The project consists of a laboratory renovation on the third floor of the existing 100,000SF ATRF facility. The renovation provides for a 6,000SF aseptic ISO 7 process area which consist of 3 suites that can operate independently of each other. Each suite houses bio-safety cabinets (BSCs) and Prodigy units used for the cell culture evaluation.
Each clean room suite is constructed of clean room panels and ceiling modules and fitted with clean room light fixtures. Specialty gases and electric power are distributed through ceiling mounted utility panels. Alarms, temperature sensor systems and room differential monitoring sensors are provided and connected to a dedicated SCADA systems which allows all data to be monitored and saved to meet validation and GMP requirements.
Size100,000 (existing facility)
LocationFrederick, Maryland
ServicesMEP Building Engineering
MarketScience & Technology
The process suites are served by two redundant 15,000 CFM GMP air-handling units serving room side replaceable HEPA filter air devices. Exhaust systems with equal capacity and redundancy serve the BSCs and general exhaust systems. All air moving equipment is roof mounted on spring isolators.
One of the unique design elements of this project is that all equipment is backed up with emergency generators and UPS back-up power. All suites have bubble tight dampers on the supply and exhaust side to enable each suite to be isolated and decontaminated so as not to interfere with the remaining operable research suites.
Material handling vestibules with high speed roll doors are provided to move equipment from the adjacent research laboratory spaces to the process suites. Pass through boxes are also situated to allow small samples to pass through the lab side from the process side. A central autoclave is provided to sterilizer any equipment/product that needs to leave the process suite. An LN2 freezer space is provide to store samples before further processing is required offsite. "