cGMP Regulations SS304 Chamber Large Steam Sterilizer With Safety Piping System
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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 DevicesSteam 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 functionSpecifications:
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 |
280Kg/cycle |
Power(KVA) |
3KVA |
Testing programmes |
Bowie & Dick test, vacuum test |
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 insure durability 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.Perfect Quality:
Maximum reliability and system safety are the focus at Mepharm. This is shown by the durable construction, the first-rate manufacturing quality and the exclusive use of high-quality materials and components. One example of this is the robust doors made of stainless steel. The claw profiles fitted on all sides optimally absorb the pressure and distribute it uniformly. This prolongs the service life of the chamber and guarantees maximum safety. The same applies to the innovative door system. The Mepharm sealing frame is made of solid stainless steel.Thanks to the precision-milled door seal slot, the solid silicone seal has a service life six times longer than that of comparable systems..