Controlled Temperature Unit (CTU) Qualification Services

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 will document and verify the following:

Standard Operating Procedures Equipment and Utility Install Verification Documentation and Drawings Verification NIH documentation (i.e. URS, GxP, PM, O&M Manual) Calibration Status of Critical Instruments Test Instrument Calibration Information Operational Controls and Setpoint Verification Verify that the control system functions as specified by the equipment manufacturer, general system options, cycle length, temperature setpoints, etc. Alarm Verification Verify the alarms associated with the equipment/system (High, Low, Power Loss, Open Door, etc.) Temperature Mapping Perform an empty chamber temperature distribution mapping study We will place a minimum of 10 mapping sensors in pre-defined locations throughout the environment to ensure that critical data has been captured.

Perform a loaded chamber temperature distribution mapping study Loaded chamber testing will be conducted to provide documented verification that the system performs per its intended use when operated under routine challenged conditions and that the unit meets the pre-approved criteria. We will place a minimum of 10 mapping sensors in pre-defined locations throughout the environment to ensure that critical data has been captured. Length of Temperature Mapping study – _24 hours each study.

After conducting a thorough review of the GSA Advantage platform, the Dynamic Small Business Search database, and records of previous government acquisitions, several potential vendors were identified that meet all the specified requirements for this project. Based on these findings, justification has been submitted indicating that only GENESIS ENGINEERS, INC., possesses the capability to fulfill the needs outlined in this requirement.