"Standing bag": Infusion king Fuze Wanmin

Project Name: New Vertical Polypropylene Medical Infusion Bag

Manufacturing technology and industrialization

Award level: National Science and Technology Progress Second Prize

Infusion is the most widely used and most important treatment in clinical practice, and its safety is closely related to the packaging form and material. Sichuan Kelun Pharmaceutical Co., Ltd. has developed a new infusion package with independent intellectual property rights that can be placed upright and fully sealed in 4 years. It is a vertical polypropylene infusion bag (referred to as “standable bag”). The secondary pollution generated during the infusion process meets the special use conditions such as airdrop. The industrialization of products that combine the advantages of the traditional four infusion packages has strongly promoted the soft plasticization process of infusion packaging. Successfully bred the new vertical polypropylene medical infusion bag manufacturing technology and industrialization project of “Keli bag” products, and won the second prize of National Science and Technology Progress Award in 2014.

At the time of crisis

"We are ordered to be in danger." When it comes to the cause of the project, Liu Zheng, the first person in the project and the chairman of Kelun Pharmaceutical, still remembers it. "In the battle against SARS in 2003, all drugs related to SARS prevention, including large infusions, were extremely scarce. Because SARS virus can be transmitted through the air, fully enclosed infusion products are in short supply. At this time, domestic infusion production It has reached 4.25 billion bottles, but the packaging forms are mainly glass bottles, plastic bottles, PVC soft bags and non-PVC soft bags. These four types of infusion products have their own problems in use: commonly used glass bottles and plastic bottle infusions need to be imported during infusion. Air can discharge liquid, which is easy to cause secondary pollution; soft bag infusion can not be placed upright, it is difficult to dispense, and it is difficult to use under special conditions such as airdrop. Clinically, it is urgent to meet a national condition, which can effectively guarantee the safety of clinical infusion. It can improve the efficiency of clinical care and is suitable for airdrop intravenous infusion products during disaster relief.

"But there are four major technical problems in the development of new products," Liu said. "One is that commercial polypropylene pellets or polyethylene pellets are not suitable for the preparation of infusion bags, and it is necessary to find suitable infusion bag materials. Second, the traditional evaluation system. It is not enough to guide the rational selection of pharmaceutical packaging materials to ensure the safety and effectiveness of the drug. It is necessary to establish a new safety assessment and control technology for the standing bag. Third, the bag type has high functional requirements and is difficult to design. It must be designed to be both erectable and configurable. Products with shrinkage function; Fourth, there are no manufacturing equipment and production technologies that are currently available for reference."

Scientific research has been targeted

Clearing up the problem can be targeted, but the process of tackling the problem is very difficult. After the project was established, Kelun Pharmaceuticals was the focus of the group, and the technical personnel formed a technical research team to break through the four major problems.

In terms of material selection, the project selected injection molding or extrusion blowing process, and after a large number of experiments, successfully developed new modified medical polypropylene pellets with good mechanical properties and biosafety. The modified pellets have good flexibility, can withstand high temperature sterilization at 121 ° C, and the biosafety conforms to the United States Pharmacopoeia standard, and replaces the imported multi-layer co-extruded film. In addition, the light transmittance and water permeability are softer than the existing non-PVC. The bag has been greatly improved.

In terms of drug safety, Kelun Pharmaceutical not only built the infusion analysis and extraction technology of infusion packaging materials, the migration monitoring technology of infusion packaging materials and other drug and packaging materials compatibility evaluation and control technology, and met the requirements for the pouch and medicine. The compatibility needs to be studied, and the safety assessment and control technology of infusion preparations is also constructed to solve the safety problem of infusion.

In terms of bag-type functions, they have taken the lead in the international development of a new infusion bag with high emptying, no blood return, and erecting - "standable bag", which solves the inherent safety hazards of traditional glass bottles and plastic bottle infusion bags. The infusion rate of glass bottles and plastic bottles is 8.2%, and the standing bag is 3.5%; the air bag breakage rate of soft bags is more than 30%, and the standing bag is only 0.94%.

In terms of manufacturing, the R&D team pioneered a safe and efficient five-in-one continuous production technology of “embroid injection-blowing bag-wash bag-filling-sealing”, which increased the bag yield rate from 84.5% to 99.8%. The product qualification rate has increased from 78.32% to 99.97%, and the product contamination rate has dropped from 2.3 parts per million to 0.17 parts per million, and the production efficiency has increased by about 65%, filling the gap in the manufacturing equipment and production process of the standable bag.

"Standing bag" Fuze Wanmin

In 2013, China Medical Quality Management Association organized the scientific and technological achievements appraisal of “Keile Bag”, and believed that the product and technology were the first at home and abroad, reaching the international leading level, and greatly promoting the development of pharmaceutical packaging materials at home and abroad. It has great social benefits in improving the safety of infusion clinical use, energy conservation and environmental protection, improving the efficiency of medical staff and emergency airdrops.

Since its launch in 2007, “Standing Bag” has been well received. The advent of “standable bag” has increased the proportion of domestic soft plastic packaging from about 17% in 2005 to about 75% in 2011, which has effectively promoted the soft plasticization process of the infusion industry and promoted the transformation and upgrading of the infusion industry.

Because it overcomes the defect that the traditional soft bag can not be placed upright and the dispensing is difficult, the "standable bag" has obvious operation convenience, can significantly reduce the labor intensity of the medical staff, and improve the work efficiency of clinical nursing. The trials of the Daping Hospital affiliated to the Third Military Medical University showed that the “standable bag” can improve work efficiency by 30% in the operation process of fully simulating the clinical infusion and dosing.

Due to its unbreakable nature, in the emergency rescue of the “5.12” Wenchuan Earthquake in 2008, the “standable bag” became the first infusion product for earthquake relief, saving countless lives.

At present, Kelun Pharmaceutical has dozens of production lines in 11 production bases with “can stand” production qualification, and successfully applied to 86 infusion products. Nowadays, “可立袋” products have been widely used in 3,990 medical institutions at all levels across the country, and have been welcomed and affirmed by the majority of medical workers.