Preventative Maintenance and FullCare Service Support for Cytiva Sepax C-PRO Cell Separation Systems
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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 procure preventative maintenance and FullCare service support for six (6) Cytiva Sepax C-PRO closed cell separation systems from Global Life Sciences Solutions USA LLC / Cytiva. The anticipated period of performance is December 18, 2026 � December 17, 2027. CCE manufactures cell-based therapies for patients enrolled in NIH-sponsored clinical trials. These manufacturing activities are conducted under Food and Drug Administration (FDA)-regulated Current Good Manufacturing Practice (cGMP) conditions. The Sepax C-PRO instruments are critical to validated manufacturing processes and require preventative maintenance, calibration, and technical support to ensure continued operational readiness and regulatory compliance. The requirement includes preventative maintenance, calibration, inspections, software updates, troubleshooting, repair support, replacement of worn or proprietary service parts, and technical support for the following six (6) Sepax C-PRO instruments: 29264741-6995.4290 29264741-6994.4253 29264741-7133.4253 29264741-8298.2213 29264741-8299.2213 29264741-8300.2213 The contractor shall ensure the equipment operates within manufacturer specifications and provide preventative maintenance documentation for review and approval by the CCE Quality Assurance team. These services are necessary to maintain compliance with applicable FDA regulations, including 21 CFR 211.63 and 21 CFR 211.67. Basis for Intended Sole Source The Government intends to award this requirement on a sole-source basis to Global Life Sciences Solutions USA LLC / Cytiva pursuant to the authority of 41 U.S.C. 3304(a)(1), as implemented by Revolutionary Federal Acquisition Regulation Overhaul (RFO) FAR 6.103-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. Global Life Sciences Solutions USA LLC / …