Cell Processing Suites
The two Cell Processing suites are designed and equipped for growing cells in incubators for cell therapy and ex-vivo gene therapy applications. The Cell Processing suites are ISO Class 7 (<352,000 particles/m3, 0.5 micron particles) cleanroom rated which is equivalent to former Federal Standard 209E class 10,000. The air supply to each room is single-pass air that is filtered with terminal HEPA filters that are located in the ceiling. The low air returns in these suites also have HEPA filters for containment purposes. Room pressures are maintained positive relative to surrounding areas to prevent potential airborne contaminant from entering the Cell Processing suites.
The Cell Processing suites are furnished with specialized equipment for cell processing. Each Cell Processing suite has a biosafety cabinet that is used for all open manipulations of cell cultures. The biosafety cabinets are Baker SterilGARD III cabinets (The Baker Company, Sanford, ME), which are type B3 hoods with six-foot working surfaces. The units meet NSF Standard 49 and are tested and certified by the UW Environmental Health Program on an annual basis.
Each suite contains either two ThermoForma Sericult 200 incubators or two ThermoForma Series II Water Jacketed CO2 Incubators (ThermoForma, Marietta, OH). In addition, a Forma model 3950 Reach-In CO2 incubator with a 35-position cell roll system is available for growing cultures in roller bottles. All incubators were provided with extensive documentation from the supplier and have been validated. Carbon dioxide gas for the incubators is supplied by the WCBF CO2 distribution system as described above. Incubators are connected to the Equipment Monitoring System, which will alarm locally and page personnel to inform them of any deviation from the acceptable operating limits for the incubator.
Each suite also contains a centrifuge that is used to sediment cells for concentration or cell washing steps. The Sorval RC3BP (Kendro, Newtown, CT) centrifuges are low-speed refrigerated centrifuges that are capable of processing up to 6 L of cell culture fluid per run. The rotor accepts sterile, single-use tissue culture containers so that potential cross-contamination risks and cleaning validation issues are eliminated. Centrifuges have undergone validation and are routinely calibrated as outlined in WCBF calibration and maintenance procedures.
- Two suites, pair of rooms available individually or in sequence
- ISO Class 7, positive pressure with Class II Type B3 biological safety cabinets (BSC) for cell processing, dedicated AHU for Mammalian Products/Cell Processing
- CO2 Incubators with medical gas supply
- Centrifuges and additional equipment for cell processing
- Available for expanded capacity with Protein/Antibody Suite
