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medical device sterile packaging in china (一)

Return list Reffer:KMNPack Click number:- Release time:2019-04-23
1.Market situation
At present, the market size of China's MDSP industry is about 500 million US dollars, which includes both materials and equipment, but the majority of materials.
However, some of the MDSP materials used cannot contribute to the domestic MDSP market boom, that is, those that are produced abroad and ordered to be shipped back to China for high-fidelity printing and then sold back to the international market. 
This situation usually occurs in the packaging of some internationally renowned medical device companies, whether it is self-production or OEM by other companies, this part of the sales of about 10 million to 20 million US dollars.Since 2003, international companies engaged in MDSP business have officially entered the Chinese market, such as the US high-end rubber and bag products supplier Bemis, Oliver and high-end hard blister supplier Prent activities, Canada Alcan (to acquire domestic The well-known flexible packaging company Baobo entered the Chinese MDSP market. The Australian-based flexible packaging giant Amcor officially entered the Chinese MDSP field in 2003 through the acquisition of the MDSP business of the well-known British flexible packaging company Rexam. In addition, there are also well-known film manufacturers Wipak from Finland. Arjowiggins, a well-known MDSP medical paper supplier from France, and several other medium and high-end hard blister suppliers from Europe. These companies share a market of about $200 million. Although they don't count a lot of labels, they are growing fast.
The other half of the domestic MDSP market share is divided by local companies. These companies are represented by Anqing Kangmingna Packaging Co., Ltd., and there are also some very small MDSP companies from North China and the Mainland, which share about 2 The market of billion dollars. Compared with the number of enterprises, this scale is not large, so the sales of these domestic enterprises are not large, mostly between 10 million and 50 million US dollars, and basically all enter the MDSP after 2000. Marketing.From the geographical distribution of these enterprises, we can also see the distribution of China's medical device manufacturing industry, that is, the Yangtze River Delta and the Pearl River Delta. The Bohai Sea and Shandong Province also have several good companies for paper packaging, while the Midwest and Northeast regions. Basically, it is blank, even if there are several products with small output and low product grade.
2. The domestic understanding of MDSP is conservative.
 The domestic understanding of MDSP should start after 2000, that is to say, it is only six or seven years, and really wait for foreign-funded enterprises to enter this market and expand domestically through relevant training and publicity. The understanding of the industry is three years late. MDSP should be a relatively unfamiliar topic for most people in China, even for practitioners in the medical device industry. For example, many domestic industry insiders understand MDSP's understanding on some details (such as packaging strength) , can not be torn, suitable for the intended sterilization method, have appropriate opening methods, etc.), but can not grasp the overall MDSP is a complete packaging system, is a typical, strict aseptic barrier system (SBS) evaluation, A complete packaging design, a packaging verification program, and a series of required packaging protocols are required to demonstrate that the packaging system is qualified.Replacing the details of the packaging with the grasp of the entire packaging system is also a significant improvement of ISO11607-2006 relative to EN868-1, but the latter is the standard set by the European Union in 1997, and some content will definitely be current The situation does not match. However, the EN868 series is also striving to introduce new ancillary standards, such as EN868-9 and EN868-10, which were introduced two or three years ago for non-glued and rubberized polyolefin nonwoven materials for MDSP.
In fact, MDSP is also a relatively unfamiliar process for those familiar with the traditional packaging business, because MDSP's materials, design and experimental requirements are relative to the domestically mature and popular food, pharmaceutical and general industrial packaging. Huge difference. Many people in the packaging industry may be more familiar with pharmaceutical packaging because there is a similarity between pharmaceutical packaging and food packaging, but there is a big gap between MDSP and pharmaceutical packaging in terms of process and materials. Because the medical device industry is highly independent and the product has unique packaging requirements, people in the medical device industry know more about MDSP packaging.
On the other hand, from the perspective of protective packaging, MDSP is not much different from other types of packaging. It uses ordinary cartons, corrugated boxes, plastic bags, trays and containers to protect the product throughout its life cycle. There will be no damage during the circulation process, but the protective and traceability requirements of medical device products for such accessory packaging may be higher and packaging printing, so there will be stricter circulation packaging test standards to ensure this, usually adopted ISTA series transport test standards.The reason for the lack of domestic understanding of MDSP is that the domestic MDSP industry started late, and it is also a matter of recent years for large companies to enter the domestic market. On the other hand, green printing, China's various packaging education has never touched any relevant MDSP. The content, even if it is very simple introductory content, so the understanding of MDSP can only be done in related companies. Even on a global scale, MDSP's system theory has not really taken shape (ISO11607-2006 mentioned in the foreword because the industry is developing too fast, and the standard needs to be re-examined for 5 years), but the actual industrial production experience dominates. Status awards, which is one of the distinctive features of the packaging engineering profession.
Of course, the real start of MDSP is very late in the world. In terms of materials, the combination of the most distinctive non-woven material from DuPont, Teweiqiang, has been printed for more than 30 years. From a large historical environment, perhaps the packaging profession as a new industrial specialty (in 1951, Michigan State University officially opened a bachelor's degree in packaging engineering, which is regarded as the starting point for modern education in this specialty), which will lead to the professional talent in China. It has a certain scarcity, which leads to the lack of systemicity of MDSP designed by non-professionals. However, cosmetic packaging, currently not paying attention to product packaging in the medical device manufacturing industry or not at all, is also an indisputable fact that leads to MDSP problems.
3. Domestic MDSP seminars in recent years
In recent years, in order to popularize and deepen the domestic understanding of MDSP, international leading companies such as DuPont, Bemis, Oliver, Amcor, Australia and TUV in Germany (providing medical device production certification training) Personalized printing, such as business), have teamed up with relevant partners to hold various seminars on MDSP in China. It is undeniable that the purpose of these business giants is to expand their influence in China's MDSP field and gain more commercial benefits. However, from the perspective of the pure knowledge of pure MDSP systems, these seminars are still very positive. At least, it has improved the domestic industry's understanding of MDSP and has concepts for related materials, standards and regulations.However, unfortunately, it may be that the ISO official is not satisfied with the standard of this transitional version. Although one of the co-authors of ISO11607, the American AAMI (American Medical Device Promotion Association), officially introduced the MDSP standard TIR 22 water supply in 2000. Run version, ISO official has wait until 2003 to officially launch the official version of ISO11607-2003. As a general standard for macro guidance, the ISO11607-2003 standard is indeed unsatisfactory. The operability of many places is not high. The control and requirements for medical device manufacturers and MDSP suppliers are also reflected in the macro aspect. Effective implementation. But one thing that can't be denied is the printing and packaging city, although the latest official version of the 2006 version of ISO11607 still has a strong shadow of the 2003 version.This may also explain why only formally promulgated three years ISO11607-2003 was newly published 2006 edition to be eliminated, because it is after all only a transitional version of the desperation of these events in ISO11607 editorial board vice chairman, DuPont Dr. Michael Scholla the account of a unified global MDSP been mentioned in an article.
The newly-launched ISO11607-2006 is a high-fidelity printing editor-in-chief of the well-known company in the medical device manufacturing industry, which is written by the users of MDSP (and the packaging standard in China is usually the packaging supplier). written), such as the two main people responsible, is a medical device giant American international Cardinal company PTC (package technology Center, packaging technology Center) and the other is either the world's largest medical device maker Medtronic, Inc. of the United States responsible for packaging Man John Spitzley.
ISO11607-2006 Although inherited the Juche idea ISO11607-2003, but it made a big change in awards, such as the content is divided into two parts, the first part is mainly about packaging materials, sterile barrier system (SBS) and packaging The second part of the system is about the verification of the MDSP. It is very sensible to separate the sterilization package from the two main contents of the packaging system design and the packaging process verification.
In the first part of ISO11607-2006, equipment maintenance and maintenance, creatively proposed the concept of "sterile barrier system (SBS)", while also considering the packaging is a material and materials, materials and equipment interaction The complete system of the composition, and can not separate the fact that has been neglected before (unfortunately, the domestic level is still at this level of understanding, that is, considering the packaging elements such as materials and equipment from the packaging system), Akiyama International, This completely replaces the understanding of MDSP by ISO11607-2003 and EN868-1, and the latter two have always stayed in the concept of "primary packaging" or "basic packaging".
In the second part of ISO11607-2006, the separate presentation of the validation of the sterilization packaging process is also very sensible, because this is not the same level as the packaging system of the first part, but the relationship between upstream and downstream, only Successful system design can pass the package verification. In ISO11607-2003, this problem was confusing, causing people who read it to fail to understand correctly, and thus did not know how to implement it, causing confusion in the standard reference. In addition, a separate description of IQ, OQ, and PQ and a clear definition of the process to be validated are also necessary to allow the person designing the package verification program to have quantified standards.
But the award for ISO11607 is not to say that this standard is a seamless assessment. In fact, in the foreword of the informal version of the standard (the author got the final draft version of this version, May 2006), it has been clearly stated Due to the rapid development of industry technology, it is necessary to re-examine Fuji Xingguang within 5 years to confirm whether it is necessary to update it. This is a very worthwhile reference in the preparation of this standard in our country. That is to say, there is room for setting standards, and we cannot expect to be all-inclusive and once and for all.
In contrast, the EN868 series of standards, which was established in 1997, was introduced almost at the same time as the first ISO11607 standard, but the content of the two is quite different. In recent years, the performance of the two has also been different: ISO11607 strives to become the standard of global unity, so it is constantly self-denying and fully self-renewing until the relatively perfect ISO11607-2006 is available; and EN868 is only based on the original Constantly expanding the coverage of the series of standards, from one material to several materials, to the specific products made of these materials, the focus is always on the material font, and only paper and non-woven fabrics, but never talk about sterilization The concept of packaging systems and how to design relevant testing standards to confirm that the system is indeed sterile and bacteriostatic throughout the life cycle of the system, and does not talk about how to ensure continuous and stable sterilization packaging production process, that is, packaging Process validation issues.
In contrast, the EN868 series of standards, which was established in 1997, was introduced almost at the same time as the first ISO11607 standard, but the content of the two is quite different. In recent years, the performance of the two has also been different: ISO11607 strives to become the standard of global unity, so it is constantly self-denying and fully self-renewing until the relatively perfect ISO11607-2006 is available; and EN868 is only based on the original Constantly expanding the coverage of the series of standards, from one material to several materials, to the specific products made of these materials, the focus is always on the material font, and only paper and non-woven fabrics, but never talk about sterilization The concept of packaging systems and how to design relevant testing standards to confirm that the system is indeed sterile and bacteriostatic throughout the life cycle of the system, and does not talk about how to ensure continuous and stable sterilization packaging production process, that is, packaging Process validation issues.
Finally, it is proposed that the recent domestic MDSP seminars are based on the ISO11607 series of standards, and the explanations are based on the system specified in ISO11607, and the ISO11067 committee itself has been Promote yourself to become the globally used MDSP standard Beiren Group, and has been working hard for the unification of the two standards of ISO and EN.
From the market segment of the downstream medical device manufacturing industry, the ISO11607 and EN868 series of standards can also be seen as important. Giants downstream of medical devices such as Cardinal, Medtronic, Baxter, CR.Bard, BD, Johnson & Johnson are all from the US (and Europe is inferior in this area), not to mention the US's strong position in MDSP suppliers. There are a large number of well-known companies such as DuPont, Bemis, Oliver, Alcan US, and Amcor US. RFID, which has been influencing the MDSP process, is also from the United States, with long-term work experience and a prominent industry background.
Based on the above facts, we have reason to believe that ISO11607-2006 will truly become the only international standard in the MDSP world that can be widely accepted and applied to the actual production of medical device manufacturers. In Europe, there is a certain gap between the MDSP and the United States, and the European MDSP industry does not like to use Tyvek, and more paper, perhaps with cost factors.
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