SPECIAL NOTICE
66 -- 3ME-SC203A TSCDII 110V
- Notice Date
- 7/7/2016
- Notice Type
- Special Notice
- 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
- 16-011746
- Archive Date
- 7/22/2016
- Point of Contact
- Andre M. Moody, Phone: 3014022677
- E-Mail Address
-
moodya@cc.nih.gov
(moodya@cc.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. The Government intends to award a fixed price purchase order to Terumo BCT, Lakwood, CO 80215. The Department of Transfusion (DTM) at the National Institutes of Health (NIH) Clinical Center (CC), Bethesda, MD has a requirement to procure the supplies listed below: The Cell Processing Section (CPS) is responsible for the manufacture of human cells and tissue based products utilized in phase I/II clinical protocols for transplantation, adoptive immunotherapy and gene therapy conducted in the Clinical Center at the NIH. Cell processing procedures are tailored to each of the 30 or more different patient-care clinical research protocols supported. Also, regarding Institute research support it: Develops biologics collection and manufacturing processes to support clinical trials Collects, manufacturers and distribute blood components for in vitro research use Collaboration in the design, planning execution and data analysis of clinical studies Collects and manufacturer specialized cellular products to support clinical trials Develops and evaluate assays for clinical application and biologics safety testing and cellular characterization. Primary Item Sought: Description:TSCDII 110V Catalog No.:#MESC203A Quantity:3 Unit of Issue:each The Terumo Sterile Connecting Devise (SCD) allow for the sterile connection of two bags together which guarantees the sterility and safety of the blood/blood products. The Terumo TSCDII that the Cell Processing Section must procure are used throughout the lab. The parts for the TSCDII are compatible and exchangeable with the existing one. It allows for a "closed system" where blood/blood products are not exposed to the air/environment and thus does not risk being contaminated. Also, tested the potentiality of the instrument for our multiple application another device would require another validation and the performance of comparability study. The proposed vendor, Terumo, is the only company that manufacturers this instrument. The Terumo Sterile Connecting Device (SCD) allows for the sterile connection of two bags together which guarantees the sterility and safety of the blood/blood products. The Terumo TSCDII that the Cell Processing Section are used throughout the lab. The parts for the TSCDII are compatible and interchangeable with the existing ones. It allows for a "closed system" where blood/blood products are not exposed to the air/environment and thus does not risk being contaminated. The Cell Processing Laboratory has over twenty (20) of these instruments. A change to another type of instrument would require revalidating (and qualifying) the instrument, retaining staff, and revising and seeking approval of SOPs.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/16-011746/listing.html)
- Place of Performance
- Address: National Institutes of Health, 9000 Rockville Pike, Building 10, Room 3C720, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04174643-W 20160709/160707235611-ba7d25b736faa695126799a4a07d2183 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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