MODIFICATION
66 -- Particle Measuring devices
- Notice Date
- 2/19/2010
- Notice Type
- Modification/Amendment
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- 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
- P171190
- Archive Date
- 3/25/2010
- 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 (NIH) Clinical Center Pharmacy Department is conducting a market survey to determine the availability and technical capability of qualified small businesses, including (8A) small businesses or HUBZone small businesses capable of providing the following services; The NIH Pharmacy, Pharmaceutical Development Services (PDS), is engaged in building a new facility in compliance with FDA current Good Manufacturing Practices (cGMP). Clean room operations in this facility are required to have environmental monitoring systems in place to ensure clean, safe drug production. Among the monitoring systems required include the ability to monitor the size and quantity of particulates and to take microbial samples in the critical areas where sterile products are formulated. These devices that are needed will automatically and aseptically measure the size and number of particles as well as help characterize the microbial burden in the air in the areas where sterile solutions are manufactured by NIH/PDS, these solutions are to be used as vaccines for children, vaccines for Homeland Security (NICHD), Bone Marrow support media, Heparin Injections (NHLBI), to name just a few. The following are the salient characteristics needed with this equipment;  The devises used must be compliant with applicable cGMPs for monitoring particles in class 100 and class 10,000 environments.  The device must have 8 monitoring ports dispersed throughout the area and to contractor must be able to advise on the ideal placement of these devices and to demonstrate their ability to properly give this advice.  All the ports must be controlled by a single central vacuum system that can operate on 120V power.  The contractor must have the knowledge to install such a vacuum device in compliance with building codes and NIH safety regulations.  The devices placed in the class 100 environments must be capable of being entirely steam sterilized.  The devices must be compatible with peroxide/acetic acid decontamination processes.  The devices must be able to work in the limited space of a commercial laminar flow hood.  Easily assembled and broken down for cleaning and decontamination.  Can be handled by a single trained operator.  Will be capable of interfacing with a documentation system installed remotely from the Clean rooms that will automatically and continuously display and save data indefinitely with the capability of being able to print out data in a span from 5 minutes to more than 2 years. This interface must also have the capability of giving audible and visible alarms when specifications are exceeded.  The interface must be effective with a 4-20 mA signal.  The contractor will also work with the interface with the documentation device and be on-site to cooperate with the associated vendor, to ensure proper integration of the hardware/software.  The microbial monitor must be capable of recording and saving operational data in compliance with appropriate cGMPs the contractor must be capable of documenting this compliance. Service Requirements  The monitoring devices must be installed by experienced craftspeople who have pharmaceutical experience.  These craftspeople must have experience working with stainless steel hoods and bio-safety cabinets, and to seal these penetrations in such a way as to withstand FDA inspection.  These craftspeople must have experience in properly making other attachments and placements in such a way as to withstand FDA inspection, this would include properly sealing penetrations created during the installation process.  The contractor must provide a drawing showing precise detail of the specified system, including P&ID and documentation describing the installation and operational tests. In addition the equipment must meet the following minimum performance standards;  The systems must operate continuously with brief(less than 24 hr) 6 month intervals for maintenance.  The modules must be designed to accommodate a broad variety of disinfectant and cleaning solutions. Offerors must provide descriptive literature or other materials that demonstrates their ability to meet the forgoing requirements. Firms with the capability of providing the required equipment as listed above are required to submit a capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502(b) whether or not this procurement will be set aside for any of the programs described above. The intended procurement will be classified under the North American Industrial Classification (NAIC) code 334516 with a size standard of 500. All respondents are requested to identify their firm's size and type of business. The capability statement should not exceed 25 pages and be in sufficient detail so that the Government can determine the experience of your firm to provide the requirements above. Capability statement must be received at the address indicated in the posting details no later than 3:00 PM EST at on March 10, 2010. This notice is a market survey and is for information and planning purposes only and does not commit the Government to any contractual agreement. This Is Not a Request for Proposals. The Government will not award a Purchase order or Contract based upon vendor 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"
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/P171190/listing.html)
- Place of Performance
- Address: National institutes of Health, 10 Center Drive, Building 10, Room 1N-249, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02070098-W 20100221/100219235645-ac6cb6bd395947353d13b3235ad59edd (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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