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THIS REQUEST FOR INFORMATION (RFI) / SOURCES SOUGHT NOTICE IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES. THIS IS NOT A SOLICITATION. SUBMISSION OF INFORMATION ABOUT PRICING, DELIVERY, THE MA... THIS REQUEST FOR INFORMATION (RFI) / SOURCES SOUGHT NOTICE IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES. THIS IS NOT A SOLICITATION. SUBMISSION OF INFORMATION ABOUT PRICING, DELIVERY, THE MARKET, AND CAPABILITIES IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI FOR PLANNING PURPOSES IN ACCORDANCE WITH (IAW) FAR 15.201(e). DISCLAIMER This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. SOURCES SOUGHT/RFI DESCRIPTION This is NOT a solicitation announcement. This is a Sources Sought Notice / RFI only. The purpose of this Sources Sought Notice / RFI is to gain information about potential qualified sources and their size classification relative to NAICS 334514 (size standard of 850 Employees). Responses to this Sources Sought Notice / RFI will be used by the Government to make appropriate acquisition decisions. After review of the responses to this Sources Sought Notice / RFI, further RFIs and/or a solicitation or other announcements may be published. The Department of Veterans Affairs (VA) is seeking sources capable of providing Bottle Tablet Counter. STATEMENT OF WORK BACKGROUND The VA Clinical Research Pharmacy Coordinating Center (CSP CRPCC) bottles drug products to ship to veteran patients across the U.S. in support of VA clinical trials. The bottles must be filled with the correct number of tablets or capsules. Accurate count of drugs is essential to veterans’ care since bottling is the most frequently used production process at CRPCC. Shipping term is FOB Destination. All shipping cost must be included in unit cost. SCOPE The contractor shall provide all equipment, parts, installation, and training. SPECIFIC TASKS DELIVERABLES CLIN Description Quantity UOM 0001 DATA Tablet Counter ICU 60 machines or equivalent bottle tablet counter 1 EA 0002 Additional accessories to perform required functions listed under salient characteristics (if applicable) 1 EA 0003 Installation and training (if applicable) 1 JB Bottle Tablet Counter must have following salient characteristics: Tablet counting approaching 100% accuracy as documented by qualifications of development machines and counters previously sold. Data must be provided with the offer for evaluation. Must take less than 3 minutes to tear down the bottle filler and less than 3 minutes to reassemble the bottle filler. Must be insensitive to dust; the counter does not have to be shut down to clean off the sensor when ‘dust’ on product (primarily from tablets) covers the sensor. Must be able to count tablets and capsules, softgels (liquid filled soft gelatin capsules), oily, shiny, translucent, or reflective products. Product changeover must not require tools. Tablet and capsules counting mechanism (camera counting system) must not touch the product to minimize cleaning. Must have wireless connectivity to allow remote connection to the machine to provide service and troubleshooting support if needed. Must have an ability to control remotely for support if needed. Filler equipment that extends over the conveyor belt and into the operator area is not acceptable due to limited space at the facility. Must be able to separate the camera vision system from the feeding track. Must provide a minimum of five (5) year parts warranty. Must be vision-based system; the system uses cameras, lighting, sensors, and imaging processing software to automatically inspect tablets and capsules for defects and deviations from pre-set (recipe driven) criteria and to accurately and quickly count the number of tablets/capsules being filled into each bottle. Must process up to 60 bottles per minute for 100 count bottles, and 15 bottles per minute for 1000 count bottles. Must have a minimum of 30L hopper capacity. Must be able to process following dimension bottles: 40mm – 200mm height, 30mm – 120mm diameter, round and oval shaped bottles. Must be able to process tablet and/or capsule of 3mm – 30mm in length, 2mm – 20 mm in diameter/width. Equipment’s input voltage must be 230 VAC 50 / 60HZ, single phase, 1000W. Compressed Air: Air intake system 6mm, dry air compressor, 6 bar – VA currently has an in-house compressed air system. Equipment exceeding this amount of compressed air is not acceptable, as it would require an additional purchase to meet the increased demand. Product contact parts must be 316L stainless steel or FDA approved product contact material. Parts must be corrosion resistant. Must provide a minimum of one year warranty on equipment and a minimum of five warranty on parts without extra charge Software upgrades over life of the bottle filler must be included in the purchase price. Must be Wi-Fi compatible (remote connectivity) Overall dimension must not exceed footprint of 45” X 22” X 76.5”. Must fit through a door with a height of 76.5”, width of 6’ Total equipment must not exceed 2,300 lbs. Must not exceed 70 decibel rating when running 7mm round tablets to prevent noise pollution at the facility. Must have a defective product verification system which recognizes defective product and broken pieces as small as 0.5mm. The counter shall stop counting when it detects a defective product and shall reject the bottle. Must include an integrated, automated gating/indexing system that facilitates continuous bottle flow and counting. Must have sensors for bottle orientation (upside down), bottle in filling position, reject station, outfeed. Must have Touch-panel/screen, PC-based HMI with intuitive graphic interface Must have adjustable height The contractor must install equipment at the Pharmacy Coordinating Center (PCC). Must detect Foreign color. Must have Color detection + 10% color difference per color for tablets or capsules being run for its accuracy. Must be capable of at least three (3) tablet/capsule precounts (precounts product to ensure continuous, uninterrupted operation of the filling line). Must be able to count tablets and capsules. Must count an infinite number of tablets per bottle. There must be no blind spots in the counting area. Must have a vision and algorithm-based counting. Must be Federal and Drug Administration (FDA) Good Manufacturing Practice (GMP) and 21 CFR Part 11 compliant. Must include an automated product recipe setup specifically designed for drug products, in order to minimize manual configuration and reduce overall setup time. Measurements shall be taken using camera and product (calibrations or similar) holding tool for input in the product recipe. Must be able to process Unlimited Recipe programs for products. Vendor must provide on-site training a minimum twice for a year. Must provide Factory Acceptance Testing (FAT) at the contractor/manufacture site and provide a video link for PCC personnel to observe the testing. Installation Qualification (IQ) and Operational Qualification (OQ) must be conducted by contractor at the PCC facility and observed by at least one PCC staff member IQ/OQ documents must be provided in English no less than one month prior to conducting IQ/OQ verifications. Must provide English Language Operations and Maintenance Manuals. Must provide English Language Equipment schematics. PERFORMANCE MONITORING Installation will be performed by a certified manufacturer-trained service engineer. Installation Qualification (IQ) and Operational Qualification (OQ) will be performed by the manufacturer-trained service engineer to ensure proper working specifications. SECURITY REQUIREMENTS This procurement is primarily for goods (equipment and software), but there is an installation component as well. Contractor’s personnel shall be required to come to the CSPCRPCC facility to install the equipment. Contractor’s personnel shall have no access to VA IT systems, PHI, or any equipment connected to the VA network. Additionally, contractor personnel shall be escorted and monitored at all times by a CSPCRPCC staff member as mandated and strictly enforced according to CSPCRPCC security policy. The C&A requirements do not apply, and a Security Accreditation Package is not required. PLACE OF PERFORMANCE VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 2401 Centre Avenue, SE Albuquerque, NM 87106 PERIOD OF PERFORMANCE Contractor must deliver equipment no later than (NLT) 3-months after receipt of contract and complete all services NLT 6-months after receipt of contract. The list of DRAFT characteristics is intended to be descriptive, not restrictive, of the supplies/services that are required. If your company is interested and capable of providing the required supplies/services, please provide the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) Submit your capabilities statement illustrating how your organization can/cannot meet the list of SOW requirements. For instances where your company cannot meet the SOW requirement(s), please explain. For instances where your company can meet the SOW requirement(s), please show how your company meets/exceeds each requirement. (2) Please review the list of SOW requirements and provide any additional feedback or suggestions. If none, please reply as N/A. (3) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran-Owned Small Business (SDVOSB), Veteran-Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc. (4) Is your company considered small under the NAICS code identified in this RFI? (5) Are you the manufacturer, authorized distributor, and/or can your company provide a solution to the required supplies/services described in the list of SOW? (6) If you are a large business, do you have any designated/authorized distributors? If so, please provide their company name, telephone, point of contact and size status (if available). (7) If you’re a small business and you are an authorized distributor/reseller for the items identified above, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified. (8) Limitations on Subcontracting: How does your business ensure compliance with the limitations on subcontracting as outlined in 13 CFR § 125.6? (9) Are the items you are identifying/providing considered Commercial of the Shelf (COTS) items as defined in FAR Part 2.101 under commercial items? (10) Non-Manufacturer Rule: If applicable, can you confirm your business complies with the Non-Manufacturer rule? Specifically, does your company: Provide a product from a small business manufacturer or processor? Not exceed 500 employees? Primarily engage in the retail or wholesale trade and normally sell the type of item being supplied? Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice? (11) Please indicate whether your product conforms to the requirements of the Buy American Act? (12) What is your lead time to deliver a single unit with all components? Is there scale in lead time with greater quantities? Please elaborate. (13) What is estimated life span of your solution? What support/services does that entail? (14) Does your proposed equipment have FDA clearance? Please specify what FDA clearance(s) have been obtained. (15) Does your organization offer a leasing solution? Please elaborate. (16) Does your company have a Federal Supply Schedule (FSS) GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract? If so, please provide the contract number(s). (17) If you are an FSS GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract holder, are all the items/solutions you are providing information about available on your schedule/contract? Please state if all or some items are available on the contract. (18) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. (19) Please provide your SAM.gov Unique Entity ID/Cage Code number. Responses to this notice shall be submitted via email to Hestia.Sim@va.gov. Telephone responses will not be accepted. Responses must be received no later than Thursday, June 19, 2025, by 10AM Pacific Local Time. All responses to this Sources Sought/RFI will be used for planning purposes only. Responses to this Sources Sought Notice / RFI are not considered a request to be added to a prospective bidders list or to receive a copy of the solicitation. If further RFIs and/or a solicitation or other announcement is issued as a result of the information provided from this RFI, all interested parties must respond to the specific posting separately IAW the specifications of that announcement.