Development of 5-layer co-extruded water-cooled film blow-molding machine for MX5B-1200QA medical infusion bag (I)

First, the purpose and significance of the development

Since the invention of the infusion product, it has been widely used as a drug formulation in treating and rescuing people. It is divided into glass bottles, plastic bottles and soft bags according to the packing form, and is divided into glass, PVC and non-PVC according to the packaging materials, among which non-PVC Including polyethylene, polypropylene and composite film / multilayer co-extruded film.

Bottled infusions have been developed for the first time since the 1970s, due to the need for secondary air pollution due to the need to introduce air during use, as well as energy waste during production and environmental impact during post-processing. PVC soft bags have gradually faded out of the market due to factors such as the use of plasticizers and non-heat-resistant sterilization in the production process.

The domestic glass infusion bottles are basically made of boron-free or low-boron type II glass. This type of device carries out de-alkali treatment on the inner surface of the bottle; a layer of silicon-rich layer is formed on the inner surface of the bottle to improve the chemical properties of the bottle. Repeated use can easily damage the silicon-rich layer on the glass surface, resulting in a decline in chemical properties. Therefore, GB2639 "glass infusion bottle" standard stipulates that this type of product should be marked with type II, and is limited to one-time use. The State Drug Administration has also repeatedly issued orders to prohibit the repeated use of such products, and through GMP certification mandatory elimination of some non-compliant small pharmaceutical and hospital preparation rooms.

Polyolefin multi-layer co-extruded membranes for transfusion are popular among doctors and patients in recent years because of their safety, efficacy, and medical compliance. The most important feature is multi-layer co-extrusion, no plasticizers and adhesives, high transparency, strong barrier properties and tear resistance, good compatibility with drugs, and no pollution to the environment after use. And so on, is the ideal environmental protection material for infusion product packaging. Li Dakui, chairman of the Pharmaceutical Committee of the Chinese Pharmaceutical Association and director of the Department of Pharmacy at Peking Union Medical College Hospital, pointed out that the clinical requirements for transfusion containers are safety, ease of use, environmental protection, and economy. The Concord Hospital conducted the use of 15 kinds of commonly used Chinese and Western medicines, including insulin, isosorbide dinitrate, paclitaxel, and Xiangdan injection, using the most commonly used glass infusion bottles, PVC infusion bags and non-PVC infusion bags. Adsorption studies have shown that the safety of non-PVC infusion bags is best. Although the adsorption of glass bottles is very small, there are problems such as back-flow air pollution, difficulty in detecting cracks in the slits, and falling off of plug powder.

At present, China encourages the production and use of advanced non-PVC infusion soft bag packaging products, and is listed as a key development project in the “tenth five-year development outline” of China's pharmaceutical packaging industry. However, at present, there are only 28 related production companies across the country, with 35 production lines. The output of one year is 90 million bags, which is far from the annual demand for nearly 3 billion infusion bags. The non-PVC infusion flexible packaging bag is a completely new concept of globally sealed intravenous infusion products. The developed countries have been in clinical use for more than 10 years. In recent years, our country has also strengthened management in this area, including the relevant content of the “Medicine Packaging Materials Container Management Measures (Interim ) has been introduced.

On the other hand, there are few equipments that can successfully produce such non-PVC flexible packaging films. There is no report on the production of such equipment in China. Therefore, the purpose of this project is to develop a five-layer co-extruded blow-molded film with internationally advanced technology. It is a co-extruded rotary blow-molding process that utilizes pharmaceutical grade polyolefin raw materials in a 10,000 clean environment. The 100-class clean air is blown into a tube film and cut into various specifications to make a soft infusion bag. The products produced are uniform in thickness, smooth in surface, good in transparency, have strong barrier properties and tear resistance, do not use plasticizers and adhesives, and do not contain chlorine components, and are ideally safe, effective, and pharmaceutical-compatible. A generation of infusion product packaging materials. It can be widely used in the packaging of electrolyte infusions, nutritional infusions, and therapeutic infusion products, replacing imports, and its core technology has reached the international advanced level. The product can completely replace the imported similar mechanical products, save foreign exchange, and earn foreign exchange through exports, with obvious social and economic benefits.

In view of the above reasons, Guangdong Jinming Plastics Equipment Co., Ltd. has developed a MX5B-1200QA medical infusion bag five-layer co-extruded water-cooled film blow-molding machine based on its extensive experience in multilayer co-extruded plastic film blow molding machines in recent years.

Second, the development process

MX5B-1200QA medical infusion bag five-layer co-extruded water-cooled film blow molding machine film products have high temperature resistance, anti-aging, high barrier, anti-extrusion, stable physical and chemical properties, and effectively prevent the pyrogen reaction and cross-contamination and air pollution Features, can fully guarantee the safety of patient infusion.

1. Medical infusion bag five-layer co-extruded water-cooled film production process

Raw materials for each layer are automatically weighed and fed - raw material plastic extrusion - extrusion melt filtration - five-layer co-extrusion head extrusion cylindrical tube - film bubble stretch inflation - bubble air cooling And water ring cooling - film rotation - traction - film drying - film correction - film winding.
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Source: China Packaging News