MEC_Final.docx
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- Solicitation number
- PANDHA-26-P-0000-039389
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This is a Minimum Essential Characteristics (MEC) specification document for an air-liquid interface (ALI) exposure system procurement by the U.S. Army Medical Research Institute of Chemical Defense (USAMRICD). The government requires acquisition of one integrated ALI exposure chamber system capable of conducting controlled airborne toxicant exposure testing on human respiratory and dermal tissue models under physiological conditions. The system must feature a heated mini-incubator with temperature and humidity controls, an airtight sealed chamber with internal vacuum operation, and internally non-reactive components to minimize toxicant loss and facilitate cleaning. The chamber design must accommodate modular, versatile configurations to evaluate various toxicant phases (gases, vapors, aerosols, particles, or mixed forms) and support flexible multi-well ALI model formats with throughput capacity for 6 to 24 simultaneous replicate samples.
The specification requires an integrated electrostatic deposition system with switchable capabilities to maximize particle deposition on tissue cultures, real-time monitoring integration for airborne test article concentration and airflow parameters, and compatibility with various upstream aerosol generation and downstream monitoring systems. The complete procurement package includes one airflow humidifier (capable of delivering in-line humidification above 75% humidity), one airflow dryer to prevent downstream condensation, one battery-operated vacuum pump as an alternative to house-provided vacuum sources, and all associated sample holders and real-time monitoring software. The entire system must fit within a standard 48" wide × 36" deep × 59" high chemical fume hood, operate with low maintenance requirements, and include post-award installation, training, and one-year warranty coverage. The related federal contract opportunity indicates the Defense Health Agency Contracting Activity (DHACA) intends to award the contract to MEDTEC BIOLAB, INC., based on other than full and open competition, for the CelTox Sampler system identified as the only system meeting all minimum essential characteristics.
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Minimum Essential Characteristics Air-liquid interface exposure system, installation, training, and warranty with shipping for U.S. Army Medical Research Institute of Chemical Defense (USAMRICD)
Quantity 1 = Air-liquid Interface Exposure Chamber
· Air-liquid interface (ALI) exposure
· Provides control over airborne test articles
· Holds and maintains cells and tissue models at physiological ALI conditions consistent with human respiratory tract or dermis
· More closely replicates mammalian lung inhalation exposure conditions by delivering airborne gas, vapor, aerosols, or dry particle test articles than traditional submerged culture models
· Exposed ALI models can be easily moved to incubators post-exposure via single insert or entire exposed plate
· Provides high quality and repeatable data comparable to published scientific literature
· Associated mini-incubator housing for controlled environment
· Heated enclosure to adjust, maintain, and record temperature and humidity close to human physiological condition
· Airtight seal to maintain physiological relevant humidity
· Operates under a vacuum to reduce potential exposure to researchers while maintaining emission source
· Internally facing components are made of material to minimize reactivity, damage to system components, and loss of toxicant to internal wall surface and make cleaning easy
· All air flow system components and sensors are housed within the system for stable reproducibility of mammalian physiological conditions.
· Modular and versatile design to evaluate different toxicant phases, experimental designs, and in vitro model formats
· All-in-One system to evaluate any type of airborne toxicant or drug delivery regardless of its physical form (gas vs. vapor vs. mixed aerosol vs particle).
· User-friendly design for someone with minimal to moderate experience with using ALI systems to conduct airborne toxicant exposures
· Modules are highly compatible and allow easy switch out capabilities
· Flexible design to handle user-defined multi-well ALI model formats
· Allows acquisition of one system under a single funded equipment ceiling budget
· Electrostatic deposition system
· Uses electrostatic unipolar charging source to push particles onto ALI culture models to maximize particle deposition and reduce the use of costly particle samples
· Can be turned off and on, or completely removed from the chamber depending on experimental goals
· Multi-well plate format
· Allows for simultaneous exposures to the same test atmosphere, for example:
· Comparison of with/without electrostatic deposition
· Comparison of two different ALI model systems
· Assess mixed aerosols (particles + gas) by allowing particles to deposit on one plate and not the other
· Dynamic exposure platform capability
· Options to maximize deposition of either gases, vapors, aerosols or particulate
· Ability to hold single “transwell” inserts or entire cell culture plate in 6, 12, or 24-well “Transwell” formats in exposure system
· Throughput design allowing between 6 to 24 replicate samples per exposure run
· Easy integration with other generation and monitoring systems
· Systems that provide liquid aerosols, dry particle, gas, vapors, and mixed aerosols can be incorporated into the system
· Real-time monitoring systems can be deployed and up- and down-stream of ALI exposure system to monitor and quantify airborne test article concentrations and air flow parameters
· Cleanup and filters can easily be incorporated into the downstream airflow to remove toxicants before discharge into laboratory exhaust
· Small physical footprint in lab
· Generation, ALI exposure system, and vacuum pump must fit within a standard (48” wide x 36” deep x 59” high) chemical fume hood
· Low maintenance cost
· Components are self-maintained by user
· Minimal maintenance services for only repairs required by company field technicians Quantity 1 = Airflow Humidifier
· Humidification of test atmospheres
· In-line humidification of test atmosphere above 75% humidity
· Easily charged and reused
· Customizable for other fittings for different tube sizes and integration with several different upstream aerosol generation systems and downstream ALI exposure designs, modules, and chambers Quantity 1 = Airflow Dryer
· Drying of test atmosphere
· Placed downstream of ALI exposure chamber to dry test atmospheres before exhausting to waste bottles or chemical fume hood
· Prevents condensation and blockage of air flow downstream of ALI exposure chambers Quantity 1 = Vacuum pump
· Provides an internal, battery-operated vacuum pump when house provided vacuum is inadequate to maintain low air flow conditions
· Small footprint and sits inside chemical fume hood
· Alternative vacuum source other than house provided
· Allows slower and controlled airflows (<0.5 L/min), especially for nozzle-based systems that require push-pull airflows Quantity 1 = Digital In-line Temperature/ Relative Humidity Sensor
· Monitor and record both temperature and humidity real-time prior to and during experimental exposure runs
· data logging capability with a user provided computer Quantity 1 = Mass flow controller
· Controls air flow upstream of chamber to create a steady and consistent airflow to deliver test atmospheres to exposure chamber
· Visual digital readout to control and monitor airflow during exposures Quantity 1 = 24 nozzle module to accommodate 24-well insert plate design
· Modular
· Compatible with temperature, humidity, and air flow control systems and read outs
· Effective gas and vapor delivery for exposures to 24-well inserts
· Push-pull vacuum control over test atmospheres
· Upstream airflow is ~ 1 L/ min while downstream airflow is < 0.5 L /min
· Each transwell insert receives its own nozzle to ensure and maximize exposure
· Control multiple doses in same experimental run
· Air flow to the module can be divided in halves or thirds to conduct clean air plus one or two target doses of test atmosphere
· Capture of toxic gases and fumes
· Provides more efficient capture of toxic gases and vapors compared to static and passive aerosol delivery systems thereby minimizing accidental exposure to internal surfaces and researchers Quantity 1 = Quartz Crystal Sensor / Microbalance
· Real-time mass quantification of aerosol and particle deposition
· Capable of fitting within exposure chamber, insert holder, or test plate
· Easy placement within chamber
· Interfaces with established software program running on a standard laptop computer
· Reusable if appropriately cleaned and maintained Quantity 1 = Software for microbalance sensor
· Evaluation of real-time mass deposition
· Ensures dry particle or aerosol exposures are occurring to ALI tissue models during exposure runs
· Helps to identify airflow anomalies or bad exposure runs prior to long downstream sample processes
· Compatible with sensor/microbalance
· Receives and logs data in acceptable format, such as text file, comma delimited (.csv), or tab delimited (.tsv)
· Export capability to other data management programs such as Microsoft Excel Freight and shipping to USAMRICD Installation and training to be completed at USAMRICD by 30 September 2026 OPTIONAL 1 year warranty
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