The current situation and future development trend

The current situation and future development trend of flexible packaging infusion in China

this chapter mainly expounds the current situation of domestic infusion industry and non PVC flexible bag infusion, the existing problems of domestic flexible packaging infusion, and the future development and prospects of flexible packaging infusion; It also makes a systematic and detailed technical and market analysis of polyolefin multi-layer coextrusion film, domestic consumables and filling equipment for domestic non PVC infusion, and puts forward the localization of non PVC soft bag infusion related consumables and filling equipment

I. The current situation of domestic infusion industry and non PVC soft bag infusion

according to the SDA statistical data of the State Food and drug administration, there are more than 250 infusion production enterprises in China at present. Most infusion manufacturers mainly produce bottled infusion, and there are only more than 30 production enterprises that can produce non PVC soft bag infusion. These 30 production enterprises probably have more than 40 soft bag production lines, with an annual design production capacity of more than 500million bags, The actual production volume in 2004 was only more than 100 million bags, and the operating rate was only about 20%. According to the current market demand of 3 billion bags in the infusion industry, non PVC soft bag infusion has less than 5% market share, while plastic bottle infusion, which started almost at the same time as soft bag infusion, has 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 restricting the development of non PVC soft bag infusion is our domestic packaging technology

China's infusion industry has been developing at an accelerated rate since its inception. From the annual production capacity of hundreds of millions of bottles (bags) in the 1980s to the current annual production capacity of 6billion bottles (bags) and the high sales volume of 4billion bottles (bags), the rapid development of China's infusion industry is obvious to all. In particular, the national SDA's requirement that infusion manufacturers must pass the GMP demonstration has pushed large infusion enterprises into the path of production development in addition to inspecting such light directly driven flights

however, in recent years, the "internal worries and external difficulties" encountered by large domestic infusion enterprises have become more and more obvious. On the one hand, due to overcapacity, the fierce competition in the domestic low-end market is escalating and becoming increasingly fierce. Shandong, Anhui and other places have successively organized price alliances to resist the "suicidal" price reduction trend. The saying that "a bottle of infusion is not as valuable as a bottle of purified water" is constantly heard, which is the current situation of the infusion market. On the other hand, the current situation that the domestic large infusion high-end market is almost controlled by foreign-funded enterprises is even more worrying. Moreover, unlike the product structure in which ordinary infusion takes up a large proportion of domestic large infusion products, "three foreign-funded enterprises" pay special attention to the R & D and market performance of metallurgical and nutritional varieties. Today, when we still use glass bottles as the main packaging materials, they basically use plastic bottles or soft bags

various signs show that many multinational enterprises are gradually taking China as their global production base with the advantages of large infusion varieties and quality. It is believed that the difficult road of the development of large-scale infusion in China, especially soft bag infusion, has just begun

at present, domestic flexible packaging infusion has the problem of single-chip computer unit connected with amplifier.

1. The authoritative standard of medical plastic infusion packaging materials needs to be further improved.

although domestic standards related to medical plastic infusion packaging containers have been issued, enterprises basically formulate the factory standards of plastic infusion packaging materials with reference to the prevailing standards in Europe and the United States. In recent years, the state has strengthened the management of policies and regulations in this regard, avoiding the confusion of project units in the selection of plastic packaging standards. At present, plastic bottles, glass bottles, PVC soft bags and non PVC soft bags coexist in the Chinese market, but the standards applicable to different packaging materials are basically the same. For example, transparency: four kinds of packaged infusion containers can meet the requirements of the "industrial standard for intravenous infusion containers", but the transparency of squeeze blow bottles is not as good as that of injection blow bottles, and the transparency of blow molded bags is not as good as that of hot pressed bags. Both the market and doctors and patients hope to use plastic flexible packaging with good transparency for infusion. Detailed and more targeted standards are what we hope to see in the future. Therefore, the national standard suitable for China's national conditions still needs time and practice to improve it

2. The production of flexible packaging infusion is lack of technology and human resources

① the introduction and operation of equipment are lack of strong supporting technical support, which makes some highly automated equipment unable to be put into production in a short time, resulting in a great waste of financial and material resources. Domestic enterprises that first introduced foreign soft bag equipment in the 1990s also embarked on the road of stable production in recent oneortwo years

② the preparation of human resources before, during and after the introduction of new technologies and equipment is insufficient, and there is a serious shortage of management personnel, technicians and operators; Since a large number of soft infusion production equipment come from abroad, they have many functions, such as sound, light, electricity, gas and so on, which makes the management and operation extremely complex. If employees lack knowledge of mechatronics, it is difficult to control these European and American advanced equipment. The phenomenon of downtime and production delay caused by the equipment itself is everywhere, and the leakage problem has always been the main problem perplexing the infusion production enterprises. In view of this problem, it needs the equipment production enterprises, consumables production enterprises and infusion production enterprises to solve it together, and strive to improve the product quality of infusion production enterprises to a new level

⑧ the production process of flexible packaging infusion lacks a mature quality assurance system. Flexible packaging infusion production is not a simple glass bottle infusion production. Its quality assurance system has changed significantly with the update of packaging. Infusion production enterprises jointly invested by multinational companies in China have brought the parent company's quality assurance system, but most of our domestic enterprises have failed to keep up with this pace

3. The production cost of flexible packaging infusion is high

① there are too many supporting imported equipment, large one-time investment and high depreciation rate; However, due to the development of domestic packaging equipment industry in recent years, this situation has improved, and the investment in basic equipment has been reduced to more than half of the original, which is also an opportunity for domestic flexible packaging infusion in China

② packaging materials high-quality medical granular materials, non PVC barrel films, film films, mouth tubes, color bands, plastic covers, etc. all need to be imported

4. There is no support of high-quality new drugs for flexible packaging transfusion

more than 90% of the currently marketed flexible packaging transfusion are common liquids, namely glucose, sodium chloride, etc. The ultimate way for soft plastic infusion enterprises to make profits depends on expanding production scale and high-quality products. If there are no high-quality products, the current high selling price is only a short-term benefit. With the increase of the introduction of flexible packaging infusion manufacturers, there may be a soft plastic infusion war in the future

5. Market problems

domestic glass bottle infusion accounts for 95% of the total market, and the price has an absolute advantage. However, due to some characteristics of soft bag infusion itself, it is being accepted by the majority of patients and hospitals. It is believed that in the near future, with the decline of cost, soft bag infusion and glass bottle may even catch up and surpass the world

therapeutic infusion with more than 6.100ml is not selected from the medical insurance catalogue

the infusion enterprises determine the specifications in the research and development of therapeutic infusion by referring to the usage and dosage in the foreign pharmacopoeia or the national clinical medication instructions. Only products with 100ml, 250ml and 500ml specifications can be produced. If therapeutic infusion products with a specification of more than 100ml cannot be included in the medical insurance catalogue, what is the rationality of the recommendation of the national drug instructions? If this situation is irreversible or will not improve, for some infusion enterprises, the production focus can only be shifted from infusion to other medical insurance dosage forms. For enterprises, the R & D investment of millions of yuan in therapeutic infusion is not a small amount for any enterprise. If there are problems of medical insurance and pricing in the case of low profits in the industry, the development of enterprises will indeed encounter great problems. This has a far more serious impact on the large infusion industry, especially the soft bag infusion

III. future development trend of flexible packaging infusion

1. Development of polyolefin multilayer coextrusion film

the development of polyolefin multilayer coextrusion film has gone through two stages. One is polyolefin composite film from 1980s to 1990s, but due to the use of adhesives in the production process, adhesives also have a potential impact on the stability of liquid medicine; The second stage is polyolefin multi-layer coextrusion film developed in recent four or five years. Adhesive is not used in the production process, and multi-layer polyolefin materials are melt cross-linked coextrusion at the same time, which not only eliminates the instability caused by adhesive, but also increases the performance of film materials, making it safer and more effective, meeting the requirements of medicine and environmental protection. It is the development direction of infusion packaging materials. In order to distinguish from the original PVC infusion film, we collectively call this polyolefin multilayer coextrusion film non PVC infusion film

2. The significance and process of localization of soft bag infusion packaging

due to the many advantages of non PVC soft bag infusion compared with glass bottle infusion, plastic bottle infusion and PVC soft bag infusion, such as closed administration, no plasticizer harmful to human body, light weight, simple and convenient recycling, no impact on the environment, etc., it is an inevitable trend for the development of infusion industry that glass bottle infusion is largely replaced by non PVC soft bag infusion and plastic bottle infusion

however, the non PVC soft bag infusion production line and non PVC infusion film have long relied on imports to coordinate consumer demands and improve user experience, and the prices of consumables related to soft bag infusion remain high, resulting in the high packaging cost of non PVC soft bag infusion (it can be seen from the current market packaging cost comparison that the packaging cost of non PVC soft bag infusion 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 localization of soft bag infusion packaging, that is to say, the localization of soft bag infusion production line and the localization of soft bag infusion film materials, provide safe and economic infusion packaging for the infusion industry, and make the packaging cost of soft bag infusion drop rapidly, which is the key to the rapid development of non PVC soft bag infusion

3. The emergence of domestic consumables and filling machines provides a good opportunity for flexible packaging infusion

in recent years, many domestic equipment manufacturers have invested a lot of human, material and financial resources to start the research and 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 the functions of printing, bag making, filling, sterilization and so on, and launched the second generation of products this year. At present, many production lines of the company have been put on the 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 highly praised by users. The successive launch of these domestic production lines, on the one hand, reduces the direct investment of infusion production enterprises, which is understood to be at least 30% cheaper than imported production lines. At the same time, there is a relatively reliable guarantee for equipment maintenance, repair and operator training

as early as 2002, a domestic pharmaceutical packaging material company has begun to produce non PVC soft bag infusion film, and has obtained the certification and registration of the State Food and drug administration. At the same time, as the largest manufacturer of pharmaceutical packaging materials in China, Lianyungang Zhongjin pharmaceutical packaging Co., Ltd. officially launched the PP/PP/PP (PP3) soft bag infusion film project, completed the project construction and product registration within one and a half years, and passed the certification and registration of the State Food and Drug Administration in October 2003. At present, the product has been put on the market