(Device Sterilization Packaging Standards and Certification, referred to as MDSP) is also not well known in the country, I have written in late 2005, an article on the status of China's MDSP industry article (published in 2006 third issue of "China Medical Device Information" , But taking into account the writing of the time when the author contact MDSP industry time is not long, some views and information less accurate, after nearly a year of accumulation and improvement imposition, the author of domestic and international MDSP market has more in-depth, Comprehensive understanding, especially to write this article with colleagues to explore and exchange.
Overview of MDSP
First of all, let us explain the concept of "MDSP". Based on the international update on MDSP the latest standard ISO 11607 (Note: 2006 edition, EN 868 series has been integrated into the latest version of ISO 11607, GB19633-2005 standard has not had time to synchronize updates) understanding and analysis of scanning, the author MDSP can still be divided into primary packaging and ancillary packaging is divided into two parts, but the new standard gives a clear, unified title, the initial packaging called "sterile barrier system (Sterile Barrier System, referred to as SBS) Called "protective packaging" development, and very strict provisions to achieve the SBS function before the packaging products and materials for the "preformed sterile barrier system (Performed Sterile Barrier System, referred to as PSBS)", . It should be noted that, because the concept of SBS and PSBS are in the latest version of ISO 11607 only proposed, so currently translated into Chinese when there is no uniform or authoritative name, the above-mentioned with the two phase The corresponding Chinese name is the author's own translation. Metal packaging
Sterile barrier system (SBS), as its name suggests, is an aseptic packaging system that directly contacts medical device products and forms a barrier to microbiological barrier, and is undoubtedly the heart of MDSP. The protective packaging is mainly about the product in its life cycle of storage, circulation in the process of protection, convenience, traceability and packaging costs of some packaging, involving the carton, plastic bags, labels, bar code, printing, Trays and containers and other content.
While insufficient protective packaging, such as cartons, can also affect SBS functionality (eg, breakage of the carton will cause some bag-like SBS packages built-in to fail), the label is focused on another that the MDSP attaches great importance to (Note: the state has specifically for the food, pharmaceutical and medical equipment industry has introduced a specific label requirements; new RFID tags are also in the United States-related industries in full swing to popular) ticket printing, but taking into account the limited space, this article only Discusses SBS (including PSBS) in MDSP.
Industrial production of SBS common are Pouch & Bag, Form-Fill-Seal (FFS) and hard plastic box-covered material (Tray Lid) three categories, the hospital SBS may also be used in sterile reel-shaped paper bag (Reel Bag).
Bags SBS can be divided into paper-poly Pouch, Paper Bag, Poly Bag, Tyvek-Pouch, Header, Bag, Vent Bag and so on. There are no standard Chinese translucent lamination in the back of the home. The Chinese name provided by the author is for reference only. There are many kinds of plastic film, mainly LDPE, HDPE, PET / PE, PA / PE, and the special straight-line easy tear film (Liner Tear Film), which are used in medical grade wrapping paper with good air permeability, Straight line tear film is very innovative status and trends, only a few leading international companies have the technology, used in the window bag (Vent Bag). SBS products in the MDSP in the use of a very wide range, from the most low-end syringes, catheters and other disposable devices to high-end implantable devices can use this product, the cost of materials and packaging with the use of different Great changes. Founder
FFS The SBS consists of two parts: the Top Web and the Bottom Web. The materials used for the Litong and Topcoat are coated or uncoated Tyvek and medical breathable paper. PA / PE, Surlyn / EVA / Surlyn, the first structure is polypropylene (PP / PE, PA / PE), the first structure is the polypropylene film, Composite membrane, affordable, the second structure of the nylon membrane strength, puncture-resistant inkjet printing, the last structure of the Surlyn layer can increase the flexibility of the composite film, good shape, beautiful appearance. FFS class SBS biggest advantage is a high degree of automation, high efficiency, and low cost inkjet printing, but it is not suitable for complex structures or high-demand packaging equipment.
Hard plastic box - cover material SBS is also composed of two parts: box and cover CD printing, box used in the material PS (polystyrene), PVC (polyvinyl chloride), PETG (cyclohexanol modified Polyester, can provide PET does not have the heat of the performance and some other processing performance, the world is only two companies can produce the resin, the price is more expensive) and PC (polycarbonate, very rare in the domestic terminology, For three types of product packaging). These SBS packages are used primarily in small surgical and surgical cases, as well as in some high-end three types of implanted medical devices, with overall costs higher than those of the first two SBS.
Last but not least, the most important MDSP packaging materials - DuPont Tyvek Tyvek, which is a kind of HDPE with more than 99.8% for the substrate offset, spinning spinning from the excellent overall performance Of the nonwoven material. The Tyvek AsuronTM, introduced in November 2005 to improve the existing Tyvek Tyvek thickness inequality, provides a higher level of protection for a variety of medical devices. DuPont Tyvek Tyvek now has four grades, namely, quantitative 56.0g / m2, 64.4g / m2, 74.6g / m2 and 68.0g / m2 Tyvek2FS, 1059B, 1078B and Asuron.
Tyvek Tyvek is used for MDSP mainly due to its good water resistance, breathability and excellent tensile, tear and puncture resistance and other physical and mechanical properties, and widely adapted to the existing various types of conventional sterilization methods, including Ethylene oxide (EtO), high pressure steam, electron beam, gamma ray and X-ray special printing, except under special conditions of high temperature steam sterilization. Equipment maintenance and repair
Powerful DuPont is involved in and responsible for the FDA, ASTM and AAMI and other medical device-related organizations, packaging testing standards and experimental demonstration. Dr. Michael Scholla, former senior staff member of DuPont Medical Packaging, is currently Vice Chairman of AAMI and has been responsible for the harmonization of ISO 11607 and EN 868. Curt Larsen, Senior Consultant, Medical Packaging, Co-Chair of the Medical Device Packaging Committee (MDPC), affiliated with the Institute of Packaging Professionals (IoPP). The existing ASTM F1929 by toluidine blue staining test SBS integrity of the method is recommended by the DuPont.
MDSP also belongs to the soft plastic packaging materials as the main body of the scientific and technological reports of India, and its common with the flexible packaging of the important difference is: medical equipment packaging material requirements are very high, in addition to meet the conventional protection and isolation from the outside world Environmental basic packaging performance, but also stressed the continued stability of material properties, as well as from the sterilization requirements extended from the compatibility with the sterilization methods, materials, microbial barrier and non-toxic, which requires SBS must be professional Of the MDSP manufacturers to produce. For this digital printing, the 2006 edition of ISO 11607 also specifically provides MDSP manufacturers to PSBS production process to confirm to ensure its quality is continuous and stable, which are sufficient to prevent the general industrial products and food packaging enterprises to enter the field of MDSP .
Of course, because the medical device product sales object and the use of objects is relatively fixed and very professional, and therefore does not attach great importance to product sales packaging design pressure bump, which is it with ordinary flexible packaging (such as high-end food, pharmaceuticals and fine craft packaging) The difference lies in the medical device product packaging design does not pay attention to the bright colors and patterns of the complex, but only a label nature of the informative content. However, MDSP and pharmaceutical packaging, label requirements are surprisingly high, because it helps to trace back and guide the use of green printing, and even serious product quality problems when the recall.