Opportunities / HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Preventative Maintenance and Service Support for Thermo Fisher Scientific HERA VIOS 160i CO2 and VIOS 250i CO2 Incubators

Description (excerpt)

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 service support for thirty-six (36) Thermo Fisher Scientific incubators, consisting of thirty-two (32) HERA VIOS 160i CO2 incubators and four (4) VIOS 250i CO2 incubators, for the period of performance January 16, 2027, through March 15, 2028. CCE manufactures patient-specific cellular therapies under Food and Drug Administration (FDA)-regulated Current Good Manufacturing Practice (cGMP) conditions in support of clinical trials conducted at the NIH Clinical Center. These incubators are critical to validated cell-manufacturing processes and require manufacturer-authorized preventative maintenance, calibration, and technical support to ensure continued operational readiness and regulatory compliance. The requirement includes annual preventative maintenance, calibration, inspections, diagnostic testing, software and firmware updates, troubleshooting, repair support, replacement of proprietary service parts, and technical assistance necessary to maintain the equipment in accordance with manufacturer specifications and applicable FDA regulations, including 21 CFR 211.63 and 21 CFR 211.67. Basis for Intended Sole Source Thermo Fisher Scientific is the original equipment manufacturer (OEM) and the only known authorized source capable of providing the full scope of preventative maintenance, calibration, software and firmware support, and repair services required for the HERA VIOS 160i CO2 and VIOS 250i CO2 incubators. These instruments incorporate proprietary software, firmware, diagnostic tools, and replacement parts requiring manufacturer-specific technical expertise and authorized access. Market research did not identify alternate vendors possessing the necessary manufacturer authorization and proprietary software access to perform all required services. Additionally, Thermo Fisher Scientific has historically maintained these instruments and has successfully completed CCE's qualification and validation requirements. The company is an approved service provider under CCE's Quality Assurance program. Utilizing an alternate contractor would require additional qualification and validation activities and could result in significant delays, increased costs, and disruptions to critical cell-manufacturing operations. Failure to maintain the incubators could compromise validated man …

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