Generally referred to as "medical wrap", "sterilization pouches", "sterilizer bags", "medical wrap,sterile packaging", etc., according to ISO-11607 and EN-868, the initial packaging used for medical equipment to be sterilization pouches is.
In ISO-11607:2006, it is called SBS (Sterile barrier systems), which is named as “sterile barrier system” in the medical device packaging industry standard being developed by the Chinese Food and Drug Administration (SFDA).
standard
Internationally used ISO-11607 terminally sterilized medical wrap, and EN-868 medical materials sterile packaging materials and systems.
Domestic use GB/T 19633 (transcription ISO-11607) and the State Food and Drug Administration SFDA is developing a new medical sterile packaging industry standard YYiT "terminally sterilized medical device packaging materials" (transcription EN-868 parts 2 to 10).
Internationally, ISO-11607 and EN-868 are being gradually integrated. ISO-11607 is a part of or regarded as a component of the initial packaging medical device, and as a guide for development and verification, and focuses on packaging forming and sealing. The EN-868 is a package-based product that specifies the material requirements and test methods.
In IS0-11607-1, the material requirements of EN-868-2~EN-868-10 can be complied with and replaced by ISO-11607 (supersede).
package style
Three-side sealing pouch (Pouch)
The top web and the bottom web are heat-sealed by three sides to form a small bag. Generally, the top surface is made of a gas permeable material for sterilization, and the bottom surface may be a paper-coated plastic or plastic composite film. The type of packaging used by most disposable consumables,
Breathable bag (bag)
The bag is made of plastic, but it is sterilizable. It can be filled with ventilation window (window), such as head bag (HeaderBag), bag (Vent Bag), middle bag, etc., full plastic bag.
The bag is made of plastic, with EZ peel easy to tear film, which is easy to open when used, but the whole plastic package can only be sterilized by Gamma.
FFS automation flexible packaging
FFS, Form-Fill-Seal is formed, filled, sealed, and automatically packaged with automatic packaging machines The top surface is generally breathable and the bottom is stretchable plastic stretch. membrane.
Hard molded shell Tray
After manually filling the device with the formed plastic box, the sealing piece is made of trough lidding. This type of packaging is mostly used in various types of equipment combinations, such as oral bags, gynecological bags, etc.
Packaging material
Medical grade paper
According to the requirements of EN-868-5 bag, the sterilizable and sterile barrier paper must comply with EN-868-3, so the ventilated paper that meets this requirement is called medical grade ventilated paper. Wiggins, Billerud, Sweden, Medwestvaco, USA, and domestic Cummina packaging, specifications are 60gsm, 70gsm, 80gsm, etc.
Tyvek
Tyvek is a patented DuPont patented product, which is widely used in medical wrap, protective clothing, and even courier envelopes. 1073B, 1059B, 2FS and the latest Asuron' TM| are medical grades. Packaging materials, high strength, water resistance, excellent permeability (sterilizable).
coating
For the bag to be effectively sealed, the top web is coated. Generally, the common materials are environmentally friendly and water-resistant adhesives, and EVA hot melt adhesives. The coating method is full coating and frame coating.
Plastic coated paper
Generally used for three-side sealing paper paper bag (paper / paperpouch), due to sterilization adaptability factors can be coated on the paper with PE, or PP can be used on the paper. This type of packaging is used for dressing products.
Plastic film
The plastic film used in medical wrap is made of different materials due to bag design and sterilization adaptability, but most of them are co-extruded or compounded with two or more materials, such as CPP/PET, PE/PET, EVA/PE/PET. Other stretched films such as FFS automatic packaging are PP/PE and PA/PE.
Sterilization method - high temperature autoclave STEAM
Sterile spore protein hydrolysis after high temperature water vapor penetrates the breathable paper to achieve sterility
There are currently two types of venting and three pre-vacuum types.
The conditions are: 121 C, 20~30 minutes, 132 °C, 4 minutes.
Not suitable for non-high temperature resistant equipment, and oil, powder and other equipment.
Sterilization method - Ethylene oxide ETO
Ethylene oxide gas, also known as ethylene oxide, has strong bactericidal power and wide spectrum of sterilization, and can kill various microorganisms including bacterial spores, and is a sterilizing agent.
Take the medium sterilizer as an example, the general requirements for sterilization conditions are: concentration 800 mg / L ~ 1000mg / L, temperature 55C ~ 60C, relative humidity 60% ~ 80%, the elbow back 6 h.
Not suitable for food, liquid, oil, oil, talcum powder, etc.
After sterilization, exhaust gas analysis is required for 8~12h.
After sterilization, the device must be left for 7 days (one sterilization) to 15 days before being marketed (secondary sterilization)
Sterilization method - irradiation GAMMA
The gamma ray or electron radiation is generated by the cobalt ten radioactive element or the electron accelerator, and the water molecules in the cell are decomposed into OH radicals and hydrogen ions attack the cell DNA to cause the cells to immediately die.
Operating parameters: time is proportional to the dose and sterilization effect,
Plastics in some branched structures can cause discoloration, hardening and even brittleness, such as PP.
Because the irradiation center needs to have a certain degree of safety protection, it is not easy to set up.
Sterilization plasma PLASMA
Plasma or weighed water is hydrogen peroxide. Plasma sterilizer uses a combination of pressure and electric wave to create plasma at low temperature. It uses hydrogen peroxide as a sterilizing agent to generate ionization decomposition under vacuum. Acting on the cells of microorganisms, destroying its vitality and achieving the purpose of sterilization. When the pressure is restored to normal atmospheric pressure, it will combine into water molecules and oxygen molecules. Therefore, the sterilization method is high temperature-free. The range of regenerative devices is wider and has no residue concerns, but also meets environmental requirements.
Not suitable for the material of “natural plant fiber”, so the packaging made of pure natural pulp made of medical grade breathable paper can not be used for this sterilization method.
Aseptic medical wrap is associated with sterilization
It is not able to pack the elbow in a sterile medical device. In order to achieve the final carrying of the medical device after the packaging, the gray fungus can be effectively carried out, and the packaging itself has a certain tolerance to gray bacteria, and will not be caused by the gray bacteria. Destroy the packaging integrity, which is the "sterilization compatibility" of 1SO-11607-1.
In ISO-11607:2006, it is called SBS (Sterile barrier systems), which is named as “sterile barrier system” in the medical device packaging industry standard being developed by the Chinese Food and Drug Administration (SFDA).
standard
Internationally used ISO-11607 terminally sterilized medical wrap, and EN-868 medical materials sterile packaging materials and systems.
Domestic use GB/T 19633 (transcription ISO-11607) and the State Food and Drug Administration SFDA is developing a new medical sterile packaging industry standard YYiT "terminally sterilized medical device packaging materials" (transcription EN-868 parts 2 to 10).
Internationally, ISO-11607 and EN-868 are being gradually integrated. ISO-11607 is a part of or regarded as a component of the initial packaging medical device, and as a guide for development and verification, and focuses on packaging forming and sealing. The EN-868 is a package-based product that specifies the material requirements and test methods.
In IS0-11607-1, the material requirements of EN-868-2~EN-868-10 can be complied with and replaced by ISO-11607 (supersede).
package style
Three-side sealing pouch (Pouch)
The top web and the bottom web are heat-sealed by three sides to form a small bag. Generally, the top surface is made of a gas permeable material for sterilization, and the bottom surface may be a paper-coated plastic or plastic composite film. The type of packaging used by most disposable consumables,
Breathable bag (bag)
The bag is made of plastic, but it is sterilizable. It can be filled with ventilation window (window), such as head bag (HeaderBag), bag (Vent Bag), middle bag, etc., full plastic bag.
The bag is made of plastic, with EZ peel easy to tear film, which is easy to open when used, but the whole plastic package can only be sterilized by Gamma.
FFS automation flexible packaging
FFS, Form-Fill-Seal is formed, filled, sealed, and automatically packaged with automatic packaging machines The top surface is generally breathable and the bottom is stretchable plastic stretch. membrane.
Hard molded shell Tray
After manually filling the device with the formed plastic box, the sealing piece is made of trough lidding. This type of packaging is mostly used in various types of equipment combinations, such as oral bags, gynecological bags, etc.
Packaging material
Medical grade paper
According to the requirements of EN-868-5 bag, the sterilizable and sterile barrier paper must comply with EN-868-3, so the ventilated paper that meets this requirement is called medical grade ventilated paper. Wiggins, Billerud, Sweden, Medwestvaco, USA, and domestic Cummina packaging, specifications are 60gsm, 70gsm, 80gsm, etc.
Tyvek
Tyvek is a patented DuPont patented product, which is widely used in medical wrap, protective clothing, and even courier envelopes. 1073B, 1059B, 2FS and the latest Asuron' TM| are medical grades. Packaging materials, high strength, water resistance, excellent permeability (sterilizable).
coating
For the bag to be effectively sealed, the top web is coated. Generally, the common materials are environmentally friendly and water-resistant adhesives, and EVA hot melt adhesives. The coating method is full coating and frame coating.
Plastic coated paper
Generally used for three-side sealing paper paper bag (paper / paperpouch), due to sterilization adaptability factors can be coated on the paper with PE, or PP can be used on the paper. This type of packaging is used for dressing products.
Plastic film
The plastic film used in medical wrap is made of different materials due to bag design and sterilization adaptability, but most of them are co-extruded or compounded with two or more materials, such as CPP/PET, PE/PET, EVA/PE/PET. Other stretched films such as FFS automatic packaging are PP/PE and PA/PE.
Sterilization method - high temperature autoclave STEAM
Sterile spore protein hydrolysis after high temperature water vapor penetrates the breathable paper to achieve sterility
There are currently two types of venting and three pre-vacuum types.
The conditions are: 121 C, 20~30 minutes, 132 °C, 4 minutes.
Not suitable for non-high temperature resistant equipment, and oil, powder and other equipment.
Sterilization method - Ethylene oxide ETO
Ethylene oxide gas, also known as ethylene oxide, has strong bactericidal power and wide spectrum of sterilization, and can kill various microorganisms including bacterial spores, and is a sterilizing agent.
Take the medium sterilizer as an example, the general requirements for sterilization conditions are: concentration 800 mg / L ~ 1000mg / L, temperature 55C ~ 60C, relative humidity 60% ~ 80%, the elbow back 6 h.
Not suitable for food, liquid, oil, oil, talcum powder, etc.
After sterilization, exhaust gas analysis is required for 8~12h.
After sterilization, the device must be left for 7 days (one sterilization) to 15 days before being marketed (secondary sterilization)
Sterilization method - irradiation GAMMA
The gamma ray or electron radiation is generated by the cobalt ten radioactive element or the electron accelerator, and the water molecules in the cell are decomposed into OH radicals and hydrogen ions attack the cell DNA to cause the cells to immediately die.
Operating parameters: time is proportional to the dose and sterilization effect,
Plastics in some branched structures can cause discoloration, hardening and even brittleness, such as PP.
Because the irradiation center needs to have a certain degree of safety protection, it is not easy to set up.
Sterilization plasma PLASMA
Plasma or weighed water is hydrogen peroxide. Plasma sterilizer uses a combination of pressure and electric wave to create plasma at low temperature. It uses hydrogen peroxide as a sterilizing agent to generate ionization decomposition under vacuum. Acting on the cells of microorganisms, destroying its vitality and achieving the purpose of sterilization. When the pressure is restored to normal atmospheric pressure, it will combine into water molecules and oxygen molecules. Therefore, the sterilization method is high temperature-free. The range of regenerative devices is wider and has no residue concerns, but also meets environmental requirements.
Not suitable for the material of “natural plant fiber”, so the packaging made of pure natural pulp made of medical grade breathable paper can not be used for this sterilization method.
Aseptic medical wrap is associated with sterilization
It is not able to pack the elbow in a sterile medical device. In order to achieve the final carrying of the medical device after the packaging, the gray fungus can be effectively carried out, and the packaging itself has a certain tolerance to gray bacteria, and will not be caused by the gray bacteria. Destroy the packaging integrity, which is the "sterilization compatibility" of 1SO-11607-1.
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