PWS_Clean Room Suite.pdf
PDF 667 KB Posted
- Attached to
- Hazardous and Non-Hazardous Clean Room Testing
- Solicitation number
- HT940725QE002
- Issued by
-
Defense Health Agency
About this file
This Performance Work Statement (PWS) details semi-annual testing and certification requirements for the 88th Medical Group Pharmacy cleanroom suite at Wright Patterson Medical Center. The scope of work includes comprehensive cleanroom testing services for hazardous and non-hazardous cleanrooms, involving certification testing, viable active air sampling, viable surface sampling, and detailed reporting. Specific testing requirements include room air change calculations, differential pressure measurements, airborne particle count surveys, work height velocity tests, airflow smoke pattern tests, enclosure integrity leak tests, and temperature/humidity measurements.
The contract period spans a base year from September 13, 2025 to September 12, 2026, with four optional one-year extension periods through September 12, 2030. The cleanroom suite supports preparation of approximately 20,000 sterile intravenous admixtures annually, targeting USP 797 Category 2 Beyond-Use Dates. The facility contains multiple HEPA filters and biological safety cabinets in both hazardous and non-hazardous areas. Contractor technicians must be Certified Environmental Testing Association (CETA) certified and possess demonstrable knowledge of current USP 797/800 standards. The testing will be performed at Wright Patterson Medical Center in specific rooms (1U25, 1U26, 1U27, 1U28).
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Text version
Department of Defense Defense Health Agency
Performance Work Statement
Cleanroom Suite Testing
September 13, 2025
Wright-Patterson AFB 88th Medical Group 4881 Sugar Maple Drive
Wright Patterson AFB, Ohio 45433
1.0 INTRODUCTION
This PWS defines the requirements for non-personal services to conduct semi-annual testing and certification of the 88th Medical Group (MDG) Pharmacy cleanroom suite at Wright Patterson Medical Center, ensuring compliance with USP 797 and USP 800 standards. The suite supports the preparation of approximately 20,000 sterile intravenous admixtures annually, targeting USP 797 Category 2 Beyond-Use Dates (BUDs).
1.1 SCOPE OF WORK
The Contractor shall provide all personnel, equipment, supplies, and resources necessary to perform the following cleanroom testing services:
Certification Testing: Semi-annual certification of the hazardous and non-hazardous cleanrooms and their respective anterooms, in accordance with current USP 797/800 standards. This includes:
Room Air Change Calculations (Air Changes Per Hour)
Room-to-Room Differential Pressures/Room Pressurization
Airborne Particle Count Survey
Work Height Velocity (Unidirectional)
Airflow Smoke Pattern Tests (Airflow Parallelism and Uniformity)
Enclosure Integrity Leak Test with Particle Count Statistical Analysis
Temperature and Humidity (single point)
Viable Active Air Sampling: Semi-annual viable active air sampling using the Tryptic Soy Agar (TSA) single plate method, with a minimum sample volume of 1000 liters per location. Sampling locations are detailed below:
Hazardous Cleanroom Suite: Minimum of 7 locations (See Diagram 1)
Non-Hazardous Cleanroom Suite: Minimum of 5 locations (See Diagram 2)
Viable Surface Sampling: Semi-annual viable surface sampling using the TSA single plate method. Sampling locations are detailed below:
Hazardous Cleanroom Suite: Minimum of 8 locations (See Diagram 1)
Non-Hazardous Cleanroom Suite: Minimum of 5 locations (See Diagram 2)
Reporting: The Contractor shall provide preliminary results after the initial 48-72 hour incubation period and a final report including Colony Forming Unit (CFU) counts and genus-level organism identification upon completion of all analysis and technical review.
Certification reports shall include a summary of testing performed, test criteria, pass/fail status, recorded data, and applicable drawings.
Equipment Details: The cleanroom suite contains the following equipment requiring testing:
Hazardous Cleanroom: 3 HEPA filters, two Baker Biological Safety Cabinets (BSCs) (ISO 5), one pass-through (ISO 7).
Hazardous Anteroom: 1 HEPA filter.
Non-Hazardous Cleanroom: 1 HEPA filter, one Panasonic BSC (ISO 5).
Non-Hazardous Anteroom: 1 HEPA filter.
Test ports are located at each HEPA filter location.
1.2 ROOM RECOVERY (OPTIONAL)
Room recovery testing, required to address failed semi-annual tests or significant downtime, is not included in the base contract price. If needed, these services will be negotiated separately on a case-by-case basis.
1.3 PERIOD OF PERFORMANCE
Base Year: September 13, 2025 – September 12, 2026
Option Year 1: September 13, 2026 – September 12, 2027
Option Year 2: September 13, 2027 – September 12, 2028
Option Year 3: September 13, 2028 – September 12, 2029
Option Year 4: September 13, 2029 – September 12, 2030
1.4 PLACE OF PERFORMANCE
Wright Patterson Medical Center, Pharmacy Cleanroom Suite (Specific room numbers: 1U25, 1U26, 1U27, 1U28)
1.5 RECOGNIZED FEDERAL HOLIDAYS
Services may be performed on Federal holidays if necessary and mutually agreed upon.
New Year’s Day Labor Day Birthday of Martin Luther King, Jr. Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth National Independence Day Christmas Day Independence Day
1.6 CONTRACTOR IDENTIFICATION
Contractor personnel shall wear visible identification badges displaying their name and company while on-site. They must clearly identify themselves as contractor personnel in all interactions.
2.0 CONTRACTOR QUALIFICATIONS
All technicians performing testing must be Certified Environmental Testing Association (CETA) certified and possess demonstrable knowledge of current USP 797/800 standards and industry best practices for cleanroom testing and certification.
3.0 POINTS OF CONTACT
Maj Christian Carroll (Christian.a.carroll4.mil@health.mil, 937-257-9015)
Maj David Vallentine (david.p.valentine2.mil@health.mil, 937-904-3927)
Lt Col Christian Banasky (christian.e.banasky.mil@health.mil, 937-656-2791).
4.0 DIAGRAMS
Diagram 1: Viable Sampling and Structural Floor Plan
Diagram 2: Non-Hazardous Cleanroom Viable Sampling and Structural Floor Plan
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