Medical sterilization package

Medical sterilization packaging bag is to prevent the items in the packaging 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

Related standards:

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).

Target customers:

Medical device manufacturer, or hospital

Product shelf life:

Three to five years (antimicrobial)

Principle of action and application:

Medical equipment in packaging (product), then the sealing, disinfection, use of packaging (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 packaging (product) aging resistance bacteria can reach 3 to 5 years.

Object:

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 packaging and high-end medical equipment packaging

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

Alias summary:

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Sterilized packaging 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 packaging, and gradually with the international medical equipment sterilization packaging.7 years be taken seriously further by home place.Introduction of medical device sterilization bags medical device sterilization packaging 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 packaging systems for maintaining the system within a sterile environment.Because this concept usually does not include the outer protective packaging system (buffer packaging and assembly packaging, etc.), medical device sterilization packaging system can also be called "sterile barrier system".About medical device sterilization packaging forms, generally has the following three categories: 1.1 soft vacuum forming - filling, heat sealing packaging system: this type of package 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 packaging 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 packaging system meets the requirements.This kind of packaging features are: high degree of automation, high efficiency, low cost of a single packaging, packaging 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 packaging 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 packaging 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 packaging materials, sterile barrier system and packing system, the second part is mainly about the relevant medical device sterilization packaging process validation problems, thus the aseptic packing according to the system design and packaging 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 packaging 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 packaging test method part 1:Accelerated aging test guidelines, ISO15223 / YY0446 medical equipment label tag and provide the information of symbols, GB/T191 packaging 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 < packaging sterilization gas sterilization factors such as size aperture size < bacterial size, sterilization packaging 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. 

In order to design a reasonable system of medical device sterilization packaging, need to follow some basic principles: 3.1 "packaging" is part of the product: the packaging here refers to the sterile barrier system, because of the sterile barrier system failure means that medical device failure, and possibly the latent risk is bigger, because this kind of failure is often more difficult to detect or more easily overlooked.Therefore, for the product developers or technical designers in the medical device industry, special attention should be paid to this point, and the product packaging design should be given priority, because this is also a part of the product design.3.2 "primary packaging systems" = "sterile barrier system:" this and the first point is mutual echo, and in ISO11607-2006 on the current international related medical equipment has the most direct the most authoritative standard, it directly in the previous version of the "early packaging system is redefined as' sterile barrier system, which is the concept of the original source.3.3 emphasis on the safety of the packaging and continuous stability: because of the particularity of medical equipment products, the packaging or not is directly related to the safety of the use of the instrument down the patient's life safety (of course some low-end medical devices may not have so serious consequences), in this life is the highest s, no one can ignore it.To achieve the absolute safety of sterilization packaging, experienced professional companies or personnel in the consulting industry, the selection of proven qualified packaging materials, sufficient and scientifically based experimental design and strict experimental operation, and reference to historical experience and experimental data that are considered to be correct should be taken into account.As for the emphasis on the continuous stability of packaging quality, this is under the condition that the major premise of sterilization packaging safety has been met, and then we should consider the problem, in fact, this is also a requirement to meet the absolute safety of packaging.

According to decades of industry experience at home and abroad, in addition to strictly abide by the ISO13485 quality management system standards designed for the medical device industry, in general, scientific and strict packaging process confirmation is also an effective way to ensure the continuous and stable packaging quality.Sterilization bag function in EO for epoxy ethane/STEAM high temperature STEAM/GAMMA irradiation cobalt 60 / plasma radiation sterilization, loading for sterilization of medical devices into the bag, seal tightly closed again after the implementation of sterilization, sterilization gas, ray through the bags in sterilization, analytical, and finally, the bacteria are not to go, because of the aperture is half permeability of packaging materials, allowing the sterilization gas, ray, prevent bacteria) is the choice of using the bags through a semipermeable dialysis, guarantee of medical equipment in the packaging, so after sterilization, the handling, transport,The storage is sterile until the hospital operating room nurses open it, the nursing book is finally opened directly with, no need to sterilize, the effective period of the material resistance of different packaging bags is generally 3-5 years, in the case of the packaging bag is not damaged, the medical equipment in the packaging bag can ensure 3 to 5 years are sterile.Sterilization bags of sterile barrier system evaluation, according to the product packaging material selection, the evaluation content includes: system requirements - microbial barrier system - products and packaging materials for validation package material biocompatibility and toxicity of physical and chemical properties of the material - - the adaptability - packaging materials and packaging materials and the sterilization process of forming and sealing process adaptability - packaging and label printing adaptability of package material of microbial barrier system evaluation based on 7.2: AGAR touch attack test of ISO 11607-2003.Question: is this test method out of date?Is the test method of F1608 necessary? This method can only be tested by a third party.Evaluation method of physical and chemical properties of packaging materials: test the tensile strength of packaging materials before and after sterilization, and compare the changes in the tensile strength of packaging materials before and after sterilization with the adaptability of packaging materials to the sterilization process.Before sterilization, the product shall be tested for the initial contamination bacteria, and after sterilization, the product shall be tested for sterility, and the suitability of the packaging material and the molding and sealing process shall be evaluated:- thermal sealing strength according to ASTM F1886:1998 Standard test method for determining integrity of seals for medical packaging by visual inspection - Standard test method for burst testing of flexible package according to ASTM f88:2000Pressurization within restraining plates used internal air pressurization.The integrity of the packaging - according to ASTM F1929:1998 "Standard test method for detecting seal leaks in porous medical packaging by dye penetration."