Designed and manufactured to comply with all pertinent cDMP requirements. Interior is manufactured with a fully welded 304L-2B stainless steel liner. All interior corners are rounded with a 3/4″ radius to provide ease of wipe downs.
Standard sterilizers are rated for 260 degrees Celsius depyrogenation.
ISO 14644-1, ISO Class 5 (209e Full Class 100) sterilizing conditions throughout the process cycle (1.5 degrees Celsius/minute ramp rate, with option of rapid capacity filters up to 10 degrees Celsius/minute ramp rate.) HEPA filters are installed in the air intake, exhaust and recirculation wall. The intake HEPA filter prevents contaminates from entering the sterilizer during operation and is protected with an upstream pre-filter. The exhaust HEPA filter ensures contamination will not be drawn into the sterilizer at the cycles end. Side wall filters provide filtration immediately prior to the process air entering the sterilization chamber.
A Bio-seal flange is provided to seal the sterilizer into the facility wall at the “clean” side of the system and ensures a positive barrier preventing particulate from entering the room from the maintenance area.
Pass through with interlocked pneumatically locked doors. The doors are provided with a pneumatic latching and locking system. The door will latch automatically and will remain locked to provide proper pass-through operation.
- UL 508A Listed Control Panel.
- Lockable Disconnect Switch on Control Panel Door. Lockout Tagout capable.
- Both control systems are 21 CFR II ready.
Accelerated Cycle Time (10 degrees Celsius/minute). The standard HEPA filters will be replaced by advanced filters that can operate under greater differential thermal expansion. In addition to the upgrade in filtration, the system will require additional heat input to maintain accelerated heat up rate.
- 316L Stainless Steel Interior.
- Cooling Coil in Intake System.
- Pressure Differential Control System.
- GAMP 4 Documentation.
- IQ/OQ Protocols (unexecuted or executed). Full validation documentation in accordance with the GAMP regulations.
- Chart Recorder.
- Stainless steel trucks and trays in standard and custom sizes.