Requirements Document - Environmental Chambers rfq.docx

Statement of Work (SOW) Environmental Chambers (Stability and Climate) 06/20/2025

Background

The Office of Analytical and Regulatory Laboratories (OARL) is comprised of four (4) medical product laboratories, two (2) were temporarily closed due to a reduction in force. Since there are only two (2) medical product laboratories providing stress testing, there is a need within all medical product labs for environmental chambers. As such, there is a need to expand OARL’s ability for stress testing the two (2) remaining medical product laboratories.

Purpose

Stress testing in pharmaceutical stability chambers involves exposing drug substances and products to exaggerated environmental conditions (like heat, humidity, and light) to accelerate degradation and identify potential degradation pathways. Stress testing helps determine a drug’s shelf life, validate analytical procedures, and understand how the drug behaves under various stress factors. Stress testing data, combined with long-term stability studies, allows for the determination of the shelf life of the drug product and the re-test period for the drug substance.

A stability and climate chamber are required to perform stress testing on pharmaceutical products that are part of the SLEP program. OARL requires two (2) Environmental Chambers. The Environmental Chambers shall be delivered to the medical product laboratories in Irvine (IRVMPL) and New York (NYMPL). Delivery addresses will be provided at the time of award.

Requirements

The Contractor shall provide and deliver two (2) Environmental Chambers that meet or exceed the following salient characteristics:

General specifications:

· Temperature Range: 0°C to 100°C without humidity. Temperature Range 10°C to 90°C with humidity

· Temperature uniformity must be equal to or less than ±0.4°C.

· Flexible PT 100 temperature load probe

· Humidity

· Controlled Humidity 10% to 98% with high pressure (2 kPa) steam generator. Humidity as precise as +/- 2.5% Incl.

· Relative Humidity controlled in 1% increments with active dehumidification for precise control of conditions Incl.

· Controller

· Color LCD Touch Screen controller (glove friendly) with Fuzzy Logic algorithm enabled digital microprocessor

· Color LCD Touch Screen icon driven controller allows for up to 100 individual programs & 100 individual segments

· Communication & Data:

· Integrated 30day data logger with SD memory card

· 4-20 mA re-transmit contacts for external data loggers: Temperature

· 4-20 mA re-transmit contacts for external data loggers: Humidity

· USB device, SD card and RS232 communication ports.

· USB flash port, Ethernet port

· Compliance: Conforms to ICH Q1A. ICH Q1B photostability available

· Monitoring:

· Building monitoring system contacts for alarms (24V, 1Amp)

· FDA 21 CFR Part 11 Compliant. Monitoring & Controlling Software. Control device & receive data to PC or Network from up to 25 BMT units

· Components: Pharmaceutical grade components of US and European origin

· Chamber:

· Chamber size must be at least 14 cubic feet but no larger than 29 cubic feet.

· Double wall stainless steel chamber

· 304 AISI Stainless steel seamless main chamber with rounded corners

· 304 AISI Stainless steel inner chamber, removable without tools for increased sterilization & cleaning standards

· Patented Forced Air movement system precisely moving air vertically & horizontally. Control air flow in 1% increments.

· Insulation: Five (5) layers of insulation for chamber uniformity, energy efficiency and safety

· Thermostat: Class 3 Digital Safety Thermostat, Acoustic and visual alarms. Soft (Visual and audible warning) and Hard Alarm (full stop)

· Door

· Alarm: Door sensor with alarm

· Automatic door lock

· Glass Door: Latched inner glass door sealing glass door to chamber gasket for viewing samples

· Access Port: 50mm (2") Stainless steel access port

· RO Water System: 100 GPD wall mounted RO water, 10 gal., pressure tank

· Water Tank:

· Thirteen (13) gallon water tank with automatic pump

· Directly feed RO water to the steam generator from suppled water tank or users or RO water from users source under 10psi

· Drain Tray: Stainless steel condensate drain water tray w/ automatic pump & hose to control and direct condensate water out of tray

· Stainless steel shelf brackets (2.8" apart), molded into inner chamber wall for smooth seamless shelf support. Incl.

· Shelves / Trays:

· At least six (6) stainless steel grated shelves included with option for additional shelves.

· Shelf capacity must be at least 19 shelves

· Exterior Cabinet: Exterior steel cabinet in attractive white finish, with rolling, locking, swiveling casters.

· IQ/OQ

· IQ / OQ protocols for Software

Preventative Maintenance, Warranty and System Updates:

The Contractor shall ensure:

1. Software shall be the most recent version available and provide 12 months access to software updates and patches.

2. The entire system shall be warranted for parts and labor for a minimum of 12 months from date of formal Government acceptance. The warranty shall include unlimited telephone/e-mail support for questions regarding operation. On-site response time for repairs during the warranty period shall take no more than 72 hours. Coverage shall include all non-consumable items and parts supplied including base instrument, computer, monitor, printer to ensure proper functioning for the entire warranty period. The Contractor shall provide original equipment manufacturer (OEM) replacement parts, software updates, notifications, and installation at no additional cost to ensure maximum system operational readiness. All engineer labor and travel costs related to the warranty shall be at no additional cost to the Government. The warranty shall include a minimum of one (1) preventative maintenance visit for each Environmental Chamber at the medical product laboratories in IRVMPL and NYMPL. The preventative maintenance visit shall return the Environmental Chamber to OEM specifications.

Delivery and Installation:

1. The Contractor shall provide onsite installation of the entire Environmental Chamber system, which shall include the cost of labor, delivery, and travel. The Government will not reimburse for any additional costs.

2. The Contractor shall provide installation of the Environmental Chamber no later than 45-days after the date of award.

3. The Contractor shall provide inside delivery, setup, installation, and clean-up of the area at the place of performance.

4. The Contractor shall provide onsite familiarization for up to three (3) Agency staff per system install within 15 days of installation. The onsite familiarization shall include basic operations and routine maintenance of the Environmental Chamber.

Delivery Addresses:

Two (2) Environmental Chambers, one (1) each, shall be delivered to:

1. US Food & Drug Administration New York Medical Product Laboratory Jamaica, NY Listed at time of award

2. U.S. Food and Drug Administration Irvine Medical Products Laboratory Irvine, CA 92612-2506 Listed at time of award

DELIVERABLES

The Contractor shall provide the following deliverables:

Travel

PERIOD OF PERFORMANCE

The warranty period is for 12 months after Government acceptance of the Environmental Chamber.

Unless otherwise specified, the Contractor shall perform work Monday through Friday (excluding Federal Holidays) between the hours of 8:00 a.m. and 4:30 p.m. EST. Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day.

Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) due to inclement weather.

Government Holidays:

January (New Year’s Day) January (Martin Luther King Day) February (President’s Day) May (Memorial Day) June (Juneteenth) July (Independence Day) September (Labor Day) October (Columbus Day) November (Veterans Day) November (Thanksgiving Day) December (Christmas Day)

GOVERNMENT POINTS OF CONTACT

The Contract Specialist /Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Specialist/Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. The Contract Specialist and Contracting Officer for the contract is listed below:

A. Contracting Officer:

Name: Linda Finan Email: Linda.finan@fda.hhs.gov

Contracting Officer’s Representative (COR)

The Contracting Officer’s Representative (COR) is responsible for the day-to-day coordination of the Task Order and will represent the CO in the administration of technical details within the scope of the Order. The COR is also responsible for the final inspection and acceptance of all deliverables and reports, and such other responsibilities as may be specified in the order. The COR is not otherwise authorized to make any representations or commitments of any kind on behalf of the CO or the Government. The COR does not have the authority to alter the Contractor’s obligations or to change the Order’s terms or conditions. If, as a result of technical discussions, it is desirable to modify Order obligations or the terms or conditions, changes will be issued in writing and signed by the CO.

For the purpose of this order, the COR is the authorized representative of the Contracting Officer. The COR will be delegated in writing at the time of task order award.

a. The COR appointed to this contract is identified below. See formal level of appointment for authorized duties/responsibilities.

COR Name: Determined at time of award COR Email Address: Determined at time of award

b. The COR may be changed at any time by the Government without prior notice to the Contractor by a unilateral modification to the Contract.

c. The responsibilities and limitations of the COR are as follows: The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

d. The COR is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the Contract price, terms or conditions. Any Contractor request for changes shall be referred to the Contracting Officer directly or through the COR. No such changes shall be made without the expressed prior authorization of the Contracting Officer (CO). The CO may designate assistant or alternate CORs to act for the COR by naming such assistant/alternate(s) in writing and transmitting a copy of such designation to the Contractor.