Hazardous and Non-Hazardous Clean Room Testing

This is a combined synopsis/solicitation for non-personal services for Hazardous and non-Hazardous Clean Room Testing for the Defense Health Agency. The Government intends to award a single, firm-fixed-price contract as a Total Small Business Set-Aside under NAICS code 5471380. The period of performance is September 13, 2025, to September 12, 2030, including a base year and four option years. Quotes are due by September 3, 2025, at 12:00 PM EST to Regina Flowers (regina.d.flowers.civ@health.mil) and must include company contact information, phone number, email, and Unique Entity Identifier (UEI). Submissions require proof of CETA certification and demonstrated understanding of USP 797/800 standards and industry best practices. Questions must be submitted by August 29, 2025, at 09:00 AM EST. Award will be based on “Best Value,” considering technical capabilities/approach, past performance, and price. Offerors must complete FAR 52.212-3, Offeror Representations and Certifications, or verify their SAM registration.

This Performance Work Statement (PWS) outlines the requirements for semi-annual testing and certification of the 88th Medical Group (MDG) Pharmacy cleanroom suite at Wright Patterson Medical Center. The purpose is to ensure compliance with USP 797 and USP 800 standards for preparing approximately 20,000 sterile intravenous admixtures annually. The scope of work includes certification testing for hazardous and non-hazardous cleanrooms, viable active air sampling, viable surface sampling, and detailed reporting. The cleanroom suite contains various HEPA filters, Baker and Panasonic Biological Safety Cabinets, and pass-throughs requiring testing. Optional room recovery testing for failed semi-annual tests or significant downtime will be negotiated separately. The period of performance is a base year from September 2025 to September 2026, with four one-year option years. All technicians must be Certified Environmental Testing Association (CETA) certified with expertise in USP 797/800 standards.

This Q&A addresses Solicitation HT940725QE002, a follow-on to Air Force contract FA860124P0164. Key questions include a request for detailed room dimensions (length, width, and ceiling height) for cleanrooms and anterooms (1U25, 1U26, 1U27, and 1U28) to facilitate accurate calculations for air changes, particle counts, and certification. Additionally, clarification was sought regarding the pricing structure. The government requires pricing broken down into Contract Line Item Numbers (CLINs) representing semi-annual requirements, with each CLIN having a quantity of two. This structure ensures a detailed breakdown for each half-year period within the Period of Performance, from September 13, 2025, to September 12, 2030, covering a base year plus four option years.