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Common Problems and Countermeasures in the Production of Medical Sterilized Paper and Plastic Packaging Bags

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  Medical sterilized paper plastic packaging bag is a one-time medical sterilization packaging material,has good air permeability,conducive to the penetration of sterilization medium,high bactericidal performance after sterilization,sterilization process chemical monitoring convenience,packaging and sealing simple,Good visibility,long safety period after sterilization,easy to open,etc.,while also greatly reducing the cost of procurement and waste recycling convenience,in line with environmental requirements,is the best overall performance of a medical sterilization packaging materials.

  However,medical sterilized paper in all aspects of the actual production of plastic bags,often encounter some problems.Here,the author mainly discusses the common problems in material selection and design of sterilization paper plastic packaging,and how to solve it,and share with the people in the industry.

  1.The right material is the first step in the manufacture of medical sterilization packaging

  According to the sterilization packaging requirements of EN868-5,ISO11607-1:2006,GB/T19633-2005 and YY/T0698-2009,medical sterilization packaging materials must meet the following basic requirements:

  Compatibility with sterilized equipment

  The nature and intended use of the device to a certain extent decided to adopt the sterilization method,and different sterilization methods affect the selection of the packaging system.

  Such as:strong adsorption of materials,not suitable for ethylene oxide sterilization;PE parts of the device is not high temperature,not suitable for high pressure steam sterilization;expensive equipment,sterilization methods are generally as short sterilization cycle,To improve the frequency of use.Therefore,the nature of the device itself to a certain extent,also decided to adopt the packaging system.

  Adapt to the sterilization method used

  After the packaging material has been subjected to the specified sterilization method,its performance should be within the limits of the specified range.

  Such as:Ethylene oxide sterilization,the material required to form a packaging system,at least one material with breathability to ensure that ethylene oxide can enter when sterilized,and can be resolved after sterilization.

  Irradiation(gamma ray)sterilization,which is less demanding on paper but has a significant effect on polymeric materials,requires that all packaging materials that make up the packaging system are resistant to radiation exposure without aging Brittle.

  High-temperature steam sterilization requires that all materials that make up the packaging system are resistant to moderately high temperatures,usually 15 to 30 minutes at 121 to 134°C.

  Low temperature formaldehyde sterilization requirements of the material is essentially the same as steam sterilization,but the penetration of formaldehyde gas is relatively poor.

  Plasma sterilization requires packaging materials that make up a packaging system that can not have biological fibers because these materials quickly interact with the oxidizer and its superoxide radicals,resulting in inadequate sterilant concentrations that lead to sterilization failure.

  There is enough penetration

  Packaging materials to facilitate access to sterilization factor to ensure sterilization.

  Microbial barrier

  Microbial barrier is the ability of the packaging system to prevent the entry of microorganisms under defined conditions.


  Packaging materials should have sufficient strength to prevent damage caused by sterilization.Including the material tensile strength,puncture strength,tear strength and bursting strength and so on.


  The material itself does not contain any potentially hazardous ingredients,but also includes the surface coating of some packaging materials,ingredients,under normal and specified sterilization environment,the material is stable,does not break down,does not split,do not transfer potentially harmful substances to be Packaging equipment surface and so on.

  Allow packaging aseptic open use

  There is high demand for the materials that make up the packaging system and for the heat sealing between different materials.When the package is opened,no fiber crumbs should be produced.

  Medical sterilized paper plastic packaging bags are part of medical sterilization packaging,the choice of materials to meet the above requirements at the same time,there are some other requirements.Such as medical sterilization paper bags should not be decolorized paper extract PH value should be greater than or equal to 5 and less than or equal to 8 in the range of fluorescence brightness should not exceed 1%,UV irradiation at a distance of 25cm irradiation,The number of fluorescent spots with an axial length greater than 1 mm per 0.01 m2 does not exceed 5,the hydrophobicity of the paper is the penetration time of not less than 20 seconds,the average pore diameter of the paper should not exceed 35 microns,and the maximum value should be less than 50 microns,As well as paper breathability,water absorption,there are certain requirements,but also to meet the requirements of paper printing.

  In addition,the selection of medical sterilization paper plastic bags,we must fully consider the operability of the material.Such as PP film,PE film is a very common plastic film,although these plastic films also meet the requirements of medical packaging materials,but in medical Zhisu bags rarely used directly,because they are not easy to bag operation,so the majority of Are the PP film or PE film with other materials composite or co-extruded before use.

  Correct choice of materials,to the perfect sterilization of Zhisu bags production,laid a solid foundation.

  2.Product design is also an important part that can not be ignored

  A qualified medical sterilization packaging,can not be separated from a reasonable design.From the packaging style to production and processing,must be fully considered.

  In the design of packaging,as much as possible to take into account the product's own characteristics and needs:the need to avoid the light of the product,you can not use Zhisu packaging should be used aluminum foil composite bag or paper aluminum composite bag;a certain thickness of the product in plastic bag packaging,There is no use of suture bag ventilation more beautiful and reliable;and need a large amount of ventilation products,as much as possible with a plastic bag or paper bag packaging;need moisturizing or liquid products,we should use good barrier material Packaging and so on.

  The following are a few frequently overlooked issues that I hope will attract the attention of the industry:

  (1)Zhisu bag peeled open the design

  Paper and plastic packaging bags on the market,in order to facilitate the opening of the plastic bag,opened the end of the plastic bag opened,the plastic film and dialysis paper generally take the wrong place of not less than 1mm(Figure 1),and try not to use Semi-circular incision.Due to the semicircular incision cut too small too shallow(shown in Figure 2),inconvenience to the thumb operation,the real meaning of incision loss;too cut too deep,although the convenience of the plastic film and dialysis paper separated,but wasting Effective area,or after the separation is too small(as shown in Figure 3).

  The ideal design to facilitate the peel open,in addition to the two layers of material to open the peel off dislocation,the paper is cut open at about 3~4mm wide rectangular concave notch,so that both the plastic film and dialysis paper separated,and Easy to separate the hands after the separation,and in general do not waste the use of the area.

  In addition,a large part of medical paper and plastic packaging bags,in order to easily open,open at the edge of the seal have chosen V-type sealing(Figure 5).Although it is convenient to open in this way,it is easy for the V-type pop-up phenomenon to occur when sterilizing,especially in the case of steam sterilization.In order to solve this phenomenon,a reinforcing strip is added to the V-shaped inner recess(as shown in FIG.6)to better meet the requirements of steam sterilization.

  (2)Zhisu packaging anti-paper design

  Paper and plastic bags in the peel open,it is prone to the phenomenon of paper dust.When this happens,most bag operators will consider them to be improper or material.Of course,there are also some of the reasons for the nature of the material,such as adhesive coating glue is not uniform,the bonding strength of the glue itself is unreasonable;there is the operating error caused by peel strength is too large,and there is peeling paper Debris phenomenon.However,a large part of the reason is due to the negligence of design time.There is no real understanding of the essence of paper and plastic in hot bag making,which leads to the generation of confetti when peeled and opened.

  Zhisu bags in the bag making process,the majority are fixed-shaped mold hot pressing,cooling,cutting a few steps.

  Whether it is heated from one side of the plastic film or dialysis paper,or the other is heated at the same time,the principle of plastic film and dialysis paper is that the plastic film and the dialysis paper melt together with the dialysis paper Or treatment surface,or do not deal with the surface,and then through a certain pressure die hot pressing,and cooling device cooling and solidification,dialysis paper and plastic film,with a certain peel strength.

  In the hot pressing process of the paper-plastic packaging bag,when the hot-bonding mold is sealed,the mold and the platform below and the silicone pad form a force,and the silicone pad can play the role of making all the hot-joining parts(hot seam)The effect of uniform heat.However,the pressure of each edge of the mold is greater than elsewhere.To satisfy the overall peel strength of the ironing seam within a certain range,the peel strength of the most edge portion will be greater than that of other portions,which tends to occur when the peel and tear are peeled off Confetti phenomenon.Solve this most edge peel strength and the occurrence of confetti phenomenon is relatively simple,just hot mold,and the contact surface of the paper all the corners,polished into a certain arc on it.

  There is also a situation,prone to peeling open when there is a piece of paper,but also the most easily overlooked aspect.In the cut molding,whether it is horizontal or vertical hot bag,cut off the knife or a round knife bag to the edge of the excess material,cut the knife and the circular knife is the key position.As we have already said,the thermal bonding between the paper and the film is based on the fact that the heat seal layer of the film melts and partially penetrates the hot face of the dialysis paper so that the peel strength between the plastic film and dialysis paper is formed.And our cutting knife cut off the plastic film and dialysis paper,cut off the principle and scissors cut off the principle is similar,if the cutter blade is not sharp enough,the cut-off place will form a plastic film and dialysis paper bite each other,If the cutter is cut off at the point where the plastic film and the dialysis paper are hot,the mutual occlusion will be more severe.

  When peeling off,the fibers of the cut end face are broken when the dialysis paper is cut,and the plastic film is no longer separated from the fibers on the surface of the dialysis paper but peeled off from the fibers on the end face of the dialysis paper so that the paper tends to be generated On the other hand,the peel strength at the edge of the incision is actually the sum of the strength of the plastic film and dialysis paper when they are hot-rolled and the strength of the plastic film and the dialysis paper when the knife is cut off,Debris phenomenon.

  In order to avoid this situation caused by stripping of paper scraps,should be considered in the design,the lateral bagging hot mold is slightly narrower than the actual bag,bag sealing hot,the first bag and the second bag hot The mold should be left between the gap,cut off the knife required between the gaps,to ensure that each bag outside the hot seam edge of the gap;and longitudinal bagging the edge of the hot melt together,there are gaps outside the two hot seam seam edge.

  Cut the knife is cut,as far as possible not cut in the hot seam(plastic film and dialysis paper at the hot place),but cut in the hot seam,in order to achieve this requirement,there are printed bags,you must Design time to take this into account.

  (3)Medical self-sealing tape sealing tape folding position design

  Medical sterilization paper plastic packaging bags,there are some medical Zifeng Dai.Medical self-styled bags,also known as medical self-adhesive bags,self-styled flat pocket or self-adhesive flat pocket and so on.

  Medical ziplock bag sealing,is to remove the bag of double-sided tape release paper,the width of the folded double-sided adhesive tape affixed to the plastic film,and the other two affixed to the dialysis paper.In order to meet this requirement,folding line positioning and form has undergone several improvements.

  Initially,a fold line is printed at the folded position(as shown in FIG.8),folded along the print fold line when folded.However,prone to shift when folded,skewed and so on.For better positioning,easy to fold,dialysis paper in the fold broken line.
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