Preventative Maintenance and Service Support for Thermo Fisher Scientific HERA VIOS 160i CO2 and VIOS 250i CO2 Incubators
The NIH Clinical Center’s Department of Transfusion Medicine/Center for Cellular Engineering intends to award a sole-source contract to Thermo Fisher Scientific for preventative maintenance and service support of 36 Thermo Fisher incubators (32 HERA VIOS 160i and 4 VIOS 250i CO2 units) used in FDA-regulated cGMP cell therapy manufacturing. The period of performance is January 16, 2027 through March 15, 2028. Required services include annual preventative maintenance, calibration, inspections, diagnostic testing, software/firmware updates, troubleshooting, repair support, proprietary parts replacement, and technical assistance to maintain regulatory compliance and validated manufacturing conditions. Thermo Fisher is identified as the OEM and only known authorized source with proprietary software, firmware, diagnostic tools, and parts access; market research found no alternate authorized vendor, and the firm is already qualified under CCE’s Quality Assurance program. Responsible sources believing they can meet the requirement may submit a capability statement demonstrating manufacturer authorization, proprietary access, FDA/cGMP compliance, and ability to satisfy CCE qualification and validation requirements.