4/BSL-3AG/BSL-3E SPACES SHALL BE FULLY WELDED OR SEAMLESS; DOORS SHALL HAVE A FLUSH CHANNEL AT TOP AND BOTTOM U.N.O.

14. FRAMES FOR VISION PANELS IN DOORS IN BSL-4/BSL-3AG/BSL-3E SPACES SHALL BE DESIGNED TO MINIMIZE JOINTS AND SEALED.

15. GLAZING IN WINDOWS/DOORS AT THE CONTAINMENT BARRIERS AND AT ALL LOCATIONS WITHIN SHALL BE BREAKAGERESISTANT AND WET-SEALED TYP.

16. WALL AND FLOOR FINISHES SHALL BE CONTINUOUS BEHIND/BELOW FIXED CASEWORK IN BSL-4/BSL-3AG/BSL-3E AREAS.

17. MDF, PLYWOOD, OR OTHER POROUS MATERIALS ARE NOT ALLOWED WITHIN THE BSL-4/BSL-3AG/BSL-3E CONTAINMENT BARRIERS.

18. CLEAN AGENT TYPE FIRE EXTINGUISHERS SHALL BE UTILIZED IN ALL AREAS WITH HEPA-FILTERED EXHAUST OR EQUIPMENT TYP UNO

19. WALL AND CEILING CONTROL JOINTS IN BSL-4, BSL-3AG, BSL-3E, ACL-3/ACL-2, cGMP & CLEANROOM SHALL BE CAULKED TO ISOLATE CRACKING OF COATINGS AND IMPROVE CLEANABILITY.

BSL-4 GENERAL NOTES

1. AGENTS RESEARCHED AT BIOSAFETY LEVEL 4 (BSL-4) ARE HIGHLY LETHAL AND EXOTIC WITH HIGH RISK OF LIFE-THREATENING DISEASE TO MAN AND/OR POTENTIAL FOR SEVERE ECONOMIC LOSS TO ANIMAL INDUSTRIES.

2. THE BSL-4 CONTAINMENT BARRIER SERVES AS A PRIMARY CONTAINMENT BARRIER IN AREAS WHERE INFECTED LOOSE-HOUSED ANIMALS/LIVESTOCK ARE HELD OR MANIPULATED; IN BSL-4 LABORATORIES AND OTHER BSL-4 SPACES, THE BSL-4 CONTAINMENT BARRIER SERVES AS A SECONDARY CONTAINMENT BARRIER.

3. PERSONNEL IN BSL-4 AREAS MUST WEAR A ONE-PIECE POSITIVE PRESSURE SUIT FOR PERSONAL PROTECTION.

4. ALL ROOM PENETRATIONS SHALL BE SEALED AIRTIGHT AS DETAILED OR NOTED.

5. ALL BSL-4 SPACES MUST PASS A PRESSURE DECAY TEST AS SPECIFIED.

6. SURFACE-MOUNTED ITEMS SHALL BE MOUNTED TO STAND-OFFS AS DETAILED OR SEALED TIGHT TO THE WALL TO FACILITATE CLEANING/DECONTAMINATION

7. ALL EXPOSED METAL FINISHES SHALL BE 316 STAINLESS STEEL UNO

8. ALL CASEWORK, PLUMBING FIXTURES, OR OTHER SPECIALTY ITEMS WITHIN BSL-4 SHALL BE FREE FROM SHARP EDGES THAT MAY CATCH OR TEAR THE POSITIVE-PRESSURE SUIT.

9. THE BSL-4/ABSL-4 AREA IS DESIGNED SUCH THAT IT MAY BE SEGREGATED INTO SEPARATE SUITES FOR RESEARCH WITH DIFFERENT PATHOGENS AND/OR OPERATION AT LOWER BIOSAFETY LEVELS.

BSL-3AG GENERAL NOTES

1. AGENTS RESEARCHED AT BIOSAFETY LEVEL 3 AGRICULTURE (BSL-3AG) HAVE POTENTIAL FOR INFECTION OF ANIMALS AND PLANTS AND CAUSING GREAT ECONOMIC LOSS TO ANIMAL INDUSTRIES.

2. THE BSL-3AG CONTAINMENT BARRIER SERVES AS A PRIMARY CONTAINMENT BARRIER AND IS APPLICABLE ONLY IN AREAS WHERE INFECTED LOOSE-HOUSED ANIMALS/LIVESTOCK ARE HELD OR MANIPULATED.

3. ALL ROOM PENETRATIONS SHALL BE SEALED AIRTIGHT AS DETAILED OR NOTED.

4. ALL BSL-3AG SPACES MUST PASS A PRESSURE DECAY TEST AS SPECIFIED.

5. SURFACE-MOUNTED ITEMS SHALL BE MOUNTED TO STAND-OFFS AS DETAILED OR SEALED TIGHT TO THE WALL TO FACILITATE CLEANING/DECONTAMINATION.

6. ALL EXPOSED METAL FINISHES SHALL BE 316 STAINLESS UNO

7. ALL ELECTRICAL RECEPTACLES, OUTLETS, AND SWITCHES SHALL RECEIVE WEATHER-PROOF COVERS UNO

BSL-3E GENERAL NOTES

1. AGENTS RESEARCHED AT BIOSAFETY LEVEL 3 (BSL-3) ARE INDIGENOUS OR EXOTIC, CAN BE CONTRACTED VIA THE RESPIRATORY ROUTE, AND MAY CAUSE SERIOUS OR LETHAL DISEASE TO MAN AND/OR MODERATE/GREAT ECONOMIC LOSS TO ANIMAL INDUSTRIES.

2. BSL-3 "E" REFERS TO AN ENHANCED BSL-3 FACILITY WITH ADDITIONAL SECONDARY CONTAINMENT FEATURES BEYOND THE STANDARD REQUIREMENTS. TYPICAL ENHANCEMENTS FOR BSL-3E SPACES IN THIS FACILITY INCLUDE BUT ARE NOT LIMITED TO:

· CENTRAL EFFLUENT DECONTAMINATION

· HEPA-FILTERED SUPPLY AND EXHAUST AIR

· ROOM ISOLATION DAMPERS

· PASS-THRU STERILIZERS

· SHOWER-OUT CAPABILITY

· ADVANCED SECURITY FEATURES

3. BSL-3E TYPE 2 SPACES ARE FURTHER ENHANCED BEYOND THE REQUIREMENTS OF TYPE 1 SPACES; THESE ADDITIONAL ENHANCEMENTS INCLUDE BUT ARE NOT LIMITED TO:

· TWO-IN-SERIES HEPA FILTERED EXHAUST AIR

· ADDITIONAL SHOWER-OUT CAPABILITY

4. UNLESS SPECIFICALLY INDICATED AND NOTED OTHERWISE, ACCESS DOORS SHALL NOT BE ALLOWED WITHIN BSL-3E SPACES AS OPENING SUCH AN ACCESS DOOR WOULD BREACH THE CONTAINMENT BARRIER. ANY APPROVED ACCESS DOORS INDICATED SHALL BE A GASKETED MODEL AS SPECIFIED AND SEALED SHUT.

ACL-3/ACL-2 GENERAL NOTES

1. "ACL" REFERS TO ARTHROPOD CONTAINMENT LEVEL, CHARACTERIZING SPACES IN WHICH ARTHROPODS ARE REARED, HOUSED, OR MANIPULATED. ARTHROPOD CONTAINMENT LEVELS CORRELATE CLOSELY WITH THE COMPARATIVE BIOLOGICAL SAFETY LEVELS, BUT WITH ADDITIONAL REQUIREMENTS SPECIFIC TO ARTHROPOD WORK.

2. INTERIOR SURFACES SHALL BE LIGHT IN COLOR TO FACILITATE LOCATION AND RECAPTURE OF LOOSE ARTHROPODS.

BSL-2 GENERAL NOTES

1. AGENTS RESEARCHED AT BIOSAFETY LEVEL 2 (BSL-2) HAVE MODERATE HAZARD TO MAN/ANIMALS AND MAY CAUSE ONLY MINIMAL ECONOMIC LOSS TO ANIMAL INDUSTRIES.

2. FIXED CASEWORK AND COUNTERTOPS SHALL BE SEALED TO THE ADJACENT WALL/FLOOR TYP.

CONTAINABLE GENERAL NOTES

1. CONTAINABLE SPACE IS DEFINED AS A SPACE, ACTING AS A TERTIARY BARRIER TO CONTAINMENT.

2. CONTAINABLE SPACES ARE SHOWN HATCHED ON THE PLAN. DESIGN FEATURES INCLUDE SHOWER OUT/CHANGE CAPABILITY, CLEANABLE FINISHES, SEALED PENETRATIONS, HEPA FILTRATION OF EXHAUST AIR, NEGATIVE DIFFERENTIAL PRESSURE TO ADJACENT SPACES, AND THE INCORPORATION OF SHUT-OFF DAMPERS TO FACILITATE IN DECONTAMINATION METHODOLOGIES.

3. CONTAINABLE SPACE IS NOT CONSIDERED TO BE "IN CONTAINMENT".

4. A PRESSURE DECAY TEST WILL NOT BE REQUIRED OF CONTAINABLE SPACES; HOWEVER, EACH CONTAINABLE ROOM WITHIN THE HATCHED ZONE SHALL BE SEALED TO AN AIRTIGHT CONDITION AND CAPABLE OF BEING INDIVIDUALLY GAS FUMIGATED.

5. ALL PIPES ROUTED FROM CONTAINMENT TO THE LIQUID DECONTAMINATION SYSTEM SHALL BE LAID OUT IN A MANNER SO THAT THEY ARE VISUALLY INSPECTABLE.

6. ALL SEALED PENETRATIONS SHALL BE LOCATED SUCH THAT THEY ARE EASILY INSPECTED AND MAINTAINED.

7. INSTALLATION AND CONSTRUCTION OF OPENINGS SHALL BE CLEANLY CONSTRUCTED WITH FLUSH CONDITIONS TO WALLS AND CEILINGS.

8. CONSTRUCT ALL OPENINGS FOR UTILITIES SUCH THAT THE SLEEVE OR FEED CAN BE TIGHTLY FITTED INTO PLACE AND EFFECTIVELY SEALED BY THE USE OF FOAM-BACKING RODS, FOAM GASKETS, RUBBER GROMMETS AND CAULK. OPENINGS IN WALLS, FLOORS AND CEILINGS THROUGH WHICH UTILITY SERVICES AND AIR DUCTS PENETRATE, SHALL BE SEALED IN ORDER TO PERMIT GAS DECONTAMINATION OF SPACE AND PREVENT RELEASE OF THAT GAS INTO ADJACENT AREAS.

9. UTILITY PENETRATIONS AT WALLS SHALL BE SEALED ON BOTH SIDES OF WALLS SEPARATING CONTAINABLE ZONES AND CORRIDORS, TO ENSURE AIR TIGHT CONDITIONS.

10. ALL DOORS SHALL BE CONSTRUCTED AS FULLY ENCLOSED. ALL DOORS AND FRAMES SHALL BE SEALED AT THE SEAMS AND JOINTS.

11. THE FLOOR, WALL AND CEILING FINISHES INSIDE THE CONTAINABLE SPACE SHALL BE MONOLITHIC AND SEAMLESS TO FORM A SEALED CONDITION.

12. ALL WALL PARTITIONS SHALL BE CONSTRUCTED TIGHT TO UNDERSIDE OF CEILING STRUCTURE WITH THE USE OF CONTINUOUS CONTAINMENT JOINT SEALANT AND BACKER ROD TO ALLOW FOR PROPER EXPANSION AND CONTRACTION OF MATERIALS. REFER TO DETAILS 17/1-A4227 AND 18/1-A4227 FOR TOP OF WALL DETAILS WITHIN THE CONTAINABLE BOUNDARY AND AT THE PERIMETER OF THE CONTAINABLE BOUNDARY.

13. ALL CONTROL JOINTS ARE TO RECEIVE CONTAINMENT JOINT SEALANT CJS-1.

14. PIPE INSPECTION PIPE SUPPORT STRUCTURAL DECONTAMINATION PROTOCAL:

· VOIDS DO NOT REQUIRE FULL CLOSURE BUT MUST BE EVALUATED AND ADDRESSED. DECON GASES REQUIRE A PATHWAY TO ALLOW COMMUNICATION OF THE GASES INTO, THROUGH, AND OUT OF SUCH AREAS

· KNOWN PIPE SUPPORT VOIDS SCENERIOS

· VOIDS FOR PIPE SUPPORT TERMINATIONS LOCATED OUTSIDE OF AND NOT OBSTRUCTED BY INSULATION (IF TUBING OR PIPING USED VS ANGLE IRON OR FALT STOCK.)

· 1/2" DIAMETER HOLE AT THE TOP ON ONE OF THE SIDES, IF NO OPENING IS PRESENT

· 1/2" DIAMETER HOLE AT THE BOTTOM ON ONE SIDE WITHIN 1" OR CLOSER TO END OF THE ITEM, IF NO OPENING IS PRESENT

· EXISTING OPENINGS (OPEN ENDS, SLOTS, ETC.) ARE ACCEPTABLE IF THEY MEET OR EXCEED CRITERIA LISTED ABOVE.

· VOIDS FOR PIPE SUPPORT TERMINATIONS LOCATED WITHIN/OBSTRUCTED BY INSULATED AREA (IF TUBING OR PIPING USED VS ANGLE IRON OR FLAT STOCK.)

· 1/2" DIAMETER HOLT AT THE TOP OF ONE OF THE SIDES, IF NO OPENING IS PRESENT

· (2) 1/2' DIAMETER HOLES AT THE BOTTOM (OPPOSITE FACES AND AT THE SAME ELEVATION OF EACH OTHER) WITHIN 1" OR CLOSER TO THE EDGE OF THE INSULATION

· THE MAXIMUM EXPECTED AND PERCEIVED IS BASED ON 3" THICK INSULATION AND THE GOAL IS FOR THE OPENING TO BE WITHIN A 3"-4" RANGE FROM END OF THE ITEM.

· THE SECOND HOLE ALLOWS FOR THE USE/INSERTION OF A BIO-INDICATOR FOR THE DECON CONFIRMATION.

· EXISTING OPENINGS (OPEN ENDS, SLOTS, ETC) ARE ACCEPTABLE IF THEY MEET OR EXCEED THE CRITERIA LISTED ABOVE.

15. SEAL AROUND ALL MEP RELATED CONNECTIONS ATTACHED TO DECK WITH SEALANT TYPE CJS-1.

16. SEAL AROUND HEPA CAISSON FEET AND EXPOSED HOLES IN CAISSON FEET WITH CJS-1.

17. CONTAINABLE / NON-CONTAINABLE PENETRATION PATCHING - REFERENCE 2/1-Q1000 FOR ADDITIONAL INFORMATION:

· NON-CONTAINABLE:

· GLAVANIZED PLATE 16 GAUGE

· PLATE IS 1" LARGER THAN PENETRATION ON ALL SIDES

· PLATE IS EMBEDDED IN CAULK

· PLATE IS TO BE SECURED WITH BOLTS ON ALL FOUR CORNERS

· DISTANCE BETWEEN ANCHORS NOT TO EXCEED 10"

· BOLTS TO BE 1/4" TO 3/8"

· ONE BLOCK MAXIMUM WITHIN CMU WALLS. PENETRATION SHALL BE SEALED TO PLATE WITH CAULK

· CONTAINABLE:

· STAINLESS STEEL PLATE 16 GAUGE

· PLATE IS 1" LARGER THAN PENETRATION ON ALL SIDES

· PLATE IS BEDDED AND SEALED IN CJS-1 CONTAINABLE CAULK

· PLATE TO BE SECURED WITH MACHINE SCREWS ALL FOUR SIDES

· FILL ALL THREADED INSERT HOLES WITH CJS-1 CONTAINABLE CAULK BEFORE PLACEMENT OF INSERT.

· NO SHARPS, ALL CORNERS TO BE ROUNDED

· DISTANCE BETWEEN ANCHORS NOT TO EXCEED 10"

· SCREWS TO BE 1/4" TO 3/8"

· ONE BLOCK MAXIMUM WITHIN CMU WALLS. PENETRATION SHALL BE SEALED TO PLATE WITH CJS-1 CONTAINABLE CAULK

· INSTALL ACORN NUTS AT EXPOSED THREADS

· ABANDONED CONDUITS:

· CONDUITS ABANDONED TO BE SEALED WITH CAULK OR PIPE PLUG

· ABANDONED SLEEVES:

· WILL BE SEALED WITH A MECHANICAL PLUG - ENSURE COATING TERMINATIONS ARE COORDINATED.

· ADDITIONAL COMMENTS:

· LINK SEAL CONDITIONS NEED TO BE ADDRRESSED REGARDING COORDINATION WITH COATING TERMINATIONS.

· ABONDONED UTILITY PENETRATIONS THROUGH CONCRETE, INCLUDING COMPRESSION PLUG WITH COORDINATION OF COATING TERMINATIONS, NEEDS TO BE EVALUATED.

18. PENETRATIONS IN RATED FLOORS REQUIRE APPOVED FIRE STOPPING DESIGN. APPLY CJS-1 SEALANT TO JOINT EXPOSED TO CONTAINABLE SIDE OF PENETRATION. REFER TO 3/1-Q1000 FOR ADDITIONAL INFORMATION.

OTHER SPACES GENERAL NOTES

1. OTHER SPACE IS DEFINED AS A SPACE, OUTSIDE OF CONTAINMENT OR OUTSIDE OF THE MAIN LAB FACILITY THAT IS NOT SUBJECT TO THE SAME LEVEL OF DETAIL AND REGULATION AS THE SPACES SPECIFICALLY LISTED AND WOULD BE CONSIDERED STANDARD OR GENERAL CONSTRUCTION.