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GMP requirement for extraction enrichment facilities

 Present situation and application of pharmaceutical machinery industry

Today, we extract concentration in the pharmaceutical machinery industry equipment industry has to realize large-scale production, many varieties, although production strength and production levels and lacked, but there is the opportunity to jump to the larger professional products industry, but as the internationalization of trade and economic integration with the international GMP, promote pharmaceutical equipment to strengthen the GMP pharmaceutical production enterprise there is a desperate need for better function, the concept of equipment GMP is becoming a hot spot of domestic and foreign trade competitiveness of technology.

Recommend extraction enrichment facilities

 

GMP pharmaceutical water preparation device has the following requirements:

1, the structure design of simple, reliable, easy to tear open outfit.

2, to facilitate tear open outfit, replacement, cleaning parts, standardized design actuators, to maximize the use of universal, systematic parts.

3, equipment internal and external wall of a smooth surface requirements, no dead Angle, easy to clean and disinfect.

The surface of the parts should be chrome plated surface treatment, corrosion, rust.

Avoid external coating device, in order to prevent the peeling off.

The preparation of 4, water purification equipment should be low carbon stainless steel or other effective do not pollute the water quality of the material.

The preparation of water purification equipment should be cleaned regularly, and the effect of cleaning validation.

5, injected water contact materials must be of high quality low carbon stainless steel (316 l stainless steel, etc.) or other material pollution of the water proved to be wrong.

The preparation of injection water equipment should be cleaned regularly, and the influence of cleaning validation.

6, purified water storage period should not be more than 24 hours, the case shall be stainless steel or verify non-toxic, corrosion resistance, make other materials do not spill ions.

Vent protection should be installed off hydrophobicity of fiber filter.

Tanks should be smooth, tube and welding should not die and the original body.

At this stage, there is no form such as water pollution parameters of temperature and pressure sensors.

Tank should be regular cleaning, disinfection and sterilization and cleansing, sterilization validation.

7, pharmaceutical water transport

1) water and purified water should be remove convenient cleaning disinfection, stainless steel pump.

In pure water and water pressure with compressed air or nitrogen injection timing, compressed air and nitrogen gas purification.

2) purified water appropriate USES circulation pipeline transport.

Piping design should be simple, should avoid blind pipe, and death.

Pipe should use stainless steel tube or verify non-toxic, corrosion resistance, no leakage pollution ions.

Valves should adopt health valve no dead Angle, purified water should be marked.

Transport purified water and water for injection (3) the pump should be regular cleaning, disinfection and sterilization, can be put into use after verified.

8, the design of the pressure vessel, shall be conducted by qualified personnel by the authorized unit, according to Chinese "steel pressure vessel" of the People's Republic of China national standard (gb150-80) and "the relevant provisions of the rules of the pressure vessels safety and technical

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