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Sterile bag-history of sterilized packaging
2024/1/4
Sterilization and packaging of medical devices is a new development field, which can be said to be a new industry all over the world, and it is still in the process of continuous accumulation and summary, especially in China. Since 2005, medical device packaging bags have been known, and they are gradually in line with international medical device sterilization packaging. In 2007, it was further valued by China. Introduction to the packaging of sterilization bags for medical devices The definition of sterilization packaging for medical devices should be understood as: a packaging system that can be used for packaging medical devices, can be sterilized, can be sterilized (such as clean opening), can provide acceptable microbial barrier performance, can protect products before and after sterilization, and can maintain a sterile environment inside the system within a certain period of time (marked validity period) after sterilization. Because this concept usually does not include the external protective packaging system (buffer packaging and collective packaging, etc.), the sterilization packaging system of medical devices can also be called "aseptic specific pathogen free".
About the forms of sterilization and packaging of medical devices, there are roughly the following three categories:
1.1 Soft blister forming-filling-heat sealing packaging system: This kind of packaging can be divided into flexible type and semi-rigid type according to the thickness of the substrate in the molding part. The substrate is thermoformed into a pre-designed shape by adjusting the temperature, vacuum degree and pressure on the specific blister packaging equipment, and then heat sealed with the corresponding top material to form a three-dimensional molding packaging system that meets the requirements. This kind of packaging is characterized by high degree of automation, high efficiency, low cost of a single package, and good matching between the packaging system and the shape of the contents, etc. However, it involves the investment of equipment and molds, and has certain requirements on the output. It is usually used in first-and second-class medical device products with large output, such as various syringes, gauze pieces, surgical gowns and medical catheter intubation, and simple third-class medical devices, such as intravenous indwelling needles!
1.2 Hard blister box-cover material packaging system: This kind of packaging uses all kinds of molded blister boxes to directly heat-seal with all kinds of cover materials suitable for heat sealing, and the so-called hard blister is more related to the thickness of the sheet used for blister molding, usually between 0.4 and 1.2 mm, and the materials involved are mainly pvc, pp, pe, ps, pet and petg from the low end to the high end. Pvc has a tendency to be gradually eliminated because it involves safety and environmental protection issues; Pp and pe, two conventional polymer materials, are not widely used in this field because of their physical and mechanical properties after molding. Because of the high cost, pc is only used in a few fields, such as dry heat sterilization. This kind of hard blister box is generally purchased, and then heat-sealed with the cover material in the medical device manufacturer, and can be heated by ordinary heat-sealing equipment.
1.3 All kinds of bag packaging systems: including all kinds of bags: paper plastic bags, plug bags, window bags, sealed bags in breathable strips, paper bags, aluminum foil composite bags with tyvek and other products, with more forms, which may be designed and produced according to the actual situation. In short, it is difficult to completely summarize their types and application scope! In China, these products, such as head bag, window bag and sealed bag in breathable strip, are welcomed by many medical device enterprises because of their special design of breathable window, which saves the cost of materials.
The new 2006 edition of the relevant laws and standards for sterilization bags was officially promulgated in April 2006. It consists of two parts, one is mainly about packaging materials, aseptic barrier system and packaging system, and the other is mainly about the process confirmation of sterilization packaging of medical devices, thus distinguishing aseptic packaging from packaging system design and packaging process confirmation. More importantly, in this edition, the popular en868 standard system in Europe was formally absorbed and merged, which not only canceled the conflicting general system en868-1, but also selectively absorbed and merged the nine sub-standards of en868-2 to -10 related to specific materials and products, which in fact announced that the globally unified sterilization and packaging standard for medical devices was finally born in 2006, namely iso11607-2006. Others, such as yy/t0698 implemented on December 1, 2010, There are also transformed gb/t19633, astm-f88 sealing, astm-f1929 dyeing penetration, astm f1980 accelerated aging, yyt_0681.1-2009 "Test method for aseptic medical device packaging" Part 1: accelerated aging test guide, iso15223/yy0446 medical device labeling and information symbols, GB/T1. Astm f1608 microbial barrier, gb/t 15171 bubble test, basic principle of non-explosion (astm f-1150/astm f-2054) sterilization bag, etc.
In order to design a reasonable sterilization and packaging system for medical devices, the following basic principles should be followed:
First, "packaging" is a part of the product: the packaging here refers to "sterile specific pathogen free", because the failure of sterile specific pathogen free means the failure of medical device products, and the potential risk may be greater, because this failure is usually more difficult to detect or easily overlooked. Therefore, for the product development or technical designers in the medical device industry, we should pay special attention to this point and focus on the product packaging design, because this is also a part of the product's own design.
Second, the "primary packaging system" = "sterile specific pathogen free": This and this are mutually echoed, and it has been directly reflected in the current international medical device standard iso11607-2006, which directly redefines the "primary packaging system" in the previous version as "sterile specific pathogen free", which is also the origin of this concept!
Third, emphasize the safety and continuous stability of packaging: because of the particularity of medical device products, the safety of their packaging is directly related to the life safety of patients who use devices (of course, some low-end medical device products may not have such serious consequences), in this era of life first, no one can ignore this. In order to realize the safety of sterilization packaging, consulting experienced professional companies or people in the industry, selecting qualified packaging materials, adequate and scientific experimental design and strict experimental operation, and referring to historical experience and experimental data that are considered correct should all be taken into account. As for the emphasis on the continuous stability of packaging quality, this is a problem that should be considered next under the condition that the safety of sterilized packaging has been met. In fact, this is also a requirement to meet the safety of packaging. According to the industry experience at home and abroad for decades, apart from strictly observing iso13485, a quality management system standard specially designed for the medical device industry, generally speaking, scientific and strict packaging process confirmation is also an effective method for continuous and stable packaging quality.
Sterile bag-history of sterilized packaging
Sterilization and packaging of medical devices is a new development field, which can be said to be a new industry all over the world, and it is still in the process of continuous accumulation and summary, especially in China. Since 2005, medical device packaging bags have been known, and they are gradually in line with international medical device sterilization packaging. In 2007, it was further valued by China. Introduction to the packaging of sterilization bags for medical devices The definition of sterilization packaging for medical devices should be understood as: a packaging system that can be used for packaging medical devices, can be sterilized, can be sterilized (such as clean opening), can provide acceptable microbial barrier performance, can protect products before and after sterilization, and can maintain a sterile environment inside the system within a certain period of time (marked validity period) after sterilization. Because this concept usually does not include the external protective packaging system (buffer packaging and collective packaging, etc.), the sterilization packaging system of medical devices can also be called "aseptic specific pathogen free".
About the forms of sterilization and packaging of medical devices, there are roughly the following three categories:
1.1 Soft blister forming-filling-heat sealing packaging system: This kind of packaging can be divided into flexible type and semi-rigid type according to the thickness of the substrate in the molding part. The substrate is thermoformed into a pre-designed shape by adjusting the temperature, vacuum degree and pressure on the specific blister packaging equipment, and then heat sealed with the corresponding top material to form a three-dimensional molding packaging system that meets the requirements. This kind of packaging is characterized by high degree of automation, high efficiency, low cost of a single package, and good matching between the packaging system and the shape of the contents, etc. However, it involves the investment of equipment and molds, and has certain requirements on the output. It is usually used in first-and second-class medical device products with large output, such as various syringes, gauze pieces, surgical gowns and medical catheter intubation, and simple third-class medical devices, such as intravenous indwelling needles!
1.2 Hard blister box-cover material packaging system: This kind of packaging uses all kinds of molded blister boxes to directly heat-seal with all kinds of cover materials suitable for heat sealing, and the so-called hard blister is more related to the thickness of the sheet used for blister molding, usually between 0.4 and 1.2 mm, and the materials involved are mainly pvc, pp, pe, ps, pet and petg from the low end to the high end. Pvc has a tendency to be gradually eliminated because it involves safety and environmental protection issues; Pp and pe, two conventional polymer materials, are not widely used in this field because of their physical and mechanical properties after molding. Because of the high cost, pc is only used in a few fields, such as dry heat sterilization. This kind of hard blister box is generally purchased, and then heat-sealed with the cover material in the medical device manufacturer, and can be heated by ordinary heat-sealing equipment.
1.3 All kinds of bag packaging systems: including all kinds of bags: paper plastic bags, plug bags, window bags, sealed bags in breathable strips, paper bags, aluminum foil composite bags with tyvek and other products, with more forms, which may be designed and produced according to the actual situation. In short, it is difficult to completely summarize their types and application scope! In China, these products, such as head bag, window bag and sealed bag in breathable strip, are welcomed by many medical device enterprises because of their special design of breathable window, which saves the cost of materials.
About the forms of sterilization and packaging of medical devices, there are roughly the following three categories:
1.1 Soft blister forming-filling-heat sealing packaging system: This kind of packaging can be divided into flexible type and semi-rigid type according to the thickness of the substrate in the molding part. The substrate is thermoformed into a pre-designed shape by adjusting the temperature, vacuum degree and pressure on the specific blister packaging equipment, and then heat sealed with the corresponding top material to form a three-dimensional molding packaging system that meets the requirements. This kind of packaging is characterized by high degree of automation, high efficiency, low cost of a single package, and good matching between the packaging system and the shape of the contents, etc. However, it involves the investment of equipment and molds, and has certain requirements on the output. It is usually used in first-and second-class medical device products with large output, such as various syringes, gauze pieces, surgical gowns and medical catheter intubation, and simple third-class medical devices, such as intravenous indwelling needles!
1.2 Hard blister box-cover material packaging system: This kind of packaging uses all kinds of molded blister boxes to directly heat-seal with all kinds of cover materials suitable for heat sealing, and the so-called hard blister is more related to the thickness of the sheet used for blister molding, usually between 0.4 and 1.2 mm, and the materials involved are mainly pvc, pp, pe, ps, pet and petg from the low end to the high end. Pvc has a tendency to be gradually eliminated because it involves safety and environmental protection issues; Pp and pe, two conventional polymer materials, are not widely used in this field because of their physical and mechanical properties after molding. Because of the high cost, pc is only used in a few fields, such as dry heat sterilization. This kind of hard blister box is generally purchased, and then heat-sealed with the cover material in the medical device manufacturer, and can be heated by ordinary heat-sealing equipment.
1.3 All kinds of bag packaging systems: including all kinds of bags: paper plastic bags, plug bags, window bags, sealed bags in breathable strips, paper bags, aluminum foil composite bags with tyvek and other products, with more forms, which may be designed and produced according to the actual situation. In short, it is difficult to completely summarize their types and application scope! In China, these products, such as head bag, window bag and sealed bag in breathable strip, are welcomed by many medical device enterprises because of their special design of breathable window, which saves the cost of materials.
The new 2006 edition of the relevant laws and standards for sterilization bags was officially promulgated in April 2006. It consists of two parts, one is mainly about packaging materials, aseptic barrier system and packaging system, and the other is mainly about the process confirmation of sterilization packaging of medical devices, thus distinguishing aseptic packaging from packaging system design and packaging process confirmation. More importantly, in this edition, the popular en868 standard system in Europe was formally absorbed and merged, which not only canceled the conflicting general system en868-1, but also selectively absorbed and merged the nine sub-standards of en868-2 to -10 related to specific materials and products, which in fact announced that the globally unified sterilization and packaging standard for medical devices was finally born in 2006, namely iso11607-2006. Others, such as yy/t0698 implemented on December 1, 2010, There are also transformed gb/t19633, astm-f88 sealing, astm-f1929 dyeing penetration, astm f1980 accelerated aging, yyt_0681.1-2009 "Test method for aseptic medical device packaging" Part 1: accelerated aging test guide, iso15223/yy0446 medical device labeling and information symbols, GB/T1. Astm f1608 microbial barrier, gb/t 15171 bubble test, basic principle of non-explosion (astm f-1150/astm f-2054) sterilization bag, etc.
In order to design a reasonable sterilization and packaging system for medical devices, the following basic principles should be followed:
First, "packaging" is a part of the product: the packaging here refers to "sterile specific pathogen free", because the failure of sterile specific pathogen free means the failure of medical device products, and the potential risk may be greater, because this failure is usually more difficult to detect or easily overlooked. Therefore, for the product development or technical designers in the medical device industry, we should pay special attention to this point and focus on the product packaging design, because this is also a part of the product's own design.
Second, the "primary packaging system" = "sterile specific pathogen free": This and this are mutually echoed, and it has been directly reflected in the current international medical device standard iso11607-2006, which directly redefines the "primary packaging system" in the previous version as "sterile specific pathogen free", which is also the origin of this concept!
Third, emphasize the safety and continuous stability of packaging: because of the particularity of medical device products, the safety of their packaging is directly related to the life safety of patients who use devices (of course, some low-end medical device products may not have such serious consequences), in this era of life first, no one can ignore this. In order to realize the safety of sterilization packaging, consulting experienced professional companies or people in the industry, selecting qualified packaging materials, adequate and scientific experimental design and strict experimental operation, and referring to historical experience and experimental data that are considered correct should all be taken into account. As for the emphasis on the continuous stability of packaging quality, this is a problem that should be considered next under the condition that the safety of sterilized packaging has been met. In fact, this is also a requirement to meet the safety of packaging. According to the industry experience at home and abroad for decades, apart from strictly observing iso13485, a quality management system standard specially designed for the medical device industry, generally speaking, scientific and strict packaging process confirmation is also an effective method for continuous and stable packaging quality.
Sterile bag-history of sterilized packaging
Sterilization and packaging of medical devices is a new development field, which can be said to be a new industry all over the world, and it is still in the process of continuous accumulation and summary, especially in China. Since 2005, medical device packaging bags have been known, and they are gradually in line with international medical device sterilization packaging. In 2007, it was further valued by China. Introduction to the packaging of sterilization bags for medical devices The definition of sterilization packaging for medical devices should be understood as: a packaging system that can be used for packaging medical devices, can be sterilized, can be sterilized (such as clean opening), can provide acceptable microbial barrier performance, can protect products before and after sterilization, and can maintain a sterile environment inside the system within a certain period of time (marked validity period) after sterilization. Because this concept usually does not include the external protective packaging system (buffer packaging and collective packaging, etc.), the sterilization packaging system of medical devices can also be called "aseptic specific pathogen free".
About the forms of sterilization and packaging of medical devices, there are roughly the following three categories:
1.1 Soft blister forming-filling-heat sealing packaging system: This kind of packaging can be divided into flexible type and semi-rigid type according to the thickness of the substrate in the molding part. The substrate is thermoformed into a pre-designed shape by adjusting the temperature, vacuum degree and pressure on the specific blister packaging equipment, and then heat sealed with the corresponding top material to form a three-dimensional molding packaging system that meets the requirements. This kind of packaging is characterized by high degree of automation, high efficiency, low cost of a single package, and good matching between the packaging system and the shape of the contents, etc. However, it involves the investment of equipment and molds, and has certain requirements on the output. It is usually used in first-and second-class medical device products with large output, such as various syringes, gauze pieces, surgical gowns and medical catheter intubation, and simple third-class medical devices, such as intravenous indwelling needles!
1.2 Hard blister box-cover material packaging system: This kind of packaging uses all kinds of molded blister boxes to directly heat-seal with all kinds of cover materials suitable for heat sealing, and the so-called hard blister is more related to the thickness of the sheet used for blister molding, usually between 0.4 and 1.2 mm, and the materials involved are mainly pvc, pp, pe, ps, pet and petg from the low end to the high end. Pvc has a tendency to be gradually eliminated because it involves safety and environmental protection issues; Pp and pe, two conventional polymer materials, are not widely used in this field because of their physical and mechanical properties after molding. Because of the high cost, pc is only used in a few fields, such as dry heat sterilization. This kind of hard blister box is generally purchased, and then heat-sealed with the cover material in the medical device manufacturer, and can be heated by ordinary heat-sealing equipment.
1.3 All kinds of bag packaging systems: including all kinds of bags: paper plastic bags, plug bags, window bags, sealed bags in breathable strips, paper bags, aluminum foil composite bags with tyvek and other products, with more forms, which may be designed and produced according to the actual situation. In short, it is difficult to completely summarize their types and application scope! In China, these products, such as head bag, window bag and sealed bag in breathable strip, are welcomed by many medical device enterprises because of their special design of breathable window, which saves the cost of materials.
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