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Double-layer aseptic package, packaging method and sterility test method for large volume injections

An injection and large-capacity technology, which is applied in packaging, food packaging, pharmaceutical packaging, etc., to achieve the effects of improving water vapor barrier performance, enhancing mechanical properties, and improving the safety of infusion and medication

Inactive Publication Date: 2015-03-25
XIAN JINGXI SHUANGHE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The technical problem to be solved by the present invention is how to provide a packaging form of large-capacity injections to solve the existing problems of plastic packaging in the field of large-capacity injection production

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] This embodiment provides a double-layer aseptic packaging of a large-capacity injection, and an outer packaging bag with excellent mechanical shock resistance, moisture barrier property, low temperature resistance and chemical stability is wrapped outside the inner packaging bag. The above-mentioned outer packaging bags can be preferentially but not limited to high-barrier plastic packaging bags. The inner packaging bag and the outer packaging bag are subjected to vacuum treatment, so that the outer packaging bag is seamlessly attached to the inner packaging bag, so that the outer packaging bag also becomes a part of the packaging bag itself, and the process of product production, loading and unloading is enhanced. , storage, transportation and use of the external mechanical impact resistance and extrusion capacity, not just play a role in dust.

[0035] In this solution, the inner packaging bag can use any large-capacity injection packaging technology in the prior art,...

Embodiment 2

[0039] This embodiment provides a packaging method using the double-layer aseptic packaging described in Embodiment 1. The typical liquid medicine production to transportation process includes: preparation—filtration—filling—sterilization—light inspection—outsourcing bag—boxing—storage—testing—release. It can be seen from this that the packaging process is only a part of the whole process from the production of the liquid medicine to the circulation of the liquid medicine in the market, but it is closely related to other processes. Therefore, this scheme combines the whole process of "preparation to release" of the liquid medicine Describe the packaging method.

[0040] In this plan, the process from liquid medicine production to transportation includes: preparation—filtration—filling—outsourcing bag—vacuum treatment—sterilization—light inspection—packing—storage—inspection —— Release, the specific process conditions are as follows:

[0041] Preparation: Completed in a C-lev...

Embodiment 3

[0052] This embodiment provides a method for aseptic detection of double-layer aseptic packaging of large-capacity injections, comprising the following steps:

[0053] Step 1: Fill the liquid medicine into the inner packaging bag and complete the sealing;

[0054] Step 2: Put the filled and sealed inner packaging bag into the outer packaging bag, seal the outer packaging bag after vacuuming, and then send it for sterilization;

[0055] Step 3: Sterilize the product, inner packaging bag and outer packaging bag together.

[0056] In this solution, after the filled and sealed inner packaging bag is loaded into the outer packaging bag and before vacuuming, water for injection or purified water is added to the inner packaging bag and the outer packaging bag. Of course, water for injection or purified water should be used in an appropriate amount, for example, between 0.01ml and 5ml is generally acceptable. The purpose of adding water for injection is to carry out moist heat steri...

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Abstract

The invention relates to the field of production of large volume injections, and provides a double-layer aseptic package, packaging method and sterility test method for large volume injections. The package comprises an inner packaging bag and an outer packaging bag wrapping the inner packaging bag. The space between the inner packaging bag and the outer packaging bag is vacuumized, so that the outer packaging bag is nearly attached to the inner packaging bag, and the space between the inner packaging bag and the outer packaging bag is aseptic. The mechanical performance and moisture blocking performance of the packaging bags are enhanced, and the problems of product pollution and medical potential safety hazard caused when packages leak or moisture evaporates in the transportation or storage process are solved. Besides, the vacuumized packaging bags are subjected to sterilization, liquid medicine in the inner packaging bag of the package is aseptic, and meanwhile the space between the inner packaging bag and the outer packaging bag is also aseptic. Thus, when the package is applied to the environment like clinical dispensing having high aseptic requirements, it is only required that the outer packaging bag is taken off, and medical staff do not need to disinfect packages one by one.

Description

technical field [0001] The invention relates to the field of production of large-capacity injections, in particular to a double-layer aseptic packaging of large-volume injections, a packaging method and a sterility testing method. Background technique [0002] In the field of large-capacity injection production, plastic packaging forms such as multi-layer co-extruded film soft bags and stand-up soft bags manufactured through blow molding and heat-tight sealing processes can reduce air return pipes and produce no blood return. Advantages such as clinical cross-contamination are widely used. However, there are advantages and disadvantages. In order to ensure that there is no need to use a return air tube and no return of blood, the above-mentioned packaging is relatively thin and soft, which not only leads to poor mechanical impact performance and is prone to leakage; it also makes the water vapor permeability large. The concentration of the drug increases during storage of t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J1/10C12Q1/04B65B3/04
Inventor 屈平定李昕梁亚君
Owner XIAN JINGXI SHUANGHE PHARMA
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