Medical device sterilization packaging belongs to a new area of development, can be said to belong to the emerging industry in the whole world, and still in the continuous accumulation of summary, in the domestic development especially slow. Began to know medical packaging bag around 2005, and gradually align with the international medical device sterilization packaging. 07 years further be paid attention. A definition of medical device sterilization bag packaging of medical device sterilization packaging should be understood as: used for medical device product packaging, can be pasteurize it, can carry out aseptic operation (such as clean open), can provide microbial barrier acceptable performance before and after sterilization, can protect the goods and after sterilization in a certain period of time internal (valid annotation) packaging system to maintain internal aseptic environment system. Because the protective packaging system outside the concept usually do not contain (buffer packaging and collection of packaging part), so the medical device sterilization packaging system can also be called "sterile barrier system".
A medical device sterilization packaging forms, there are generally three types:
1.1 soft blister forming - filling - sealing packaging system: this kind of packaging in accordance with the substrate thickness molding part can be divided into flexible and semi-rigid type two kinds, the base material in plastic packaging equipment specified by temperature, vacuum suction and pressure adjustment and thermoformed into pre design good the shape, and the corresponding top material sealing, the three-dimensional molding packaging system requirements. This kind of packing is characterized by: a high degree of automation, high efficiency, low cost, individual packaging packaging system and contents with good shape, but relates to the equipment and tooling investment, there are certain requirements for production, usually used in the production of large scale of one or two types of medical equipment products, such as various syringe, gauze piece operation, clothing and medical catheter, and a simple three kind of medical instruments, such as a typical vein indwelling needle!
1.2 hard plastic box and cover material and packaging systems: this type of packaging is the use of various types of molding plastic box directly and suitable for heat sealing, according to the shape of pre cut a good cover material and heat sealing, and the so-called hard plastic, is more relevant and for the thickness of sheet of plastic molding, usually between 0.4-1.2mm, involved to the material, from low-end to high-end mainly include PVC, PP, PE, PS, PET, PETG and PC, among which PS, PET and PETG these three kinds of materials used; PVC due to the safety and environmental protection, have gradually been eliminated trend; PP and PE these two kinds of conventional polymer given the limited material, physical and mechanical properties of its forming, in this field is not used in many; PC is the reason because of the high cost, used only in very few areas, typically need to dry heat sterilization. This kind of hard plastic box is purchased, and then in the medical device manufacturers and cover material for heat sealing, heating heat sealing equipment.
1.3 kinds of bag packaging system: including all types of bags: plastic bag, bag bag plug, windows, ventilation strip in sealed bags, paper bags, with Tyvek aluminum foil bags and other products, more form, may be in accordance with the actual situation to design and production, in a word is difficult to summarize the types and applications! In China, these products, such as header bag, bag and a window ventilation in sealed bags and other products because of its special design ventilation window, save material cost, subject to many medical instruments enterprises welcome.
Sterilization bag related regulations and standards of the latest 2006 edition, on 2006 formally promulgated in April, has two parts, the first part is mainly about the packaging materials, sterile barrier systems and packaging systems, the second part mainly describes the process of medical device sterilization packaging of the confirmation, the aseptic packaging in packaging system design and packaging process validation of this two big main content to distinguish. More importantly, in this version, the EN868 standards system formally absorbed popular in Europe, to cancel the general system EN868-1 this conflict, selective absorption with EN868-2 to -10 of the 9 specific materials and sub standard products, which will in fact declared the sterilization of medical instruments packing in global standard was born in 2006, ISO11607-2006. Other such as the December 1, 2010 implementation of the YY/T0698, and transformed GB/T19633, ASTM-F88, ASTM-F1929, ASTM sealing dye penetration of F1980 accelerated ageing, "YYT_0681.1-2009" test method for packaging of sterile medical devices part first: accelerated aging test guide, ISO15223/YY0446 medical tag and provides the information symbols, GB/T191 packing and the sign, ASTM, F1608 microbial barrier GB/T 15171 bubble test, no blasting (ASTM F-1150 / ASTM F-2054) sterilization bag principle.
In order to design a reasonable medical sterilization packaging system, need to follow some basic principles:
One, "packaging" is part of the product: the packaging is refers to "the sterile barrier system", because the failure of sterile barrier system means that the medical device product failure, risk and hidden there may be greater, because this kind of failure is often more difficult to be detected or more easily overlooked. So for the medical device industry product development and technical design staff, to pay special attention to this point, to focus on product packaging design, because it is a part of product design.
"At the beginning of two, the packaging system" = "sterile barrier system:" this and the first point is echoed each other, and in the ISO11607-2006 of the current international the most authoritative standard for medical devices is displayed in the most direct, it directly in the previous version of "primary packaging system is redefined as' sterile barrier system, this is the concept of the original source!
Three, emphasize the safety of packaging and continuous stability: because of the special medical equipment products, the packaging is safe or not is directly related to the use of equipment life safety of patients. (of course, some low-end medical products may not have such serious consequences), in this life first time, no one can ignore this point. In order to achieve absolute safety sterilization packaging, consulting industry experienced Professional Company or person, choose proved experimental design qualified packaging materials, adequate and has scientific basis and experimental operation, strict reference is considered to be the correct historical experience and experimental data, should be taken into account. As for the emphasis on packaging quality continuous stability, this is the premise of sterilization packaging safety has to meet the conditions, should consider the issue again next, in fact this is also meet a requirement of absolute security package. According to decades of international and domestic industry experience, in addition to strictly abide by the ISO13485 for the medical device industry design of quality management system standards, generally speaking, packaging process strictly scientific confirmation is effective way to ensure continuous and stable packaging quality.