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Medical Packaging Bag Sealer A Brief Discussion on Sterile Medical Device Packaging

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  Clarification:The louvres are divided into two ways,round and square windows.

  1.1.3,plastic boxes and blisters category:

  Composition:coated paper/AL/PE+copper-aluminum paper/AL/PE

  Features:clean stripping,moderate price,and visual within the package.

  Width(wet sample)chemical category≥100mm2 chemical,should not be affected by the sealing process.

  2,one-time use of sterile medical equipment Category:In accordance with the usefulness of the product divided into:

  Use:bad luck.

  Heat sealed with paper

  Plastic film should be two or more layers made of composite.Plastic tie layer does not break up or whitish.

  1.1,flat bag:

  5,meet the basic needs of the physical,not easy to aging.

  1,one-time use of sterile medical equipment:refers to the sterile,pyrogen-free,after passing the test,one-time indirect use within the invalid period of medical equipment.Can also be understood as:a one-time use,after use of sterile medical equipment.

  Figure XII

  One-time use of sterile medical equipment packaging,including all early packaging,packaging box three departments.This article is mainly concerned about the equipment factory packaging bags from the factory to buy the first packaging semi-refuse bags,containers and packages(preformed barrier system)from the beginning to the beginning of the packaging process of completion of some of the relevant knowledge.Access to the bags(containers and packages)data selection,bag selection,sealing(heat),sterilization,storage and other five links.Focus on business information selection,bag design(selection)and the heat of several links French.

  Useful:Used mainly for the type of product under batch.

  Plastic film used for CPP/PET composite film or PE/PET composite film.

  Composition:plastic film/paper.That is,both sides of the plastic film on both sides plus a piece of breathable paper.PET/PE+Tyvek strong breathable or PET/CPP+breathable(domestic or export)paper.

  4,excellent biological barrier.

  Dialysis paper

  5,the secondary effect of medical device packaging is the supply and sterilization in the process of supply,the final device before use in sterile form.

  1.1.3.1,plastic box(Figure XI,Figure XII):

  1.1.2.4,plastic bags(Figure I,Figure II):

  Category:According to the layout can be divided into:flat bag;tube bag;Zifeng Dai;breathable window bag;in the envelope;head bag;plane bag;Blister(blister);package information.

  Polyester film(PET):high mechanical strength,the tensile strength of PE is 5-10 times.Heat resistance,cold resistance,resistance to freezing,low temperature cooking.Oil resistance,good chemical resistance.Good water resistance,low water absorption,good wettability,good gas barrier.Brightness,high gloss but not easy to seal.

  1.1.2.9,flat bag(Figure IX,Figure X):

  Features:strong bacterial barrier,excellent air permeability,clean stripping,high strength.Can be used for ethylene oxide,gamma rays,plasma sterilization.Can be dressed roughly equipment.High price.

  7,sterilization compliance,that is,before sterilization,sterilization,sterilization,the data and its layers,ink and other equipment does not reflect the attack,the formation of purification equipment.

  Plastic film should be able to heat the paper with the manufacturer.

  Features:Can be arbitrarily cut according to the length of user needs.Can bag products,low prices.

  Figure X.

  Use:Catheterization package,trace analgesic pump,maternity package,ophthalmic surgical package,combination package,blood transfusion filter,obstetric dressing package,first aid kit and so on.

  1.1,Category:According to the package is divided into:flat bag seal,blister seal plastic box seal.

  ③,all kinds of medical catheters and others

  Features:Feel soft,loose,high moisture absorption,a necessary oil absorption results.Looks closer to conservative textiles than other nonwovens.High strength,low hairiness.Good air permeability.Drape is good.

  Origin:domestic or international famous French brand Arjowiggins produced crepe paper.The 60g specifications are the most commonly used.

  Lack of:most of the manufacturers cut the plastic bag no word easy to tear.

  3,a one-time use of sterile medical packaging:for the packaging of medical equipment products,can be sterilized on it,you can stop the aseptic operation(such as clean),can provide a take over microbial barrier function,before and after sterilization The product is stopped and after it has been extinguished,the fragmented,externally sterile packaging system can be kept within the required engraved days(marked expiry date).Can also be understood as:by the production enterprises and sterilized sterile supply,medical units do not need to stop sterilizing and indirect use of medical equipment.

  Composition:plastic composite film/paper.Corresponding to the other side of the bottom can be uncoated or coated body.Plastic film used for CPP/PET composite film or PE/PET composite film.

  Figure eight

  Plastic film should be no pinhole.

  1.1.2.8,tube bag:plastic compound film/paper.Corresponding to the other side of the paper can be uncoated or coated.Plastic film used for CPP/PET composite film or PE/PET composite film.

  Although so,at this stage the overall level of international processing enterprises,whether it is processing,technology or testing is still the whole part of the foreign companies with the necessary differences.

  9.Before,during and after sterilization,the materials and the composition(coating,ink and chemicals)should not reflect the attack of the instrument and purify the instrument.The seal width and strength(tensile strength and/Or bursting strength)should meet the request;stripping layout should be sustained,average,no effect,no open and pulled out of the data layering or cutting chips;sealing and/or closure of microorganisms to provide barriers.

  The physicochemical function has paid for the functional request of the product.The physicochemical function has meticulous goals and methods in EN868,the paper bag meets EN868-4,the paper-plastic bag meets EN868-5,these targets and methods are stopped by the medical device manufacturer According to.

  3,under the premise there is no dissolution.

  Features:heavy load,breathable common.The price is lower.

  Figure XV

  Affirming:The products of larger thickness can choose this package.

  The width of the heat sealing≥6mm The breaking point of the plastic film should be≥20N/15mm Width The strength of the heat sealing point before and after sterilization should be≥115N/15mm width(dry sample)and≥112N/15mm;

  This article is based on a one-time production of sterile medical equipment business engineering staff perspective,a one-time use of sterile medical equipment packaging needs to learn a summary of the learning needs.I hope this will lead to throwing jade,and then reached with peers and experts to exchange,learn from and cooperate with the goal of progress.

  1.1.2.7,head(seal)bag(Figure VI):

  1.1.1.3,the appearance of the request:

  1.1.1,the formation of secondary information:

  ①,one-time use of infusion,blood transfusion,injection equipment.

  Features:High level of initiative,high efficiency,low cost of a single package,put into large,suitable for high yield products.

  8,such as packaging materials should be covered with adhesive layer should also be content:?Continuous coating,no gaps or continuous,the quality of the coating and nominal differences;when the data and another information constitute a seal,the minimum seal strength should be obtained.

  1.1.1.1,dialysis paper:According to the origin is divided into domestic paper and export paper;export paper to paper,mostly French paper.Tyvek:1059B 1073B:It has excellent water blocking,breathable and excellent tensile,tear and resistance and other physical and mechanical functions,and generally comply with existing types of conventional sterilization methods;Weight:60-85g.Any small,light weight of popular instruments or inexpensive devices can choose domestic or export dialysis paper.DuPont Tyvek1059B(64g)or 1073B(75g)is a must for premium and demanding.

  Medical equipment,bags and bags are generally used in water-based environmental protection ink ink and water should be attached to the appropriate ISO10993 biocompatibility testing scale,heavy metal content suitable for IEC 62321:2008,US EPA 3052:1996 request.And about the general use of flat bags up to leave the entire overview of 50%of the product without printing.Ink should not touch the device.

  1.1.1.2,membrane selection criteria:

  Polypropylene(PP):able to accept more than 100Oc low temperature,it is mainly used for steam sterilization places.Polypropylene to radiation.

  Disposable sterile medical devices cover health information,disposable medical gloves,disposable infusion sets/blood transfusion,medical textiles,medical surgical instruments,disposable catheters(eg catheters,drains,etc.),cardiac surgical instruments,Vascular surgery equipment,obstetric equipment,anesthesia equipment,oxygen masks thousands of categories.

  Composition:Paper/Paper PP or Paper/Paper PE as the main body of the package.One side is formed of medical-grade porous paper,which is secondary to the supply of beneficial sterile gas inlet and outlet channels for sterilization.The other side is not coated or coated two.For and with the fit,usually made of paper and plastic plastic or composite,made of PP or PE,this side is secondary to provide the function of bonding and can be pulled apart.Paper texture:medical grade dialysis paper.

  Features:dark,medical bags decay resistance,strong barrier.

  1.1.2.2,paper bag:

  Features:With water,disinfectant,antistatic function;longer sterile retention(90 days of cotton 7 days);lower desquamation rate;better comfort,more simple,feel comfortable.

  1.4.1,flat bag sealing:rare manual or electric intermittent sealing machine and crawler continuous heat sealing machine three.

  1.1.2.3,aluminum paper bag:

  1.1.5,combined packaging(Figure XVI,Figure XVII):

  1.1.2.6,ventilation window bag(Figure IV,Figure V):

  The manufacturer of the medical device shall request the product suitability presentations for this batch,which may be issued by the manufacturer of the medical device package data or may be issued by a third party.

  Use:Commonly used disposable medical consumables such as surgical clothing,urine bags,catheters,injectors,needles and other products.

  Figure II

  Composition:box/dialysis paper.Box:PET,PS,perhaps PETG,cover material:medical adhesive tape,mostly DuPont Tyvek adhesive tape.

  Use:Surgical package,catheterization package,analgesic pump/infusion pump,anesthetic puncture bag,maternity package,oral inspection package,first aid kit.

  Composition:Plastic composite film/paper.Corresponding to the other side of the paper can be uncoated or coated.

  Polyethylene(PE):Easier heat sealing due to its low melting point.Therefore often used as a composite film blend layer.Suitable for sterilization with ethylene oxide.

  Data:PP/PE,PA/PE,PP/PA/PE,PA and so on.

  1,non-toxic,interesting.No perforation,damage,tear,wrinkles or uneven thickness.

  Bags reserved for a start,the other completed in the bag factory.

  Use:Surgery film,anti-mucosal packaging,biological sutures,can receive anti-adhesion membrane,etc.(sterilizing system for the gamma rays)

  6,contentment of basic chemical needs,pH,chloride.

  2,can take over the cleanliness,particle purification and falling off degree.

  Figure V

  The packaging as a one-time medical equipment(in addition to sterilization outside)the first one process,the uneven degree of processing on the quality and quantity of production have a decisive role.Thus improving the degree of packaging manufacturing,on the promotion and safety of medical equipment has not replaced the role.Throughout our history of using disposable sterile medical devices to produce packaging products,like most foreign enterprises,most of them are growing from food packaging bags processing enterprises,which has been characterized by a low end and a slow growth record.However,in recent years,with the national supervision of the one-time sterile medical device industry has been increasing,the well-known foreign-funded enterprises to enter,in terms of pollution,processing equipment,data level,the experimental wrist is still the processing technology and craft level Long-term progress.

  Composition:Film/film.That is,a film or the upper part of the circle or square with a small area ofdialysis paper window.PE/PE+paper or PET/PE+paper or PET/CPP+paper.

  The inner surface of the surface is flat,no purification,no foreign body,perforation and significant wrinkles.Heat sealing site indentation straight average,no fracture leak seal,no obvious bubble.Print handwriting marks and patterns clearly well intact without broken fade color.The outline of seal line should be removed when the seal is peeled off.

  In this demand statement,all plastic bags can only be sterilized by irradiation.This is due to the small pore size of the plastic membrane,which is gas permeable but far less breathable than medical grade dialysis paper.Therefore,sterilization with ETO in a full plastic bag may result in incomplete sterilization or gas Residual in the bag.

  1.4.2 Selection criteria:In view of the process to confirm the needs of the selection of sealing machine should be selected with a close control and show the time,temperature or pressure equipment.Therefore,the optional electric intermittent sealing machine and crawler sealing machine,manual intermittent sealing machine should not be selected.

  Plastic film and adhesive area,there should be no harm known to be enough to cause the health risk of release.

  Affirming:poor mechanical properties of paper packaging materials,packaging should not be too tight or too loose,to prevent sterilization package filled with liquid fullness of the boring.

  1.1.1.4,printing:

  As a medical device product,the most basic request is safe and effective to ensure human well-being and life safety.

  Use:Secondary use for urine bags,drainage bottles and other products.

  According to the sterilization method can be divided into:ETO ethylene oxide,cold dry steam at low temperature,gamma cobalt 60 radiation,plasma,formaldehyde and so on.

  Features:lighter weight bearing;can bag equipment;slightly higher price.

  Features:Load-bearing small,inexpensive.Inside the device can not be ignored.Small range of use.

  Composition:film/membrane head together with the bag width and height of the dialysis paper.Multi-layer coextrusion PE+Tyvek or PET/CPP+(domestic or export)or PET/PE+Tyvek

  1.5,blister packaging sealing equipment:

  ②,one-time health dressing

  1.4,heat sealing equipment:

  1.1.2.5,the closure(breathable strip)bag(Figure III):

  Figure XIII

  Composition:Commonly used for composite membrane PE/PP(suitable for ethylene oxide sterilization)or PE/PA(suitable for ethylene oxide and radiation sterilization)and the other side is coated or uncoated Medical grade dialysis Paper can also use Tyvek.Often used in smaller,complex layouts and with the necessary thickness of the product.

  1.1.4.1,non-woven fabric(non-woven):medical health out of products selected for the spunlaced spunlace method,also known as the cloth produced.

  1,bags:the most common category is also the most common category.As small as a few grams of sutures or toothpicks,as large as kg/set/bag outer round tube.Such as:toothpicks,suture needles,medical gloves,medical syringes,hemostatic gauze,surgical holes,medical catheters,endotracheal intubation,surgical clothing,protective clothing and other general packaging and dialysis,medical catheters and other medical equipment packaging.As for the product with the necessary thickness or the elevation of the sub-class,the priority is given to the use of flat bags with large external volumes or high-strength head bags.

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