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