Analysis on the current situation of sterilization

Analysis on the current situation of sterilization packaging of medical devices in China

before introducing the current situation of sterilization packaging of medical devices in China, we must first clarify the concept of "sterilization packaging of medical devices". Iso11607, en868 series and gb19633 (equivalent to iso11607) are authoritative standards for sterilization packaging of medical devices. Based on the understanding and analysis of these standards, the author believes that 14 kinds of minerals can be identified as key minerals by medical devices. The sterilization packaging of raw materials can be divided into two parts: primary packaging and auxiliary packaging. In general, the sterilization packaging of medical device products refers to the initial packaging of products, that is, the part that directly contacts with products and forms a microbial barrier; Accessory packaging is mainly about the protection, convenience, traceability and packaging cost of products in the storage and circulation process within their life cycle, involving cartons, plastic bags, labels, bar codes, printing, pallets and containers. This article only focuses on the initial packaging of medical device sterilization products, and does not discuss the latter

■ medical device packaging has characteristics

the main materials of sterilization packaging of medical devices are paper poly bag, plastic bag, medical grade paper with excellent permeability, for mfilled film, trays of various materials and Tyvek of DuPont company, which is the material with the most characteristics of medical device packaging, It is a kind of non-woven material with excellent comprehensive performance, which is made of 100% HDPE as the base material

it can be seen that the sterilization packaging of medical devices should also belong to the category of flexible packaging with paper and plastic materials as the main body, and its important feature is that the requirements for packaging materials of medical devices are very high. In addition to meeting the basic packaging performance of routine protection and isolation of the external environment, such parts as experimental bench, experimental fixture, control cabinet, computer control software and data processing software are required, More emphasis is placed on the sustainability of material properties. After blending with polyethylene glycol (PEG), anisotropic hydrogel fiber scaffolds are made. The stability, adaptability to sterilization methods, microbial barrier and non-toxic of materials, which are extended from sterilization requirements, are the main obstacles to prevent enterprises engaged in general industrial products and food packaging from entering the field of medical device packaging

of course, because the sales and use objects of medical devices are relatively fixed and professional, they do not pay much attention to the sales packaging design of products, which is also the difference from ordinary soft packaging design, such as the packaging of high-end food, drugs and exquisite handicrafts. Now the packaging appearance design of medical devices does not pay much attention to the bright colors and complicated patterns, And pay more attention to the suggestive content of label nature

■ the market capacity is still unknown on the basis of preserving some characteristics of plastics to a large extent.

according to relevant estimates, the global market capacity in 2003 was 1.65 billion US dollars, and the North American market is the largest sterilization packaging market in the world, accounting for 50% of the market share, that is, 800 million US dollars; Europe and Asia are almost equally divided, each accounting for about 20% of the market share, while South America accounts for the remaining 8%; Due to the weakness of the medical industry, Africa cannot reflect its market share

then turn their attention to the domestic medical device packaging market. Jiao Fei, the head of China of Bemis (one of the most famous American enterprises in the field of medical device packaging), once analyzed the data from the medical device industry association and estimated that the current domestic market capacity of medical device packaging should be about US $50million. However, based on the author's understanding of the annual sales of well-known domestic suppliers in the field of medical device packaging, the author believes that this is a slightly underestimated figure, but a more accurate and specific figure is still unknown

■ the understanding of the industry needs to be improved

the lack of detailed and authoritative market data is caused by the lagging development of this field. Sterilization packaging of medical devices is still a relatively unfamiliar topic for most people in China, even for practitioners in the medical device industry. In September, 2005, the medical polymer branch of China Medical Device Industry Association and Beijing Guanghua medical device Certification Center, as well as DuPont and KPMG jointly hosted the "2005 International Symposium on sterilization packaging of medical devices" in Beijing. Most of the delegates attending the meeting came from well-known enterprises in the industry. Among them, there were those who specialized in product design and sterilization process. However, except the author, none of them specialized in product packaging. Professionals responsible for the certification and audit of medical device enterprises from government departments also believe that the knowledge of enterprises in this regard is insufficient, or even blank, and said that more training on the packaging of sterile products is needed to improve the overall packaging level of products in the industry

in the existing domestic packaging industry system, medical device packaging is often ignored. Because the pharmaceutical packaging materials and methods are very similar to food packaging, more people in the packaging industry are more familiar with pharmaceutical packaging, while medical device packaging and pharmaceutical packaging have great differences in technology and materials, and they know less about it. Take accessory packaging as an example, the packaging of any ordinary industrial products is the same - the most common cartons, cartons, plastic bags, pallets and containers are used, but medical device products have higher requirements for the protection and traceability of accessory packaging, so there are more stringent circulating packaging test standards to ensure this

the industry's neglect of product packaging or lack of correct understanding is also an important reason for the lagging development of medical device packaging. After all, medical devices are different from ordinary industrial products, which are related to saving lives and healing injuries. The product packaging must not be sloppy, and must comply with relevant national laws and regulations to ensure the packaging quality and continuous stability of products before they can be sold on the market. Enterprises should raise awareness and never make the mistake of focusing only on product R & D and production, not on product packaging design

■ talent training must be strengthened

as a new industrial specialty, the scarcity of professionals is also a bottleneck restricting the development of the industry. As early as the early 1950s, the United States began to set up undergraduate education in packaging engineering at the University of Michigan, followed by Europe and Japan, vigorously developing packaging professional education. However, the undergraduate education of packaging engineering started relatively late in China. In the middle and late 1970s, the predecessor of Xi'an University of technology first started the research in this field, but mainly focused on printing equipment and packaging materials. Hunan University of Technology (formerly Zhuzhou Institute of Technology), established in 1979 and now affiliated to China National Packaging Corporation, is the first higher education institution in China that specializes in packaging and printing; Beijing Printing Institute, established in 1981, focuses more on printing and packaging. Although packaging and printing are two inseparable industrial processes, which are linked in most cases, the importance of printing has been greatly reduced in the medical device packaging industry, because the printing method and pattern are generally relatively simple. It was not until 1984 that the National Academic Degrees Committee officially established the undergraduate major of packaging engineering, and then opened the postgraduate education course of packaging engineering in Xi'an University of technology, but it was soon cancelled, and can only rely on other professional names (such as papermaking or food) to carry out postgraduate education in the field of packaging and printing. It can be seen that higher education in the field of packaging and printing in China is limited to a few schools. Until 2000, more colleges and universities have opened this major, including Zhejiang University, Wuhan University and other famous universities. However, it is worth noting that the educational methods of these colleges tend to inculcate theoretical knowledge, and students have less opportunities to practice in factories

■ high technical requirements for equipment

in the world, the packaging of medical devices also started relatively late. For example, DuPont's invention of Tyvek, a non-woven material, has only been for more than 30 years. The companies that really positioned themselves in the packaging of medical devices from the beginning are also very young, so the scale is unlikely to be large. Most of the well-known medical device packaging suppliers have transferred from the field of food or other industrial products packaging, especially in the field of food packaging, because they are the closest to medical device packaging and have the possibility of such transfer. For example, the most well-known companies in the field of medical device packaging, such as the American KPMG company, the Australian Amcor company and the Finnish Wipak company under the wihuri group, are all successful cases of transfer

accordingly, most of the medical device packaging equipment is transferred from the field of food packaging equipment, such as German Multivac company and tiromat company. Compared with food packaging equipment, medical device packaging equipment has higher requirements for sealing products, because the materials commonly used for heat sealing packaging are plastic film or box, gelatinized paper or Tyvek, and there are very strict requirements for the cleanliness, integrity and strength of sealing, which must be tested by strict experimental standards; Food packaging is relatively simple. Generally, the heat sealing material is plastic film to film, or some auxiliary vacuum pumping or inert gas filling processes, but there are no strict requirements on the sealing quality. As for the simple pure heat sealing machine, as long as the three parameters of temperature, pressure and time are controlled, and the heat sealing is carried out on a silica gel panel with appropriate hardness and high levelness, it can meet the use requirements, so the cost is very low. Of course, there are also high-quality and high-priced equipment with high degree of automation and high parameter accuracy, For example, Suzhou Dongye Electromechanical Equipment Co., Ltd. is currently developing a highly automated and efficient blister box heat sealing machine based on the technology of Swiss MPs company

however, because the equipment itself has a series of characteristics different from materials, such as small technical concealment, long development cycle, small revolutionary changes, and parts that are easy to form standardized modules, which determine that the equipment is easy to be imitated, the gap between domestic and foreign equipment is not particularly large, such as Hangzhou Zhongyi, the leader of domestic medical device blister packaging equipment, and the equipment of Hangzhou Shenghe, which are in the process of solving It is more than enough for low-end products. However, it must also be realized that compared with foreign advanced equipment, domestic equipment still has a certain gap in parts processing accuracy, service life and control line, stability and accuracy of control system (especially mold temperature difference). However, compared with the price difference of nearly ten times, it is very reasonable to choose domestic equipment, unless the packaging quality requirements of the product itself are very high

now, the above-mentioned well-known foreign companies have entered the Chinese market to carry out the sales of medical device packaging materials in the form of offices, but they have not set up factories in China, and the products they sell are produced abroad. Domestic medical device packaging enterprises have also made great progress in recent years. The well-known enterprises transferred from the traditional packaging field are baobai group (now Alcan propack), which is more an extension of the self-development of medical device enterprises. Among them, the well-known ones are Shanghai's kantlai group (KDL), Dongguan's Chuntian packaging (medipack) and Henan's camel group

world famous companies in the medical device packaging industry enter China