Statement of Work- OC-2026-136029- Revised Final- 09.23.2026.docx

Statement of Work Environmental Chamber for Temperature and Humidity Conditioning of regulatory samples prior to testing.

Background The FDA laboratory at WEAC uses an environmental chamber to condition regulatory samples (such as tampons, gowns, patches, etc.) at specific temperature and humidity levels before physical testing. The chamber also supports CDRH-directed research and test method development for other medical devices received by the laboratory for analysis.

The laboratory analyzes medical devices under the Federal Food Drug and Cosmetic Act. Some products, such as tampons, are subject to the Code of Federal Regulations (CFR) performance standards, while others are tested against consensus standards or manufacturer’s specifications. Because of this variety, the laboratory requires a wide range of temperature and humidity conditions.

The current environmental chamber is over 15 years old. It has required costly repairs in recent years and experienced extended periods of downtime due to funding constraints and approval delays. A new environmental chamber will ensure that our capabilities remain consistently available.

General Requirements The contractor shall provide an environmental chamber that uniformly conditions samples across a variety of temperature and humidity settings. The chamber must meet the following specifications:

1. Temperature range: at least -20°C to 180°C

2. Humidity range: 10% to 95% relative humidity (RH)

3. Capacity: 4 cu. Ft.

4. Power: Standard power cord and plug (no hardwiring)

5. Water supply: Easily accessible water supply connection

6. Humidity sensor: Solid-state humidity sensor

7. Leak Detection: Must have a water leak containment and detection system

8. Viewing window: For visual monitoring of samples

9. Interior shelf: At least one internal shelf

10. Mobility: Mobile cart with space-saving footprint (lab has no bench space and limited floor space for the chamber)

11. Cable port: At least one 2-inch diameter cable port with a flexible plug

12. Calibration: Factory calibration with an ISO 17025 certificate, or instrument calibration at start-up with ISO 17025 certificate

13. Warranty: At least one year

Generally, for regulatory compliance with the FDA 21 CFR 801.430 for a stability/environmental chamber to satisfy these good laboratory practice (GLP) and medical device validation requirements, mandate the following tolerances:

• Incoming Water requirement- they need to include a water conditioning/purification setup that conforms to their water requirements when it is supplied with Lab Cold Water. (Their requirements for input to the instrument may not be DI).

On-site Installation, Training and Commissioning

1. On-site installation and commissioning of the Environmental Chamber Trade and Service Specification

1. All components shall be newly manufactured, not used or refurbished, and/or previously used for demonstration.

2. System installation shall occur after being received at the laboratory.

3. The entire system shall be warranted for parts and labor for a minimum of 12 months from date of formal government acceptance after on-site installation.

4. The warranty must include unlimited telephone/e-mail support for questions regarding operation.

Additional Section 508 Requirements:

· Must meet WCAG 2.0 A and AA

· E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

· E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

· E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

· E205 Electronic Content (Appendix A, Application and Scoping Requirements)

· 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

· Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/making-files-accessible/index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional- resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

· E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

· Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria

· E206 Hardware (Appendix A, Application and Scoping Requirements)

· Chapter 4 Hardware (Appendix C, Functional Performance Criteria and Technical Requirements) and Technical Requirements)

· E207 Software (Appendix A, Application and Scoping Requirements)

· Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)