Inhalation Exposure System for Healthcare Facility

ve purposes and shall not be construed as an intention by the Department of Veterans Affairs to procure that specific product. When a brand name product is identified, or certain features, prospective vendors shall treat such reference as a benchmark for design, performance, or quality standards. This is meant to increase competition not restrict it. STATEMENT OF WORK

Background: The VA Pittsburgh Healthcare System (VAPHS) is in need of an inhalation exposure system to support controlled experimental exposure studies involving aerosolized particulates, vapors, and gaseous agents. The system shall be designed to enable reproducible delivery of defined aerosolized or gaseous exposures to in vivo animal models and in vitro cellular systems under controlled laboratory conditions. This shared research resource will enhance the capability of investigators at VAPHS to conduct translational and preclinical studies related to respiratory health, toxicology, military exposure research, environmental exposure science, and related biomedical research areas. Scope: The Contractor shall construct and install a modular inhalation exposure system capable of providing reliable and reproducible exposure conditions suitable for a variety of inhalation research applications, including aerosolized particulates, vapors, and gaseous agents, while supporting appropriate environmental control, monitoring, and safety

requirements. The inhalation exposure system shall be capable of supporting both in vivo animal models and in vitro cellular, as required by specific study designs, as well as include integrated controls for airflow, temperature, humidity, aerosol/gas concentration monitoring, and exposure duration. The system shall also incorporate multiple engineering and procedural safety features intended to minimize risk and ensure compliance with institutional safety standards.

Deliverables/Technical

Requirements The inhalation exposure system shall include: Base Toxicant Inhalation Exposure System (BExp1): This system includes: Cube 150 Stainless-Steel Exposure Chamber to hold up to 12 rats or 36 mice Air-cleaning System Module (pressure regulator, air dryer, carbon filter and HEPA filter) Generator Mass Flow Controller Diluent Mass Flow Controller Gravimetric Sampling Mass Flow Controller Mass Flow Controller Hub Temperature and Humidity Probe CO2 Monitor USB Hub 24 Volt Power Supply Exhaust Mass Flow Controller Exhaust HEPA Filter with Housing Exhaust Activated Carbon Filter with Housing Generator Pressure Transducer Exposure Chamber Pressure Transducer Custom Stainless-Steel Aerosol and Gas Disperser Light Scattering Device that estimates the real-time mass concentration of the aerosols in the exposure chamber Photo Ionization Detector to estimate the real-time volatile organic compound gas levels in the exposure chamber Emergency Shut Down Button Multi-function input/output board that interfaces with the computer to digitize analog signals Laptop computer Custom Base Software that acts as a graphical user interface to monitor, control and record exposure variables All associated cables and tubing -Instruction manual Low-Noise Exhaust Vacuum Pump with Sound Shield (VPump) Automatic Super Humidifier Controller for the Toxicant Inhalation Exposure System (HumLab1): This fast-acting, high-accuracy humidifier conditions the diluent gas stream and can also provide additional humidity to the generator air stream, which must otherwise remain dry during aerosol generation. It enables precise humidity control and allows the system to achieve high relative humidity levels when required. Cell Exposure System (CellExpo1): This system will be housed within the Toxicant Exposure Chamber during exposure procedures. During operation, the Cell Exposure System will be surrounded by test toxicants, which will be monitored using standard gas and aerosol monitoring instrumentation. Toxicant-laden air will be drawn into the Cell Exposure Chamber using a dedicated sample pump. It includes: A pre-humidifier to add additional humidity to the toxicant stream before entering the Cell Exposure Chamber MedTec Model 625S CelTox Exposure Chamber Electrostatic precipitation option for enhanced aerosol deposition on cell samples Sample Pump with pre-filter to pull toxicants into Cell Exposure Chamber Dry Powder Acoustical Aerosol Generator (HP AG): This modular aerosol generator will be used in conjunction with the Base Toxicant Inhalation Exposure System during inhalation exposure studies. Bulk dry powder is loaded into the generator, where acoustical energy is used to deagglomerate and aerosolize the material. The system also includes a Venturi pump, which serves as a secondary particle deagglomeration stage to further improve aerosol dispersion and uniformity. The Light Scattering Device integrated with the base system may be used to monitor and control aerosol concentration throughout the exposure process. Small High Pressure Acoustical Generator (HP-AG-0.5): This modular aerosol generator will be used in conjunction with the Base Toxicant Inhalation Exposure System during inhalation exposure studies. It is functionally similar to the larger Acoustical Generator; however, it is specifically designed for studies in which only limited quantities of dust are available for aerosol generation and exposure. High Pressure Nebuilzer Liquid Aerosol Generator (Neb1): This modular liquid aerosol generator will be used in conjunction with the Base Toxicant Inhalation Exposure System during inhalation exposure studies. Bulk liquids are introduced into the generator, where liquid droplets are produced using a high-velocity air jet. The Light Scattering Device integrated with the base system may be used to monitor and control aerosol concentration throughout the exposure process. Jet Fuel Liquid Combustion Generator (LiqComG ): This modular liquid aerosol generator will be used in conjunction with the Base Toxicant Inhalation Exposure System during inhalation exposure studies. Jet fuel or similar liquid accelerants are pumped from a reservoir and dripped into a high temperature chamber where combustion occurs. The Photo Ionization Detector measurement with the base system may be used to monitor and control the emissions. Modification to allow Jet Fuel Liquid Combustion Generator to also function as a Heated Vapor Generator (VapMod1): Bulk liquid is delivered into a heated block using a computer-controlled syringe pump. As the liquid is heated, it is vaporized and mixed with diluent air to generate vapors of interest. The Photo Ionization Detector integrated with the base system may be used to monitor and control vapor emissions throughout the exposure process. E-Cig Puff Vape Generator (Puff): This modular e-cigarette puff generator will be used in conjunction with the Base Toxicant Inhalation Exposure System during inhalation exposure studies. The system is compatible with a variety of Electronic Nicotine Delivery Systems (ENDS) and vape liquids. The generator utilizes a custom-machined stainless-steel piston to produce user-defined puffs that activate the ENDS device and draw the resulting emissions into the piston chamber. The piston then delivers the emissions into the diluent air stream before they enter the exposure chamber. The Photo Ionization Detector and/or the Light Scattering Device integrated with the base system may be used to monitor and control emissions throughout the exposure process. Base Control Inhalation Exposure System (Expo1): This system assumes similar conditions to Toxicant Chamber. It includes: Rotameter for airflow Cube 150 Stainless-Steel Exposure Chamber to hold up to 12 rats or 36 mice Rotameter to set chamber airflow. Exhaust HEPA Filter with Housing. Exhaust Activated Carbon Filter with Housing Automatic Control Inhalation Exposure System (AutoCon): This system is fully automated. It includes: Temperature and Humidity Probe CO2 Monitor Input Air Mass Flow Controller Multi-function input/output board that interfaces with the computer to digitize analog signals Laptop Computer Custom Control Software that acts as a graphical user interface to monitor, control and record exposure variables Heating and Cooling System for the Control Inhalation Exposure Systemm(ChHeCo2): This system provides the capability to heat and cool the exposure chamber, supporting applications such as cell exposure experiments, heat stress studies, and other environmental exposure research protocols. Automatic Super Humidifier Controller for the Control Inhalation Exposure System (HumLab1): This fast-acting, high-accuracy humidifier conditions the control chamber air stream and enables precise humidity regulation. This option allows the system to achieve and maintain high relative humidity levels when required. Custom Stainless Steel Mouse Cage for 36 Individually Housed Mice (MCAGE1): Two custom stainless-steel cages will be acquired: one for use within the Toxicant Exposure Chamber and one for use within the Control Chamber. Each cage is designed to accommodate up to 36 individually housed mice during exposure studies. Custom Stainless Steel Rat Cage for 12 Individually Housed Rats (RCAGE1): Two custom stainless-steel cages will be acquired: one for use within the Toxicant Exposure Chamber and one for use within the Control Chamber. Each cage is designed to accommodate up to 12 individually housed rats during exposure studies. System installation at customer site (INST1): The Contractor shall deliver, install, and set up the equipment at the laboratory site. Delivery is included as part of the installation cost. System use training (TRN1): Training includes three (3) full days of on-site instruction provided by the Contractor representative, along with unlimited email and telephone support. Annual Service Contract (ServQuad): This annual service contract includes four (4) on-site maintenance visits per year. During each visit, preventative maintenance will be performed including filter replacement, sensor calibration, replacement of disposable parts showing wear, and updates/tuning of exposure control systems. Any equipment issues or failures will be identified during these visits; however, the cost of replacing any damaged or non-functional equipment will be the responsibility of the Customer. Contractor

Requirements: System Delivery and Installation The Contractor shall deliver all system components to the designated laboratory site and perform complete installation. Installation shall include assembly, integration of modules, connection to facility utilities as required, and verification of full system functionality and operational readiness. System Validation and Performance Verification The Contractor shall perform full system validation, including: functional verification of all system components; calibration of sensors and monitoring devices; validation of aerosol, gas, and vapor generation performance; confirmation of exposure control stability and reproducibility; and demonstration of proper operation of all safety and control systems Training