Sterile injection water production technique

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 pharmaceutical production, in particular to a production process of sterile water for injection 。 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 glass ampoule bottle, that is, when the glas...

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Problems solved by technology

Brings a greater safety hazard to clinical use

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