MARKET SECTOR: SCI-TECH
SIZE: 22,000 SF
PS&S provided regulatory, architectural and engineering services for the upgrade and expansion of an existing 22,000 sf biotech facility for Clinical Manufacturing and subsequent launch of a smallpox vaccine.
Following the terrorist attacks of 9/11, this project was fast-tracked due to a national priority to combat a potential resurgence of the disease.
THE PS&S SOLUTION
PS&S provided a Master Plan for capital spending options and performed a buy vs. make analysis. Several manufacturing suites were designed to be isolated from each other and served by a separate air handling units. The facility was constructed for sterile processing of the vaccine bulk and sterile filling in 2 ml vials. The manufacturing environment was maintained at class 10,000 active (Grade B) with once through air and biosafety cabinets for the process zone. The process utilities included WFI and clean steam systems.
PS&S prepared the Validation Master Plan and generated protocols for field execution of IQ/OQ activities.
The validation scope included:
- Process equipment
- Sterile utilities
- HVAC systems
- Active pressurization control
- Clean Room (Grade B) monitoring for viables, non-viables, humidity and temperature
- Containment control and monitoring