The hottest plastic soft bag infusion packaging te

Research on plastic soft bag infusion packaging technology (Part 1)

infusion refers to the large-dose injection injected into the body by intravenous drip. It is one of the five commonly used clinical preparations. It provides water, electrolytes and nutrients required by patients, and can also be used as a carrier for intravenous drug delivery. Since the ninth five year plan, the infusion production in China has developed steadily and healthily, with the output increasing from 13. 5% in 1995 800 million bottles (bags) increased to 29. 5% in 2001 100million bottles (bags), with an average annual growth of 16 1%. In 2003, the market volume of infusion reached 3.5 billion bottles (bags) [1]. At present, the packaging forms used in infusion production in China include glass bottles, plastic bottles and plastic soft bag packaging, of which plastic soft bag packaging is divided into PVC (polyvinyl chloride) bags and non PVC soft bag packaging

1 glass bottle infusion packaging technology

glass bottle infusion has long been the main form of infusion packaging in China. At present, 95% of infusion in China still uses glass bottle packaging. As a traditional packaging form of infusion, glass bottle infusion mainly has the following advantages:

1) the transparency of glass bottle is good, which is conducive to the detection of insoluble particles in infusion

2) glass, therefore, this also greatly reduces the cost expenditure. The glass bottle has good thermal stability, which is conducive to the use of high-temperature sterilization in the production process of infusion to remove bacteria and ensure the quality of infusion

3) it has good chemical inertia, barrier and tightness, ensuring the stability of the quality of drugs during storage

however, there are some defects in the technology of glass bottle packaging for infusion, mainly including:

1) inconvenient transportation and limited geographical range of use. The glass bottle is brittle and easy to break due to violent vibration and impact, so the glass bottle infusion is not suitable for long-distance transportation, which limits the geographical scope of its application

2) complex process and low production efficiency. The infusion is packaged in glass bottles. Compared with other infusion packaging technologies, the production process adds several complex processes, such as rubber stopper, isolation film and glass bottle washing. The process route is longer and the production cycle is relatively prolonged. "Advanced multi card combined technology, so the production efficiency is low

3) high production cost. Due to the complex process route, many equipment, wide floor area, high equipment investment costs and housing construction costs, and the need to consume a lot of water in the processing of packaging containers and auxiliary materials, the production cost is high

4) there are potential safety hazards in clinical use. When inserting a needle into a glass bottle for infusion, medical staff should not only puncture the rubber plug, but also pierce the polyester film. It is inevitable to introduce insoluble particles into the infusion. Insoluble particles in the infusion may block the microcirculation of the human body, and even cause thrombolytic bleeding [2]; In addition, during clinical application, in order to make the infusion process smoothly, it is necessary to insert a ventilation pipe to introduce air into the solution, resulting in a pressure difference. At this time, the infusion is in a fully open state, and the dust and microorganisms in the air may enter the glass bottle and pollute the infusion, resulting in serious infusion reaction

due to its heavy quality, high brittleness, easy damage, and inconvenient to carry and transport, in the 1960s, infusion with plastic containers as packaging containers appeared internationally, ending the dominance of infusion packaging technology in glass bottles

2 plastic bottle infusion packaging technology

plastic bottle infusion packaging technology mainly uses polypropylene (PP) and polyethylene (PE) as the materials of packaging containers. In 1984, Tianjin Otsuka Pharmaceutical Co., Ltd. was the first to introduce the packaging production technology of polypropylene resin bottles [3] to produce China's first bottle of PP bottled infusion. The advantages of plastic bottle infusion packaging technology are:

1) light weight, the bottle weight is only 1/5 of the weight of glass bottle, which is not easy to be damaged, and is conducive to long-distance transportation

2) the plastic bottle has good chemical stability, barrier property and compatibility with drugs, which is conducive to the long-term preservation of the liquid medicine

3) advanced technology and high production efficiency [4]. In the production process of plastic bottled infusion, bottle making and filling are carried out in the same production area, or even in the same machine. Bottles only need to be purged with sterile air, or even filled directly without washing, eliminating the complex washing process of glass bottled infusion, shortening the production cycle and improving the production efficiency

although plastic bottle packaging technology overcomes the shortcomings of glass bottle packaging technology, which is not easy to transport and low production efficiency, we must see that there are still some problems in plastic bottle infusion:

1) clinical application, there are infusion safety problems. Plastic bottle infusion, like glass bottle infusion, belongs to an open infusion method. In the process of use, it is still necessary to insert an air needle and establish an air channel to make the infusion drip smoothly, Microorganisms and particles in the air can still enter the infusion through the air needle, causing damage to the human body

2) PEKK material for plastic bottles is an ultra-high performance polymer with excellent strength, chemical resistance, low and high temperature resistance, radiation resistance and excellent wear resistance. Its lightness is not as good as that of glass bottles, which is not conducive to the inspection of infusion clarity

3) the thermal stability of plastic bottles is inferior to that of glass bottles, PP plastic bottles are not resistant to low temperature,

brittle when cold. "This kind of plate spring must be very tough and have durability and cracking, PE plastic bottles are not resistant to high temperature, and cannot meet the 121 ℃ [5] required by FDA during sterilization.

(to be continued)