23-007210

Submitted by fratecm on
Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Repair of CGMP hot cells
Contracting Office
National Institute of Mental Health (NIMH)

Contact Points

Primary Contract Specialist

Cheryl
Leone
cleone@mail.nih.gov

Secondary Contracting Officer

Dionne
Draper
dionne.draper@nih.gov
NAICS Code Number
334516
Analytical Laboratory Instrument Manufacturing
FPDS Classification Code
N049
Estimated Period of Performance
approximately 60 days ARO
Competition Status
Non-Competitive
Vendor Name
Mirion Technologies (Capintec), Inc.
Vendor Address
7 VREELAND ROAD
FLORHAM PARK, NEW JERSEY 07932 USA
Single-Sole Source Determination
The proposed repair service for cGMP hot cell manufactured by Capintech Inc. herein, is available from only one source, Capintech Inc. and competition is precluded for the reasons indicated below. There are no substitutes available. There is no other hot cell manufacturer who repairs mechanical parts and replace broken parts manufactured by another company. All the hot cell doors in the CGMP laboratory in building 10 room B3-6620 is manufactured and installed by Capintech, and therefore, parts and labor for repairing the front door must be provided by Capintech. The HEPA filters are specially fabricated for these hot cells and only CAPINTECH can obtain these HEPA filters.
Background/Description of Requirement
  1.  

  2. The CGMP hot cell is designed to be capable of maintaining the air quality of ISO 6. The replacement of HEPAfilters will re-enable the capability of maintaining the air quality.

    The clogged filters will obstruct the air flow into the hot cell and the generate high pressure difference between the outside and inside of the hot cell. The new filter will ease the load of the motors for supplying air. All the mechanical parts for the operation of the vertical doors must be inspected and serviced by the certified engineers from the manuifacturers.

  3.  
  4. The HEPA filters needs to be replaced annually according to the manual of hot cell manufacturer, but they were never replaced since 2017.  The required filters are available only through the original manufacturer, CAPINTECH. The clean air is recommended for the safe production of drugs for human subject. Also, all the gear boxes and motors needs to be serviced by the certified engineers from the manufacturer.
  5.  
  6.  
    1. Description of the Item or Service.

1) Inspection of the hot cell vertical door drive system that

would include adjustment of positioning of the driven timing belt.

pulley and replacement of damaged or missing components like

keys or set screws.

2) Maintenance of the hot cell drive system and its components

that would include lubrication of drive screws and gearboxes, and

drive shaft support bearings.

3) HEPA and exhaust carbon filters replacement on

(4) vertical doors hot cells

(2) Mini cells.

If additional repairs or parts replacement would be found

necessary, the additional quotation would be generated and

provided upon completion of the service.

Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.