Principle and Application:

The demand of the sterile and non-heating is very high in Biopharmaceutical process, so the sterilizer and other related projects also be required high technology. It mainly contain two aspects as follows:

1. sterilization medium:

Heat sterilization use saturated steam as the sterilizing medium. The main component of the bacterial protein will be killed by occurs hydration and solidification within a certain time make use of the physical characteristics of the release of condensation latent heat. In demanding sterilization processes in biological products, the place must be entirely pure steam heat source in order to ensure the cleanliness of energy in line with GMP requirements.

2, engineering material: 

All articles in contact with sterile container and energy pipeline must meet sanitary requirements. All connected with the sterilization chamber energy pipeline adopts 316L sanitary pipes.

The series of pure steam sterilizer is in strict accordance with the GMP standard design, with horizontal rectangle inside and outside the two-tier structure. The inner working process using pure steam as sterilizing medium, cover layer using boiler steam preheating and drying.

The equipment in addition to a pulsating vacuum sterilizer of all functions, but also need to set some of the biopharmaceutical industry dedicated program according to the user.

General Procedure

1. General Instruments, fabric procedures: pre-way rule out a pulsating vacuum residual cold air inside to ensure uniform penetration and steam sterilization temperature uniformity. The program is suitable for sterilization hundred other clean area and aseptic filling containers with clothing and other items.
2. common liquid program: for small capacity without sealing the filling liquid sterilization

General Process Description:

1. Clothing, equipment program:

 Automatic detection → preheating → vacuum → heating → sterilization → cooling → drying end

2. Ordinary liquid program:

 Automatic detection → preheating → heating → sterilization → cooling → End

Special program: with the user to determine the sterilization process.

The device performance characteristics

1. Germany's Siemens industrial control system, superior performance.
2. Key components with high-quality original imported parts are used in the industry, and most parts in our country has about 50% market share.
3. The device has a standard GMP validation interfaces, the company has 16 standard computer verification instruments and can provide users with GMP authentication service at any time.

Main structure

1. The cabinet: is composed of an inner layer, an outer layer, insulating layer.

 ① lining: the sterilization chamber, high-quality 316L stainless steel, polished inner surface precision machinery, smooth and no dead ends, meet the GMP requirements of the biopharmaceutical industry.

② jacket layer: Preheat boiler steam and dry, durable.

 ③ Insulation: insulation performance, minimize heat conduction and heat radiation body

2. The sealing door: motorized door with safety interlock, two-door interlock function.

 ① safety interlock: The equipment comes with complete safety interlock devices: the door is not sealed and not allowed into the steam chamber; the chamber pressure is not allowed to open the door. Full compliance with national standards for the relevant departments of the safety interlock pressure vessel.

② two-door interlock: According to GMP requirements with a two-door interlock function to ensure the direction of the different regions of isolation and logistics.

 3. Decorative cover: brushed stainless steel plate, nice and easy to clean.