e-cigarette smoking machine
MARKET RESEARCH PURPOSES ONLY
NOT A REQUEST FOR PROPOSAL OR SOLICITATION
The U.S. Food and Drug Administration (FDA), is conducting market research to support the National Center for Toxicological Research (NCTR) requirement for an e-cigarette smoking machine to evaluate the toxicity and inflammation produced by electronic nicotine delivery systems (ENDS) using human in vitro airway models.
The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, and subsequently maintaining, a U.S. made product of a small business manufacturer or producer for the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.
The associated North American Industry Classification System (NAICS) Code is-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 employees.
The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), has a new collaborative research project with the Center for Tobacco Products (CTP) that is identical to an existing project (project No. E07549.01) with the only difference that the new project involves the use of ENDS as the smoke source to conduct toxicity evaluation of e-vapors generated from a variety of ENDS using both non-intensive and intensive smoking regimens in airway in vitro tissue models. NCTR requires the purchase of an additional Vitrocell VC-10 S-type smoking robot with an 24/48 exposure module for 6.5mm cell culture inserts or technologically similar instrument with supporting hardware/software to use in a new collaborative project with CTP. Such collaborative work will generate scientific evidence that support the regulatory mission of CTP using the toxicology expertise and facilities at NCTR. Generating whole smoke aerosols or e-vapors from tobacco products for exposing cells at the air-liquid interface in vitro or animals in vivo requires using a specialized smoking robot. The smoking machine and the exposure modules will, therefore, be the core equipment in this joint study and the performance of the smoke exposure system (i.e., the smoking robot and exposure system) is crucial for the success of this project.
To better mimic the human puffing pattern, NCTR proposes to expose airway air-liquid-interface (ALI) cultures to e-vapors diluted to different concentrations in an intermittent manner. E-vapors will be generated from a variety of ENDS products. E-vapors will be delivered to a dilution system interfaced with the Vitrocell® Exposure Modules and diluted with clean air, and then drawn to the air-liquid interface of the cultures by a vacuum pump. Temperature of the e-vapor path from the smoking robot to the exposure module will be maintained at 37oC to prevent condensation of the test substances before reaching the cells. In this way, cells will be exposed to various dilutions of e-vapors produced using non-intensive or intensive E-cigarette smoking regimens; the parameters for the smoking regimens remain to be determined. The smoking robot should have the capacity to either increase the puff duration to greater than 3 seconds or puff frequency to greater than 2 puffs/minute. Cultures will be exposed to a range of e-vapor concentrations every day for at least 5 consecutive days. Changes in cytotoxicity, tissue integrity, cilia beating frequency, mucin secretion, cytokine secretion, and morphology will be measured at several timepoints. The test doses and treatment durations will be optimized based on the responses measured with these endpoints. Smoking machine shall generate e-vapors from ENDS and an exposure system for exposing cells at the air-liquid interface in vitro. The Sources Sought is for Brand Name or Equal solution. Proposed equal needs to meet all the salient characteristics listed below.
Performance requirements
General specifications:
The components and/or equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration. All electrical components shall be US standard plugs and voltages (115 V or 208 V, 60 Hz).
- The smoking machine shall be able to activate a variety ENDS products either by puffing or pressing down a button actuator;
- The engineering of the smoking machine shall be in compliance with ISO3308:2012 Routine analytical cigarette-smoking machine and CRM81; ISO3308 and CRM81-specified parts shall be provided by the manufacturer;
- The Contractor shall include information demonstrating the compatibility of the smoking machine with the commercially available Vitrocell® Exposure Modules for 24-well tissue culture inserts which are currently being used for NCTR's in vitro aerosol exposures, which will be connected to the smoking machine solicited in this document;
- The smoking machine shall be operated in a rotary fashion;
- The smoking machine shall automatically load, light, and extract cigarettes;
- The smoking machine shall have at least 2 syringe drives with pinch valves;
- The entry and exit valves of the syringe drive shall not be in direct contact with e-vapors or mainstream smoke for easy cleaning and switching between tobacco products;
- The e-vapor pathway within the smoking machine shall be heated to 37oC;
- The leakage rate of the smoking robot shall be in compliance with the ISO33008 and no more than 5 millimeters/minute;
- The smoking machine shall be capable of adjusting the air flow rate in accordance with the ISO3308;
- The smoking machine shall operate without consuming a large quantity of oil-free compressed air. Dilution of the cigarette smoke aerosols of e-vapors shall be conducted using compressed air commercially available in cylinder/tanks;
- Regarding the source of compressed air for the tobacco smoke generating machines, the requirements for the compressed air source shall be specified by the contractor in order to properly determine the compressed air requirements in each room;
- If the tobacco smoke generating machine requires fume extraction for operation, the requirements for the exhaust shall be specified by the Contractor in order to properly determine the requirements in the smoking lab;
- The smoking machine shall NOT include an aerosol dilution system in the syringe for the whole smoke and e-cigarette aerosol; such dilution shall take place at the level of the exposure system;
- The smoking machine shall be equipped with a cigarette feeder having the capacity of holding more than 200 cigarettes for the smoking machine to load into the carousal for extended exposure runs;
- The smoking machine shall have no less than 10 cigarette/ENDS positions on the cigarette carousal;
- The smoking machine shall have the capability of smoking 1 cigarette at a time or up to 10 cigarettes in series;
- For the conventional combustion cigarettes, the smoking machine shall be equipped with a butt length sensor and be able to be operated under both puff count mode or butt length mode;
- The smoking machine shall be able to smoke tobacco products ( i.e. both conventional combustion cigarettes and ENDS) using either bell-shaped, square-shaped puffs, or user defined puffing regimens;
- The smoking machine shall be able to smoke cigarettes using partial puffs at the accuracy of 0.1 puff (10% of a whole puff);
- Each smoking machine shall be designed with the capability of delivering intact whole mainstream cigarettes smoke (i.e., gas phase and particulate phase) or e-vapors as it is generated;
- The smoking machine shall have at least 10 individual exhaust lines for delivering whole smoke or e-vapors to the exposure system;
- The dead space within the smoking machine shall be as small as possible, e.g., less than 10 mL;
- For conventional combustion cigarettes, the smoking machine shall be able to deliver whole smoke to the piston pump with minimum total particulate matter (TPM) loss;
- The smoking machine shall be capable of operating under the ISO, Canadian Intense (CI), Massachusetts and CRM81 regimens or under a user-defined machine smoking regimen without additional upgrades;
- For conventional combustion cigarettes, the smoking machine shall be capable of delivering whole smoke at higher frequencies than ISO and CI by smoking a specified number of cigarettes consecutively;
- The smoking machine shall have the option to be connected to an external human puff profiler and capable of smoking the recorded human puff profiles;
- The manufacturer shall provide holders for smoking a variety of ENDS products currently on the market with different activating mechanisms and dimensions;
- The smoking machine shall have a position for holding in-line Cambridge filter holders for TPM and e-vapor collection;
- The smoking machine shall be able to connect to impingers for e-vapor collections;
- The smoking machine shall be operated using software that is capable of recording the operational data (number of cigarettes smoked, puff counts, start/end time of an experiment);
- The operational software shall be able to be upgraded to be in compliance with good laboratory practice (GLP);
- The smoking machine shall be capable of storing a minimum of 30 standard or user-defined smoking recipes;
- Operational information stored on the computer shall be able to be exported in the Excel format;
- Any computer components, whether it be hardware or software or an actual computer that is required to perform the functions of the smoking machine, shall be included with the machine and listed as line items on the quote;
- The Contractor shall supply, with the quote, information regarding installation requirements, including unit footprint, electrical, air supply, and smoke extraction requirements;
- The Contractor shall provide Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) data on the smoking machine delivered, including measurements of TPM and CO as the testing parameters;
- The Contractor shall supply information on chemical and solvent compatibility for the parts of the smoking machine that may come in contact with the test articles. Specifically, the Contractor will provide documentation on preferred cleaning procedures for the equipment following the use of the test articles and provide information regarding the compatibility of the components to detergents and solvents that may be used in the cleaning process;
Required minimal specifications for the 24/48 exposure module:
- The module must have at least 48 places for 24-well sized cell culture inserts that are routinely used in the lab;
- The base module must have electronic heating system for maintaining temperature at 37oC;
- The module must have an aerosol exposure top with 48 individual inlets to allow 8 doses with 6 replicates;
- The module shall have the capability to set the trumpet height at different levels;
- The module must come with the required vacuum calibration valves, all required tubing, and distribution line/tubing/materials;
- The module shall hold 0.5-2.0 mL of media in each position;
- The module must be made of medical grade stainless steel;
- The module, which is in contact with media, cells, bacteria, etc., must be autoclavable at 121oC for 20 min;
- The module shall allow dose regulation via dilution, exposure time, and/or flow rate;
- The module must have condensation-free operation, 1 shell housing, 1 heating system, 1 sensor for heating monitoring, and software for read-out of sensor data to computer;
- The module shall have trumpet-shaped inlets made of stainless steel for controlled flow and good distribution/deposition;
- Exposure of cultures must take place at the air-liquid interface for realistic assessment of exposure particles;
- The aerosols must be diluted with clean air dynamically for dose-response measurements in a freely defined dilution range of 0.1-12 L air/min;
- The flow of the dilution clean air shall be set and recorded by a software;
- The dilution system must be made of medical grade stainless steel with a non-stick surface treatment;
- Exposure top and base module should fit in a rack system with locking device;
- The exposure system must have a humidification station that provides a pressure regulator with safety valve, liquid separator, a heated probe, instrument panel for monitoring relative humidity and temperature, rotameters for adjusting the humidity level, and all connectors must be provided; the humidification system shall provide a minimum of 80 % RH at 37°C supplied to the dilution systems;
- All electronic components must be US plugs 115 V 60 Hz;
- The exposure module shall have a clean air distribution system, humidification station, calibration valves, mass flow meter to check for vacuum flow;
- The exposure system must be housed inside a climatic chamber equipped with a heating system for maintaining the ideal temperature at 37°C consistent with the culture of the cells (must not require an incubator to maintain the temperatures);
- The exposure system shall be airtight with a Borgwaldt leak tester drop rate maximum of 15 mm/min;
- The manufacturer shall provide documentation or guidance on preferred cleaning procedures for the equipment following the use of the test articles and provide information regarding the compatibility of the components to detergents and solvents that may be used in the cleaning process;
- The manufacturer shall provide a list of the maintenance and cleaning requirements for the end users;
- Vendor shall provide installation materials, minimum of 5 days of on-site training and product installation;
- The manufacturer shall provide Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) on the exposure module delivered;
Installation, Training and Additional System Requirements.
The contractor shall provide in-side delivery, installation and operator familiarization training for the system. The contractor shall provide a minimum of two (2) day of on-site training (in addition to installation of the system) for up to six personnel to include operations (including software), calibration, optimization, basic and routine preventative maintenance procedures and cleaning requirements.
Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA's stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.
Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include trouble-shooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of 1-year.
Availability of system support by the company for annual maintenance contract or service agreement.
Post-Warranty Preventative Maintenance Agreement shall, at a minimum, include the following
- Minimum of one (1) planned preventative maintenance visit per contract period.
- Unlimited phone and email support during the contractor's normal operating hours.
- Pricing shall be inclusive of all labor, travel, and parts (except consumables);
- Performance by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.
- Access by the FDA Technical Point of Contact (TPOC) and system operator personnel to the manufacturer's call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.
- System software and firmware updates required for reliability improvements and correction of any defects;
- Service Records and Reports
The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, provide the end-user of the equipment and the Contracting Officer with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced.
FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery/installation date is within 120 calendar days after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA located at 3900 NCTR Road, Jefferson, AR 72079.
Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum brand name or equal technical requirements.
The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:
• Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm);
• Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.
• Information on available service/maintenance plans.
• Three (3) years of past performance information for the manufacture and/or sale and maintenance support in which the offeror has provided same or substantially similar system solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent.
• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.
• Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment.
• If a large business, identify the subcontracting opportunities that would exist for small business concerns;
• Standard commercial warranty and payment terms; and
• Though this is not a request for quote, informational pricing is encouraged.
The government is not responsible for locating or securing any information, not identified in the response.
The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.
Interested Parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before July 26, 2019 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov, or mail to the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, Building 50, Room 422, Jefferson, AR 72079-9502. Reference FDA1217394.
Notice of Intent
Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.
Disclaimer and Important Notes
This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation.
Confidentiality
No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
Nicholas E Sartain, Contract Specialist, Phone 870-543-7370, Email nick.sartain@fda.hhs.gov
