Vacuum leak-detection sterile dual-valve soft bag transfusion combined bag

Abstract

The invention relates to a vacuum leak-detection sterile dual-valve soft bag transfusion combined bag. A manufacturing process of the vacuum leak-detection sterile dual-valve soft bag transfusion combined bag comprises the following steps of sterilizing a material membrane of a liquid medicine bag, feeding the material membrane into a packing workshop, welding the material membrane with a transfusion valve to form an inner packaging bag, filling the inner packaging bag with liquid medicine to form soft bag transfusion, performing sterilization for a second time and performing drying; performing lamp detection for a first time to remove unqualified products with wrong package printing, wrong welding and large impurities in the packaging bag; covering the liquid medicine bag with an outer packaging bag, vacuumizing space between the outer protective bag and the liquid medicine bag or filling space between the outer packaging bag and the liquid medicine bag with protective gas preparations or liquid preparations or solid preparations, performing sterilization for a third time, packing the combined bag in a case, and putting the case in storage for later use; performing lamp detection for a second time to remove leaked products. By means of the vacuum leak-detection sterile dual-valve soft bag transfusion combined bag, bacteria cannot retain in an interlayer, microleaked large volume injection formed in the inner packaging bag can be discharged effectively and conveniently, and the liquid leakage rate when the combined bag leaves the factory is reduced below 0.029%. The period of validity of the vacuum leak-detection sterile dual-valve soft bag transfusion combined bag is prolonged to five years from two years.

Description

technical field [0001] The invention relates to a medical soft bag infusion, which belongs to the field of pharmaceutical manufacturing, especially a combined infusion infusion that can achieve aseptic packaging, high pass rate of ex-factory products, and temporary inspection of whether the packaging is leaking in the field of use. Soft bag packaging. Background technique [0002] Soft bag infusion is a new packaging form of medicinal liquid. Soft bag infusion is a medical drug administration route. The medicinal liquid is filled in the soft infusion bag in an aseptic operation, and then injected into the human body through the vein, so as to achieve the goal of giving drug treatment effect. Double-valve soft bag infusion means that two infusion valves for adding medicine are set on the infusion bag, so that during use, one is used for adding medicine, and the other is used for inserting the infusion needle, and the infusion can be performed at the same time without mutual ...

AI Technical Summary

Problems solved by technology

In the actual working process, this light inspection method can find products with microporous liquid leakage, and can detect a large part of the packaging with impurities, obvious welding problems in the packaging, serious damage to packaging materials, and printing defects in packaging, etc. Products with quality problems, and this part of products with obvious quality problems have not been eliminated in advance, which will increase the cost of subsequent temporary storage and transfer work (because this part of products will also be transferred to the production process together with qualified products, which is actually for waste of production resources)

[0009] 3. Because there are too many problems to be inspected in light inspection (including not only picking out micropores and microleakages, but also detecting impurities, welding problems, printing problems, packaging problems, etc.), it will affect the specificity and pass rate of inspection micropores. And it makes the light inspection workers have too many inspection items, resulting in visual fatigue and prone to errors

If the liquid medicine is filled and then sterilized, bacteria may be mixed in the liquid medicine, and the purpose of complete sterilization cannot be achieved.

The outer packaging and the inner packaging have been sterilized together for a long time under high temperature and high pressure, and may be damaged (the inner packaging is used to fill the liquid medicine, and its performance requirements are high, and in order to save costs, the material performance of the outer packaging is lower than that of the inner packaging, so it cannot undergo the same intensity of sterilization process as the inner packaging)

[0011] 5. After putting on the outer packaging and extracting the vacuum, carry out high-pressure high-temperature sterilization for a long time. In this environment, the strength of the packaging material is reduced. If there is vacuum pressure in the packaging layer, both the inner and outer packaging are more likely to be damaged, reducing the product quality. Pass rate

[0012] 6. There is no application example of packaging technology in double-valve soft bag infusion

[0013] 7. The stability of the quality of the liquid medicine in the inner bag extends the validity period of the product without demonstration, and no better measures are taken to protect the stable quality of the liquid medicine in the inner bag

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