The hottest new field of sterilization packaging f

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Sterilization packaging of medical devices - new field of soft packaging

kerstan agreed: "Some other automobile manufacturers have said that according to the basic list of coke wood-based panel universal testing machine, head of Bemis company in China, a well-known American enterprise in the field of medical device packaging: rotating wear testing machine flies. According to the statistical analysis of the data of the medical device industry association, it is estimated that the total domestic market capacity should be about US $50million at present.

but the fact is that the sterilization and packaging of medical devices is a relatively unfamiliar topic for most upholstery factories. In the field of medical device packaging, some specialize in product design, some in sterilization process, but few in product packaging

current situation of sterilization packaging of medical devices

in general, sterilization packaging of medical devices refers to the initial packaging of products, that is, the part that directly contacts the products and forms a microbial barrier; The main materials of sterilization packaging of medical devices are plastic bags, form filled films, etc. Medical device products have very high requirements for packaging materials. In addition to meeting the basic packaging performance of conventional protection and isolation from the external environment and ensuring that there will be no abnormal noise during the use process, it also emphasizes the continuous stability of material performance, as well as the adaptability to sterilization methods, microbial barrier and non-toxic of materials extended from the sterilization requirements

at the just concluded "Symposium on sterilization and packaging of medical devices", the problems mentioned by most participants in the medical device industry (most of whom are quality managers responsible for quality and system certification) also showed that their knowledge of product packaging is insufficient. In addition, 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 of products in the industry

the sterilization and packaging market of medical devices has yet to be opened.

medical devices are different from ordinary industrial products. Because they are related to saving lives and healing injuries, the product packaging must not be sloppy. The product packaging must comply with the relevant national laws and regulations, and ensure the packaging quality, continuous stability and safety of the product before it can be sold on the market

however, in the existing domestic packaging industry system, medical device packaging is ignored, and many people in the packaging industry may be more familiar with drug packaging, because the materials and methods of drug packaging are very similar to food packaging, but medical device packaging and drug packaging are two concepts with a great gap in technology and materials, so they are relatively unfamiliar with the current domestic packaging industry

it is understood that due to the strong independence of the industry, the medical device industry puts forward high requirements for easy operation of product packaging. In the current market with relatively sticky sterilization packaging of medical devices and imbalance between supply and demand, the voice of the medical device industry for product sterilization packaging is growing. This undoubtedly provides an opportunity for the heating up of the medical device packaging market

involved in the sterilization and packaging of medical devices

according to statistics, the companies that positioned themselves in the packaging of medical devices from the beginning are very young and small. 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 most similar to medical device packaging, so they also have the most possibility of such transfer, and finally they have achieved success, such as Bemis, the most famous company in the field of medical device packaging in the United States, Amcor of Australia and Wipak of wihuri group of Finland. Now these companies have entered the Chinese market to carry out the sales of medical device packaging materials in the form of offices, but none of them has set up factories in China, and the products they sell are produced abroad

domestic medical device packaging enterprises (including Taiwan enterprises) have transferred from the traditional packaging field to the well-known Baobo group, and many of them are extensions of the self-development of medical device enterprises, among which the well-known are kantlai group in Shanghai, Chuntian packaging in Dongguan and camel group in Henan

several important factors to pay attention to in developing the market

compared with food packaging, medical device packaging has higher requirements for sealing, because the materials commonly used for heat sealing packaging are plastic film and gelatinized paper, and there are very strict requirements for the cleanness, integrity and strength of sealing, and there are strict experimental standards to test; 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

for domestic medical device packaging enterprises, the entry of foreign advanced packaging materials and equipment into the domestic market also provides a solid foundation for the improvement of their product packaging grade. However, the problem that cannot be ignored is that products exported to developed countries use good packaging, while products sold in the domestic market are dealt with carelessly. For example, all syringes exported to the United States need paper and plastic bags, but more than 80% of syringes sold in the domestic market are packed with ordinary LDPE Bags. There are many differences in EO sterilization efficiency and effect between the two kinds of packaging; Some domestic products may also be packaged with PVC film or blister boxes, but this is expressly prohibited in developed countries

based on the author's experience, it is reasonable that the packaging cost of the first and second categories of low-end and low-value medical device products produced and sold domestically accounts for 5% to 30% of the total cost, while the total packaging cost (including freight) of the products produced domestically and sold abroad may account for about 10% to 40% of the total cost, and even more than 50% in extreme cases, due to the improvement of freight and the requirements for accessory protective packaging. Due to the high value of the three types of products, although the packaging requirements are very strict and the cost is also high, the ratio of the three types of products to the overall cost is lower, which can generally be controlled within 5%. This is bound to provide a favorable entry point for packaging enterprises to get involved in the field of medical device packaging

the current medical device manufacturers have gradually formed the view that the most expensive packaging cost is packaging failure, because the medical device products apply the error recall system, that is, the manufacturer should be responsible for the recovery of the defective products and compensate for the resulting losses. This will lead to serious loss of reputation of the manufacturer, or even bankruptcy. Therefore, if you are required to recall the product because of the packaging problem of the product, it is not worth the loss


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recently, the State Food and drug administration received "temporary emergency corrective measures for the unpacking of multi link RX zeta coronary stent system" from Jiateng company of the United States. There is a warning in the product manual: do not use if the package is opened or damaged. The company took urgent corrective measures for the unpacking of products. All 448 sets of multi link Rx zetatm coronary stent systems imported into Japan, whether in hospitals or at agents, were inspected, and 128 sets of products with and possible to be unpacked were recovered. Some products have been sent back to Jiateng company in the United States

for medical device products, if there is a warning "do not use if the package is opened or damaged" on the instructions or package, it means that the product can be used normally only when the package is intact. In particular, the opening or damage of the packaging of sterilized medical devices will greatly damage the safety. For such products, the use specifications should be strictly implemented. It is strictly forbidden to use those whose packages are opened or damaged

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sterilization packaging of disposable medical devices includes: disposable catheters, infusion sets, surgical instruments, surgical clothes, dressings and other packaging materials that need to disinfect products

the key of medical device packaging design lies in:

minimizing the harm to patients and medical personnel

no toxicity; Barrier to microorganisms and germs

applicable to the corresponding disinfection process

minimize the possible risks in packaging, disinfection, transportation, storage, disassembly and use

bacterial barrier performance within the limited warranty period. These are reliable guarantees of safety performance

source: Global flexible packaging industry

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