Water for Injection/Pure Steam Generation and Distribution Systems Maintenance

Statement of Work (SOW) / Performance Work Statement (PWS)

This Performance Work Statement (PWS) outlines the requirements for providing non-personal services to maintain water for injection (WFI)/pure steam generation and distribution systems at the Walter Reed Army Institute of Research (WRAIR), Pilot Bioproduction Facility (PBF).

• Services: Preventative maintenance (quarterly, semiannual, annual), calibration, five-year overhaul, and emergency service for MECO-manufactured WFI/pure steam generation and distribution systems.

• Maintenance Tasks: Includes tasks such as reviewing logbooks, performing safety checklists, checking calibration, inspecting for leaks, cleaning strainers, descaling, and replacing components.

• Emergency Service: Requires a response time not to exceed 24 hours for evaluation and repair, with onsite support within 48 hours.

• Documentation: Contractor must provide detailed service reports, maintenance schedules, and comply with Good Documentation Practices (GDP) and Current Good Manufacturing Practices (CGMP).

• Staffing: Maintain a 95% fill rate and fill vacancies within 30 days.

• Deficiencies: Receive no more than three deficiency reports during the contract.

• Compliance: Maintain GDP compliance >99% of the time and CGMP compliance >99% of the time.

• Customer Support: Respond to inquiries within 24 hours, 99% of the time.

• System Uptime: System shall attain >85% uptime.

• Period of Performance (PoP): Base Period (29 April 2026 – 28 April 2027) with four Option Periods extending through 28 April 2031.

• Place of Performance: On-site at WRAIR, 501 Robert Grant Avenue, Silver Spring, Maryland, 20910.

• Personnel: Technicians must be factory trained and have a minimum of two years of experience on the contracted Medical Devices/Medical Device Systems (MD/MDS). Must have a licensed electrician and plumber on staff.

• Training: Required training includes Level I Antiterrorism, HIPAA and Privacy Act, Controlled Unclassified Information, and CGMP/GDP specific training.

• Security: Public Trust determination may be required. Standard WRAIR post requirements apply for installation access.

• Materials: Contractor to provide rigging, materials, supplies, and like-for-like parts. Government provides access to equipment and facilities.

• Other Direct Costs (ODCs): Emergency maintenance invoiced as ODCs, not to exceed contract price ceiling. ODCs over $3,000 require competition and KO approval.

Statement of Work (SOW) / Performance Work Statement (PWS)

To perform preventative maintenance (quarterly, semiannual, annual), calibration, five-year overhaul, and emergency service for the Water For Injection (WFI) System Repairs and Emergency Maintenance at the Walter Reed Army Institute of Research (WRAIR), Pilot Bioproduction Facility (PBF). The goal is to ensure the continued operation of the MECO-installed systems that supply process water and pure steam for Current Good Manufacturing Practice (CGMP) operations.

• Maintenance and repair services for WFI/Pure Steam Generation and Distribution Systems.

• Provision of all necessary materials and supplies for maintenance and repairs.

• Support for systems used to supply process water to autoclaves, fermenters, and other equipment, as well as pure steam for sterilization.

• Compliance with CGMP standards (PRS #1): >99% of the time.

• Compliance with Good Distribution Practices (GDP) documentation (PRS #2): >99% of the time.

• Replacement pump delivery within eight weeks of order receipt, with successful certification (PRS #3).

• System uptime: >85% (PRS #5).

• Emergency services response within 24 hours and timely completion (PRS #6).

• Quality Deliverables: 95% compliance with requirements, submitted on schedule (PRS #7).

• Not explicitly stated in this document, but implied to be at the Walter Reed Army Institute of Research (WRAIR), Pilot Bioproduction Facility (PBF).

• Services must support CGMP-compliant pharmaceutical manufacturing.

• Contractor must adhere to Quality Assurance Surveillance Plan (QASP) procedures for monitoring and evaluation.

• Combatting Trafficking in Persons (CTIP) compliance is mandated.

• Performance ratings will be evaluated using definitions from FAR 42.1503 Table 42-1 (Exceptional, Very Good, Satisfactory, Marginal, Unsatisfactory).

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for commercial items, issued as a Request for Quote (RFQ), for Water for Injection/Pure Steam Generation and Distribution Systems Maintenance. The requiring activity is the Walter Reed Army Institute of Research (WRAIR).

• Maintenance of Water for Injection/Pure Steam Generation and Distribution Systems.

• Services include quarterly, semi-annual, and annual on-site maintenance, potentially in confined spaces.

• Emergency maintenance and repair services with guaranteed maximum response time.

• Use of Original Equipment Manufacturer (OEM) new or OEM refurbished repair parts.

• Provision of a detailed annual maintenance schedule, example maintenance service report, and identification of any anticipated subcontractors.

• The estimated value is USD 19,000,000.00.

• The North American Industry Classification System (NAICS) code is 238220 (Plumbing, Heating, and Air-Conditioning Contractors) with a size standard of $19 million.

• Product Service Code (PSC) is J046.

• The contract type is anticipated to be Firm Fixed Price (FFP).

• The period of performance for the base year is 05 May 2026 to 04 May 2027. Option years extend through 04 May 2031.

• Offers are due by 01 May 2026, 11:00 AM EST.

• Questions are due by 24 April 2026, 12:00 PM EST.

• Offers must be submitted electronically via email.

• Proposals will be evaluated based on Technical Approach, Past Performance, and Price. A best-value tradeoff process will be used.

• Only offers rated "Acceptable" or higher for the Technical Approach will be considered for award.

• Offerors must be registered in the System for Award Management (SAM).

• This acquisition is not set-aside for small business concerns; it is an unrestricted procurement.

• The solicitation incorporates provisions and clauses by reference. Full text can be accessed at www.acquisition.gov.

• Offerors must submit a signed copy of the solicitation and acknowledge any amendments.

• The offeror's proposal shall be valid for 60 days from the due date.