Fosdick & Hilmer provided overall project management and engineering services for design of mechanical, electrical, plumbing, fire protection and automation systems related to this 1,400 GSF, Biosafety Level 2 (BL-2) cleanroom for manufacturing viral vectors and other products for Phase I & II clinical trials. The cGMP cleanroom facility is divided into functional areas with cleanroom classifications appropriate to the activities performed in each area. Facility is designed for compliance with cGMP regulations (21 CFR Parts 210 & 211).
All open-container processing is performed inside Class 100 (ISO Class 5) Biological Safety Cabinets in the TCLs. Air inside the cleanroom is HEPA-filtered, and manufacturing conditions have been further optimized by a system of differential air pressures between individual rooms. All rooms and surfaces are regularly maintained and monitored for viable and non-viable contamination. Critical laboratory equipment is connected to a central alarm system and is validated to function properly prior to use.
The VPF is operated and managed by personnel from the Division of Experimental Hematology of the Cincinnati Children’s Research Foundation.
- Facility construction meets CDC/NIH requirements for Biological Safety Level 2.
- Tissue Culture Lab (TCL) Airlocks are positively pressurized Class 10,000 (ISO Class 7) environments that effectively separate the Common Area from the TCLs.
- VPF holds two 166 square feet Tissue Culture Labs (TLCs). The TLCs are Class 10,000 (ISO Class 7) environments that are equipped with a biological safety cabinet, CO2 incubators, a refrigerator, multipurpose work area with water bath and microscope, and wire-molded shelving. CO2 for the incubators is piped in from the compressed gasses room. As the TCLs are completely separated, and only one clinical product is allowed to be processed in each TCL at the same time, the facility has a production capacity of two products simultaneously.
- Common Area is a 342 square foot Class 100,000 (ISO Class 8) environment that contains common laboratory equipment including two -80°C freezers, one -20°C freezer, one refrigerator, and two centrifuges.
- Compressed gases room holds the CO2 gas and liquid N2 tanks and is equipped with an automatic change-over manifold that ensures delivery of CO2 gas to the TCLs from one of two CO2 banks.
- Testing laboratory is a fully equipped 100 square feet non-cleanroom BL-2 research laboratory designed to support the VPF. This lab is primarily used to prepare and process microbiological samples and other materials that cannot be manipulated in the cleanroom and for research grade vector production. The lab contains a microbiological safety cabinet, a CO2 incubator, a combination refrigerator/freezer, microbiological incubators, and a multipurpose work bench with sink and storage shelving, and cabinets.