The blister packaging of pharmaceuticals began in Europe in the 1930s. In our country, blister packaging and its “PTP†materials were mainly imported in the early 1970s. In the 1980s, China has successively introduced Japan's pharmaceutical “PTP†aluminum foil printing and coating equipment from Guangzhou, Lianyungang, and Jinzhou, and its main raw materials still need to be imported. In the 1990s, our country can not only manufacture monochrome "PTP" pharmaceutical aluminum foil coating equipment, but also mass production of color, gold series "PTP" products, the main material of aluminum foil and aluminum foil ink, adhesives can meet Domestic production needs. As a manufacturer of pharmaceutical "PTP" packaging materials, the selection of high-quality raw materials is a prerequisite for the production of customer-satisfactory products. Therefore, based on the performance of homemade "PTP" materials and printing materials, this article describes its quality standards and testing methods. And use these materials in the gravure coating process problems that appear to analyze its causes.
1. Medicinal aluminum foil printing principle and its material performance standards 1.1 The principle of aluminum foil printing: aluminum foil printing is carried out on a dedicated aluminum foil printing and coating machinery, the principle of which is to complete the printed text or pattern through the concave surface of the printing roller surface. It is also called gravure printing. It is to make the printing plate plate through the outer processing to make the printing plate artwork, the picture part is eroded into the ink hole or the pit on the copper surface of the roller, the non-graphic part is the copper surface of the roller itself, India The platen roller rotates in the ink tank, and each ink hole is filled with thin ink. When the roller rotates to rotate out of the surface ink tank, the excess ink on the upper surface is wiped by the ink installed on the surface of the plate cylinder. When the knife is scraped away and the printing roller rotates in contact with the aluminum foil, the surface of the printing roller is pressed against the printing roller by an elastic embossing roller, so that the ink of the ink hole is transferred to the surface of the aluminum foil and the printing of the aluminum foil is completed. The main raw materials used in printing are pharmaceutical aluminum foil, aluminum foil ink and solvent material, and aluminum foil coating binder material. The following is a brief introduction.
1.2 The performance of medicinal aluminum foil and its physical and mechanical strength testing.
Medicinal aluminum foil is made of electrolytic aluminum with a purity of 99% or more. It is non-toxic and odorless, has excellent electrical conductivity and shading properties, and has extremely high moisture resistance, gas barrier and taste protection. Aluminum foil has a highly dense metal crystal structure, it can completely block any gas, water vapor and light, so it can protect the most effective drugs, in modern packaging almost all opaque or high barrier composites are used to block aluminum foil The layer, especially pharmaceutical packaging, requires the aluminum foil's physical and mechanical properties to be greater than 90 Kpa in attack strength, 98 Mpa in tensile strength, and 0.02 mm in thickness. The surface is clean and free from wrinkles, indentations and damage. No sheet of fluorescent material, pinholes with a diameter greater than 0.3 mm, no more than one per square meter, and a wet surface tension of not less than 32. 1Aluminum foil attack strength measurement: Take 40 mm×40 mm specimens from the aluminum foil finished product with an attack strength meter, place the pieces one by one in the cracks of the instrument, and turn on the oil pump, depending on the indicated numerical value on the pressure gauge, the attack strength is not low. At 90K pa. 2 Needle hole test: Use a wooden box of 800mm x 600mm x 300mm or an appropriate volume. Install a 30W fluorescent lamp inside the wooden box. Put a glass plate on the wooden box to line the black paper and leave 400 x 250mm space to check the pinhole of the aluminum foil. In the finished product of aluminum foil, 10 samples of 400 mm in length and 250 mm in width were taken and placed one by one on a pinhole inspection table, and the pinholes were checked in the dark place to see if they met the standards. 3 Aluminum foil fluorescent substances were measured using an ultraviolet analyzer with wavelengths of 254mm and 365mm. Five pieces of 100 mm×100 mm lines were taken from the finished product of the aluminum foil. The fluorescence was not observed in the above wavelengths. 5 The tensile strength of aluminum foil is performed on a fully automatic tensile testing machine. Take a sample of a certain size of aluminum foil. The sample is clamped on the upper and lower clamps of the testing machine, and the tensile testing machine is started. Record whether the test data and the standard control meet the standards. Claim.
1.3 The properties and detection methods of ink and solvent materials for aluminum foil: 1 Composition of ink for aluminum foil: It is mainly composed of pigment, filler, synthetic resin and solvent. 2 Quality standards for aluminum foil inks: Color: Approximate to standard color samples (scratch visual inspection), tinting strength: 95-110% compared to standard samples. Fineness: ≤ 25μm. Viscosity: 25-70S with No. 4 coating cup at 25°C. 3 ink solvent performance: refers to the solvent used in the printing and coating process is mainly represented by: aromatic hydrocarbons of xylene (C 6 H 4 (OH 3) 2) is the fraction of coal tar by light oil or Catalytic reforming of light gasoline by fractionation or by disproportionation of toluene obtained, is a colorless, transparent and volatile liquid, aromatic odor, toxic, insoluble in water. Ketone solvent is represented by acetone (CH 3 COCH 3) is a colorless volatile and flammable liquid, the melting point of -94.6 ° boiling point 56.5 ° flash point -20 ° more active chemical properties, explosion limit 2.55- 12.8% (volume).
The ester solvent is ethyl acetate (CH 3 COOC 2 H 5), also known as ethyl acetate. The colorless flammable liquid has a fruit aroma. It is obtained by distilling acetic acid and ethanol after heating in the presence of sulfuric acid. Melting point -83 .6 ° Boiling point 77.1 °, easy to fire, slightly soluble in water, the explosion limit of 7.2-11.2%. 5 solvent detection method: the water content of the solvent should not exceed 0.2%, and its purity is not less than 99%. Control method: using a gas chromatograph, using nitrogen as a carrier, and a thermal conductivity cell detector, to make a set of solvent peaks with different concentrations, peak heights and concentrations, to obtain a working curve, and then sample each batch of solvent under the same conditions. The corresponding peak height is obtained and the concentration is obtained. The specific detection method: using gas chromatography with nitrogen as a carrier, thermal conductivity cell detector, a set of different concentrations of solvent peaks, peak height and the role of the concentration, the working curve, and then under the same conditions for each batch of solvent sampling Make the corresponding peak height to get the concentration. The specific detection method: gas chromatography, gasification chamber temperature of 250 °C detection chamber temperature of 200 °C, column room temperature of 150 °C to polymer porous beads for column packing. An analytically pure reagent that chemically purifies the solvent is distilled. The purified solvent and water were used to prepare a standard solvent with water content of 0.02%, 0.05%, 0.1%, 0.15%, and 0.2%. The injection volume of 0.1 ml was sampled. Under a certain bridge current and attenuation, the response peak of water was obtained, and the peak height of water was plotted against the concentration to obtain the working curve. Samples were taken from each batch of raw materials and the same sample was injected under the same conditions. Peak heights were used to compare the corresponding concentrations with the standards in the working curve. Each start-up test must be done with the working curve, regardless of whether the conditions are the same as before, the same preparation purity of 100%, 99.8%, 99.5%, 99.2%, 99% of the concentration, the injection is 0.1 Inject milliliters, the peak height of the test diluent is obtained, the peak height vs. concentration is plotted, the working curve is obtained, and then the peak height is also obtained by sampling, and the corresponding concentration is obtained according to the working curve.
1.4 Adhesive properties and testing for aluminum foils; currently used adhesives are two-component polyurethane adhesives because the main agent is composed of many active hydrogens, such as hydroxylamino substances, and the curing agent is polyisocyanate. The compound composition, when the isocyanate group in the curing agent is in contact with the active hydrogen in the main agent molecule, it will automatically carry out the addition reaction to generate the urethane structure, so that the molecular weight is multiplied after the combination of the main agent and the curing agent. Even cross-linked products with a three-dimensional conformation with a branched structure are characterized by high temperature resistance, high adhesion, and the like. The isocyanate group (-NCO) in the curing agent is an active reactive group that, in addition to reacting with the active hydrogen in the main agent molecule, also stays reactive with the active hydrogen in the surface material molecules of the adherent material. Chemical bonds allow the adhesive molecules to act as a bridge to the aluminum foil PVC material, resulting in stronger adhesion. The main indicators of adhesive testing: 1 Determination of solid content: take the adhesive 5 grams placed in a beaker, the beaker was dried in an oven at 110 °C for 2 hours and then reweighed: solid content = dry film weight / 5 g × 100% . 2 Measurement of adhesive viscosity: The viscosity at 25°C was measured with a rotational viscometer. The method is: under the conditions of 25 °C, the sample glue thermostat 0.5 hours or more, according to the viscosity of the provided adhesive, using a viscometer to check the comparison. 3 Acidity According to GB/T1458-83, it can be measured with a glass telegraph acidometer. Precision pH can also be used to detect its pH.
2. The main quality problems and analysis of medicinal aluminum foil printing are easy to appear 2.1 The appearance quality requirements of pharmaceutical aluminum foil printing 1 aluminum foil printing surface hue is correct, bright uniform, super bright color, ink soft, clean edges of the imprint. 2 Printing fastness: The use of transparent adhesive tape does not discolor ink. 3 pattern text, lines are clear and complete, not deformed. 3 pattern text, lines are clear and complete, not deformed. 5 Printed textured layers are rich and outlets are clear. 5 The appearance of the printing is clean and tidy, no obvious pollution of the knife wire 6 after the final inspection of the same color density deviation and the same batch of the same color color difference indicators meet the requirements.
2.2 Foil printing word or pattern line incomplete: Analysis: 1 ink drying too fast, resulting in dry version. 2 excessive wind and heat affect the printing roller concave surface drying. 3 plate corrosion, ink adhesion less 5 squeegee knife in the distance between the roller and the imprinting point too far. 5 The speed is too slow.
2.3 Aluminum foil printed surface colored lines (lines): Analysis: 1 Squeegee knife close to the printing roller at the hard particles, impurities must be removed. If you encounter a fixed line must be sharpened or tool change can be. 2 If the lines are fixed, there are hard impurities embedded in the printing roller outlets and must be removed by parking. 3 When the new roll was put into use, it was found that the fixed line mark was generally caused by aluminum plating and was then sanded or repaired, resulting in pinholes. 4. The resin and pigment in the ink are not ground, it will also cause line marks, which must be removed with steel mesh filter. 5 Scraper angle and position, hardness must be adjusted properly.
1. Medicinal aluminum foil printing principle and its material performance standards 1.1 The principle of aluminum foil printing: aluminum foil printing is carried out on a dedicated aluminum foil printing and coating machinery, the principle of which is to complete the printed text or pattern through the concave surface of the printing roller surface. It is also called gravure printing. It is to make the printing plate plate through the outer processing to make the printing plate artwork, the picture part is eroded into the ink hole or the pit on the copper surface of the roller, the non-graphic part is the copper surface of the roller itself, India The platen roller rotates in the ink tank, and each ink hole is filled with thin ink. When the roller rotates to rotate out of the surface ink tank, the excess ink on the upper surface is wiped by the ink installed on the surface of the plate cylinder. When the knife is scraped away and the printing roller rotates in contact with the aluminum foil, the surface of the printing roller is pressed against the printing roller by an elastic embossing roller, so that the ink of the ink hole is transferred to the surface of the aluminum foil and the printing of the aluminum foil is completed. The main raw materials used in printing are pharmaceutical aluminum foil, aluminum foil ink and solvent material, and aluminum foil coating binder material. The following is a brief introduction.
1.2 The performance of medicinal aluminum foil and its physical and mechanical strength testing.
Medicinal aluminum foil is made of electrolytic aluminum with a purity of 99% or more. It is non-toxic and odorless, has excellent electrical conductivity and shading properties, and has extremely high moisture resistance, gas barrier and taste protection. Aluminum foil has a highly dense metal crystal structure, it can completely block any gas, water vapor and light, so it can protect the most effective drugs, in modern packaging almost all opaque or high barrier composites are used to block aluminum foil The layer, especially pharmaceutical packaging, requires the aluminum foil's physical and mechanical properties to be greater than 90 Kpa in attack strength, 98 Mpa in tensile strength, and 0.02 mm in thickness. The surface is clean and free from wrinkles, indentations and damage. No sheet of fluorescent material, pinholes with a diameter greater than 0.3 mm, no more than one per square meter, and a wet surface tension of not less than 32. 1Aluminum foil attack strength measurement: Take 40 mm×40 mm specimens from the aluminum foil finished product with an attack strength meter, place the pieces one by one in the cracks of the instrument, and turn on the oil pump, depending on the indicated numerical value on the pressure gauge, the attack strength is not low. At 90K pa. 2 Needle hole test: Use a wooden box of 800mm x 600mm x 300mm or an appropriate volume. Install a 30W fluorescent lamp inside the wooden box. Put a glass plate on the wooden box to line the black paper and leave 400 x 250mm space to check the pinhole of the aluminum foil. In the finished product of aluminum foil, 10 samples of 400 mm in length and 250 mm in width were taken and placed one by one on a pinhole inspection table, and the pinholes were checked in the dark place to see if they met the standards. 3 Aluminum foil fluorescent substances were measured using an ultraviolet analyzer with wavelengths of 254mm and 365mm. Five pieces of 100 mm×100 mm lines were taken from the finished product of the aluminum foil. The fluorescence was not observed in the above wavelengths. 5 The tensile strength of aluminum foil is performed on a fully automatic tensile testing machine. Take a sample of a certain size of aluminum foil. The sample is clamped on the upper and lower clamps of the testing machine, and the tensile testing machine is started. Record whether the test data and the standard control meet the standards. Claim.
1.3 The properties and detection methods of ink and solvent materials for aluminum foil: 1 Composition of ink for aluminum foil: It is mainly composed of pigment, filler, synthetic resin and solvent. 2 Quality standards for aluminum foil inks: Color: Approximate to standard color samples (scratch visual inspection), tinting strength: 95-110% compared to standard samples. Fineness: ≤ 25μm. Viscosity: 25-70S with No. 4 coating cup at 25°C. 3 ink solvent performance: refers to the solvent used in the printing and coating process is mainly represented by: aromatic hydrocarbons of xylene (C 6 H 4 (OH 3) 2) is the fraction of coal tar by light oil or Catalytic reforming of light gasoline by fractionation or by disproportionation of toluene obtained, is a colorless, transparent and volatile liquid, aromatic odor, toxic, insoluble in water. Ketone solvent is represented by acetone (CH 3 COCH 3) is a colorless volatile and flammable liquid, the melting point of -94.6 ° boiling point 56.5 ° flash point -20 ° more active chemical properties, explosion limit 2.55- 12.8% (volume).
The ester solvent is ethyl acetate (CH 3 COOC 2 H 5), also known as ethyl acetate. The colorless flammable liquid has a fruit aroma. It is obtained by distilling acetic acid and ethanol after heating in the presence of sulfuric acid. Melting point -83 .6 ° Boiling point 77.1 °, easy to fire, slightly soluble in water, the explosion limit of 7.2-11.2%. 5 solvent detection method: the water content of the solvent should not exceed 0.2%, and its purity is not less than 99%. Control method: using a gas chromatograph, using nitrogen as a carrier, and a thermal conductivity cell detector, to make a set of solvent peaks with different concentrations, peak heights and concentrations, to obtain a working curve, and then sample each batch of solvent under the same conditions. The corresponding peak height is obtained and the concentration is obtained. The specific detection method: using gas chromatography with nitrogen as a carrier, thermal conductivity cell detector, a set of different concentrations of solvent peaks, peak height and the role of the concentration, the working curve, and then under the same conditions for each batch of solvent sampling Make the corresponding peak height to get the concentration. The specific detection method: gas chromatography, gasification chamber temperature of 250 °C detection chamber temperature of 200 °C, column room temperature of 150 °C to polymer porous beads for column packing. An analytically pure reagent that chemically purifies the solvent is distilled. The purified solvent and water were used to prepare a standard solvent with water content of 0.02%, 0.05%, 0.1%, 0.15%, and 0.2%. The injection volume of 0.1 ml was sampled. Under a certain bridge current and attenuation, the response peak of water was obtained, and the peak height of water was plotted against the concentration to obtain the working curve. Samples were taken from each batch of raw materials and the same sample was injected under the same conditions. Peak heights were used to compare the corresponding concentrations with the standards in the working curve. Each start-up test must be done with the working curve, regardless of whether the conditions are the same as before, the same preparation purity of 100%, 99.8%, 99.5%, 99.2%, 99% of the concentration, the injection is 0.1 Inject milliliters, the peak height of the test diluent is obtained, the peak height vs. concentration is plotted, the working curve is obtained, and then the peak height is also obtained by sampling, and the corresponding concentration is obtained according to the working curve.
1.4 Adhesive properties and testing for aluminum foils; currently used adhesives are two-component polyurethane adhesives because the main agent is composed of many active hydrogens, such as hydroxylamino substances, and the curing agent is polyisocyanate. The compound composition, when the isocyanate group in the curing agent is in contact with the active hydrogen in the main agent molecule, it will automatically carry out the addition reaction to generate the urethane structure, so that the molecular weight is multiplied after the combination of the main agent and the curing agent. Even cross-linked products with a three-dimensional conformation with a branched structure are characterized by high temperature resistance, high adhesion, and the like. The isocyanate group (-NCO) in the curing agent is an active reactive group that, in addition to reacting with the active hydrogen in the main agent molecule, also stays reactive with the active hydrogen in the surface material molecules of the adherent material. Chemical bonds allow the adhesive molecules to act as a bridge to the aluminum foil PVC material, resulting in stronger adhesion. The main indicators of adhesive testing: 1 Determination of solid content: take the adhesive 5 grams placed in a beaker, the beaker was dried in an oven at 110 °C for 2 hours and then reweighed: solid content = dry film weight / 5 g × 100% . 2 Measurement of adhesive viscosity: The viscosity at 25°C was measured with a rotational viscometer. The method is: under the conditions of 25 °C, the sample glue thermostat 0.5 hours or more, according to the viscosity of the provided adhesive, using a viscometer to check the comparison. 3 Acidity According to GB/T1458-83, it can be measured with a glass telegraph acidometer. Precision pH can also be used to detect its pH.
2. The main quality problems and analysis of medicinal aluminum foil printing are easy to appear 2.1 The appearance quality requirements of pharmaceutical aluminum foil printing 1 aluminum foil printing surface hue is correct, bright uniform, super bright color, ink soft, clean edges of the imprint. 2 Printing fastness: The use of transparent adhesive tape does not discolor ink. 3 pattern text, lines are clear and complete, not deformed. 3 pattern text, lines are clear and complete, not deformed. 5 Printed textured layers are rich and outlets are clear. 5 The appearance of the printing is clean and tidy, no obvious pollution of the knife wire 6 after the final inspection of the same color density deviation and the same batch of the same color color difference indicators meet the requirements.
2.2 Foil printing word or pattern line incomplete: Analysis: 1 ink drying too fast, resulting in dry version. 2 excessive wind and heat affect the printing roller concave surface drying. 3 plate corrosion, ink adhesion less 5 squeegee knife in the distance between the roller and the imprinting point too far. 5 The speed is too slow.
2.3 Aluminum foil printed surface colored lines (lines): Analysis: 1 Squeegee knife close to the printing roller at the hard particles, impurities must be removed. If you encounter a fixed line must be sharpened or tool change can be. 2 If the lines are fixed, there are hard impurities embedded in the printing roller outlets and must be removed by parking. 3 When the new roll was put into use, it was found that the fixed line mark was generally caused by aluminum plating and was then sanded or repaired, resulting in pinholes. 4. The resin and pigment in the ink are not ground, it will also cause line marks, which must be removed with steel mesh filter. 5 Scraper angle and position, hardness must be adjusted properly.
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