(device sterilization packaging standard and certification, referred to as MDSP) is not well known in China. At the end of 2005, the author wrote an article about the current situation of China's MDSP industry (published in the third issue of China medical device information in 2006). However, considering that the author had not been in contact with MDSP industry for a long time at that time, some opinions and information were not accurate Indeed, after nearly a year's accumulation and improvement of the mosaic, the author has a deeper and more comprehensive understanding of the domestic and international MDSP market, and specially wrote this article to discuss and exchange with peers.
MDSP overview
First of all, let's explain the concept of "MDSP". Based on the understanding and analysis of the latest international authoritative standard ISO 11607 (Note: it is the 2006 edition, the en 868 series has been unified into the latest ISO 11607 edition, and the GB19633-2005 standard has not yet been updated synchronously), the author thinks that MDSP can still be divided into two parts: primary packaging and accessory packaging, but the new standard gives clear and unified We call the primary packaging as "sterile barrier system" and the accessory packaging as "protective packaging" development, and strictly stipulate that the packaging products and materials before realizing the SBS function are "preformed sterile barrier system" (PSBs) & R Dquo; It should be noted that since the concepts of SBS and PSBs are put forward in the latest version of ISO 11607, there is no unified or authoritative way to call them when they are translated into Chinese. The Chinese names mentioned above corresponding to the two are all translated by the author himself. Metal packaging
As the name implies, pre press technology, sterile barrier system (SBS) is a sterile packaging system that directly contacts with medical devices and forms a microbial barrier. Undoubtedly, it is the core part of MDSP. And protective packaging is mainly about the protection, convenience, traceability and packaging cost of products in the process of storage and circulation in its life cycle, involving cartons, plastic bags, labels, bar codes, 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 (for example, the damage of cartons will lead to the crushing and invalidation of some bag type SBS packages inside), and the label focuses on another issue that MDSP attaches great importance to & mdash; traceability (note: the country has specially issued relevant label requirements for the food, drug and medical equipment industry; new RFID Labels are also popular in related industries in the United States. However, due to the limited space, this paper only discusses SBS (including PSBs) in MDSP.
There are three kinds of SBS commonly used in industrial production, i.e. Pouch & bag, form fill seal (FFS) and tray lid. There may also be reel bag for SBS used in hospital disinfection.
According to the common degree, bag SBS can be divided into paper poly pouch, paper bag, poly bag, Tyvek pouch, header bag, vent bag, etc. at present, there are no standard Chinese translation film covering for the latter three kinds. The Chinese name provided by the author is only for reference. The paper used here are all medical grade packaging paper with good air permeability. There are many kinds of plastic films used, mainly LDPE, HDPE, PET / PE, PA / PE, and special linear tear film. Among them, the linear tear film is very innovative in the current situation and trend. Only a few leading international companies have this technology, which is used in the vent bag. The bag SBS products are widely used in MDSP, ranging from disposable devices such as syringes and catheters at the lowest end to high-end implantable devices. The cost varies greatly with the use of materials and packaging. Founder
SBS of FFS is composed of two parts: top web and bottom web, of which, Litong is mainly used as the top material, including Tyvek and medical ventilation paper coated with glue or not, film with special peeling coating, etc.; the bottom material is mainly soft absorption molding film of various structures, and PP / PE, PA / PE, Surlyn / EVA / Surlyn are the most common structures in China, the first one is PP / PE, PA / PE, Surlyn / EVA / Surlyn One structure is polypropylene composite film, which is economical and economical. The nylon film in the second structure has high strength and is resistant to puncture and ink-jet printing. The Surlyn layer in the last structure can increase the softness, good formability and beautiful appearance of the composite film. The biggest advantage of FFS SBS is high automation, high efficiency, and low cost ink-jet printing, but it is not suitable for complex structure or high requirements of device packaging.
SBS of rigid plastic box and cover material is also composed of two parts: box and cover disc printing. The materials used in the box mainly include PS (polystyrene), PVC (polyvinyl chloride), PETG (cyclohexanol modified polyester, which can provide the thermal properties and some other processing properties that pet does not have. Now only two companies in the world can produce the resin, which is relatively expensive) and PC (polycarbonate) Ester, a very rare term in China, is expensive and is used in the packaging of three kinds of products. This kind of SBS packaging is mainly used in small surgical operation kits and operation boxes, and also used in some three types of high-end implantable medical devices. Its total cost is higher than the first two types of SBS.
Last but not least