Medical Sterilization Pouches
Medical sterilization pouches bag is to prevent the items in the pouches bag from bacterial contamination, generally in a completely closed form, the bacteria can not get into the effect.
Generally according to customer requirements manufacturers qualification: ISO13485 certification, CFR820, the United States FDA certification, 100,000 grade purification workshop, 5000 square meters of plant, registered capital of more than 5 million
ISO14644 ISO10993, ISO14971, ISO11135 / GB18279 ethylene oxide sterilization, ISO11137 irradiation sterilization, ISO11134 GB18278 / ISO17665 (NEW) wet and heat sterilization
Suitable sterilization and disinfection methods:
EO ethylene oxide sterilization, steam high temperature and pressure steam wet heat sterilization, gamma cobalt 60 irradiation sterilization, plasma sterilization (non-paper).
Medical device manufacturer, or hospital
Product shelf life:
Three to five years (antimicrobial)
Principle of action and application:
Medical equipment in pouches (product), then the sealing, disinfection, use of pouches (product) through the sterilization factor, not through the half dialysis of bacteria through , to professional organizations in suzhou university medical testing of EN868 professional testing, after that pouches (product) aging resistance bacteria can reach 3 to 5 years.
Medical gloves, medical syringes, hemostatic gauze, surgical towels, medical catheters, tracheal intubation, surgical gowns, protective clothing, endovascular catheters, indwelling needles, electric knife pens, heparin caps, three-way cocks, bellows covers, balloons, artificial joints, sealing devices and other medical supplies pouches and high-end medical equipment pouches
Quality determination method:
Testing the stripping force of sealing edge;No paper scraps during separation;The test of sealing side to prevent bacteria leakage has no leakage, etc
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Sterilized pouches for medical devices is an emerging field of development. It can be said that it belongs to the emerging industry all over the world and is still in the process of accumulation and summary, especially in China.In 2005 or so began to understand the medical equipment pouches, and gradually with the international medical equipment sterilization pouches.7 years be taken seriously further by home place.Introduction of medical device sterilization bags medical device sterilization pouches should be understood as: the definition of the packing for medical device products, can to sterilization, aseptic operation can be performed, such as clean open), can provide acceptable performance of germs, to protect the product before and after sterilization and sterilization after can within a certain period of time (with) the period of validity of pouches systems for maintaining the system within a sterile environment.Because this concept usually does not include the outer protective pouches system (buffer pouches and assembly pouches, etc.), medical device sterilization pouches system can also be called "sterile barrier system".About medical device sterilization pouches forms, generally has the following three categories: 1.1 soft vacuum forming - filling, heat sealing pouches system: this type of pouches according to the forming part of the substrate thickness and can be divided into flexible and semi-rigid type two kinds, the substrate on specific blister pouches equipment through the adjustment of the temperature, vacuum and pressure absorption and thermoforming become upfront design good shape, and the corresponding top material and thermal bonding, form a three-dimensional molding pouches system meets the requirements.This kind of pouches features are: high degree of automation, high efficiency, low cost of a single pouches, pouches system and contents with good shape, but involves equipment and mold, have a certain request for production, usually used in the production scale is big, 2 kinds of medical equipment products, such as all kinds of syringe, gauze piece, gown and medical catheter intubation, three categories of medical apparatus and instruments, as well as the simple typical such as intravenous indwelling needle!
1.2 hard blister box cover material packing system: this class is to use all kinds of forming blister pouches box directly with all kinds of suitable for heat sealing and shape according to the cutting good heat sealing cover material in advance, and the so-called hard blister, is more used for vacuum forming and sheet thickness, usually between 0.4 1.2 mm, and the materials involved, from low-end to high-end mainly PVC, PP, PE, PS, PET, PETG, PC and so on, especially in PS, PET, PETG these three materials commonly used;Because PVC involves safety and environmental protection issues, there is a trend of gradually being eliminated;PP and PE, two conventional polymer materials, due to the limitations of their physical and mechanical properties after molding, are not used very much in this field;PC is because of the high cost, only in a very few areas of application, such as the need for dry heat sterilization occasions.This kind of hard blister box is generally purchased, and then in the medical device manufacturers and cover material for heat sealing, ordinary heating heat sealing equipment can be.1.3 all kinds of bag body pouches system: including all kinds of bags: paper and plastic bags, top bags, window bags, breathable strip sealing bags, paper bags, aluminum foil composite bags with Tyvek and other products, more forms may be designed and produced according to the actual situation, in short, it is difficult to completely summarize the types and application range!In China, these products, such as the top bag, window bag and breathable strip sealing bag and other products because of its special design of breathable window, save the cost of materials, by many medical equipment enterprises welcome.Sterilization bags from the 2006 edition of the latest relevant laws and regulations standard, formally issued in April 2006, has two parts, the first part is mainly about pouches materials, sterile barrier system and packing system, the second part is mainly about the relevant medical device sterilization pouches process validation problems, thus the aseptic packing according to the system design and pouches process to confirm the two apart from the body content.More importantly, in this version, formal absorbed the European popular EN868 standard system, already cancelled EN868-1 the conflicting general principles of the system, the selective absorption merger EN868-2 to 10 the nine sub standard for specific materials and products, it is in fact declared the global uniform standard of medical device sterilization pouches finally was born in 2006, both ISO11607-2006.Others, such as YY/T0698 performed on December 1, 2010, are converted GB/T19633, astm-f88 sealing, astm-f1929 staining penetration, ASTM F1980 accelerated aging, yyt_0681.1-2009 _ aseptic medical device pouches test method part 1:Accelerated aging test guidelines, ISO15223 / YY0446 medical equipment label tag and provide the information of symbols, GB/T191 pouches storage and transportation graphic symbol, ASTM, GB/T 15171 bubble F1608 microbial barrier test, no blasting (ASTM/ASTM F F - 1150-2054), the basic principle of sterilization bags < pouches sterilization gas sterilization factors such as size aperture size < bacterial size, sterilization pouches materials through the sterilization factor (such as ETO epoxy ethane, high temperature steam, cobalt 60 gamma rays, etc.),But it prevents the bacteria from being semi-permeable.