Container Closure Integrity Testing Equipment

Background
The purpose of this solicitation is to award a purchase order for Container Closure Integrity Testing (CCIT) equipment to include an FMS Carbon Dioxide (CO2) headspace analyzer and Container Closure Integrity (CCI) test vessel along with associated software, certified gas standards with case for storage and transport, change part sets, and validation documentation. The solicitation is issued by the Walter Reed Army Institute of Research (WRAIR), which aims to conduct biomedical research responsive to Department of Defense (DoD) and U.S. Army requirements. The WRAIR's mission is to discover, design, develop, and deliver globally impactful solutions for military infectious diseases, brain health, and performance optimization through innovative research.

Work Details
Specific products to be manufactured or delivered under the contract include:
- FMS CO2 Headspace Analyzer (Quantity 1)
- CCI Test Vessel (Quantity 1)
- Certified Gas Standards with Case (Quantity 2)
- FMS Change Part Set (Quantity 2)
- Full FMS validation documentation package to include validation plan, functional requirements, design specification, requirements trace matrix, 21 CFR Part 11 assessment, installation qualification, and operational qualification documents
- GxP software package with enhanced compliance features
- On-site user training for approximately five personnel covering all applications, uses, functions, and basic cleaning, maintenance, and care of the delivered equipment
The Contractor shall also provide on-site installation of the equipment and accessories in the space designated by the COR at the WRAIR along with full installation qualification and operational qualification. Shipping and handling as well as on-site service travel expenses are also included.

Period of Performance
The delivery date for the supplies/services is within 90 days after contract award.

Place of Performance
The products will be delivered to the Walter Reed Army Institute of Research (WRAIR) located in Silver Spring, Maryland.