Controlled Temperature Unit Ctu Qualification Tender - 148352442

The National Institute of Health (NIH) intends to negotiate and award a purchase order without providing for full and open competition to GENESIS ENGINEERS, INC. The purpose of this requirement is to provide a firm-fixed-price contract for Controlled Temperature Unit (CTU) Qualification Services in the Department of Laboratory Medicine (DLM).
The Sterility Testing Service is seeking IOPQ services for validation of equipment that are to be used in cGMP Sterility Testing Laboratory.
In adhering to cGMP regulations, the Sterility Testing Service has to ensure all critical environmental chambers are revalidated (IQ/OQ/PQ) at appropriate intervals as defined by a detailed Equipment Classification and Validation Risk Assessment (ECVRA). All equipment is subject to the Validation and Calibration Master Plan that defines the frequency of revalidation work, justified by the ECVRA in compliance with internal Quality System procedures that are compliant with cGMP equipment control requirements. As such, the purpose of this procurement is to contract the IQ/OQ/PQ services required for the re-qualification of the equipment currently being used by the Service.
These environmental chambers are used in the process of performing cGMP product sterility and environmental monitoring testing, in support of the cGMP manufacturing programs across the NIH Bethesda campus. Proper revalidation of the equipment ensures that the equipment continue to operate in a state of control and is critical to achieving the Service-s mission. Additionally, performance of these qualification activities will ensure the Sterility Testing Service remains compliant with the cGMP requirements in the aforementioned regulatory documents.
Scope of Work:
1. Develop CTU IOPQ protocols.
2. Execute IOPQ protocol for (7) CTUs and one (1) centrifuge.
3. Provide temperature mapping equipment (Dataloggers).
4. Collation of the Data Packs.
5. Provide IOPQ post execution summary reports. The IOPQ ...
Notice ID: 26-007408

Department/Ind. Agency: health and human services, department of

Sub-tier: national institutes of health

Office: national institutes of health olao

Product Service Code: j066 - maint/repair/rebuild of equipment- instruments and laboratory equipment

NAICS Code: 541330 - Engineering Services

Inactive Dates: sep 18, 2026

Inactive Policy: 15 days after response date