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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.
MEDPHARM Company team is committed to providing quality sterilization products, service, parts and
maintenance training at significant savings. From customized parts packages to turnkey&n... MEDPHARM Company team is committed to providing quality sterilization products, service, parts and
maintenance training at significant savings. From customized parts packages to turnkey&n...
