This chapter mainly describes the domestic infusion industry and the non-PVC soft bag infusion status, the problems of domestic soft packaging infusion and the future development and prospects of flexible packaging infusion; and the domestic multi-PVC co-extrusion film for non-PVC infusion, domestic consumables As well as the filling equipment, detailed system technology and market analysis were carried out, and localization of non-PVC soft bag infusion related consumables and filling equipment was proposed.
I. Current status of domestic infusion industry and non-PVC soft bag infusion
According to the statistics of SDA of the State Food and Drug Administration, there are currently more than 250 infusion production enterprises in China. Most infusion manufacturers mainly produce bottled infusions. There are only 30 manufacturers that can produce non-PVC soft bag infusions, and these 30 There are more than 40 soft bag production lines in the production enterprises. The annual production capacity is more than 500 million bags, and the actual production volume is only 100 million bags in 2004, and the operating rate is only about 20%. According to the current market demand for 3 billion bags of infusion industry, non-PVC soft bag infusion has a market share of less than 5%, and plastic bottle infusion which starts almost at the same time as soft bag infusion has occupied more than 10% market share. The development of non-PVC soft bag infusion has lagged behind the development of plastic bottle infusion, and the main reason for restricting the development of non-PVC soft bag infusion is our domestic packaging technology.
China's infusion industry has almost always developed with acceleration since its inception, from the annual production of hundreds of millions of bottles (bags) in the 1980s to the current production capacity of 6 billion bottles (bags) and 4 billion bottles (bags). Philippine sales, the rapid development of Chinese infusion is obvious to all. In particular, the infusion manufacturers proposed by the national SDA must pass the GMP demonstration to push the large infusion enterprises into the road of standardized production development.
However, in recent years, the “internal and external difficulties†encountered by domestic large infusion enterprises have become more and more obvious. On the one hand, due to overcapacity, the fierce competition in the domestic low-end market has been escalating and becoming more and more fierce. Shandong, Anhui and other places have organized price alliances to resist the “suicidal†price cuts. "A bottle of infusion is not as good as a bottle of pure water." This is the current status of the infusion market. On the other hand, the status quo of the domestic high-infusion high-end market is almost entirely controlled by foreign-funded enterprises. Moreover, unlike the product structure in which large infusions account for a large proportion of domestic large infusion products, “three-funded enterprises†pay special attention to the research and development and market performance of the therapeutic and nutritional varieties. Today, we still use glass bottles as the main packaging material, they basically use plastic or soft bag packaging.
There are indications that many multinational companies are relying on large infusion varieties and superior quality to gradually adopt China as their global production base. I believe that the difficult road of China's large infusion, especially the development of soft bag infusion, has just opened its head.
Second, the current problems of domestic soft packaging infusion
1. Authoritative medical plastic infusion packaging material standards need to be further improved
Although the domestic standards for medical plastic infusion packaging materials have been introduced, the enterprises basically set the factory standard for plastic infusion packaging materials according to the standards adopted in Europe and the United States. In recent years, the state has strengthened the management of policies and regulations in this respect, avoiding the confusion of project units in the selection of plastic packaging materials. At present, the current situation in the Chinese market is that plastic bottles, glass bottles, PVC soft bags and non-PVC soft bags coexist, but the standards applicable to different packaging materials are basically the same. For example, transparency: four kinds of packaging infusion containers can meet the "intravenous infusion container industry standard" requirements, but the extrusion blowing bottle does not have a good transparency of the injection blowing bottle, the blow bag does not have a heat-pressed bag with good transparency, and the market and doctors and patients want to use Transparent plastic packaging infusion with good transparency. Refined, more targeted standards are what we hope to see in the future. Therefore, national standards that suit China's national conditions still require time and practice to perfect it.
2. Flexible packaging infusion production lacks technical and human resources
1 The lack of powerful supporting technical support for the introduction and operation of equipment has made it impossible for some equipment with high degree of automation to be put into production in a short time, which causes great waste in financial and material resources. The earliest enterprises in China that introduced foreign soft bag equipment in the 1990s also took the path of stable production in the past one or two years.
2 The preparation of human resources in the early, middle and late stages of the introduction of new technologies and new equipment is insufficient, and the management personnel, technicians and operators are seriously lacking. Since a large number of soft infusion production equipments come from abroad, they already have sound, light and electricity. Many functions, such as gas, make management and operation extremely complicated. If employees lack the knowledge of mechatronics, it is difficult to control these advanced equipment in Europe and America. Due to the equipment itself, the phenomenon of downtime production is abound. The leakage problem has always been a major problem that plagues infusion manufacturers. To solve this problem, equipment manufacturers, consumables manufacturers and infusion production companies need to be solved together. Improve the quality of infusion production companies to a new level.
3 The process of flexible packaging infusion production lacks a mature quality assurance system. Flexible packaging infusion production is not a simple glass bottle infusion production replacement packaging, its quality assurance system has undergone significant changes with the packaging update, multinational companies in China joint venture infusion production companies have brought the parent company's quality assurance system, and most of us Domestic companies have failed to keep up with this pace.
3. Flexible packaging infusion production costs are high
1 There are more supporting equipments, one-time investment is large, and the depreciation rate is high; however, due to the development of packaging equipment industry in recent years in China, such situation has improved, and the investment in basic equipment has dropped to more than half of the original. It is also an opportunity for China's domestic soft packaging infusion.
2 Packaging materials, high-quality medical pellets, non-PVC cylinder membranes, film, mouth tube, ribbon, plastic cover, etc. are all imported.
4. Flexible packaging infusion without quality new drug support
At present, more than 90% of the flexible packaging infusions are liquid, namely glucose and sodium chloride. The ultimate way for soft plastic infusion companies to profit is to expand production scale and rely on quality products. If there is no quality product, the current high selling price is only a short-term benefit. With the increase in the introduction of flexible packaging infusion manufacturers, there may be a soft plastic infusion war in the future.
5. Market problem
Domestic glass bottle infusion accounts for 95% of the total market, and the price has an absolute advantage. However, some characteristics of the soft bag infusion itself are being accepted by the majority of patients and hospitals. I believe that in the near future, with the decline of cost, soft Bag infusions and glass bottles evenly catch up with the world may even appear.
6.100ml or more of the therapeutic infusion lost to the "medical insurance catalogue"
Infusion companies in the development of therapeutic infusion of the specifications are determined in accordance with the "use and dosage" in the foreign pharmacopoeia or national clinical medication instructions, will be 100ml, 250ml and 500ml specifications. If more than 100ml of therapeutic infusion products can not enter the "medical insurance catalogue", then what is the rationality of the national medication requirements? If such a situation is irreversible or will not improve, for some infusion companies only focus on the production from infusion To other medical insurance dosage forms, the investment in research and development of millions of dollars for therapeutic infusions is not a small amount for any enterprise. If there is a problem of medical insurance and pricing in the case of general meager profit in the industry, the enterprise Development does encounter big problems. This has far more impact on the large infusion industry, especially in soft bag infusions than expected.
Third, the future development trend of flexible packaging infusion
1. Development of polyolefin multilayer coextruded film
The development of polyolefin multilayer co-extruded film has gone through two stages. One is the polyolefin composite film from the 1980s to the 1990s, but the adhesive is used in the production process, and the adhesive is also used. The stability of the liquid has a potential impact; the second stage is a polyolefin multi-layer co-extruded film developed in the past four or five years. No adhesive is used in the production process, and the multilayer polyolefin material is simultaneously melt-crosslinked. Extrusion, which eliminates the instability caused by the adhesive, increases the performance of the membrane, makes it safer and more effective, meets the requirements of medicinal and environmental protection, and is the development direction of infusion packaging materials. In order to distinguish from the original PVC infusion film, we collectively refer to this polyolefin multi-layer co-extruded film as a non-PVC infusion film.
2. The significance and process of localization of soft bag infusion packaging
Due to the advantages of non-PVC soft bag infusion compared with glass bottle infusion, plastic bottle infusion and PVC soft bag infusion, such as the realization of closed drug delivery, no plasticizer harmful to human body, light weight, simple and convenient recycling, no environmental protection Influence, etc., glass bottle infusion by non-PVC soft bag infusion and plastic bottle infusion a large number of replacement is an inevitable trend in the development of the infusion industry.
However, non-PVC soft bag infusion production line, non-PVC infusion film has long relied on imports, and the price of soft bag infusion related supplies is high, resulting in high packaging cost of non-PVC soft bag infusion (from the current market packaging cost comparison can be seen, non The cost of PVC soft bag infusion packaging is more than 60% higher than that of plastic bottle infusion. Therefore, the growth rate of non-PVC soft bag infusion is significantly lower than that of plastic bottle infusion, which seriously hinders the development of domestic non-PVC soft bag infusion. Therefore, the soft bag infusion packaging is domestically produced, that is to say, the localization of the soft bag infusion production line and the localization of the soft bag infusion film, providing safe and economical infusion packaging for the infusion industry, so that the packaging cost of the soft bag infusion is rapidly reduced is a non-PVC soft bag. Infusion can be the key to rapid development.
3. The emergence of domestic consumables and filling machines provides a good opportunity for flexible packaging infusion
In recent years, many equipment manufacturers in China have invested a lot of manpower, material resources and financial resources to start the development of non-PVC soft bag production lines.
In 2003, a pharmaceutical machinery company in Hunan launched a non-PVC soft bag infusion production line with functions of printing, bag making, filling, sterilization, etc., and launched a second generation product this year. At present, there are many production lines of the company. Target market. In 2004, the first non-PVC soft bag infusion production line of a pharmaceutical machinery company in Shandong has also been put on the market, and has been well received by users. The successive introduction of these domestic production lines has reduced the direct input of the infusion production enterprises. It is understood that at least 30% cheaper than the imported production line, and the maintenance, maintenance and operation personnel training of the equipment have a relatively reliable guarantee.
As early as 2002, the pharmaceutical packaging materials company in China has begun to produce non-PVC soft bag infusion film, and has obtained the certification registration of the State Food and Drug Administration. At the same time, the PP/PP/PP (referred to as PP3) soft bag infusion film project of Lianyungang Zhongjin Pharmaceutical Packaging Co., Ltd., the largest manufacturer of pharmaceutical packaging materials in China, was officially launched and completed in one and a half years. Project construction and product registration, and in October 2003 passed the certification of the State Food and Drug Administration, the current product has been put on the market. In addition, many places in China, such as Liaoning, Beijing, Jiangsu, Anhui, Hunan, Sichuan, Guangdong, etc., have some enterprises in the non-PVC soft bag infusion film project, which will accelerate the improvement of domestic non-PVC soft bag infusion. The level of film manufacturing is a good thing for the infusion industry. Moreover, the domestic non-PVC soft bag infusion film put on the market is lower than the imported film, and the domestic material can send the goods to any place in the country in a short time, which greatly shortens the supply period of the film, and the domestic film supply There is no limit on the quantity of purchases, which can reduce the waste of funds for infusion manufacturers. For other related consumables, there are quite a few companies that can produce and sell them, such as combination covers and interfaces. It is foreseeable that the competition for these consumables will be more and more motivated, so that the sales price will drop rapidly. At the same time, some enterprises are also Develop more economical consumables, save materials, reduce costs, such as using anti-bacterial membrane technology, changing the shape of the interface and so on. In addition, as the demand for the entire market increases rapidly, the cost of consumables manufacturers will also be rapidly reduced, resulting in further selling space.
I believe that domestic non-PVC soft bag infusion manufacturers, infusion production line manufacturers, membrane manufacturers, and other related consumables manufacturers will work together to strengthen cooperation and exchanges, and strive to improve the performance of equipment and consumables, reduce costs, to China Infusion companies provide safe and economical soft bag infusion packaging, contributing to the process of speeding up the infusion of soft bags into the mainstream of Chinese infusion!