Description
The National Institutes of Health (NIH) Clinical Center seeks a sole‑source contractor to provide preventative maintenance, calibration, software updates, troubleshooting, repairs, and full‑care service support for six Cytiva Sepax C‑PRO closed‑cell separation systems over a one‑year period. The contractor must be the original equipment manufacturer (OEM) or an authorized service provider with proprietary software access and parts, ensuring compliance with FDA cGMP regulations and delivering documented maintenance reports for quality‑assurance review. This effort is critical to maintaining validated cell‑therapy manufacturing processes for NIH‑sponsored clinical trials.
• Provide scheduled preventive maintenance, calibrations, inspections, and software updates for six Sepax C‑PRO instruments.
• Supply replacement of proprietary service parts and perform troubleshooting/repair to keep equipment within manufacturer specifications.
• Deliver detailed maintenance documentation for review by the CCE Quality Assurance team and ensure compliance with 21 CFR 211.63/211.67.
Attached files
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