Comply cGMP Regulations SS304 Chamber Large Steam Sterilizer With Safety Piping System
Quality Standards
- cGMP
- ISO 9001:2008 - Quality Management Systems
- ISO 13485:2012 Quality Management System – Medical Devices
Steam Sterilizer Feature
- Single or double door version and flexible load capacity
- High quality chamber with fine polished of quality stainless steel
- Extreme process reliability
- User-friendly HMI
- Parameters could be easy adjusted for perfect compliance with various customer requirements
- Efficient drying based on a high performance vacuum system
- Excellent ergonomics together with well-adapted accessories
- Integrated automatic PLC control system with one key operation function
Specifications
Model | MDR-0.8 |
Door type | Motorized Hinge Door ,Single door or double door |
Material (chamber and jacket) | SS304 / Steel |
Chamber volume | 800 liters |
Chamber Size | 61*91*145cm |
Overall Size | 150*190*179cm |
Net Weight | 1400kg |
Steam | 35Kg/cycle |
Water | 80Kg/cycle |
Power(KVA) | 3KVA |
Testing programmes | Validation port |
Sterilization items | Rubber plugs and Aluminum caps |
Main adjustable parameters | Sterilization temperature rage: at 105°C to 134°C
Sterilization time rage: 0---99 minutes
Vacuum times: 0---9 times
Drying time: 0---99 minutes |
Piping Design
- Standard piping for the cGMP steam sterilizer utilizes SS304 sanitary orbital welded tubing and tri clamp connections for the chamber process piping (clean steam, air, and to first isolation valve in sterilizer drain). Standard internal finish for stainless steel piping is 180 grit polish.
- A safety relief valve, sanitary rupture disk, and pressure switch for burst detection is provided for the chamber. Weld-in-place pneumatic piston globe valves are incorporated in the piping design to ensure urability and low maintenance. Care is taken in the fabrication of the pipework to insure deadlegs are minimized to less than 6:1 ratio and that the pipework is free-draining.
- Carbon steel construction is used for the jacket piping and all non-process lines.
- Steam traps are provided at low points in the piping system. A drain condenser is provided to reduce the chamber exhaust temperature to below 135oF to comply with all local plumbing codes. Process chamber and non-process drains are provided to allow re-cycling of the non process condensate to be directed back to user’s house boiler system.
- A vacuum pump is provided as the means for air evacuation of the chamber. The vacuum pump is a close-coupled .
- A 0.22 um disposable vent filter is provided as standard for air admission into the chamber. The option includes an independent sterilization cycle for the filter. The filter is installed in a 304 stainless steel housing.
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Brochure load down from here
Medpharm medical large steam autoclave brochure.pdf
