Description
Background Food and Drug Administration (FDA) Winchester Engineering and Analytical Center (WEAC) has participated in annual interlab round robin studies for condom air burst testing based on the ASTM D-3492 standard. WEAC is the only FDA lab that participates in the robin round studies. Center for Devices and Radiological Health (CDRH) relies on WEAC’s work with air burst condom testing. WEAC has also performed air burst condom testing on suspected counterfeit condoms, which is very important for public health and safety. WEAC is also involved in the reviews and revisions for the ASTM and ISO-4074 condom standards. Our feedback is based on our results from condom air burst testing. IRVLMP instrument is in support of WEAC and these inititives to further FDA’s capabilty for protecting public health. The current air burst machine WEAC uses is manual, was purchased in 1990, and can only test one condom at a time. A new and modern automatic condom air burst machine that can test multiple condoms at the same time would be more efficient and increase productivity for both laboratories. Objectives Purchase two (2) Automated Condom Air Burst Machines (1 for WEAC and 1 for IRVLMP). Demonstrate system functionalities and acceptable performance per manufacturer’s specifications after installation. Provide onsite training on basic operation, routine maintenance, and system troubleshooting. Requirements The requested automated condom air burst machines shall be a product with all the software, hardware, and accessories, necessary to properly conduct condom air burst round robin studies and sample analysis. The contractor shall meet or exceed the following salient characteristics and ensure the following: Accurate Inflation System (AIS) for determining bursting volume and pressure of male condoms (with adapters available for female condoms). Shall Include PC with MS Excel and application software for data acquisition and analysis. Shall be installed in soundproof chambers Shall have the ability to test at least 2 condoms at the same time. Shall have an automatic push button operation control. Shall have a pressurized air regulator with fine filters. Shall have spare parts including O-rings, fuses, spare fine filters, pneumatic connectors. Displacement Calibration Instrument (DCI) shall allow in-house calibrations and eliminate the cost of external calibration services. Shall include a length mandrel for male condoms. Shall have approximate footprint requirements for each individual cabinet: Length: 2’, Width: 2’, Height: 5’. (Each cabinet would contain 1 condom.) Performance Specifications. Volume, and Pressure Accuracy: Within ± 1.0% of the Measured Value. Installation/Delivery, Warranty, Training, Preventive Maintenance (PM) and System Updates: The components and/or equipment shall be a newly manufactured, not used, refurbished, or previously used for demonstration. FOB Point destination to include inside delivery and clean-up of area after installation. The entire system shall be warranted for parts and labor for a minimum of 1 year from date of formal government acceptance. The warranty must include unlimited telephone/e-mail support for questions regarding operation. Lifetime technical assistance shall be included. Offered systems shall be a turn-key solution, (i.e. the contractor shall be responsible for providing all software, hardware, components, and accessories.) The products shall be fit for its intended purpose. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. The vendor shall demonstrate upon installation that the system meets or exceeds all performance specifications which have been included in the vendor’s response and/or used are evaluation criteria for award. The instrument shall not be accepted until those performance specifications have been met. No subcontractors or other personnel not employed by the offeror shall be utilized for instrument service. Onsite training on basic operations and familiarization of the installed automated condom air burst tester shall be provided to at least one operator. All service costs, (i.e., software, accessories, labor, freight, and travel) must be included. Shall have included support for the lifetime of the automated condom air burst machine. Delivery Location/Place of Performance Delivery must be coordinated with each laboratory at least 48 hours in advance. Shall enter the building from the loading dock Shipping locations: FDA Winchester Engineering and Analytical Center (WEAC) 109 Holton Street Winchester, MA 01890 Attn: To be identified at time of award FOB destination FDA - The Irvine Medical Products Laboratory (IRVLMP) 19701 Fairchild Irvine, CA 92612 Attn: To be identified at time of award FOB destination Security Check in with Security at front entrance. Period of Performance: The Period of Performance begins the date of contract award execution and continues for one year (or longer depending on how long the OEM offered warranty period is) from the date of formal government acceptance. Instrument to be delivered no later than 60 days after award is made. Type of Contract: The Government anticipates issuing a firm fixed-price purchase order.