The aluminum-plastic blister packaging of medicines is also called blister packaging, referred to as PTP packaging. It is to form a film of packaging material by heating vacuum forming or cold stamping to form a groove suitable for the shape of a tablet and a capsule, and then filling the drug. Then, the aluminum foil coated with the heat-sealable coating is heat-sealed with the aluminum foil to form a unit package.
The covering material of the aluminum-plastic blister package of the medicine is generally aluminum foil (referred to as aluminum foil for medicine blister packaging), and the foaming substrate is generally made of polyvinyl chloride (PVC) hard sheet. However, with the continuous development of the pharmaceutical industry, this "conventional packaging method exposes its defects" - due to the limited barrier properties of PVC rigid sheets, it is difficult to ensure that the quality of the drug does not change during its lifetime. In view of the limited barrier properties of ordinary blister packs, people have developed cold stamping and compression forming hard sheets in the early 1980s with a new concept. Cold stamping molding uses stamping to replace the vacuum forming of the original blister pack, so that the blister packaging sheet can use a pure aluminum foil composite as a foaming material. The application of high-strength alloy aluminum foil in cold stamping formed hard sheets also makes the cold stamped formed hard sheets have extremely high water vapor resistance, oxygen and light barrier properties that cannot be achieved by any other materials.
The cold stamped formed hard sheet generally consists of three functional layers: a surface supporting strength layer, an intermediate aluminum foil barrier layer, and an inner surface heat sealing layer. The surface support layer can be printed with the color or pattern desired by the customer, and the layers are bonded together by a bonding method to form a composite film as a whole. The surface support strength layer of the cold stamped formed hard sheet is required to be smooth and flat, has good transparency, has high mechanical strength, excellent impact resistance, and has certain wear resistance and puncture resistance, and mechanical protection for the entire package. . The surface support layer of the cold stamped formed hard sheet generally uses a biaxially stretched nylon film (BOPA) excellent in high strength and impact resistance. Because the cold stamping and forming hard sheet is subjected to the impact force and stretching during the cold stamping process of the package, the 15μm thick BOPA for general flexible packaging cannot meet the requirements, except for the case of shallow stamping. 25 μm thick BOPA was used as the surface support strength layer. For the case of shallow stamping into foam, in order to save cost, a biaxially stretched ester film (BOPET) or a biaxially stretched polypropylene thin (BOPP) may be used instead of the biaxially stretched nylon film.
In addition to the barrier function, the intermediate aluminum foil barrier layer used in cold stamping has the functions of strength support, stamping and stretching resistance, and thus is different from the intermediate aluminum foil barrier layer used in general cold packaging cold stamping. In addition to the functional function, it also has the functions of strength support, anti-stamping and stretching, and thus is different from the general flexible packaging composite aluminum foil. The aluminum foil used in cold stamping is not a general pure aluminum foil, but an alloy aluminum foil having extremely high strength and good elongation. Since the cold stamped formed hard sheets are subjected to press forming. Therefore, the thickness of the aluminum foil used is also much thicker than that of the ordinary composite film. Generally, an aluminum foil of 45 μm thickness is used. For the case of punching into a shallow foam, the thickness of the aluminum foil can be appropriately reduced. Generally, the thickness of the aluminum foil can be reduced to 3 μm, which is particularly suitable for punching into bubbles. In the case of deep (≥15mm) or when the cold-formed hard sheet is required to have good stiffness, the thickness of the aluminum foil can be appropriately increased, and the thickness of the zui can be increased to 70 μm.
The inner surface heat seal layer of the cold stamped formed hard sheet is generally made of a polyvinyl chloride (PVC) hard sheet, so that the cold stamped formed hard sheet can be heat-sealed like a PVC hard sheet for ordinary blister packaging and a PTP aluminum foil for pharmaceutical packaging. The PVC used for cold stamping hard sheets is different from ordinary PVC. Considering the factors such as compounding and stamping, it is usually not used for ordinary plasticizers and lubricants, but by grafting plasticizer factors in PVC molecular segments. Internal plasticization and internal lubrication. At the same time, in order to improve the impact resistance of PVC, the reinforcing agent added in the PVC hard sheet is much more than the ordinary PVC hard sheet, so that it has good composite performance and stamping forming performance. The thickness of PVC in the cold stamping formed sheet is generally 60 μm. In the case where the product is required to have high rigidity and stiffness, the thickness of the PVC can be appropriately increased, and the height can be as high as 100 μm, and polypropylene can be used in some special occasions. , polyethylene; polyester and sandal (Surlyn) resin as a heat seal layer.
The surface support strength layer, the aluminum foil barrier layer, and the inner surface heat seal layer in the cold stamping formed sheet are bonded by an adhesive, and they are organically combined to form a composite material. It is necessary to ensure that the cold stamped formed hard sheet does not leave the layer under the strong impact forming force and does not break. The selection and use of the adhesive is quite critical, and the adhesion of the bonded aluminum foil to the surface support strength layer and the heat seal layer is generally required. The strength is up to 8N/15mm. In the formulation design process, the ratio of the soft segment and the hard segment of the molecular segment in the polyurethane adhesive should be controlled to meet the requirements of cold stamping. Generally, it is difficult to achieve the above requirements for ordinary adhesives, and thus the adhesive used for cold stamping of the rigid sheets is generally a specially formulated special adhesive.
Although the cold stamped blister package has a good appearance and high barrier properties, the product has many different characteristics from other packaging materials during use, and often causes the following problems during use:
1. When the cold stamping formed hard sheet is formed into bubbles, the cracks and pinholes of the aluminum foil occur on the bubble forming bubbles; and the separation between the composite films, the main causes of these defects are as follows:
*Class is a problem with the quality of cold stamped hard sheets. Cold stamping and forming hard film is a kind of product with high technical content. It has many special requirements for raw materials and production processes. If the various links in production are not well controlled, quality problems are very likely to occur. The quality problem of cold stamping and forming hard sheets can be easily determined by replacing cold stamping and forming hard sheets of different batch numbers and even different manufacturers.
The support strength layer of the cold stamped formed hard sheet is mainly a 25 μm thick nylon film which is biaxially stretched by the outer layer. The nylon membrane has a low hardness; it is easily scratched by hard objects; if the nylon surface is scratched, even a slight flaw; the strength of the nylon membrane is greatly reduced, resulting in cold stamping of the hard sheet in the stamping. During the process, the aluminum foil and the nylon membrane were broken at the scratched portion. In the actual production process, the scratching of the cold stamping formed hard piece, especially the slight scratching, is difficult to find with the naked eye, and is often found when the punching is formed into a bubble; thus causing loss. The scratch of the cold stamped formed hard sheet is generally caused by the inflexible rotation of the guide roller during the running of the composite film, the foreign matter on the guide roller, and the contact of the composite film with the fixing portion of the device (such as an electrostatic brush). Scratches may be generated either during the production process of the manufacturer or by the user on the packaging equipment.
The cold-stamped hard sheet contains hygroscopic nylon material. After the moisture absorption of the nylon, it is easy to cause the cold-stamped hard sheet to form a separation of the nylon film and the aluminum foil during the stamping process, and the tin foil is broken or pinholes are generated, thereby reducing The foaming rate of the cold stamped formed sheet. Even in the finished product of cold stamped blister packaging, the foaming part is easy to leave the layer of nylon and aluminum foil after being parked in a humid environment (not released when it is produced, but it is left in a humid environment for a while) Layer), thus cold stamping formed hard sheets and their double aluminum blister packaging products. It should be stored in a dry environment.
The second category is that the stamping die design is flawed. The cold stamping forming hard sheet is formed by mechanical stamping forming, and the force and tensile deformation of the cold stamping forming hard sheet during the stamping process are very large, which is close to the limit of the material. If the stamping die is improperly designed, it may lead to punching. The aluminum foil is broken during molding. The design of the mold includes the material of the mold and the geometry of the punch.
Generally, the POM mold has a lower friction coefficient and better punching performance than the stainless steel mold, and the Teflon mold has a lower friction coefficient and better punching performance than the POM mold. The lower friction coefficient is beneficial to reduce the friction in the stamping process and avoid uneven stress on the cold stamping forming material, which can greatly avoid the occurrence of cracks in the aluminum foil and the separation of the composite film during the stamping process. For drugs of the same size, the friction coefficient can be reduced to have a larger press-stretch ratio, thereby effectively reducing the area of ​​the packaging material and reducing the cost. The friction coefficient of the polyvinyl chloride, polyoxymethylene and stainless steel molds and the cold-formed hard sheets on the PVC surface are 0.4, 1.2, and 2.1, respectively. For the same medicines, the same depth is achieved. The bubble area ratio is 1:1.2:1.4. The use of Teflon punch can effectively prevent the aluminum foil from rupturing and the composite film from being delaminated during the stamping process, and at the same time save packaging materials. Therefore, in addition to the shallow stamping, PTFE is generally used as the stamping die. . Of course, PTFE also has a disadvantage that the hardness is not high enough, and the stamping die is easily damaged and scratched. Using a damaged die to form a bubble, it is easy to cause cracking of the aluminum foil pinhole and increase the rejection rate.
In addition to the material importance of the cold stamping die, the size and geometry of the punch have a great influence on the fracture of the stamped aluminum foil and the separation of the composite film. Stamping-formed dies generally have two types: smooth over-type and over-stepped. The blister punched out by the smooth over-type die is aesthetically pleasing, but relatively poor in stamping resistance and resistance to stamping cracking. The step-over-type die is divided into several steps with angular steps, which are stepwise stretched during the stamping process. The cold-stamped hard sheet has less contact area with the stamping die during the stamping process, which is favorable for uniform stretching into bubbles. Since the size and shape of the stamping die have a great influence on the foaming rate of the stamping, a corresponding computer software has been specially developed, which can automatically design a stamping die with a good effect according to the outer dimensions of the packaged tablet. Geometric shape. Thereby, the cold stamping formed hard sheet is prevented from being locally stressed and stretched excessively in the punching.
The third category is improper control of the stamping process. The cold stamped formed hard sheet is drawn into a foam by mechanical stamping. The aluminum foil as a metal layer material has a limited elongation in a cold state, although the aluminum foil used for cold stamping is a special alloy aluminum foil, and its elongation is only 20 %about. If the stamping is too deep, the aluminum foil is stretched too much, and it is easy to cause cracking of the aluminum foil and separation of the composite film. The stamping depth of the general cold stamping blister packaging machine is designed to be adjustable, and the punching depth should be minimized in the case where the PTP aluminum foil is not sticky when the drug is contained and heat sealed. The cracking of the aluminum foil during the stamping process is related to the thickness of the aluminum foil. If it is necessary to punch into a deep bubble, in addition to increasing the area of ​​the die hole, the thickness of the aluminum foil material in the cold stamped die can be appropriately increased. Improved. The cold stamping process generally has four forms of hydraulic cylinder stamping, pneumatic cylinder stamping, mechanical crankshaft stamping, and high pressure gas inflation; in any form, its bubble forming speed cracks and composites of aluminum foil. The separation layer of the film has a certain influence; in general, the bubble formation speed is too fast, which is not conducive to the uniform stretching and stress relaxation of the cold stamping formed piece; thus, the waste rate of the bubble formation is increased. The stamping of cold-formed hard sheets is foamed near the strength limit of the material. Any damage on the stamping die (even a small burr) may cause the scrap rate to rise, and the stamping die is damaged. It is a common thing in equipment.
Many blister packaging machines that use cold stamped rigid sheets have a preheating device before stamping, which allows the cold stamped formed sheets to be preheated to a certain temperature prior to stamping, thereby "favorable" for cold stamped formed sheets. Stamped into bubbles. In fact, whether preheating is conducive to stamping into bubbles depends on the specific conditions. The temperature rise of the cold stamped formed sheet is indeed beneficial for the stamping of PVC, but the temperature rise of the cold stamped sheet has two negative effects. One is the increase in temperature, and the PVC and aluminum foil and aluminum foil at high temperatures. The composite strength of nylon will decrease, and the decrease in composite strength will lead to an increase in the fracture of the aluminum foil and the separation of the composite film during the stamping process. Second, the temperature rise will cause the friction coefficient of the punch and PVC to increase, and the influence of temperature on the friction coefficient is related to the material of the punch (polytetrafluoroethylene, polyoxymethylene, stainless steel) and PVC. The effect of preheating on the stamping into foam in the actual production process; due to the different equipment (the material of the punch) and the cold stamping of the different suppliers (the formula of PVC), it is not conducible that preheating is beneficial. Stamped into bubbles. Even in the case where preheating is favorable for stamping into bubbles, it should be verified that a suitable temperature is selected, and the relationship between friction coefficient and composite strength and temperature is not linear. When the preheating temperature is too high, the punch and PVC are The coefficient of friction may suddenly become large, and the composite strength between the layers of the cold stamped formed piece may suddenly become small, so that the aluminum foil is broken and the composite film is separated from the layer when the cold stamping is formed into a bubble.
Although it is possible to optimize the design of the computer by changing the material of the punch and the shape of the punch, and controlling the production process, it is possible to effectively prevent the aluminum foil from being broken and the composite film from being separated during the foam forming. However, due to the complexity of the production process and the influence of many uncertain factors, it is absolutely impossible to guarantee 100% no problem in the foaming process. The fine rupture of the aluminum foil and the pinholes do not cause the perforation of the composite material, and it is usually not possible to be tested by a leak test (vacuum test); it is generally not possible to check with the naked eye. However, the cold-formed hard sheet has a fatal effect on the cracking of the aluminum foil and the pinhole on the shelf life of the drug during the stamping process, which will greatly reduce the shelf life of the drug. For safety reasons, only the defect-free blister is allowed to move forward for drug filling. A "pinhole detector" has been invented, and the formed cold stamping blister is in-line detected by optical signal or far-infrared ray. The sensitivity of the detecting device can be adjusted, and the allowable zui large pinhole diameter range is 30. ―200μm, when the “pinhole detector†detects that the bubble generation has a pinhole with a hole diameter larger than the set value, the “pinhole detector†can remove the defective blister plate through the linkage device on the device. : Thus 100% guarantee the quality of the drug.
2. Cold stamping and forming hard sheets are prone to heat sealing problems. Although cold stamping forming hard sheets are similar to ordinary PVC blister packs, they are also heat-sealed with polyvinyl chloride and PTP aluminum foil for pharmaceutical packaging. In fact, there are still major differences; PVC in ordinary PVC blister packs has a thickness of 200-300 μm, while PVC in cold-stamped rigid sheets generally has a thickness of only 60 μm and a thickness less than a quarter of that of ordinary PVC blister packs. The general-purpose PTP aluminum foil has an aluminum foil thickness of only 20 μm.
The thickness of the heat seal layer is only 3-4 μm. At present, whether it is cold stamping blister packaging or ordinary PVC blister packaging, for the sake of beauty, the heat sealing mold is made into a point-like heat seal instead of a line mesh heat seal. The line mesh heat seal is a staggered grid line in the heat seal. The point heat seal is a point because the heat seal is a point. If the heat seal layer does not have sufficient thickness, there is not enough pressure during heat sealing. There is not enough flowable heat sealing resin to fill the gap between the heat sealing points; then the air is likely to contact the medicine through the gap between the points, then the tearing feels the heat sealing strength; but in the pumping Air leaks often occur during vacuum testing. We have sampled the double-aluminum blister packaged drugs circulating in the market and found that 18% of the drugs have air leaks, which is a very serious problem. We recommend that the thickness of the heat seal layer of the PTP aluminum foil heat-sealed with the cold stamped die should be appropriately increased. What is the thickness of the PTP aluminum foil heat seal layer for the dot heat seal mold? It is related to the size of the dots, the height of the dots, and the density of the dots. The specifics should be judged by experiments.
The cold stamping formed hard sheet is formed by punching, and the force and deformation of the material during the stamping process are large. In addition to the deformation of the foaming position, the non-foaming portion of the cold stamped formed hard sheet after stamping is also Will be deformed. After the cold stamping formed piece is deformed, it will have two adverse effects. First, the deformed part is likely to wrinkle when heat-sealed, which affects the appearance and air tightness. Second, the material is warped and corrugated after deformation, and the package is in this case. It is easy to produce left and right swing during the feeding process, and it is not conducive to the front and rear positioning of the material. The cold-stamped formed hard sheet after foaming is unstable in the packaging process, which may cause the formed blister to be inaccurately aligned on the heat-sealed bottom mold, and the bubble-forming portion is flattened when the heat-sealing is performed. Such defects are less affected in the case of large bubbles, as long as they are not too outrageous, generally acceptable, but when the cold-punched blister is small and the positioning accuracy is high, such a pressure-biased defect often causes waste. The excessive deformation of the non-foamed portion of the cold stamped formed hard sheet during the foaming process is generally caused by the following reasons.
a. The cold stamping forming hard sheet has poor press forming performance, and the material is too soft and not stiff enough.
b. The die design of the stamping molding is unreasonable, the stretching of the stamping process is uneven or the cold stamping formed hard piece cannot be well clamped.
c. The tension control of the traction mechanism and material of the packaging equipment is unreasonable.
3, after cold stamping blister packaging, it is difficult to check the drug.
The double-aluminum blister package made of cold-stamped hard sheets does have other packaging forms of medicine, and the pharmaceutical company can only strengthen the inspection during the packaging process. Many domestic double-aluminum blister packaging machines are designed to facilitate the inspection of artificial eyes, and the operating areas after foaming and filling are designed to be convenient for personnel to inspect and handle. However, due to the speed of the drug packaging process, it is not easy to check with the naked eye, and the visual inspection has problems such as fatigue, personnel responsibility, etc., and it is impossible to ensure that the packaged tablets are 100% reliable. In order to solve this problem, some double aluminum blister packaging equipment, after cold stamping into foam, in addition to the installation of "pinhole detection" equipment, also installed in the PTP aluminum foil heat sealing before the camera contrast system, will be broken, bad And the missing products are excluded (there are also high-precision electronic weighing systems installed after packaging), and electronic camera systems with different resolutions can be installed according to the strict requirements of the products. Some electronic camera contrast systems may have some special requirements for the gloss and reflective properties of cold stamped rigid sheets. In electronic camera contrast systems without filters and polarizers, if cold stamped hard sheets are foamed The surface reflection is too strong, which will cause disturbance to the camera effect, affect its resolution, and even fail to distinguish the quality of the product.
The double-aluminum blister package made of cold-formed hard sheets is opaque on both sides, so it is impossible to check whether the PTP aluminum foil is crushed by the heat-sealing mold during the heat-sealing process. There are two cases in which PTP aluminum foil is crushed. One is to be pressed through the blister position without heat sealing. This pressure will completely destroy the sealing property of the medicine; the medicine may deteriorate in a short period of time. The press-through of the sealed blister position can be detected by a vacuum test. Another type of crushing of PTP aluminum foil is that the heat-sealed mold has burrs or the pressure of the aluminum foil at the sealing point due to excessive heat sealing pressure, which does not damage the airtightness of the blister package. Sex, can not be checked by vacuum test.
For ordinary transparent PVC blister packaging, due to the low barrier property of PVC itself, the overall barrier property of the package is mainly determined by the PVC of the hot blister forming part. The pressure injury at the heat-sealed position has little effect on the shelf life of the drug. At the same time, since the PVC is transparent, the finished product is also easily accessible by observing the light, but there is also a fatal problem - packaging. The finished product can't see the drug, and the drug factory can only strengthen the inspection during the drug packaging process. Many domestic double-aluminum blister packaging machines are designed to facilitate the inspection of artificial eyes, and the operating areas after foaming and filling are designed to be convenient for personnel to inspect and handle. However, due to the speed of the drug packaging process, it is not easy to check with the naked eye, and the visual inspection has problems such as fatigue, personnel responsibility, etc., and it is impossible to ensure that the packaged tablets are 100% reliable.
In order to solve this problem, some double aluminum blister packaging equipments, after cold stamping into foam, in addition to the installation of "pinhole detection" equipment, also installed electronic camera contrast system before PTP aluminum foil heat sealing, will be fragmented, bad and The missing products are excluded from the production (there is also a high-precision electronic weighing system installed after packaging), and electronic imaging systems of different resolutions can be installed according to the strictness of the requirements of the products. Some electronic camera contrast systems may have some special requirements for the gloss and reflective properties of cold stamped rigid sheets. In electronic camera contrast systems without filters and polarizers, if cold stamped hard sheets are foamed The surface reflection is too strong, which will cause disturbance to the camera effect, affect its resolution, and even fail to distinguish the quality of the product.
The double-aluminum blister package made of cold-formed hard sheets is opaque on both sides, so it is impossible to check whether the PTP aluminum foil is crushed by the heat-sealing mold during the heat-sealing process. There are two cases in which PTP aluminum foil is crushed. One is to be pressed through the blister position without heat sealing. This pressure will completely destroy the sealing property of the medicine; the medicine may deteriorate in a short period of time. The press-through of the sealed blister position can be detected by a vacuum test. Another type of crushing of PTP aluminum foil is that the heat-sealed mold has burrs or the pressure of the aluminum foil at the sealing point due to excessive heat sealing pressure, which does not damage the airtightness of the blister package. Sex, can not be checked by vacuum test.
For ordinary transparent PVC blister packaging, due to the low barrier property of PVC itself, the overall barrier property of the package is mainly determined by the PVC of the hot blister forming part. The pressure injury at the heat-sealing position has little effect on the shelf life of the drug, and since the PVC is transparent, the finished product can easily judge whether there is a pressure-piercing problem by observing the light. The double-aluminum blister package made of cold-formed hard sheet is a highly barrier-packed product. The press-through of the PTP tin foil in the heat-sealed position does not affect the airtightness of the blister pack, but it is The barrier properties of the package and the shelf life of the drug have a large impact. The double-aluminum foil blister package is opaque in both eyes, and it is difficult to check and find out whether the heat-sealed position is pressed or not. In a sense, it is impossible to check and judge. In order to ensure that nothing is lost, in addition to strengthening the strict verification of the production process, the thickness of the PTP aluminum foil can be appropriately increased to solve the problem. The thickness of the aluminum foil in the general PTP aluminum foil is 20 μm, and the thickness of the PTP aluminum foil for the cold stamping hard film can be used. For 25μm aluminum foil, 30μm aluminum foil can be used for some high requirements.
The cold stamping blister packaging of medicines has developed over the past two decades. At present, the technology is maturing, the automation of related equipment is getting higher and higher, and the packaging is more perfect. With the localization of cold stamping formed hard sheets and double aluminum foil blister packaging machines and the reduction of prices, there will be more and more medicines used in cold stamping blister packaging in China.
The covering material of the aluminum-plastic blister package of the medicine is generally aluminum foil (referred to as aluminum foil for medicine blister packaging), and the foaming substrate is generally made of polyvinyl chloride (PVC) hard sheet. However, with the continuous development of the pharmaceutical industry, this "conventional packaging method exposes its defects" - due to the limited barrier properties of PVC rigid sheets, it is difficult to ensure that the quality of the drug does not change during its lifetime. In view of the limited barrier properties of ordinary blister packs, people have developed cold stamping and compression forming hard sheets in the early 1980s with a new concept. Cold stamping molding uses stamping to replace the vacuum forming of the original blister pack, so that the blister packaging sheet can use a pure aluminum foil composite as a foaming material. The application of high-strength alloy aluminum foil in cold stamping formed hard sheets also makes the cold stamped formed hard sheets have extremely high water vapor resistance, oxygen and light barrier properties that cannot be achieved by any other materials.
The cold stamped formed hard sheet generally consists of three functional layers: a surface supporting strength layer, an intermediate aluminum foil barrier layer, and an inner surface heat sealing layer. The surface support layer can be printed with the color or pattern desired by the customer, and the layers are bonded together by a bonding method to form a composite film as a whole. The surface support strength layer of the cold stamped formed hard sheet is required to be smooth and flat, has good transparency, has high mechanical strength, excellent impact resistance, and has certain wear resistance and puncture resistance, and mechanical protection for the entire package. . The surface support layer of the cold stamped formed hard sheet generally uses a biaxially stretched nylon film (BOPA) excellent in high strength and impact resistance. Because the cold stamping and forming hard sheet is subjected to the impact force and stretching during the cold stamping process of the package, the 15μm thick BOPA for general flexible packaging cannot meet the requirements, except for the case of shallow stamping. 25 μm thick BOPA was used as the surface support strength layer. For the case of shallow stamping into foam, in order to save cost, a biaxially stretched ester film (BOPET) or a biaxially stretched polypropylene thin (BOPP) may be used instead of the biaxially stretched nylon film.
In addition to the barrier function, the intermediate aluminum foil barrier layer used in cold stamping has the functions of strength support, stamping and stretching resistance, and thus is different from the intermediate aluminum foil barrier layer used in general cold packaging cold stamping. In addition to the functional function, it also has the functions of strength support, anti-stamping and stretching, and thus is different from the general flexible packaging composite aluminum foil. The aluminum foil used in cold stamping is not a general pure aluminum foil, but an alloy aluminum foil having extremely high strength and good elongation. Since the cold stamped formed hard sheets are subjected to press forming. Therefore, the thickness of the aluminum foil used is also much thicker than that of the ordinary composite film. Generally, an aluminum foil of 45 μm thickness is used. For the case of punching into a shallow foam, the thickness of the aluminum foil can be appropriately reduced. Generally, the thickness of the aluminum foil can be reduced to 3 μm, which is particularly suitable for punching into bubbles. In the case of deep (≥15mm) or when the cold-formed hard sheet is required to have good stiffness, the thickness of the aluminum foil can be appropriately increased, and the thickness of the zui can be increased to 70 μm.
The inner surface heat seal layer of the cold stamped formed hard sheet is generally made of a polyvinyl chloride (PVC) hard sheet, so that the cold stamped formed hard sheet can be heat-sealed like a PVC hard sheet for ordinary blister packaging and a PTP aluminum foil for pharmaceutical packaging. The PVC used for cold stamping hard sheets is different from ordinary PVC. Considering the factors such as compounding and stamping, it is usually not used for ordinary plasticizers and lubricants, but by grafting plasticizer factors in PVC molecular segments. Internal plasticization and internal lubrication. At the same time, in order to improve the impact resistance of PVC, the reinforcing agent added in the PVC hard sheet is much more than the ordinary PVC hard sheet, so that it has good composite performance and stamping forming performance. The thickness of PVC in the cold stamping formed sheet is generally 60 μm. In the case where the product is required to have high rigidity and stiffness, the thickness of the PVC can be appropriately increased, and the height can be as high as 100 μm, and polypropylene can be used in some special occasions. , polyethylene; polyester and sandal (Surlyn) resin as a heat seal layer.
The surface support strength layer, the aluminum foil barrier layer, and the inner surface heat seal layer in the cold stamping formed sheet are bonded by an adhesive, and they are organically combined to form a composite material. It is necessary to ensure that the cold stamped formed hard sheet does not leave the layer under the strong impact forming force and does not break. The selection and use of the adhesive is quite critical, and the adhesion of the bonded aluminum foil to the surface support strength layer and the heat seal layer is generally required. The strength is up to 8N/15mm. In the formulation design process, the ratio of the soft segment and the hard segment of the molecular segment in the polyurethane adhesive should be controlled to meet the requirements of cold stamping. Generally, it is difficult to achieve the above requirements for ordinary adhesives, and thus the adhesive used for cold stamping of the rigid sheets is generally a specially formulated special adhesive.
Although the cold stamped blister package has a good appearance and high barrier properties, the product has many different characteristics from other packaging materials during use, and often causes the following problems during use:
1. When the cold stamping formed hard sheet is formed into bubbles, the cracks and pinholes of the aluminum foil occur on the bubble forming bubbles; and the separation between the composite films, the main causes of these defects are as follows:
*Class is a problem with the quality of cold stamped hard sheets. Cold stamping and forming hard film is a kind of product with high technical content. It has many special requirements for raw materials and production processes. If the various links in production are not well controlled, quality problems are very likely to occur. The quality problem of cold stamping and forming hard sheets can be easily determined by replacing cold stamping and forming hard sheets of different batch numbers and even different manufacturers.
The support strength layer of the cold stamped formed hard sheet is mainly a 25 μm thick nylon film which is biaxially stretched by the outer layer. The nylon membrane has a low hardness; it is easily scratched by hard objects; if the nylon surface is scratched, even a slight flaw; the strength of the nylon membrane is greatly reduced, resulting in cold stamping of the hard sheet in the stamping. During the process, the aluminum foil and the nylon membrane were broken at the scratched portion. In the actual production process, the scratching of the cold stamping formed hard piece, especially the slight scratching, is difficult to find with the naked eye, and is often found when the punching is formed into a bubble; thus causing loss. The scratch of the cold stamped formed hard sheet is generally caused by the inflexible rotation of the guide roller during the running of the composite film, the foreign matter on the guide roller, and the contact of the composite film with the fixing portion of the device (such as an electrostatic brush). Scratches may be generated either during the production process of the manufacturer or by the user on the packaging equipment.
The cold-stamped hard sheet contains hygroscopic nylon material. After the moisture absorption of the nylon, it is easy to cause the cold-stamped hard sheet to form a separation of the nylon film and the aluminum foil during the stamping process, and the tin foil is broken or pinholes are generated, thereby reducing The foaming rate of the cold stamped formed sheet. Even in the finished product of cold stamped blister packaging, the foaming part is easy to leave the layer of nylon and aluminum foil after being parked in a humid environment (not released when it is produced, but it is left in a humid environment for a while) Layer), thus cold stamping formed hard sheets and their double aluminum blister packaging products. It should be stored in a dry environment.
The second category is that the stamping die design is flawed. The cold stamping forming hard sheet is formed by mechanical stamping forming, and the force and tensile deformation of the cold stamping forming hard sheet during the stamping process are very large, which is close to the limit of the material. If the stamping die is improperly designed, it may lead to punching. The aluminum foil is broken during molding. The design of the mold includes the material of the mold and the geometry of the punch.
Generally, the POM mold has a lower friction coefficient and better punching performance than the stainless steel mold, and the Teflon mold has a lower friction coefficient and better punching performance than the POM mold. The lower friction coefficient is beneficial to reduce the friction in the stamping process and avoid uneven stress on the cold stamping forming material, which can greatly avoid the occurrence of cracks in the aluminum foil and the separation of the composite film during the stamping process. For drugs of the same size, the friction coefficient can be reduced to have a larger press-stretch ratio, thereby effectively reducing the area of ​​the packaging material and reducing the cost. The friction coefficient of the polyvinyl chloride, polyoxymethylene and stainless steel molds and the cold-formed hard sheets on the PVC surface are 0.4, 1.2, and 2.1, respectively. For the same medicines, the same depth is achieved. The bubble area ratio is 1:1.2:1.4. The use of Teflon punch can effectively prevent the aluminum foil from rupturing and the composite film from being delaminated during the stamping process, and at the same time save packaging materials. Therefore, in addition to the shallow stamping, PTFE is generally used as the stamping die. . Of course, PTFE also has a disadvantage that the hardness is not high enough, and the stamping die is easily damaged and scratched. Using a damaged die to form a bubble, it is easy to cause cracking of the aluminum foil pinhole and increase the rejection rate.
In addition to the material importance of the cold stamping die, the size and geometry of the punch have a great influence on the fracture of the stamped aluminum foil and the separation of the composite film. Stamping-formed dies generally have two types: smooth over-type and over-stepped. The blister punched out by the smooth over-type die is aesthetically pleasing, but relatively poor in stamping resistance and resistance to stamping cracking. The step-over-type die is divided into several steps with angular steps, which are stepwise stretched during the stamping process. The cold-stamped hard sheet has less contact area with the stamping die during the stamping process, which is favorable for uniform stretching into bubbles. Since the size and shape of the stamping die have a great influence on the foaming rate of the stamping, a corresponding computer software has been specially developed, which can automatically design a stamping die with a good effect according to the outer dimensions of the packaged tablet. Geometric shape. Thereby, the cold stamping formed hard sheet is prevented from being locally stressed and stretched excessively in the punching.
The third category is improper control of the stamping process. The cold stamped formed hard sheet is drawn into a foam by mechanical stamping. The aluminum foil as a metal layer material has a limited elongation in a cold state, although the aluminum foil used for cold stamping is a special alloy aluminum foil, and its elongation is only 20 %about. If the stamping is too deep, the aluminum foil is stretched too much, and it is easy to cause cracking of the aluminum foil and separation of the composite film. The stamping depth of the general cold stamping blister packaging machine is designed to be adjustable, and the punching depth should be minimized in the case where the PTP aluminum foil is not sticky when the drug is contained and heat sealed. The cracking of the aluminum foil during the stamping process is related to the thickness of the aluminum foil. If it is necessary to punch into a deep bubble, in addition to increasing the area of ​​the die hole, the thickness of the aluminum foil material in the cold stamped die can be appropriately increased. Improved. The cold stamping process generally has four forms of hydraulic cylinder stamping, pneumatic cylinder stamping, mechanical crankshaft stamping, and high pressure gas inflation; in any form, its bubble forming speed cracks and composites of aluminum foil. The separation layer of the film has a certain influence; in general, the bubble formation speed is too fast, which is not conducive to the uniform stretching and stress relaxation of the cold stamping formed piece; thus, the waste rate of the bubble formation is increased. The stamping of cold-formed hard sheets is foamed near the strength limit of the material. Any damage on the stamping die (even a small burr) may cause the scrap rate to rise, and the stamping die is damaged. It is a common thing in equipment.
Many blister packaging machines that use cold stamped rigid sheets have a preheating device before stamping, which allows the cold stamped formed sheets to be preheated to a certain temperature prior to stamping, thereby "favorable" for cold stamped formed sheets. Stamped into bubbles. In fact, whether preheating is conducive to stamping into bubbles depends on the specific conditions. The temperature rise of the cold stamped formed sheet is indeed beneficial for the stamping of PVC, but the temperature rise of the cold stamped sheet has two negative effects. One is the increase in temperature, and the PVC and aluminum foil and aluminum foil at high temperatures. The composite strength of nylon will decrease, and the decrease in composite strength will lead to an increase in the fracture of the aluminum foil and the separation of the composite film during the stamping process. Second, the temperature rise will cause the friction coefficient of the punch and PVC to increase, and the influence of temperature on the friction coefficient is related to the material of the punch (polytetrafluoroethylene, polyoxymethylene, stainless steel) and PVC. The effect of preheating on the stamping into foam in the actual production process; due to the different equipment (the material of the punch) and the cold stamping of the different suppliers (the formula of PVC), it is not conducible that preheating is beneficial. Stamped into bubbles. Even in the case where preheating is favorable for stamping into bubbles, it should be verified that a suitable temperature is selected, and the relationship between friction coefficient and composite strength and temperature is not linear. When the preheating temperature is too high, the punch and PVC are The coefficient of friction may suddenly become large, and the composite strength between the layers of the cold stamped formed piece may suddenly become small, so that the aluminum foil is broken and the composite film is separated from the layer when the cold stamping is formed into a bubble.
Although it is possible to optimize the design of the computer by changing the material of the punch and the shape of the punch, and controlling the production process, it is possible to effectively prevent the aluminum foil from being broken and the composite film from being separated during the foam forming. However, due to the complexity of the production process and the influence of many uncertain factors, it is absolutely impossible to guarantee 100% no problem in the foaming process. The fine rupture of the aluminum foil and the pinholes do not cause the perforation of the composite material, and it is usually not possible to be tested by a leak test (vacuum test); it is generally not possible to check with the naked eye. However, the cold-formed hard sheet has a fatal effect on the cracking of the aluminum foil and the pinhole on the shelf life of the drug during the stamping process, which will greatly reduce the shelf life of the drug. For safety reasons, only the defect-free blister is allowed to move forward for drug filling. A "pinhole detector" has been invented, and the formed cold stamping blister is in-line detected by optical signal or far-infrared ray. The sensitivity of the detecting device can be adjusted, and the allowable zui large pinhole diameter range is 30. ―200μm, when the “pinhole detector†detects that the bubble generation has a pinhole with a hole diameter larger than the set value, the “pinhole detector†can remove the defective blister plate through the linkage device on the device. : Thus 100% guarantee the quality of the drug.
2. Cold stamping and forming hard sheets are prone to heat sealing problems. Although cold stamping forming hard sheets are similar to ordinary PVC blister packs, they are also heat-sealed with polyvinyl chloride and PTP aluminum foil for pharmaceutical packaging. In fact, there are still major differences; PVC in ordinary PVC blister packs has a thickness of 200-300 μm, while PVC in cold-stamped rigid sheets generally has a thickness of only 60 μm and a thickness less than a quarter of that of ordinary PVC blister packs. The general-purpose PTP aluminum foil has an aluminum foil thickness of only 20 μm.
The thickness of the heat seal layer is only 3-4 μm. At present, whether it is cold stamping blister packaging or ordinary PVC blister packaging, for the sake of beauty, the heat sealing mold is made into a point-like heat seal instead of a line mesh heat seal. The line mesh heat seal is a staggered grid line in the heat seal. The point heat seal is a point because the heat seal is a point. If the heat seal layer does not have sufficient thickness, there is not enough pressure during heat sealing. There is not enough flowable heat sealing resin to fill the gap between the heat sealing points; then the air is likely to contact the medicine through the gap between the points, then the tearing feels the heat sealing strength; but in the pumping Air leaks often occur during vacuum testing. We have sampled the double-aluminum blister packaged drugs circulating in the market and found that 18% of the drugs have air leaks, which is a very serious problem. We recommend that the thickness of the heat seal layer of the PTP aluminum foil heat-sealed with the cold stamped die should be appropriately increased. What is the thickness of the PTP aluminum foil heat seal layer for the dot heat seal mold? It is related to the size of the dots, the height of the dots, and the density of the dots. The specifics should be judged by experiments.
The cold stamping formed hard sheet is formed by punching, and the force and deformation of the material during the stamping process are large. In addition to the deformation of the foaming position, the non-foaming portion of the cold stamped formed hard sheet after stamping is also Will be deformed. After the cold stamping formed piece is deformed, it will have two adverse effects. First, the deformed part is likely to wrinkle when heat-sealed, which affects the appearance and air tightness. Second, the material is warped and corrugated after deformation, and the package is in this case. It is easy to produce left and right swing during the feeding process, and it is not conducive to the front and rear positioning of the material. The cold-stamped formed hard sheet after foaming is unstable in the packaging process, which may cause the formed blister to be inaccurately aligned on the heat-sealed bottom mold, and the bubble-forming portion is flattened when the heat-sealing is performed. Such defects are less affected in the case of large bubbles, as long as they are not too outrageous, generally acceptable, but when the cold-punched blister is small and the positioning accuracy is high, such a pressure-biased defect often causes waste. The excessive deformation of the non-foamed portion of the cold stamped formed hard sheet during the foaming process is generally caused by the following reasons.
a. The cold stamping forming hard sheet has poor press forming performance, and the material is too soft and not stiff enough.
b. The die design of the stamping molding is unreasonable, the stretching of the stamping process is uneven or the cold stamping formed hard piece cannot be well clamped.
c. The tension control of the traction mechanism and material of the packaging equipment is unreasonable.
3, after cold stamping blister packaging, it is difficult to check the drug.
The double-aluminum blister package made of cold-stamped hard sheets does have other packaging forms of medicine, and the pharmaceutical company can only strengthen the inspection during the packaging process. Many domestic double-aluminum blister packaging machines are designed to facilitate the inspection of artificial eyes, and the operating areas after foaming and filling are designed to be convenient for personnel to inspect and handle. However, due to the speed of the drug packaging process, it is not easy to check with the naked eye, and the visual inspection has problems such as fatigue, personnel responsibility, etc., and it is impossible to ensure that the packaged tablets are 100% reliable. In order to solve this problem, some double aluminum blister packaging equipment, after cold stamping into foam, in addition to the installation of "pinhole detection" equipment, also installed in the PTP aluminum foil heat sealing before the camera contrast system, will be broken, bad And the missing products are excluded (there are also high-precision electronic weighing systems installed after packaging), and electronic camera systems with different resolutions can be installed according to the strict requirements of the products. Some electronic camera contrast systems may have some special requirements for the gloss and reflective properties of cold stamped rigid sheets. In electronic camera contrast systems without filters and polarizers, if cold stamped hard sheets are foamed The surface reflection is too strong, which will cause disturbance to the camera effect, affect its resolution, and even fail to distinguish the quality of the product.
The double-aluminum blister package made of cold-formed hard sheets is opaque on both sides, so it is impossible to check whether the PTP aluminum foil is crushed by the heat-sealing mold during the heat-sealing process. There are two cases in which PTP aluminum foil is crushed. One is to be pressed through the blister position without heat sealing. This pressure will completely destroy the sealing property of the medicine; the medicine may deteriorate in a short period of time. The press-through of the sealed blister position can be detected by a vacuum test. Another type of crushing of PTP aluminum foil is that the heat-sealed mold has burrs or the pressure of the aluminum foil at the sealing point due to excessive heat sealing pressure, which does not damage the airtightness of the blister package. Sex, can not be checked by vacuum test.
For ordinary transparent PVC blister packaging, due to the low barrier property of PVC itself, the overall barrier property of the package is mainly determined by the PVC of the hot blister forming part. The pressure injury at the heat-sealed position has little effect on the shelf life of the drug. At the same time, since the PVC is transparent, the finished product is also easily accessible by observing the light, but there is also a fatal problem - packaging. The finished product can't see the drug, and the drug factory can only strengthen the inspection during the drug packaging process. Many domestic double-aluminum blister packaging machines are designed to facilitate the inspection of artificial eyes, and the operating areas after foaming and filling are designed to be convenient for personnel to inspect and handle. However, due to the speed of the drug packaging process, it is not easy to check with the naked eye, and the visual inspection has problems such as fatigue, personnel responsibility, etc., and it is impossible to ensure that the packaged tablets are 100% reliable.
In order to solve this problem, some double aluminum blister packaging equipments, after cold stamping into foam, in addition to the installation of "pinhole detection" equipment, also installed electronic camera contrast system before PTP aluminum foil heat sealing, will be fragmented, bad and The missing products are excluded from the production (there is also a high-precision electronic weighing system installed after packaging), and electronic imaging systems of different resolutions can be installed according to the strictness of the requirements of the products. Some electronic camera contrast systems may have some special requirements for the gloss and reflective properties of cold stamped rigid sheets. In electronic camera contrast systems without filters and polarizers, if cold stamped hard sheets are foamed The surface reflection is too strong, which will cause disturbance to the camera effect, affect its resolution, and even fail to distinguish the quality of the product.
The double-aluminum blister package made of cold-formed hard sheets is opaque on both sides, so it is impossible to check whether the PTP aluminum foil is crushed by the heat-sealing mold during the heat-sealing process. There are two cases in which PTP aluminum foil is crushed. One is to be pressed through the blister position without heat sealing. This pressure will completely destroy the sealing property of the medicine; the medicine may deteriorate in a short period of time. The press-through of the sealed blister position can be detected by a vacuum test. Another type of crushing of PTP aluminum foil is that the heat-sealed mold has burrs or the pressure of the aluminum foil at the sealing point due to excessive heat sealing pressure, which does not damage the airtightness of the blister package. Sex, can not be checked by vacuum test.
For ordinary transparent PVC blister packaging, due to the low barrier property of PVC itself, the overall barrier property of the package is mainly determined by the PVC of the hot blister forming part. The pressure injury at the heat-sealing position has little effect on the shelf life of the drug, and since the PVC is transparent, the finished product can easily judge whether there is a pressure-piercing problem by observing the light. The double-aluminum blister package made of cold-formed hard sheet is a highly barrier-packed product. The press-through of the PTP tin foil in the heat-sealed position does not affect the airtightness of the blister pack, but it is The barrier properties of the package and the shelf life of the drug have a large impact. The double-aluminum foil blister package is opaque in both eyes, and it is difficult to check and find out whether the heat-sealed position is pressed or not. In a sense, it is impossible to check and judge. In order to ensure that nothing is lost, in addition to strengthening the strict verification of the production process, the thickness of the PTP aluminum foil can be appropriately increased to solve the problem. The thickness of the aluminum foil in the general PTP aluminum foil is 20 μm, and the thickness of the PTP aluminum foil for the cold stamping hard film can be used. For 25μm aluminum foil, 30μm aluminum foil can be used for some high requirements.
The cold stamping blister packaging of medicines has developed over the past two decades. At present, the technology is maturing, the automation of related equipment is getting higher and higher, and the packaging is more perfect. With the localization of cold stamping formed hard sheets and double aluminum foil blister packaging machines and the reduction of prices, there will be more and more medicines used in cold stamping blister packaging in China.
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