Annual Preventative Maintenance and Service Support for Seven (7) Miltenyi CliniMACS Prodigy Instruments

Ce que l'acheteur demande

The National Institutes of Health (NIH), Clinical Center (CC), Department of Transfusion Medicine (DTM), Center for Cellular Engineering (CCE), intends to award a sole-source, firm-fixed-price contract to Miltenyi Biotec, Inc. for annual preventative maintenance and service support of seven (7) CliniMACS Prodigy automated cell-processing instruments, Serial Numbers 0327, 611, 1223, 1326, 1415, 1855, and 917006. Period of Performance: December 1, 2026 – November 30, 2027 These instruments are critical to the manufacture of cell-based therapies for patients participating in clinical trials at the NIH Clinical Center. The equipment operates within Food and Drug Administration (FDA)-regulated Current Good Manufacturing Practice (cGMP) facilities and must be maintained in accordance with applicable regulatory requirements, including 21 CFR 211.63 and 21 CFR 211.67. The required services include annual preventative maintenance, calibration, software updates and patches, inspections, diagnostic testing, troubleshooting, repair support, replacement of proprietary service parts, and technical support necessary to maintain validated operating conditions. The contractor shall provide preventative maintenance reports for each instrument for review and acceptance by the CCE Quality Assurance team. Sole-Source Authority and Justification The Government intends to procure these services on a sole-source basis pursuant to 41 U.S.C. 3304(a)(1) and Revolutionary FAR Overhaul (RFO) FAR 6.103-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. Miltenyi Biotec, Inc. is the original equipment manufacturer (OEM) of the CliniMACS Prodigy instruments and the only known authorized source capable of providing the required preventative maintenance, calibration, software support, and repair services. The CliniMACS Prodigy instruments are proprietary systems requiring manufacturer-specific diagnostic tools, software access, replacement parts, and specialized technical expertise. Market research conducted by the Government identified no alternative sources possessing the necessary proprietary rights, manufacturer authorization, software access, and technical capabilities to perform the required services. The instruments have been qualified and incorporated into validated manufacturing processes supporting patient-specific cellular therapies. Utilizing an unauthorized service provider could compromise equipment qualification, disrupt manufacturing operations, increase regulatory compliance risks, and require extensive and costly requalification activities. Such disruptions could adversely affect ongoing clinical trials and patient treatment schedules. Accordingly, Miltenyi Biotec, Inc. has been identified as the only responsible source capable of satisfying the Government's requirements without jeopardizing validated manufacturing processes, operational readiness, and continuity of patient care. Capability Statement Submission This notice is not a request for competitive quotations or proposals. However, all responsible sources that believe they can meet the Government's requirements may submit a written capability statement for consideration. Interested parties must provide sufficient documentation demonstrating their technical capability to perform the required services, including evidence of: Manufacturer authorization to service and maintain Miltenyi CliniMACS Prodigy instruments. Access to proprietary diagnostic software, service tools, technical documentation, and OEM replacement parts. Demonstrated experience performing preventative maintenance, calibration, and repairs on CliniMACS Prodigy instruments. Ability to maintain equipment qualification and compliance with FDA-regulated cGMP manufacturing requirements. Ability to provide required maintenance documentation and technical support without disrupting ongoing clinical manufacturing operations. All capability statements must be received no later than…

Langue de cet avis : English. Le titre et la description sont affichés tels que publiés par l'acheteur.

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