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Pharmaceutical aluminum foil packaging ink and materials applications
Aug 21, 2017

Abstract: This paper focuses on the characteristics of pharmaceutical PTP aluminum foil printing and coating equipment, from the perspective of the final production of the user, the use of medicinal aluminum foil, pharmaceutical PVC hard film, printing ink, adhesives and so on the development and prospects. Keywords: medicinal aluminum foil, medicinal PVC hard film, printing ink, adhesive drug aluminum plastic blister packaging, also known as blister eye packaging, referred to as PTP (Press Through Packing). The packaging of this medicine has many advantages: First, the patient can provide a dose of drug packaging, both convenient and cost-effective. Second, the aluminum plastic blister packaging to protect the performance of drugs, production speed, low cost, storage required relative space is small, light weight, easy to transport. Third, the security is good, because the blister packaging aluminum foil printed on the text that the hair in the release of many tablets can avoid the wrong medicine, the occurrence of a mixture. Therefore, the pharmaceutical industry will be more substantial increase in the amount of high-quality blister packaging, some experts predict that the packaging for pharmaceutical blister materials will account for future pharmaceutical tablets, capsule packaging 60% to 70%. In the "pharmaceutical packaging aluminum foil" national standards for health food, medical aluminum foil printed text surface quality requirements are clear, the protective layer, the performance of the adhesive layer also have physical and chemical indicators, so as to protect the PTP aluminum foil has a good barrier , Health safety, heat sealing and good physical and mechanical properties. And in the PT P aluminum foil printing coating production process to achieve the standard performance, still need to be familiar with the application of raw material properties, and in the operation process should pay attention to some problems. At present, health food and pharmaceutical tablets, capsule packaging using blister packaging is becoming more and more common. Blister packaging is also known as industrial pure aluminum foil as the substrate, in the medicinal PTP aluminum foil coating machinery, the use of gravure printing and roller coating method in the aluminum foil surface printed text patterns, and coated protective layer, in the aluminum foil One side coated with adhesive layer of the linkage process. Drug blister packaging is the rise of Europe in the thirties of the twentieth century, China in the early seventies used blister packaging materials mainly rely on imports, the eighties China's Guangzhou, Lianyungang, Jinzhou and other places has introduced Japan's medicinal Aluminum foil gravure coating equipment and its application technology, but the main materials such as substrate aluminum foil are imported. To the nineties, China has been able to manufacture monochrome or multi-color aluminum foil printing coating equipment, and can print gold series of pharmaceutical packaging of aluminum-plastic products, and blister packaging used in the use of medicinal aluminum foil materials, , Aluminum foil with protective agent, adhesives have been made, and to meet domestic demand. First, the characteristics of medicinal PTP aluminum foil printing coating machinery The device is mainly by the printing system, coating system, drying system and retractable system and other components. Throughout the production process, the surface quality of the gravure printed text pattern and the heat seal strength to be achieved with the adhesive layer, the adhesion of the protective layer and its drying temperature, and the speed and tension control of the coating machine operation are required in the process operation Strictly grasped. 1, aluminum foil printing system: the principle is through the printing roller concave surface to print text patterns, commonly known as gravure printing. It is the plate cylinder through the outer processing made of plate graphic, graphic part of the drum copper surface is corroded into ink holes or pits, non-graphic part of the outer layer of copper outer surface of the drum itself. The printing drum rotates in the ink tank and is filled with thin ink in each ink hole. When the drum rotates out of the surface ink tank, the excess ink is scraped by a doctor blade mounted on the surface of the plate cylinder go with. When the plate cylinder rotates and the substrate aluminum foil is contacted, the surface has the elastic impression cylinder to press the aluminum foil to the plate cylinder, so that the ink in the ink hole is transferred to the surface of the aluminum foil. Throughout this process, the process is the printing process of aluminum foil. 2. Aluminum foil coating system The so-called aluminum foil coating system is a device for coating (dipping) an adhesive or a protective agent on an aluminum foil substrate. Most of the equipment is coated with a concave roll, also known as a cable coating. The applicator is characterized by a carved recessed shape on the surface of the drum and the anilox roll is immersed in the roll chute. When the roller is rotated, the excess paint (adhesive or protective agent) is scraped by the scraper, The coating in the concave surface of the anilox roller surface is transferred to the aluminum foil substrate between the groove of the concave roller and the embossing roll. The amount of coating depends on the depth and density of the pits, and the density is like a sieve. The sieve is the same as the sieve. The more thick, the greater the diameter and depth of the pit, the more the coating will be, the greater the amount of coating corresponding. Such as 200 pyramidal veneers, that is, 200 pits per inch, about 8 pits per millimeter, the coating capacity of only 1,000 square feet, weighing about 0.5 pounds, or 2.4 grams / square meter. The 24 triangular thread, the coating of the amount of up to 13 pounds per 1000 square feet, that is, 63 grams / square meter. The viscosity of the fluid coating must be as low as possible to ensure that the coating can be smoothly transferred from the anilox roller to the aluminum foil substrate under nip pressure. 3, drying and receiving and unwinding system: drying system are used far-infrared drying, and divided into five drying areas, each drying area are set to have a different temperature gradient, so that the printed graphic and coated Layer is even dry. The unwinding system uses a magnetic clutch device to ensure the stability of the tension of the aluminum foil roll. Second, the pharmaceutical packaging with aluminum foil pharmaceutical blister packaging used in aluminum foil is sealed in the plastic hard film sealing material, also known as the cap material, commonly known as PTP medicinal aluminum foil. It is a hard industrial aluminum foil as the base material, with non-toxic, corrosion-resistant, impermeable, hygienic heat, moisture, etc., it is easy to high temperature sterilization, and can light, protect the drug from light damage , Aluminum foil cover in the plastic sheet with a plastic seal on the printing machine before the printing of the text description, and coated with a protective agent, the other side of the aluminum foil coated with adhesive. The purpose of coating the protective agent is to prevent the mechanical wear of the aluminum foil surface ink, but also to prevent the aluminum foil in the mechanical winding of the outer ink and the inner layer of adhesive contact caused by pollution. The effect of the coating adhesive is such that the aluminum foil and the plastic sheet have a good adhesive strength. PTP aluminum foil used in the production of raw materials for the industrial pure aluminum foil, the general requirements of the thickness of 0.02mm, tensile strength of 98kPa, breaking strength of 90kPa, the surface clean, flat, no wrinkles, no indentation damage,Surface wetting tension of not less than 32. Aluminum foil material is 99% of the electrolytic aluminum, after the extension and other means of processing made of non-toxic and tasteless, with high quality conductivity and shading and high moisture resistance, gas barrier. For medicinal, health care products with aluminum foil pinhole requirements of the diameter of 0.1 ~ 0.3mm pinhole not more than 1 / m2. As the aluminum foil pinhole is a penetrating defect, health food, drugs by oxygen, water vapor and light intrusion will reduce the efficacy or deterioration, so the requirements of the pinhole is very strict; another aluminum foil thickness if the required Of the deviation (10%), the adhesive layer and the protective layer of the coating will have an impact. At present, the application status of China's pharmaceutical aluminum foil, compared with the quality of imported products, there are still gaps, mainly in the following areas: 1, medicinal aluminum foil pinhole number can not meet the requirements. The number of aluminum foil pinholes is a penetrating defect that seriously affects the barrier properties of aluminum foil, especially on the packaging of the drug. It is easy to reduce the oxygen, water vapor and light. 2, domestic medicinal aluminum foil thickness is uneven, low tensile strength. The thickness of different, will affect the use of adhesive coating uniformity, thereby affecting the aluminum foil and plastic heat sealing strength. Low tensile strength will lead to the printing process when the volume of aluminum foil after the application of tension after the broken foil, can not be continuous printing operations. 3, aluminum foil surface residual grease. As the aluminum foil in the rolling, stretching the process of oil to cool the stereotypes, so in the aluminum foil products often exist in the oil. This surface of the oil will affect the aluminum foil printing ink and protective agent and aluminum foil material adhesion, resulting in a series of quality problems, such as illegible, protective agent and aluminum foil stripping. Especially in the aluminum foil surface coated with gold or printed color patterns, due to the presence of grease on the surface of aluminum foil, so that the word and the aluminum foil with almost no adhesion, resulting in fade off the word, serious impact on product quality. Third, the pharmaceutical packaging blister materials Pharmaceutical packaging with the blister material, the current majority of the use of polyvinyl chloride (PVC) hard film and polyvinylidene chloride (PVDC) hard film. As the drug on the moisture, moisture, light through the very sensitive, easy to be affected by this deterioration or failure. So the requirements of plastic hard film to have a good water, steam, light and other barrier, polyvinyl chloride (PVC) in the resistance to moisture and gas barrier is not ideal, manufacturers have polyvinylidene chloride (PVDC) or Its composite materials are used in this field. Polyvinylidene chloride (PVDC) or its composite material has good barrier properties for oxygen and water vapor, carbon dioxide (CO2) in the air. Compared with the same thickness of the material, the barrier capacity of PVDC to oxygen is polyethylene PE) 1500 times, 100 times the polypropylene (PP), polyester (PET) 100 times, water blocking performance and resistance to air and other properties are better than PVC. In addition, PVDC sealing performance, impact strength, tensile strength, durability and other indicators can meet the requirements of pharmaceutical packaging. Another trend is: the gradual use of such as PVC / PVDC / PE, PVDC / OPP / PE and other plastic composite materials to replace the use of plastic hard film. Its broad masses of the comprehensive advantages can be reflected in one, will greatly meet the packaging requirements, performance indicators, is the future direction of development. Fourth, aluminum foil printing ink with aluminum foil printing

 

 

Ink should have a good adhesion to the aluminum foil, printed text patterns to be strong and solid, while the solvent release performance to fast, good heat resistance, abrasion resistance and gloss performance, and non-toxic, will not pollute the packaging Drugs, practical viscosity should be consistent with the speed of aluminum foil printing and drying requirements. Aluminum foil printing ink is currently divided into two categories: one for the polyamide-based ink. This ink has a good adhesion to all kinds of substances, dispersibility, gloss, abrasion resistance, and solvent release is good, soft, and more used for printing plastic film. When used in the printing of aluminum foil materials, the excellent performance of the ink can be expressed, and its heat resistance can meet the requirements of aluminum foil printing. The other is based on vinyl acetate vinyl acetate copolymer resin / acrylic resin as the main component of the aluminum foil special ink, which is characterized by bright color, high concentration, and aluminum foil adhesion is particularly strong, good transparency, but because of Gravure printing, the solvent volatile, for health food, medicinal PTP aluminum foil printed sheet is likely to cause gravure roll ink hole in the ink dry, deposition, paste paste phenomenon. 5, aluminum foil printing ink, solvent materials, performance and detection methods Aluminum foil printing ink mainly by the pigment, filler, synthetic resin and solvent composition. The color rate is 95% ~ 110% compared with the standard sample; fineness, ≤25μm; viscosity, 25 ℃ under the conditions of No. 4 coating The cup is 25 ~ 27s. The solvent used in the ink is used in the printing and coating process, mainly: ketone solvents such as acetone (CH3COCH3) is a colorless volatile and flammable liquid, melting point -94.6 ℃, boiling point 56.5 ℃, flash Point -20 ℃, more lively chemical properties, the explosion limit of 2.55% to 12.8% (volume ratio). Ester solvents are ethyl acetate (CH3COOC2H5), also known as ethyl acetate, colorless flammable liquid, fruit aroma, acetic acid and ethanol in the presence of sulfuric acid in the distillation and obtained, melting point -83.6 ℃, boiling point 77.1 ℃, easy to fire, slightly soluble in water, the explosion limit of 7.5% -11.2%. Solvent detection method - indicators: its water content should not exceed 0.2%, the purity of not less than 99% (according to GB3728-91). Control method: Using a gas phase spectrometer and a thermal conductivity detector, nitrogen was used as a carrier to make a set of solvent peaks, peaks and concentrations for different concentrations. The working curves were obtained. Then, under the same conditions, Samples were made at the corresponding peak height to get the concentration. Specific operation: a) gasification chamber of the gasification chamber temperature of 250 ℃, the detection room temperature of 200 ℃, the column temperature of 150 ℃, with polymer porous ball as column packing. B) Distillate and chemically purify the solvent for analytical reagents (different for different solvents). C) Prepare the standard solvent with the water content of 0.02%, 0.05%, 0.1%, 0.15% and 0.2% with the purified solvent and water. The injection volume was 0.1ml injection. Under certain bridge current and attenuation, The response peak of the water is plotted against the peak height of the water to obtain the working curve. D) each batch of raw materials, under the same conditions, the same injection, with the peak height in the work curve to get the corresponding concentration, compared with the standard. E) Whether or not the condition is the same as before, every time the boot test must be done the work curve. F) the same preparation of 100% purity, 99.5%, 99.2%, 99% of the solubility, the injection is 0.1ml into the amount of the measured diluent peak height, the peak height of the plot, get the working curve, And then sampling also peak high, according to the work curve to get the corresponding concentration. 6, aluminum foil printing adhesive In the aluminum foil adhesive, the main component of polyvinyl acetate and nitrocellulose mixed solvent-based adhesive, which is mainly composed of polymer compounds. The solid content of the binder solution is generally about 18-22%, can meet the aluminum foil and plastic hard film after hot pressing heat sealing strength. Industrial production of medicinal aluminum foil is printed on the surface of aluminum foil text or pattern coated with ink protection agent, and the other side of the aluminum foil coated with adhesive. The purpose of applying a protective agent on the surface of the aluminum foil is to prevent the printing of the ink layer on the surface of the aluminum foil, and to prevent the contamination of the drug when the outer ink is brought into contact with the inner layer of the adhesive layer during the mechanical operation. The role of the adhesive layer is to make aluminum foil and plastic hard film heat can be bonded together, so that drugs are sealed up. Most of the protective agents currently used are solvent-based, and their main chemical components are: nitrocellulose synthetic resin, plasticizer, real solvent, cosolvent, diluent and so on. These ingredients are mixed according to a certain ratio, with the reactor stirred to form a solvent, the printing machinery coated on the aluminum foil to produce a protective film. The specific requirements of the protective agent is: with the aluminum foil has a good coating adhesion and flexibility, transparent gloss good, good heat resistance, no residual odor, to protect the printing ink layer does not fall off, and high wear resistance. The currently used adhesives are mainly monocomponent sols or bicomponent sols. One-component sol is the main component of natural rubber or synthetic rubber, can also be nitrocellulose, acrylic and solvent from the deployment. As the main agent is a high molecular elastomer, together with the tackifier as auxiliaries, organic solvents can be used in the reactor by stirring the reaction to mix into the emulsion. This emulsion has a dry and hot melt, aluminum foil coated with a certain degree of adhesive strength, and after dry coating with PVC hot paste, heat sealing better, this adhesive has been widely used In production. However, with the pharmaceutical packaging materials, hygiene and sealing performance requirements, the use of two-component adhesive trend is becoming increasingly evident. Two-component adhesive is a polyurethane adhesive, which is mainly composed of the main agent and ammonia curing agent. The main agent generally contains many active hydrogen such as hydroxyl, ammonia and other substances, curing agent is composed of polyisocyanate compounds. When the curing agent in the isocycline and the main agent molecules in the active hydrogen contact, it will automatically add reaction, the formation of Ammonic acid ester structure, so that the main agent and curing agent after the combination of molecular weight will increase , And even to produce a branched structure of the three-dimensional structure of the cross-linked products. It has a good resistance to high and low temperature, anti-medium erosion, high adhesion. As the polyurethane molecules contain a large number of polar group, the dip moment is large, the material is a great adhesion, so the aluminum foil, plastic and other packaging materials play a role. In addition, the isofatide in the curing agent is a very lively reaction group, which in addition to the main agent molecules in the active hydrogen reaction, but also with the surface material

 

 

The active hydrogen in the sub-reaction, the formation of chemical bonds, so that the adhesive molecules with the bonding material from the bridge, resulting in a stronger adhesive force. Because of this adhesive bonding strength, widely used in aluminum-plastic composite packaging and various types of plastic film composite flexible packaging products. The future application of the adhesive for aluminum foil coating will gradually develop toward the solvent-free direction, and its composition is also a two-component type of polyurethane adhesive, with the exception that the main agent and the curing agent have a higher viscosity at room temperature With the rolling, is a semi-solid material, the use of the main agent and curing agent in proportion to the mixture into the heating function of the container, heating and then let the viscosity decreased, and then through the insulation function of the intaglio roll coated to the printing aluminum foil Material, the glue does not need to bake directly after the hot drying, because the glue itself without any solvent, can be directly with another pottery material for bonding, so there is no exhaust emissions, is conducive to environmental protection, and because not Need to be in the printing coating equipment with a large drying machine drying dryer and blast ventilator, but also save equipment investment costs. Seven, aluminum foil and plastic hard film after sealing the drug packaging plant will be printed after the aluminum foil provided to the pharmaceutical factory, through the automatic blister packaging machine on the aluminum foil and plastic hard film or composite materials for hot pressing, and fill Into the drug. The whole process is: plastic hard chip blister molding → put the drug or capsule into the blister → plastic hard film and aluminum foil hot pressing sealing → cut in accordance with the design requirements cut into a plate fast. In order to ensure the quality of the enclosed blister pack, the printing manufacturer should first carry out the sealing performance test. The common method is to put the sample in a container which is subjected to 0.1mPa, tightly sealed and vacuum 80 ± 13Kpa. After 30 seconds, inject colored water, restore normal pressure, open the lid to check whether the liquid into the blister. Blister packaging damp heat test and other test methods can be ZBC08003 "pharmaceutical aluminum plastic blister packaging" within the requirements of quality inspection. 8, aluminum foil printing precautions 1, the deposition of ink freezing the necessary pre-treatment, the method is to freeze the frozen ink or increase the temperature (water bath). If the ink storage time is too long, the ink will appear deposition, resulting in the upper layer of ink resin solution, the lower pigment, the upper color light, the lower color deep, should also be used after mixing. 2, the amount of solvent added to the ink should be appropriate. When the viscosity of the original ink need to use a large number of thinner dilution, should be added side of the diluent while stirring, so that the diluent evenly distributed throughout the ink. The dosimeter is measured between about 20 and 30 s. Indoor temperature and humidity, the impact on the ink concentration, it is best to use the ink concentration detector to determine the amount of solvent added, and according to the temperature and humidity changes, at a certain time to determine the concentration of ink. The use of gravure printing and printing of aluminum foil products, the ink concentration is too low, will cause the printed text pattern color is not bright, the textured paste paste phenomenon; ink concentration is too high, the map will produce cracks, not only waste ink, and Easy to cause the printing surface is not smooth, not beautiful. 3, according to the aluminum foil printing machine speed and printing gravure roll ink depth to develop the best ink. Adhesives should meet the requirements of PTP aluminum foil adhesive is

Coated on the inside of the aluminum foil, its role is to make aluminum foil and medicinal PVC hard film can be a strong hot press, so that plastic pockets of drugs and the outside world separated from the outside, to achieve the purpose of sealing drugs. In the process of loading the drug for heat sealing, the adhesive layer is activated by hot pressing, which is firmly bonded with PVC plastic hard chip, which requires the adhesive layer and PVC resin should have good heat sensitivity and with the substrate Of the compatibility. Printing and coating to master the dry temperature and time of the printed text and the adhesive layer and the protective layer in the coating process are required to dry, aluminum foil surface coating drying needs a process, it needs to stay in the equipment drying channel for some time , Depending on the speed of the coating machine winding and the temperature selected in the bunker should be maintained in the corresponding relationship between the two. 4, the adhesive should meet the requirements. PTP aluminum foil adhesive is coated on the inside of the aluminum foil, its role is to make aluminum foil and medicinal PVC hard film can be a strong hot pressing, so that the plastic hard film blister medicine separated from the outside world, to make the drug sealed purpose. In the process of loading the drug for heat sealing, the adhesive layer is activated by hot pressing, which is firmly bonded with PVC plastic hard chip, which requires the adhesive layer and PVC resin should have good heat sensitivity and with the substrate Of the compatibility. 5, due to the different thickness of aluminum foil, physical and mechanical properties are different, and the material in the equipment running when the thermal expansion, shrinkage, extensibility also have some differences, it should not stay at a very high temperature too long, Otherwise the aluminum foil is also prone to wrinkle and surface discoloration phenomenon. General bake channel temperature control in 170 ℃ ~ 210 ℃ is appropriate. Printing coating speed, coating tension and coating thickness and bonding quality analysis of the coating process of coating thickness of the adhesive layer of plastic PVC hard film on the degree of strong adhesion, the adhesive layer is too thin, hot PVC hard film will be due to lack of material and reduce the bond fastness; adhesive layer coating is too thick, not only increase the cost, but also to increase the drying time, so need to control in the appropriate thickness range. The coating thickness of the adhesive layer is affected by the concentration of the adhesive, the coating tension, the coating speed, and the number of the anilox rollers. In the case of the shape, depth, the number of lines per inch and the contact pressure between the two rollers, the greater the adhesive concentration, the smaller the coating tension, the faster the coating, the more coating thick. The thickness of the adhesive layer is therefore generally adjusted by the concentration of the adhesive and the tension of the coating machine. Different types of aluminum foil on the adhesive layer thickness requirements are also different, the general coating thickness should be controlled at 3.5 ~ 7um appropriate. In the aluminum foil printing coating, the machine speed, temperature, tension between the three are interrelated, but also contain each other, between them with good or bad, directly related to the quality of aluminum foil printing coating. In short, as the production of medicinal "PTP" packaging materials manufacturers, in the prepress selection of high-quality thick material is to produce customer satisfaction products prerequisite, aluminum foil and ink and other printing materials, the quality of the quality of the product Good and bad, before printing to avoid the quality of the problem, must be on the detection and control of raw materials.

 

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