Descriptions
The GM100 series dry heat sterilizer (heat source remover) is a device elaborately designed and developed by our company on the basis of accumulating rich experience in designing and manufacturing various electrothermal sterilizers, absorbing and digesting advantages of other products of its kind at abroad according to China's actual conditions The device conforms to the requirements in FDA, new edition GMP and US Federal Standard 209E,providing reliable help for GMP reformation and FDA certification in China's pharmaceutical industry.
Application range
The equipment is suitable for sterilization and heat source removal of heat resistant materials, such as glass bottles, glass vessels, vials, metal vessels, metal plates, equipment parts, etc.
Equipment and document system conform to the standards
Conforming to national new edition GMP
Conforming to FDA requirements
Conforming to requirements in US Federal Standard 209E
人User-friendly control system
It adopts Siemens PLC control for reliable running
The human machine interface adopts Siemens touch screen with reliable pedormance and convenient operation
The software system is specially designed with perfect functions according to special requirements in the pharmaceutical industry.
The data storing system can store and print temperature, time and other running parameters
Technical features
• The real dynamic 100-grade standard and gad temperature distribution evenness of the sterilizer are displayed through the following unique technical designs
• The temperature in the process chamber is detected by the temperature measuring probe at many points
• In order to ensure that the sterilized products reach absolute asepsis when they are taken out, the equipment cavity pressure must be ensured to be +30Pa
• The fan is a high temperature resistant direct coupling fan that adopts imported technology It is provided with the cooling system, does not have any bearing, does not need lubrication oil and meets GMP requirements
• The negative pressure sealing ct unique technology is adopted to avoid any possible pollution to handled products
• The process door is provided with double-lip sealing strip Special sealing gaskets that have been subject to treatment can form negative pressure, so that good sealing of the door can be ensured during each circulation process This design avoids heat and possible pollution
• The equipment air intake system, cavity inside and air exhaust system are installed with high efficiency filters, which have a particle stopping efficiency of 99.99%
• The laminar plate on the inner wall of the cavity adopts a specially designed microporous structure to realize even air temperature distribution with temperature difference less than or equal to ±5℃
• It is provide with automatically controlled pneumatic door lock linkage
• Pressure and temperature in the process chamber are controlled automatically
• Online particle verification test and temperature distribution test can be carried out
• The DOP verification port is res~Ned in the HEPA high efficiency filter
• The main filter in the process chamber adopts a double-sealing structure In addition, negative pressure is adopted fur detecting sealing between the filter and cabinet, so as to ensure effective sealing of the filter.
Rotation of materials to be sterilized
Structural features
• The sterilization charnber air regulator is provided with the air regulating plate and punched plate structure to effectively adjust temperature distribution
• The process chamber the inside of two leaf door aid laminar plate are made of AIS316L stainless
• The process chamber is subject to argon arc welding process nd precision polishing with a round corner structure and polishing degree less than or equal to O.5u
• The special heat insulation technology ensures that the temperature on the exterior surfaces of tile
equipment is less than of equal to room temperature +15℃.
Technical Parameter
Our company can customize the products according to special requiements of users,you will not be notified of any changes in advance!