Application of double-layer vacuum time-delay leak detection technique in large capacity injection

Abstract

The invention relates to application of a double-layer vacuum time-delay leak detection technique in a large capacity injection. The large capacity injection mainly comprises an interior package, a liquid medicine and a protection outer bag outside the interior package. The process for detecting the leakage of the interior package comprises the following steps of: performing vacuum extraction between the protection outer bag and the interior package; putting the large capacity injection in a temporary storeroom for 13 to 15 days; and turning out the large capacity injection to perform inspection, wherein when an infusion soft bag with obvious water fog or water droplets is formed between the interior package and the protection outer bag, a micro-leakage large capacity injection is generated and is winkled out. The double-layer vacuum time-delay leak detection technique puts off the leakage detection time to 15 days (not the day when a product is offline) and then performs liquid leakage inspection on the large capacity injection, so the large capacity injection generating micro-leakage or has potential micro-leakage shows out and is removed. Through a technical skill of the invention, the ex-factory micro-leakage rate is reduced to 0.003 to 0.005 percent. Thus, medical accidents are reduced and the excellent health of people is ensured.

Description

technical field [0001] The invention relates to the field of manufacturing large-capacity injections for medical use. Background technique [0002] Large-capacity injections, that is, for intravenous infusion, including glass bottle infusion, plastic bottle infusion, soft bag infusion, upright infusion bag, and stand-up packaging infusion bag. [0003] During the production, packaging, and delivery of large-capacity injections, very few packaging experiences micropores or micro-slits due to accidental factors, resulting in leakage of the liquid medicine: [0004] Such as glass bottle infusion, in the process of production, packaging or transportation, there will be micro-slits or micro-holes due to the collision between glass bottles; plastic bottles may have local uneven thickness and other factors in the blow molding process. , produce leaks or leaks; soft bag infusion or upright infusion bag, vertical infusion bag, because of the edge sealing process around the bag body ...

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Problems solved by technology

On the other hand: other external factors (such as harmful gases, air) will also affect the stability and biological characteristics of the liquid medicine, which may cause the liquid medicine to deteriorate or cause harm to the patient's body.

[0007] In terms of controlling the microleakage of large-capacity infusions, most infusion manufacturers can only use artificial quality control in the production process to prevent products with microleakage from leaving the factory. However, due to the diversity and status of microleakage products The inconspicuousness, it is difficult to effectively artificially control

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