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IQ/OQ/PQ services required for the qualification of new equipment

Maryland, United States
Government : Federal
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The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Department of Laboratory Medicine (DLM), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to:

PEPPERELL, MA, 01463-1486,


The intended procurement is classified under NAICS code 541990 with a Size Standard $15.0 million.

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2019-06 September 10, 2019. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000).

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.




1. Title: IQ/OQ/PQ services required for the qualification of new equipment

2. Background Information: The Department of Laboratory Medicine serves as the clinical laboratory of the NIH Clinical Center. It provides laboratory support for patient care and research protocols and performs research and training in disciplines of Clinical Pathology. In doing so, DLM provides state-of-the-art laboratory testing in support of Clinical Center patient care and serves as a center of excellence in research and training in laboratory medicine, particularly in areas which utilize the unique strengths of the National Institutes of Health.

The Sterility Testing Service, within DLM, was formally established in DATE to support the cGMP manufacturing facilities across the NIH Bethesda campus by offering cGMP compliant sterility testing and environmental monitoring services. Prior to formation of the Sterility Testing Service, testing activities were provided by the Microbiology Service, which is part of the CLIA and CAP accredited laboratory. This was not in compliance with the cGMP regulations that testing laboratories that support cGMP manufacturing operations are held to. To comply with cGMP requirements, specifically 21CFR211 §68(a), 21CFR211 §100(a), FDA Validation Guidance, ICH Q10, 3.2.1, and WHO Annex 3-GMP, 4.3, equipment used in the manufacture of drug products must be validated and continuously monitored for performance to ensure the processes they are used in have not been compromised. The equipment currently used by the Sterility Testing Service has not undergone the necessary qualification testing required to comply with the aforementioned requirements and the monitoring being performed on the equipment has not been justified based on the necessary qualification data.

To ensure compliance with the cGMP regulations, all critical environmental chambers, including but not limited to, refrigerators, incubators, and freezers, must be qualified for their intended use. Qualification of these types of chambers can be broken down into three distinct parts including the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). IQ ensures that the equipment has been installed in accordance to the manufacturer's requirements, while operational qualification ensures the equipment is capable of operating as the manufacturer intends. Before the chamber can be released for routine use, the PQ must be executed. The PQ ensures the equipment operates in the final location in a state of control. PQ testing for environmental chambers include empty chamber temperature mapping studies, full chamber temperature mapping studies, open door studies, and power failure studies. All of this testing must be thoroughly documented during performance by technicians that are trained in cGMP documentation and validation activities. Final reports must also be prepared summarizing all of the testing activities and associated data. Final reports must also be reviewed by representatives of the group performing the validation activities and the Quality Control Unit.
3. Purpose or Objective: The Sterility Testing Service is procuring new equipment for the Sterility Testing Laboratory, some of which will be used to replace the current equipment that was inherited from the Clinical Microbiology Laboratory. All new equipment being procured will have to be on-boarded 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 qualification of the new equipment being purchased by the Service.

These environmental chambers will be 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 installation and qualification of the equipment ensures that the equipment can 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.
4. Period of Performance: Base Period of one (1) year starting on or around 9/27 with an additional option period of one (1) year.


The vendor, in accordance with the written control, will prepare protocols for each unique chamber type being validated, setup, program, and configure validation equipment, preform pre-validation chamber adjustments, perform cGMP calibration services, execute the IQ/OQ/PQ protocols, and prepare final comprehensive reports to satisfy FDA, cGMP, GLP, and other regulatory requirements for each chamber. The control also includes three round trips to the NIH campus by one technician to execute the IQ/OQ/PQ activities.

As part of the validation, a complete testing protocol for each unique chamber type will be generated that includes the following items being tested, at a minimum.
Verification of the digital controls, recording system and sensors for temperature, traceable to NIST standards.
Verification of the installation criteria as established in the protocol.
Verification of the operational criteria as established in the protocol, including but not limited to:
Verification of chamber alarm responses.
Performance of one open door study.
Performance of one power interruption test.
Verification of the performance criteria including but not limited to:
Performance of one 24-hour empty thermal distribution study using 16 sensors.
Performance of one 24-hour loaded thermal distribution study using 16 sensors.
Performance of one open door study.
Performance of one power failure recovery study.
As part of the validation, a complete final report will be generated summarizing the results for the qualification testing and will include the followings items, at a minimum.
Executed protocols or SOPs.
Real-time, hard and soft copies of the mapping data.
Summary results.
Calibration certificates for all mapping equipment used, noting NIST traceability
Sensor calibration reports.
Validation personnel training records.
Independent review of vendor's Quality Assurance department.


This is a requirement for services for qualification of new environmental chambers in a cGMP Sterility Testing Laboratory. There is only one known vendor that can provide these services that is also ISO 9001 and ISO 17025 certified and not a manufacturer of the equipment (being a manufacturer has inherent conflicts of interest with regard to this type of services for certification). The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research.


This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM)

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.
All responses must be received by September 25, 2019, 05:00 PM Eastern time and must reference solicitation number 19-012204. Responses may be submitted electronically to Mr. Christopher Lauver, Contracting Specialist at Fax responses will not be accepted.

"All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."

Christopher D. Lauver, Contract Specialist, Phone 301-594-5914, Email

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