THIS IS A SOURCES SOUGHT ANNOUNCEMENT ONLY. It is neither a solicitation announcement nor a request for proposals or quotes and shall not obligate the Government to award a contract. The purpose of this Sources Sought Announcement is for market research to gain knowledge of potential qualified sources interested and capable of performing the work and obtain their size classification relative to the North American Classification System (NACIS) Code 333993 with a size standard of 500 employees. A. GENERAL INFORMATION Background: The Department of Veterans Affairs (VA) Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) requires the purchase of a new tablet press machine to replace a seven year old unit purchased in 2006 to modernize CSPCRPCC capability to efficiently manufacture active and placebo tablets for research clinical drug trials. Pharmaceutical equipment manufacturers stop supporting their software and equipment after about seven years due to advances in the equipment and software technology. Scope of Work: The contractor shall provide the equipment, installation, validation package, training and all other resources required to deliver the requirements stated in this SOW. This contract is tablet manufacturing for the purchase of equipment which the CSPCRPCC will use to make active and placebo tablets that will be taken by veteran patients residing in the U.S. and throughout the world that are participating in VA research clinical trials. This is a salient requirement, and is not flexible. The following are the minimum salient characteristics that must be met: a) The tablet press must be GMP compliant. b) The tablet press must have 20 stations. c) The tablet press must have a turret sized for TSM "D" tooling. d) The tablet press must be able to produce single sided tablets. e) The tablet press must have an exchangeable turret. f) The tablet press must include a device to lift the turret out of the press. g) The turret for the tablet press must have its own service cart. h) The tablet press must have Compression Force of at least 75kN. i) The tablet press must have Precompression Force of at least 35kN. j) The tablet press must output at least 95,000 Tablets/Hour. k) The tablet press must include a touch screen. l) The touch screen for the tablet press must have a software control system. m) The software control system for the tablet press must have the following capabilities: ? 21 CFR Part 11 compliant ? Password login ? Display of critical parameters ? Alarm and alarm history audit trail ? Event log audit trail ? Product recipe storage and retrieval n) The tablet press must have single tablet rejection capabilities. o) The tablet press must be fully automated. p) The tablet press must have a modular design for ease of cleaning q) The tablet press must have an enclosed compression zone. r) The tablet press must run at less than 75decibals. s) The tablet press must have at least a one year warranty. t) The tablet press must include three sets of TSM "D" round tooling. u) The tablet press must have a sampling discharge chute. v) The tablet press must come with a basic tool kit for use on the tablet press. w) The tablet press must be manufactured within the United States or Europe. x) The tablet press must go through a Factory Acceptance Test at its facility. y) A report from the tablet press' Factory Acceptance Test must be included. z) The tablet press must include on-site installation. aa) The tablet press must include on-site calibration bb) The tablet press must include on-site execution of validation protocol. cc) The tablet press must include on-site training program. REQUESTED INFORMATION: STATEMENT OF CAPABILITY: Submit a brief description (five [5] pages or less) that shows your company can provide the required services. One additional page may be included explaining experience in performing these services to the VA, other government agencies, or for private facilities. Potential sources should identify business name, point of contact, business size and any applicable business socio-economic category (i.e. small business, SDVOSB, VOSB, SB, etc), DUNS number, address, and any additional information felt to be pertinent. All vendors must be registered in SAM https://www.sam.gov/portal/public/SAM/ prior to contract award. Responses to this notice should be electronically mailed in PDF format or word format to
[email protected]. Telephone responses will not be accepted. Written responses must be received no later than 3:00 PM (EST), Friday, July 26, 2013. Contracting Office Address: Department of Veterans Affairs; Service Area Office East, 323 North Shore Drive, Pittsburgh PA 15212. Delivery and Place of Performance: Equipment is to be delivered and installed by the contractor at: VA Cooperative Studies Program 2401 Centre Avenue, SE ATTN: CSP Warehouse (151-I) Albuquerque, NM 87106-4180 Type of Contract: Stand Alone Contract. Point of Contact(s): Cheryl Homison Contracting Officer 412-822-3493
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