Purification isolating device of aseptic powder needle split-charging production line

Abstract

The invention discloses a purification isolating device of an aseptic powder needle split-charging production line, which aims at solving the problem that the operation mode of an existing powder needle split-charging production line possibly damages aseptic environment and is high in construction cost. The purification isolating device of the aseptic powder needle split-charging production line directly integrates an isolating device on a powder needle split-charging production line by arranging an isolating device cabin body, a built-in split-charging production line, a glove operating system, a static pressure box, a one-way laminar flow air supply system, an air return system, an exhaust system, an integration interface board and the like, has the beneficial effects that operators can be isolated from the production process of split charging and stopper adding of medicines and the like, and split-charging aseptic environment of the medicines can be more effectively guaranteed.

Description

technical field [0001] The invention relates to a purification and isolation device for a sterile powder injection subpackaging production line. Background technique [0002] The powder injection sub-packaging production line is to clean the vials used for product packaging with purified water and water for injection in the bottle washing machine, dry the residual water with sterilized compressed air, dry heat sterilization in a tunnel oven, and remove the heat source, and then transfer the vials Sorting, and then powder filling (dividing) packaging, and immediately stoppering the vials, and finally sending the vials to a capping machine for capping to complete the production of sterile powder injection filling (dividing) packaging. Sterile powder injection refers to the sterile powder for injection made by aseptic technology. The powder injection is a non-terminal sterilized injection, which has the characteristics of sterility, no pyrogen and high purity. Compared with oth...

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Problems solved by technology

[0003] As far as the existing technology is concerned, first of all, the powder injection subpackaging production line has not completely separated people from medicines. At present, operators wearing sterile work clothes are still operating around the sterile powder injection subpackaging production line, while the human body It is the largest source of pollution in a sterile environment. Under the conditions of Class A cleanliness defined in Appendix 1 of the 2010 version of GMP, such an operation method is likely to cause damage to the sterile environment; secondly, the prior art The cost and maintenance cost are relatively high. Ordinary aseptic powder injection production lines still use the purification system inside the clean room, but hang plastic curtains or surround partitions as barriers in the key core areas, which require the cleanliness of the entire clean room Under the condition that the degree level must be A-level, it is expensive to build a large-area A-level clean room, and the operation and maintenance costs are relatively high

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