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Sterile injection water production technique and sterile compressed air preparation method

A water for injection and production process technology, applied in chemical instruments and methods, medical preparations of non-active ingredients, pharmaceutical formulas, etc., can solve problems such as potential safety hazards, achieve safety assurance, improve sterility assurance levels, and control heat sources The effect of content

Active Publication Date: 2014-04-02
ZHONGQI PHARMA IND HENGSHUN ZHONGQI
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  • Description
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Problems solved by technology

Brings a greater safety hazard to clinical use

Method used

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  • Sterile injection water production technique and sterile compressed air preparation method
  • Sterile injection water production technique and sterile compressed air preparation method

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Embodiment Construction

[0029] Such as figure 1 As shown, the production process of sterile water for injection of the present invention is firstly to carry out online cleaning CIP and online sterilization SIP to all pipelines, preparation tanks and storage tanks used for the production of sterile water for injection with distilled water or pure steam.

[0030] The online cleaning CIP is to keep the pressure under the condition of 0.15MP sterile compressed air for 15 minutes, and then perform pre-washing; after pre-washing, use 300kg of distilled water with a temperature above 80°C to rinse and sterilize the storage tank for more than 15 minutes; then use 80°C distilled water, online rinse at a pressure of 0.25 MP for more than 15 minutes, and finally use sterile compressed air to dry at a pressure of 0.15 MP for 15 minutes.

[0031] The online sterilization SIP requires pure saturated steam detection first, that is, to detect the steam generated by the pure steam generator. When the steam reaches 0...

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Abstract

The invention discloses a sterile injection water production technique and a sterile compressed air preparation method. The sterile injection water production technique comprises the following steps: firstly, performing online cleaning CIP (Cleaning in Place) and online SIP (Sterilization in Place) and online drying to all pipelines, a preparation tank and a storage tank used in the production of sterile injection water through distilled water or pure steam, and delivering distilled water into the preparation tank; heating and sterilizing the distilled water, and leading into the storage tank and cooling; and finally, performing sterile filtration to the distilled water through a redundant filtration system, and injecting in a blowing-pouring-sealing three-in-one pouring machine through a sterile pipeline system for sterile pouring and sealing, thus obtaining the product. Through the production technique, the injection water is strictly sterilized before pouring and sealing, heat source content can be effectively controlled, an additive and an antioxidant of a plastic bottle can be prevented from diffusing into the injection water and no impurities of scraps and the like do not exist when terminal high-temperature sterilizing is carried out, therefore, the sterile injection water can provide powerful guarantee for the clinical use safety.

Description

technical field [0001] The invention relates to the field of medicine production, in particular to a production process of sterile water for injection and a preparation method of sterile compressed air. Background technique [0002] At present, water for injection is usually packaged in glass ampoules and polypropylene (PP) plastic ampoules, and the sterility is guaranteed through the terminal sterilization process. [0003] At present, there is a problem that glass ampoules cannot be cleaned safely. Glass ampoules need to be washed with water to wash the inner and outer surfaces of the ampoule, but they cannot be cleaned safely. Especially when the washed glass ampoules enter the drying process in the dryer, the inner wall of the ampoule is prone to delamination, forming glass particles. Moreover, when the glass ampoule is filled and sealed at a high temperature with a flame, burning particles will be produced and fall into the ampoule. There is another problem with the g...

Claims

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Application Information

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IPC IPC(8): C02F9/10A61K47/04
Inventor 潘林张洪飞
Owner ZHONGQI PHARMA IND HENGSHUN ZHONGQI
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