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Overview of Medical Device Sterile Packaging (MDSP)
2024/1/4
Based on the understanding and analysis of iso 11607 (note: it is the 2006 edition, en868 series has been unified into this new iso11607 edition, and the standard of gb19633-2005 has not been updated synchronously), mdsp can still be divided into two parts: primary packaging and accessory packaging, but the new standard gives a clear and unified title. The primary packaging is called' aseptic barrier system (sbs)', and the auxiliary packaging is called' protective packaging)'. Moreover, it is very carefully defined that the packaging products and materials before sbs function are' performed sterile barrier system (hereinafter referred to as psbs), because this concept and the above sbs concept were put forward in the new version of iso 11607, so there is no unified or name in translation at present, and these corresponding Chinese names are all translated by the author himself'. The concept of sbs has clearly explained what kind of packaging system it is: the aseptic packaging system that directly contacts with medical device products and forms a microbial barrier is the core part of mdsp; Protective packaging is mainly about the protection, convenience, traceability and packaging cost of products during their life cycle, involving cartons, plastic bags, labels, barcodes, printing, pallets and containers.
Although the strength of protective packaging such as cartons is not enough, it will also affect the realization of sbs functionality (note: if the carton is damaged, the pouch sbs packaging inside will be crushed and fail), while the label pays attention to another issue that mdsp pays great attention to-traceability (note: the state has issued a special document on the relevant label requirements for the food, medicine and medical device industries; A new tag radio frequency identification technology-－rfid is also popular in related industries in the United States), but considering the limited space, this paper only discusses sbs (including psbs) of mdsp.
There are three common sbs in industrial production: pouch&bag, form-fill-seal (ffs) and tray+lid. Sbs used for disinfection in hospitals may also have reel bag.
Among them, bag sbs can be classified into paper-plastic bag, paper bag, plastic bag, tyvek-bag, header bag, vent bag, etc. The last three types are given English names but Chinese translations are given in brackets because there is no standard translation in China. The paper used here is medical-grade paper with good air permeability, and there are many kinds of plastic films used, mainly ldpe, hdpe, pet/pe, pa/pe, and special liner tear film (a very innovative linear tear-off film, which is only available by several big international companies and used in vent bag). Bag products are widely used in mdsp, ranging from low-end syringes, catheters and other devices to high-end implantable devices, and their costs vary greatly with the materials used and packaging purposes.
Although the strength of protective packaging such as cartons is not enough, it will also affect the realization of sbs functionality (note: if the carton is damaged, the pouch sbs packaging inside will be crushed and fail), while the label pays attention to another issue that mdsp pays great attention to-traceability (note: the state has issued a special document on the relevant label requirements for the food, medicine and medical device industries; A new tag radio frequency identification technology-－rfid is also popular in related industries in the United States), but considering the limited space, this paper only discusses sbs (including psbs) of mdsp.
There are three common sbs in industrial production: pouch&bag, form-fill-seal (ffs) and tray+lid. Sbs used for disinfection in hospitals may also have reel bag.
Among them, bag sbs can be classified into paper-plastic bag, paper bag, plastic bag, tyvek-bag, header bag, vent bag, etc. The last three types are given English names but Chinese translations are given in brackets because there is no standard translation in China. The paper used here is medical-grade paper with good air permeability, and there are many kinds of plastic films used, mainly ldpe, hdpe, pet/pe, pa/pe, and special liner tear film (a very innovative linear tear-off film, which is only available by several big international companies and used in vent bag). Bag products are widely used in mdsp, ranging from low-end syringes, catheters and other devices to high-end implantable devices, and their costs vary greatly with the materials used and packaging purposes.
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