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FBO DAILY ISSUE OF SEPTEMBER 08, 2005 FBO #1382
MODIFICATION

66 -- Freeze Dryer

Notice Date
9/6/2005
 
Notice Type
Modification
 
NAICS
334516 — Analytical Laboratory Instrument Manufacturing
 
Contracting Office
Department of Commerce, National Institute of Standards and Technology (NIST), Acquisition Management Division, 100 Bureau Drive, Building 301, Room B129, Mail Stop 1640, Gaithersburg, MD, 20899-1640
 
ZIP Code
20899-1640
 
Solicitation Number
SB1341-05-Q-0994
 
Response Due
9/12/2005
 
Archive Date
9/13/2005
 
Small Business Set-Aside
Total Small Business
 
Description
Questions received by September 2 and responses to each of them are as follows: Question 1: Is the stainless steel construction out of 304SS or 316L SS? Answer to Question 1: At a minimum, stainless steel construction shall be of 316L for shelves and 304 for other parts. Question 2: Is the condenser internal or external? Answer to Question 2: Condenser may be either internal or external. Question 3: Can the equipment be water cooled? Answer to Question 3: Yes. Question 4: The ?freeze dryer? shall drop from +20C to -40C in less than 20 minutes. Is this the shelf temperature or the condenser temperature spec? Answer to Question 4: This is the shelf stack temperature. Question 5: Please clarify cGMP and FDA inspection and requirements. Answer to Question 5: The original minimum acceptance criteria in the RFQ are deleted and replaced with the following new criteria: ?Acceptance will be contingent upon completion of installation at the Government Facility (Hollings Marine Laboratory) and receipt of Factory Acceptance/Site Acceptance Tests (IQ/OQ) Basic Documentation which includes: quality control (QC) test data, calibration certificates, refrigeration and wiring diagrams, MSDS Sheets, component serial numbers, acceptance criteria and suggested Operational Qualification (OQ) protocols for the instrument.? All other terms and conditions from the original RFQ remain unchanged.
 
Record
SN00886881-W 20050908/050906211647 (fbodaily.com)
 
Source
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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