Attachment 1_Statement of Needs_B1 BSC Replacements.pdf

ATTACHMENT 1: STATEMENT OF NEEDS

Acquisition Title: B1 Biological Safety Cabinet (BSC) Replacements, DIR

1.0 INTRODUCTION/OVERVIEW

The mission of the National Institute of Allergy and Infectious Diseases (NIAID), as stated in Title W, Part C, Subpart 6, Section 446 of the Public Health Service Act (42U.S.C. Sec. 285 F) is the conduct and support of research, training, health information dissemination, and other programs with respect to allergic and immunologic diseases and disorders and infectious diseases, including tropical diseases.

To accomplish Institute goals, the NIAID Division of Intramural Research (DIR) conducts basic, translational, and clinical research in its laboratories in Bethesda and Rockville, Maryland and Hamilton, Montana. The NIAID DIR supports basic research in the disciplines of virology, bacteriology, parasitology, mycology, molecular biology, immunobiology, immunochemistry, immunoregulation, immunogenetics, transplantation biology, and immunopathology. Pathogen and medical research include COVID, AIDS, malaria, tuberculosis, influenza, and additional high consequence human diseases most of which require laboratories equipped with critical scientific equipment like Biological Safety Cabinets (BSCs).

2.0 BACKGROUND

The overall goal of the NIAID DIR research programs is to improve methods for the prevention, diagnosis, and treatment of infectious and immune-mediated diseases. NIAID Investigators are devising new approaches to combat infectious agents and are uncovering new ways to enhance the protective powers of the immune system and to diminish its destructive effects or restore deficiencies when it malfunctions. Their efforts are facilitated by advances in molecular biology, which now permit a better understanding of microorganisms and cells at the fundamental molecular level.

BSCs are an essential part of a laboratory, serving as primary barriers for working with infectious microorganisms, viruses, and prions. Biomedical researchers also utilize BSCs for sterile environments to culture animal cells and tissues that requires laminar air flow and HEPA filtration that exists in Class II BSCs. All Class II cabinets are designed for work involving microorganisms assigned to Risk Groups (RG) 1–4. Class II BSCs provide the microbe-free work environment necessary for cell culture propagation and may be used for the formulation of nonvolatile antineoplastic or chemotherapeutic drugs.

The Class II BSCs (Types A2, B1, and B2) provide personnel and environmental protection from biological hazards being used inside the cabinet and sample protection from contamination by creating a sterile work environment inside the cabinet. These cabinets are used for routine cell culture procedures as well as animal procedures, prion, and virus work at BSL2, 3 and 4. Class II, Type B1 BSCs are chosen when there is a need to exhaust the air from inside the cabinet out of the room. B1 cabinets are ducted, partial-exhausted where 70% of the downflow air exits the rear grille, is HEPA filtered and discharged through building exhaust systems. The remaining 30% of air is recirculated inside the cabinet. These cabinets allow for use of minimal amounts of volatile toxic chemicals and radionuclides. They are used in laboratories where sterile procedures or procedures that require personal and protection also involve the use of small amounts of volatile chemicals.

3.0 SCOPE

The purpose of this acquisition is to procure replacement B1 BSCs to support NIAID DIR research programs in accordance with regulations and requirements established by NIH Department of Occupational Health and Safety (DOHS), NIH Division of Technical Resources (DTR), Center for Disease Control (CDC), and CDC/NIH Biosafety in Microbiological Biomedical Laboratories (BMBL).

As part of equipment lifecycle replacement, NIAID, DIR seeks to acquire eighteen (18) BSCs in two (2) different configurations, with a potential of 80 units over a five-year period. These units must be compatible with existing building infrastructure for a phased lifecycle replacement project in DIR laboratory facilities located in Bethesda and Rockville, Maryland and Hamilton, Montana. The BSCs are critical components and act as primary containment barriers for researchers working with infectious microorganisms, viruses, and prions.

4.0 REQUIREMENT

This Statement of Needs is for the acquisition of up to eighty (80) NSF/ANSI 49 certified Class II, Type B1 BSCs capable of providing primary barrier containment, along with associated supplies, services, and delivery to NIAID DIR laboratories in Bethesda and Rockville, Maryland, Hamilton, Montana, and in NIAID contract/leased spaces in the Washington, DC, metropolitan area.

During the base period, DIR intends to acquire eighteen (18) units to replace BSCs that are now experiencing failure issues and are most at risk of reaching the end of their lifecycle. No quantity options are requested for the base period. Following the base period , there are four (4) 12-month option periods, with 17, 16, 15, and 14 units included in each respective period, to address the anticipated need for DIR upgrades and replacements.

The BSC units, along with their associated supplies and services, must meet all the required minimum characteristics listed below:

4.1 6ft Standard Base model

• Weight: BSC net weight shall not exceed 740 lbs.

• Exterior Dimensions: 74 ½” w x 33 ¼” d x 61 3/8” h.

• Interior Dimensions: 70 3/8” w x 22 7/8” d x 26 ¼” h.

• Containment Protection: Cabinet shall provide biological containment protection for both operator and product proven by an actual test, (e.g. test conducted by NSF) and routinely validated.

• Airflow: 30% recirculation through HEPA filtered work zone and 70% exhaust through cabinet's internal exhaust HEPA filter and exhaust duct work to a remotely located roof exhaust blower.

• Fumigation: Cabinet shall be easily fumigated employing an established procedure such as that recommended by NSF.

• Exhaust Connection: Direct connection exhaust, 12” diameter duct connection, 410 CFM.

• Exhaust Placement Flexibility: Exhaust placement requirements must include flexibility to move the exhaust cabinet connection to a new fixed point on the cabinet while maintaining NSF certification within the stated nominal base and following flexible ranges:

o Base placement: Exhaust nominal base placement on top right; 12” from back, 22 1/8” from right side.

o Horizontal (left to right) flexibility: Horizontally from center of exhaust nominal base placement value by -10” or +10”.

o Vertical flexibility (back to front): Vertically from center of exhaust nominal base placement value by -1 ½ or +5”.

• Sealed Connection: Shall provide a manual 12” airtight stainless steel butterfly damper and stainless steel hardware to create a sealed permanently fixed connection between the cabinet exhaust connection, the butterfly damper, and the local building exhaust duct.

• Construction: Cabinet interior shall be composed of 16 GA, Type 304 stainless steel with all welded monolithic leak-free construction.

• Work Surface: One-piece removable dished stainless steel work surface, 16 GA stainless steel reinforced with stainless steel U channels to minimize vibration.

• Access Opening: 8” work access opening.

• HEPA Filter: Supply HEPA filter protected by perforated metal diffuser covering the entire top of work zone.

• Air Velocity: Air velocity from the supply filter shall average 65 to 75 fpm with no single point outside the 20% of average range measured in a horizontal plane defined by 4 inches above the bottom edge of window.

• Inflow Velocity: Average inflow velocity shall nominally be 105 fpm.

• Digital Sensors: Digital pressure sensors and controls to notify users of any adverse functionality of the unit.

• Electrical Supply: Electrical power shall be supplied with 12 foot 3-wire cord with molded plug.

Electrical supply shall be 115V, 60Hz protected with thermal circuit breaker from distribution panel.

• Outlets and Valves: Cabinet shall come standard with one duplex outlet with drip proof covers on left inside wall with option of additional duplex outlet on right inside wall. One gas valve / one service coupling on right side wall.

• Ergonomics and ADA Compliance: The cabinet shall be ergonomically designed for maximum user comfort and adjustability to meet the requirements of the American Disabilities Act (ADA.).

o Standard non-metallic armrest/airfoil incorporating large 1-1/2 inch (38mm) forearm support area with 1/2 inch (12mm) recessed front grill designed for armrest comfort while maintaining containment performance.

o Maximum visibility into cabinet workzone shall be at least 20-1/2 inches (521mm) from front access airfoil to exterior light housing.

o Cabinet shall have a centrally located instrument panel within the control center that is easily serviced with quick disconnects.

o Cabinet shall have the capability of incorporating a user-adjustable basestand or base storage cabinet as an option.

o The cabinet shall have a smooth operating sliding window from 1 inches (25 mm) closed to full opening at 18-1/2 inches (470mm).

o Cabinet shall have a large worktray (17.875 inch (454mm) depth) removable with coved corners for easy cleaning.

• Pressure Plenums: The cabinet shall have all positive pressure plenums surrounded by a vacuum relative to the room.

• Control System: Cabinet shall contain a control system which is a self-contained electronic module that will perform the following functions:

o Easy use interface with color LCD.

o Control blower DC ECM motor via solid-state DC Motor Controller that provides automatic compensation (constant volume control) for both filter loading and line voltage variances.

o Fast, accurate, reliable dual thermistor, airflow sensors and digital differential velocity pressure flow grid powered by TSI to control and monitor cabinet airflows to setpoints.

o Control lights via solid state switch.

o Control outlets via solid state switch.

o Display date/time w/battery backup.

o Display blower and optional UV light run timers.

o Display alarm setpoints high/low for error conditions (downflow / inflow).

o Display complete calibration, option menu and diagnostic functions.

• Exhaust Interlock System: The cabinet shall contain an exhaust interlock system that prevents operation of the internal supply blower unless the exhaust flow is sufficient to provide the correct air barrier inflow velocity at start up.

• Motor/Blower Positioning: Motor/blower shall be positioned so as to create an even filter loading, thereby prolonging the life of the supply HEPA filter, and shall deliver over 250% of the initial HEPA filter static pressure with no more than a 10% decrease of CFM.

• Filter Removal: Cabinet shall be capable of front filter removal without disassembly of the control panel and sliding window tracks/hardware.

• Lighting: Fluorescent lighting shall be externally mounted and provide 90 to 120 foot-candles (968 to 1291 LUX) on work surface. The ballast is to be electronic containing thermal protection with automatic reset.

• Transportability: The cabinet shall be easily transportable through a standard 36 inch (914mm) wide door without disassembly.

• Sound Level: Sound level shall be no more than 63 dbA measured 15 inches (381mm) above the work tray and 12 inches (305mm) in front of viewing window.

• Heat Rejection: Heat rejection shall not exceed 774 BTU/h.r

The following additional services are required:

• Delivery and Setup: Shall deliver and set-up all components of new unit to specified campus location.

• Transport and Assembly: Shall provide service to transport, assemble and level new unit in laboratory location.

• Documentation: Shall provide necessary documentation including warranty information.

4.2 4ft Standard Base model

• Weight: BSC net weight shall not exceed 550 lbs.

• Exterior Dimensions: 50 ½” w x 33 ¼” d x 61 3/8” h.

• Interior Dimensions: 46 3/8” w x 22 7/8” d x 26 ¼” h.

• Containment Protection: Cabinet shall provide biological containment protection for both operator and product proven by an actual test, (e.g. test conducted by NSF) and routinely validated.

• Airflow: 30% recirculation through HEPA filtered work zone and 70% exhaust through cabinet's internal exhaust HEPA filter and exhaust duct work to a remotely located roof exhaust blower.

• Fumigation: Cabinet shall be easily fumigated employing an established procedure such as that recommended by NSF.

• Exhaust Connection: Direct connection exhaust, 12” diameter duct connection, 270 CFM.

• Exhaust Placement Flexibility: Exhaust placement requirements must include flexibility to move the exhaust cabinet connection to a new fixed point on the cabinet while maintaining NSF certification within the stated nominal base and following flexible ranges:

o Base placement: Exhaust nominal base placement on top right; 12” from back, 16 1/8” from right side o Horizontal flexibility (left to right) : Horizontally from center of exhaust nominal base placement value by -3” or +3” o Vertical flexibility (back to front): Vertically from center of exhaust nominal base placement value by -1 ½’ or +5”

• Sealed Connection: Shall provide a manual 12” airtight stainless steel butterfly damper and stainless steel hardware to create a sealed permanently fixed connection between the cabinet exhaust connection, the butterfly damper, and the local building exhaust duct.

• Construction: Cabinet interior shall be constructed of 16 GA, Type 304 stainless steel with all welded monolithic leak-free construction.

• Work Surface: Shall have one-piece removable dished stainless steel work surface, 16 GA stainless steel reinforced with stainless steel U channels to minimize vibration.

• Access Opening: 8” work access opening.

• HEPA Filter: Shall have a supply HEPA filter protected by perforated metal diffuser covering the entire top of work zone.

• Air Velocity: Air velocity from the supply filter shall average 65 to 75 fpm with no single point outside the 20% of average range measured in a horizontal plane defined by 4 inches above the bottom edge of window.

• Inflow Velocity: Average inflow velocity shall nominally be 105 fpm.

• Digital Sensors: Digital pressure sensors and controls to notify users of any adverse functionality of the unit.

• Electrical Supply: Electrical power shall be supplied with 12 foot 3-wire cord with molded plug.

Electrical supply shall be 115V, 60Hz protected with thermal circuit breaker from distribution panel.

• Outlets and Valves: Cabinet shall come standard with one duplex outlet with drip proof covers on left inside wall with option of additional duplex outlet on right inside wall. One gas valve / one service coupling on right side wall.

• Ergonomics and ADA Compliance: The cabinet shall be ergonomically designed for maximum user comfort and adjustability to meet the requirements of the American Disabilities Act (ADA.).

o Standard non-metallic armrest/airfoil incorporating large 1-1/2 inch (38mm) forearm support area with 1/2 inch (12mm) recessed front grill designed for armrest comfort while maintaining containment performance.

o Maximum visibility into cabinet workzone shall be at least 20-1/2 inches (521mm) from front access airfoil to exterior light housing.

o Cabinet shall have a centrally located instrument panel within the control center that is easily serviced with quick disconnects.

o Cabinet shall have the capability of incorporating a user-adjustable basestand or base storage cabinet as an option.

o The cabinet shall have a smooth operating sliding window from 1 inches (25 mm) closed to full opening at 18-1/2 inches (470mm).

o Cabinet shall have a large worktray (17.875 inch (454mm) depth) removable with coved corners for easy cleaning

• Pressure Plenums: The cabinet shall have all positive pressure plenums surrounded by a vacuum relative to the room.

• Control System: Cabinet shall contain a control system which is a self-contained electronic module that will perform the following functions:

o Easy use interface with color LCD o Control blower DC ECM motor via solid-state DC Motor Controller that provides automatic compensation (constant volume control) for both filter loading and line voltage variances o Fast, accurate, reliable dual thermistor, airflow sensors and digital differential velocity pressure flow grid powered by TSI to control and monitor cabinet airflows to setpoints o Control lights via solid state switch o Control outlets via solid state switch o Display date/time w/battery backup o Display blower and optional UV light run timers o Display alarm setpoints high/low for error conditions (downflow / inflow) o Display complete calibration, option menu and diagnostic functions

• Exhaust Interlock System: The cabinet shall contain an exhaust interlock system that prevents operation of the internal supply blower unless the exhaust flow is sufficient to provide the correct air barrier inflow velocity at start up.

• Motor/Blower Positioning: Motor/blower shall be positioned so as to create an even filter loading, thereby prolonging the life of the supply HEPA filter, and shall deliver over 250% of the initial HEPA filter static pressure with no more than a 10% decrease of CFM.

• Filter Removal: Cabinet shall be capable of front filter removal without disassembly of the control panel and sliding window tracks/hardware.

• Lighting: Fluorescent lighting shall be externally mounted and provide 90 to 120 foot-candles (968 to 1291 LUX) on work surface. The ballast is to be electronic containing thermal protection with automatic reset.

• Transportability: The cabinet shall be easily transportable through a standard 36 inch (914mm) wide door without disassembly.

• Sound Level: Sound level shall be no more than 63 dbA measured 15 inches (381mm) above the work tray and 12 inches (305mm) in front of viewing window.

• Heat Rejection: Heat rejection shall not exceed 543 BTU/hr.

The following additional services are required:

• Delivery and Setup: Shall deliver and set-up all components of new unit to specified campus location.

• Transport and Assembly: Shall provide service to transport, assemble and level new unit in laboratory location.

• Documentation: Shall provide necessary documentation including warranty information.

5.0 PERIOD OF PERFORMANCE

The anticipated period of performance will be for one (1) twelve (12) month base period with four (4) twelve (12) month option periods. The option periods may be exercised at the discretion of the Government.

6.0 PLACE OF PERFORMANCE

The principal place of work will be Bethesda and Rockville, Maryland, Hamilton, Montana, and in contract/leased spaces in the Washington, DC, metropolitan area.