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    Home > Active Ingredient News > Drugs Articles > Current situation and Prospect of sterilization packaging

    Current situation and Prospect of sterilization packaging

    • Last Update: 2017-06-01
    • Source: Internet
    • Author: User
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    However, it is an unfortunate fact that the sterilization packaging of medical devices should be a relatively unfamiliar topic for most people in China, even for the practitioners of the medical device industry In September 2005, it was mainly run by DuPont company and Bemis company in Beijing, and co organized by China Medical Device Industry Association and Beijing Guanghua medical device Certification Center At the 2005 International Symposium on sterilization and packaging of medical devices, among the representatives of well-known enterprises in the industry, there were those who specialized in product design and sterilization technology, but none of them except the author specialized in product packaging At the just concluded (December 2005) Symposium on sterilization and packaging of medical devices organized by TUV company, most participants in the medical device industry (most of them are quality management personnel in charge of quality and system certification) raised some questions, which also made the author feel that the packaging knowledge they had about products was lacking The professionals in charge of the certification and audit of medical device enterprises from government departments also think that the knowledge of enterprises in this field is insufficient, even blank, and they say that more packaging training on sterilization products is needed to improve the overall packaging level of products in the industry Overview of packaging materials In the current domestic packaging industry system, medical device packaging is ignored It is possible that many packaging industry insiders will be more familiar with medical packaging, because medical packaging materials and methods are very similar to food packaging, but medical device packaging and medical packaging are two concepts that have a great gap in technology and materials, so it is right and wrong for the current domestic packaging industry Often strange It is precisely the people in the medical device industry who have a better understanding of product packaging because of the strong independence of the industry and the unique requirements of products for packaging From the perspective of accessory packaging, any ordinary industrial product is almost the same, that is, using Zui ordinary cartons, cartons, plastic bags, pallets and containers, etc., but the requirements for the protection and traceability of this accessory packaging of medical device products may be higher, so there will be more stringent test standards for circulation packaging to ensure this Of course, in the world, the real start of medical device packaging is also very late In terms of materials, Tyvek ⑧, a non-woven material of DuPont company, has been invented only for more than 30 years, which makes the companies that are really positioned at the beginning of medical device packaging are very young, so the scale is unlikely to be very large, and most famous medical device packaging suppliers are transferred from the field of food or other industrial products packaging, especially food packaging In the field, because they are similar to the packaging of medical devices, Zui has the possibility of such transfer, and after Zui, it is often successful, such as the famous Bemis company in the United States, Amcor company in Australia, wihuri group in Finland and Wipak company Now these companies have entered the Chinese market to carry out the sales business of medical device packaging materials in the way of agency, but none of them have set up factories in China, and the products they sell are produced abroad The domestic medical device packaging enterprises (including Taiwan enterprises) have transferred from the field of Jiatong packaging to the well-known baobai group (now alcarpropock), many of which are extensions of the self-development of medical device enterprises, including the well-known kantle group (KDL) of L sea, the Chuntian packaging group (medipack) of Dongguan and the camel group of Henan Equipment overview as for medical device packaging equipment, most of them are transferred from the field of food packaging equipment, such as the well-known German Multivac company and tiromat company Compared with food packaging equipment, medical equipment packaging equipment has higher requirements for sealing, because the materials commonly used for heat sealing packaging are plastic film or box, coated paper or tyvekm, and there are very strict requirements for the cleanness, integrity and strength of sealing, with strict experimental standards to test; However, food packaging is relatively simple Generally, the heat sealing material is plastic film to film, or some auxiliary vacuumizing or inert gas filling processes, but there is no strict requirement for sealing quality As for the simple pure heat sealing machine, as long as the 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 price equipment with high automation degree and high parameter accuracy, such as Suzhou Dongye mechanical and Electrical Equipment Co., Ltd The former is developing a high automatic and efficient blister box heat sealing machine relying 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 change, easy to form standardized module parts, etc., which determine that the equipment is easy to be imitated, so the gap between domestic and foreign equipment is not particularly large, such as Hangzhou Zhongyi and Hangzhou, the leading domestic medical equipment blister packaging equipment Zhou Shenghe's equipment is more than enough to deal with medium and 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, control line, stability and performance of control system (especially mold temperature difference), but compared with nearly ten times of the price difference, it is very reasonable to choose domestic equipment, unless the packaging quality requirements of the product itself are very high Our expectation It should be a good thing for the domestic medical device industry that the world-famous companies in the medical device packaging industry enter the Chinese market After all, this enables us to have the object of learning and copying (advanced products and the company's management mode) Because in this field, we need to learn and make progress too much In China, except for the enterprises in Europe and the United States, we can have some technical content There are only one R in Taiwan However, enterprises in mainland China, such as Shanghai Jianzhong and Ningbo Xinhua, can only make simple coating, printing and bag making of ordinary breathable paper We are not afraid of backwardness What Zui is afraid of is that we still don't know if we are backward, and we still don't take action to make up for this backwardness This is what Zui, who is working in packaging technology in China, should be responsible for For domestic manufacturers of medical devices, the entry of foreign advanced packaging materials and equipment into the domestic market also provides a solid foundation for the upgrading of their product packaging, and then obtains the license for export to developed countries such as Europe, the United States and Japan But this also leads to a packaging political problem, that is, the products exported to developed countries use good packaging, while the products sold in the domestic market or other developing countries are careless The typical example of Zui is: all the syringe packages exported to the United States need paper plastic bags, but more than 80% of the syringes sold in the domestic market are packed with ordinary LDPE Bags Yes, there are many differences between the two kinds of packages in the efficiency and effect of EO sterilization; there are also some products in China that may be packaged with PVC film or blister box, but it is forbidden in developed countries Of course, this difference is due to the consideration of product packaging cost However, it is not necessarily advisable to sacrifice packaging quality, efficiency and stability in order to save packaging cost Based on the author's experience, the packaging cost of class I and class II low-end and low-value medical device products produced and sold in China accounts for 5%} 30% of the total cost, while the total packaging assembly of products produced in China and sold abroad is reasonable due to the improvement of freight and packaging requirements for subsidiary protection The cost (including freight) may account for about 10%} 40% of the total cost, and even more than 50% in extreme cases However, due to the high value of the three kinds of products, although the packaging requirements are very strict and the cost is very high, the ratio of the three kinds of products to the total cost is lower, which can generally be controlled within 5% After Zui, medical device manufacturers should also bear in mind that Zui's expensive packaging cost is packaging failure, because the medical device products are applicable to the wrong recall system, that is, the manufacturer should be responsible for the recovery of the defective products and compensate for the resulting losses This is a very serious problem, which may lead to serious loss of reputation of manufacturers So if we are asked to call back the product because of the packaging problem, it's a bit of a loss.
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