MODIFICATION
66 -- Vacuum/Gravity, Microcomputer-Controlled Steam Sterilizer
- Notice Date
- 8/7/2007
- Notice Type
- Modification
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001, UNITED STATES
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-07-0038
- Response Due
- 8/13/2007
- Archive Date
- 8/28/2007
- Point of Contact
- London Johnson, Contract Specialist , Phone 301-827-7041, Fax 301-827-7039, - London Johnson, Contract Specialist , Phone 301-827-7041, Fax 301-827-7039,
- E-Mail Address
-
London.Johnson@fda.hhs.gov, London.Johnson@fda.hhs.gov
- Description
- Questions and Answers to FDA-SOL-07-00338 (Sterilizers) 1. Specification stated requirements for Automatic Steam boiler Blowdown and secondary low water cutoff which are for steam generators. However, spec state house steam is available, no power is available for a boiler, and no clean steam is available either. Is a clean steam generator required? Will the power be available? A steam filter will be put in place to clean up the steam. Power will be available for any need for the operation of the unit. 2. Specification states requirements for a vacuum pump. However no power is available for the pump. Please advise if the vacuum pump is required or if power will be made available for the pump? The vacuum pump is needed to evaluate the steam and dry the contents of the autoclave to remove as much steam and water as we can. This will keep the vials from collecting water in and around the vials 3. A Cross Contamination Barrier is requested but it looks like only a single door is required. Cross Contamination Barriers are used with double door units. Is this unit a single or double door? The unit requested is a single door. 4. If it is a double door, which side should the Cross Contamination Barrier be on, the control side (load end) or the remote end (unload end)? Not applicable, we need a single door unit. 5. A boiler control and safety device (CSD-1) option is requested but the unit does not request an integral boiler. This option is only used in conjunction with an integral boiler and you have house steam available it looks like. Please verify. No, in checking with the on-site engineers, we do not need this device. There was some confusion about this matter with the architects, but I think we have resolved the issue. 6. The Auto Blowdown option is also only used in conjunction with an integral boiler and you have house steam I believe. Please verify. We do have house steam and since we do not need the control/safety device, we also do not need this option. 7. Stainless Steel piping to the chamber is requested and typically a facility has clean steam available when stainless piping is used. Is this in fact the case or if you do not have clean steam? I think you might want to consider using copper and brass piping to save money if clean steam is not available. Clean steam is not available in this facility, but we had anticipated installing a filter on the steam line to remove as much physical debris as possible before the steam enters the autoclave jacket to protect the unit. Where possible, we would like to have stainless Steel, perhaps on the downstream side of the filter. Above the filter, we could specify Copper and brass piping. 8. What is being sterilized that a vacuum pump is required? The unit you specified comes with a water ejector to create a vacuum and run the vacuum cycles. The addition of the vacuum pump option is only used to pull a deeper vacuum after the water ejector. I do not think this is required and can save significant cost as well. We have to dry wrapped goods in the unit, and were under the impression that additional vacuum was necessary to dry these materials. Because this was not specified in earlier purchases, a unit was purchased that did not have any vacuum cycles. We wanted to be sure that we can dry wrapped goods in the unit; perhaps those are the key words we need in the request. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (07-AUG-2007); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-07-0038/listing.html)
- Place of Performance
- Address: United States Food and Drug Administration Center for Biologic Evaluation and Research NLRC RMD 174 HFM-407 5516 Nicholson Lane Kensington, Maryland
- Zip Code: 20895
- Country: UNITED STATES
- Zip Code: 20895
- Record
- SN01365344-F 20070809/070807224842 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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