SOURCES SOUGHT
H -- Clean Room Systems and Equipment Maintenance and Support
- Notice Date
- 8/3/2011
- Notice Type
- Sources Sought
- NAICS
- 811219
— Other Electronic and Precision Equipment Repair and Maintenance
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- P11-007944
- Archive Date
- 8/30/2011
- Point of Contact
- Brian J. Lind, Phone: 301-402-0735
- E-Mail Address
-
LindBJ@cc.nih.gov
(LindBJ@cc.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought/Market Survey Notification The National Institutes of Health, Clinical Center is conducting a market survey/sources sought to help determine the availability and technical capability of qualified businesses, veteran-owned small businesses, service disabled veteran-owned small businesses and/or HUBZONE small businesses capable of serving the needs mentioned below. This market survey/sources sought announcement is not a request for proposals and the Government is not committed to award a contract pursuant to this announcement. The information from this market research is for planning purposes only and will assist the Government in planning its acquisition strategy. This is strictly market research and the Government will not entertain questions concerning this market research. The Government will not pay for any costs incurred in the preparation of information for responding to this market survey. The National Institutes of Health (NIH), Clinical Center (CC) the Pharmacy Department; Pharmaceutical Development Section (PDS) has a requirement to procure a comprehensive maintenance contract for the High Purity Water Systems and other essential equipment, to maintain the equipment and systems operating and in compliance with regulatory standards that govern clean rooms and cGMP certified facilities. The North American Industrial Classification Code is 811219 and the size standard is $19,000,000.00 The vendor is to provide maintenance and support for the following systems and equipment located in the new PDS facility: High Purity Water System A single, Purified Water system provides high purity water to the facility for cleaning as well as pretreatment water for the Water for Injection/Pure Steam (WFI/PS) System. City water is fed to a custom fabricated Purified Water system. The pretreatment system consists of carbon filters and water softeners to protect a reverse osmosis / deionization (RO/DI) system. Pretreated water feeds the RO/DI system on demand, based on the operating state of the equipment. The RO/DI quality water then goes either to a pure steam generator for conversion to WFI, or in the case of the Purified Water, United States Pharmacopeia (USP) system, it goes into a 100 gallon break tank where it is pumped into a 100 gallon high purity storage tank. Purified Water is continuously circulated through a single natural polypropylene supply header running through the building. The following are the individual major components of the system. • Thermostatic Mixing Valve • Duplex Water Softener • Carbon Filter • Reverse Osmosis Unit • Deionization System • Distribution Pumps • Ultraviolet Sterilizer • Cooling Heat Exchanger • Conductivity Monitor Pure Steam Generator The MECO Clean Steam Generator is a skid-mounted, self-contained unit that uses the principals of evaporation to generate steam by evaporating high-purity water within the tubes of the vertical tube heat exchanger (evaporator). The pure steam generator provides USP Pure Steam (PS) for use in cleaning, compounding, autoclave sterilization, and vial washing. It consists of a single generator with separate WFI condenser and distribution of steam to an autoclave and vial washer. Reverse Osmosis/De-Ionized (RODI) water is fed to a PS Generator on a demand based on the operating state of the equipment. The generator converts the RODI water through distillation into Pure Steam for distribution to the users. The Pure Steam is condensed into WFI at 80 ± 2ºC based on tank level. Pure Steam is continuously supplied through a single 1.5" OD tubing supply header running through the building. The header is designed to supply PS at 45 psi with a pressure drop less than 10% of the supply value. The header is designed with sanitary steam traps to remove condensate on a continuous basis. The primary component is a vertical shell and tube evaporator. The unit is equipped with blow down cooler, control valves, and all the piping and instrumentation necessary to operate automatically. Water for Injection (WFI) The WFI-Pure Steam (PS) generator produces of Water-for-Injection (WFI) as defined by the USP. The WFI system will store and circulate water at 80°C from a 400 gallon SS316L storage tank and through SS316L piping to four distribution points. WFI from the WFI-PS generation equipment is fed to the Storage Tank on a demand based on level and temperature maintained by plant steam through a heating jacket. The tank temperature is controlled by a PLC system. The tank is maintained at atmospheric pressure by a jacketed hot hydrophobic vent filter. WFI is continuously circulated through a single 1.5" OD tubing supply header running through the building. The header is designed to maintain WFI velocity between 10 feet per second (fps) and the velocity range is maintained based on the hydraulic design of the system. The WFI Storage and Distribution Systems as installed is passivated to reduce corrosion and must be periodically de-rouged to maintain smooth, clean surfaces and reduce the potential for biological contamination. The following are the individual major components of the WFI system. • WFI Storage Tank • WFI Storage Tank Jacket • WFI Vent Filter Cartridge and Housing • WFI Circulation Pump • WFI Point of Use Exchanger Listing of Processing Equipment in PDS Beta Star (RVII) Steam Sterilizer Despatch Dry Heat Sterilizer LCC2-14-3PT Cozzoli GW24 Vial Washer Glatt Fluid Bed Dryer GPCG-2 Virtis Genesis 35 Super XL Freeze Dryer Killian Pressima Tablet Press Zanasi 6F Encapsulator 1 Cu Ft Twin Shell SD Portable Blender Miele Laboratory Glassware Washer Nitrogen/Argon System Compressed Air System HVAC and Environmental Vial Filler Syringe Filler Masterflex Pump Small Deduster Bubble Point Tester The contractor will be responsible for developing and maintaining a comprehensive maintenance agreement for the high purity water systems and equipment listed in order to keep systems operating to specification, maintain the validated state of the systems and equipment, and to meet regulatory requirements. Maintenance shall include such functions but not limited to the following: • Regular Inspections • Critical tests and checks • Troubleshooting • Replacement of consumable parts • Maintenance work such as passivation of stainless steel piping • Maintaining function of critical component systems The vendor must be completely up to date and have the requisite experience to maintain the listed systems and equipment according to the following regulatory guidelines and regulations. This list is provided as a reference and does not limit the knowledge base necessary for this requirement to these specific references. Current Good Manufacturing Practice (cGMP) Section 501 [21 U.S.C. § 351] (a) (2) (B) of the Federal Food, Drug, and Cosmetic Act Code of Federal Regulations 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, Or Holding Of Drugs; General Part 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals 21 CFR Part 600 Biological Products: General Miscellaneous cGMP for Phase I Investigational Drugs and Sterile Drug Products Produced by Aseptic Processing - cGMPs. 21 CFR 211.67 Subpart D and FDA guidance and inspection documents The contractor response shall also include any other specific and relevant information related to the requirements of this project that will enable the Government to determine the capabilities of the company to perform the specialized requirements described in this synopsis. Interested organizations must demonstrate and document in any response submitted, to this market survey extensive experience with and the ability to perform all of the specialized requirements elsewhere described. This notice is a market survey and is for information and planning purposes only and does not commit the Government to a contractual agreement. THIS IS NOT A REQUEST FOR PROPOSAL. The Government will not award a Contract based upon Contractor responses to this announcement. The Government shall not assume any costs for preparing or submitting any information in response to the market survey or the Government's use of the information. Any proprietary information should be clearly identified as "proprietary information".   Contractors must send written capability responses by August 15, 2011 to Mr. Brian Lind, Contract Specialist at Lindbj@cc.nih.gov or by mail at the address below. For any questions, please contact Mr. Brian Lind at 301-402-0735. Mr. Brian Lind Contract Specialist Clinical Center Office of Purchasing and Contracts 10 Center Drive Building 10, Room 1-1444, MSC 1604 Bethesda, MD 20892-5480
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/P11-007944/listing.html)
- Place of Performance
- Address: National Institutes of Heath, Clinical Center, Pharmacy Department, 10 Center Drive, Building 10, Room 1C266, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02520137-W 20110805/110803235326-2f2810dda784092cafcc04c316f05803 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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