Preventative Maintenance and Service Support for Miltenyi Biotec CliniMACS Plus 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 procure preventative maintenance and service support for seven (7) Miltenyi Biotec CliniMACS Plus instruments from Miltenyi Biotec, Inc. The requirement supports the continued operation of critical cell-processing equipment used in manufacturing patient-specific cellular therapies for patients enrolled in clinical trials at the NIH Clinical Center. CCE manufactures cell-based therapies under Food and Drug Administration (FDA)-regulated Current Good Manufacturing Practice (cGMP) conditions. The requirement includes preventative maintenance, calibration, inspections, software updates, diagnostic testing, troubleshooting, repair support, replacement of proprietary service parts, and technical support for CliniMACS Plus instruments bearing serial numbers 2600, 2602, 2632, 2635, 2634, 2619, and 2756. These services are necessary to maintain equipment reliability, validated manufacturing processes, and compliance with applicable FDA regulations, including 21 CFR 211.63 and 21 CFR 211.67. Basis for Intended Sole Source Miltenyi Biotec, Inc., is the original equipment manufacturer and the only known authorized provider capable of performing the required preventative maintenance, calibration, and technical support services for the CliniMACS Plus instruments. The equipment incorporates proprietary software, diagnostic tools, replacement parts, and manufacturer-specific technical requirements that are not available to unauthorized third-party service providers. The seven instruments have been qualified and incorporated into validated manufacturing processes supporting patient-specific cellular therapies. Utilizing an alternate service provider without the required manufacturer authorization, proprietary software access, and technical expertise could compromise equipment performance, jeopardize regulatory compliance, and requ…