The blister packaging of pharmaceuticals is selected from the hard industrial pure aluminum foil as the basic material, which is called the cover material. It is a special equipment for printing and coating aluminum foils, printing text patterns and protective agents on the surface of aluminum foil, on the other side of aluminum foil. Apply adhesive. The purpose of the coating protector is to prevent the wear of the ink layer of the printed characters, and to prevent the contamination of the drug due to the contact between the outer layer ink and the inner layer adhesive during the coating process and after winding. The adhesive layer is mainly used to ensure the adhesion of the aluminum foil and the PVC Plastic Film, and the adhesive strength of the aluminum foil and the PVC after heat sealing is usually measured by the heat seal strength test. The following describes several test equipment and aluminum foil and PVC heat seal strength test methods and analysis of factors affecting the aluminum foil and PVC heat seal strength.
First, the heat seal strength value of aluminum foil and PVC of tensile testing machine is usually made on tensile testing machine. Tensile testing machine is generally composed of main components such as loading mechanism, force measuring mechanism, drawing device, buffer device and force transmission mechanism. According to the different methods and principles of force measurement, it is generally divided into the lever pendulum type, pendulum type and electronic type. Regardless of the type of tensile testing machine, conventional mechanical performance tests such as drawing, compression, bending, shearing, tearing, and peeling can be performed after the replacement of the holder.
1. Lever pendulum type tensile testing machine: The working principle of this machine is: When the sample is subjected to force deformation, the force acting on the upper holder passes through the two-level lever, driving the pendulum to rotate around the fulcrum and lift it up. A lever has two fulcrums. When the specimen is pulled, it takes 1 point as the fulcrum. At 2 o'clock, when it is under pressure, it will be automatically replaced with 2 points as the fulcrum, and 1 point will be disengaged. In this way, the pendulum always swings to one side regardless of stretching and retraction. The pendulum rod pushes the horizontal gear and the pointer, and the angle of rotation of the pointer is proportional to the force of the sample, and the figure on the dial is the force of the sample. The loading method may use a maneuvering and hand-operated device, and the speed adjustment may use a continuously variable transmission. The general testing machine can replace the weights of four kinds of pendulums in three columns, and there are also three columns and four kinds of scales on the measuring dial, which respectively represent the measuring range.
2. Pendulum-type tensile testing machine: This type of testing machine is used to pull a sample at a certain speed, so that the pendulum will be opened and the size of the pull force will be expressed by the change in the angle of the pendulum's lift. Its principle of action is: during the test, when the tensile force P of the sample is acted on the sector wheel by the steel band or chain, the moment M1=P·r (r is the radius of the fan-shaped wheel), and it is integrated with the sector wheel. The pendulum tilts at an angle α, thus producing a moment of balance M2. M2=Qlsinα (Q pendulum weight, l pendulum length) Since M1=M2, Pr=Qlsinα, P=(Ql·sinα)/r Because of the radius r, the pendulum length l and pendulum weight Q are constant so Ql /r is also a constant. Let c = Ql/r be P = c · sinα, that is, the pull force P is proportional to the sine of the pendulum tilt angle. According to this relationship, a dial can be established to indicate the size of the pull force.
3. Electronic tensile testing machine: The force applied to the deformation of the sample of the electronic tensile machine is converted into an electrical signal through the resistance strain gauge attached to the elastic element in the force sensor and preamplified to the x axis of the XY recorder. The small deformation uses a differential transformer as a sensor, and the large deformation utilizes a synchro-synthesizer. After the measurement signal is amplified, it is input to the Y-axis of the XY recorder, so that the load deformation curve can be automatically drawn on the recorder. The differential transformer is mounted on the extensometer and the extensometer is connected to the sample. With the deformation of the specimen, the core of the differential transformer also has a corresponding displacement. After this displacement is converted into an electrical signal lightly, the deformation of the specimen can be recorded on the recorder. The measurement of large deformation is that when the cross beam connecting the lower holder is displaced, the gear box connected with the screw is driven by a certain gear ratio to send the synchro-synthesizer to rotate through the sending autosynthesizer and the XY recorder. The rotary transformer consists of follow-up lines to determine the elongation. The speed of the lower gripper movement is controlled by a complete set of servo systems. The synchronous motor drives the Synchro machine to rotate at a certain speed through a speed change gear. The receiving selsyn machine is connected with the main unit wheel box. The main gear drives two high-precision ball screws to rotate, and the cross beam rises and falls accordingly. If the cross beam moving speed is not corresponding to the sending selsynthetic machine, two self-steering angles are achieved. The machine has an angular difference. After the signal is amplified, the voltage of the SCR is supplied to the AC motor so that the cross beam can obtain a stable speed. This kind of system makes the beam displacement speed change with the sending autogenerator. Change the gear mesh of the gear box and get different speeds.
4. Automatic tensile testing machine: This testing machine is a fast automatic measurement testing machine. The tester has a conveyor belt with automatic conveying patterns, a metering device, an extension tracking device, a pneumatic ejector device for automatically removing the sample, and an electronic computer. The computer is used to indicate and calculate test results. The tester can automatically mark the sample with different colors, white or other colors, and measure the thickness of the sample. After the job is completed automatically, the sample is clamped by the pneumatic gripper and sent to the tensile device for tensile test. The machine's stretching speed is 500mm/min or 50mm/min. The machine can be automatically operated for 4-5 hours continuously, and the test results are finally printed out by a computer or saved as punched cards.
Second, the pharmaceutical aluminum foil and PVC heat sealing strength test This test at the speed specified in the tensile machine, the sample is applied on the adhesive surface of the vertical uniform tension, 180 ° peel the sample, when the measurement of aluminum foil and PVC hard film peeling The average strength required. Test equipment: automatic recording tensile tester, lever-type heat sealer, and standard test piece cutter.
1. Sample Preparation Requirements: 1 Sampling: Cut 100mm×100mm test pieces in finished aluminum foil, meet the requirements of GB5663 for medical use PVC hard sheets 100mm×100mm test pieces; 2 Heat sealing conditions: Lever type heat sealing The temperature of the instrument is 150-160°C, the pressure is 0.2×104Pa, and the time is 1s. 3 Operation: The adhesive layer of the sample is laminated with the PVC sheet, inserted into a heat sealer for heat sealing, and cut into 15mm width with a standard cutter. For the sample, take the middle three for testing.
2. Test methods and procedures: 1 Adjust the tensile tester and make the recorder pointer “zeroâ€. "Zero" adjustment: When the test pointer is in the "zero" position, the pendulum should be vertical. Increase or decrease the weight on the fact that the "zero" remains unchanged. If you find that the "zero point" is inaccurate, identify the reasons for adjustment in time. The general “zero point†should not have the following phenomena: a. The heavier the twist, the greater the value of the pointer. The most obvious is between the empty swing bar and the maximum squat. Cause: The position of the balance pole is incorrect, causing the swing bar not to be vertical. Adjustment method: adjust the balance é“Š to increase the maximum é“Š and no increase é“Š indicate the same value. b. The heavier the crown is, the smaller the indicator value is, and the most obvious is between the empty swing bar and the largest pole. Cause: The position of the balance pole is incorrect, causing the swing bar not to be vertical. Adjustment method: Adjust the balance in the opposite direction from the previous item, until the maximum value is the same as the value without the indicator. c. Regardless of which one is added, the pointer will not indicate zero, but the position will not change. Cause: The initial position of the indication gear is incorrect. Adjustment method: Adjust the ball until the pointer points to zero. 2 set the tensile speed is 200mm/min, the PVC in the sample is clamped on the upper clamp of the tester, the aluminum foil in the sample is clamped on the lower clamp of the tester, the standard peeling angle is 180°, and the sample is peeled off, the test The automatic recording device records the peeling load and the peeling length, and draws the peeling load curve.
3. Test results: 1 The average value of the curve drawn by the automatic recorder is the heat seal strength value (unit: N/15mm width); 2 The heat seal strength can be expressed by the formula: Q=k·L/b Medium: K-peel curve on the load unit represented by the load coordinate unit length N
Length of the load coordinate in the effective peel length on the L-peel curve mm
B—the width of the sample bonding layer mm
When L is calculated by a planimeter method, it should be accurate to 0.1 cm. If the peeling strength fluctuates beyond 15% of the average peel strength in the effective peel length, the test data of the sample is invalidated. Calculate the average value of each group of samples should take two significant figures, and apply the formula to calculate the standard deviation.
Third, the pharmaceutical aluminum foil and PVC heat seal strength test factors:
1. Bonding area: The heat-sealing strength of aluminum foil and PVC are expressed by the force per unit area. In the test, the size of the bonding area has influence on the bonding strength; the bonding area is too small, and the preparation of the sample is not easy. Accuracy, the relative error of the bonding measurement is also larger, the increase in the bonding area, the probability of bonding defects increases, so the determination of the heat sealing strength should be prepared according to the required width of the length of the sample.
2. The clamping method of the sample: At present, the adhesion performance of PVC and aluminum foil is generally determined by a pendulum pulling machine. According to the force measuring principle of the pendulum pulling machine, the force measured by the testing machine can be introduced as the force in the direction of the lead weight of the sample. If the direction of the force received by the sample deviates from the vertical direction, the measured force is The component force in the vertical direction is therefore smaller than the actual force applied to the sample. In other words, if the line of action of the force exerted by the specimen deviates from the vertical line passing through the center of the fixture, the test result will be low. Therefore, the center line of the fixture, the line of action of the force applied to the specimen, and the vertical The three lines coincide.
3. The tensile speed of the testing machine: the tensile speed of the testing machine is different from the selected value. The test results are different. With the increase of the tensile speed, the heat seal strength value increases. Therefore, the tensile speed of the tensile force must be specified as 200mm/min. (Author's Unit Shandong Pharmaceutical Packaging Institute Bai Bing)
First, the heat seal strength value of aluminum foil and PVC of tensile testing machine is usually made on tensile testing machine. Tensile testing machine is generally composed of main components such as loading mechanism, force measuring mechanism, drawing device, buffer device and force transmission mechanism. According to the different methods and principles of force measurement, it is generally divided into the lever pendulum type, pendulum type and electronic type. Regardless of the type of tensile testing machine, conventional mechanical performance tests such as drawing, compression, bending, shearing, tearing, and peeling can be performed after the replacement of the holder.
1. Lever pendulum type tensile testing machine: The working principle of this machine is: When the sample is subjected to force deformation, the force acting on the upper holder passes through the two-level lever, driving the pendulum to rotate around the fulcrum and lift it up. A lever has two fulcrums. When the specimen is pulled, it takes 1 point as the fulcrum. At 2 o'clock, when it is under pressure, it will be automatically replaced with 2 points as the fulcrum, and 1 point will be disengaged. In this way, the pendulum always swings to one side regardless of stretching and retraction. The pendulum rod pushes the horizontal gear and the pointer, and the angle of rotation of the pointer is proportional to the force of the sample, and the figure on the dial is the force of the sample. The loading method may use a maneuvering and hand-operated device, and the speed adjustment may use a continuously variable transmission. The general testing machine can replace the weights of four kinds of pendulums in three columns, and there are also three columns and four kinds of scales on the measuring dial, which respectively represent the measuring range.
2. Pendulum-type tensile testing machine: This type of testing machine is used to pull a sample at a certain speed, so that the pendulum will be opened and the size of the pull force will be expressed by the change in the angle of the pendulum's lift. Its principle of action is: during the test, when the tensile force P of the sample is acted on the sector wheel by the steel band or chain, the moment M1=P·r (r is the radius of the fan-shaped wheel), and it is integrated with the sector wheel. The pendulum tilts at an angle α, thus producing a moment of balance M2. M2=Qlsinα (Q pendulum weight, l pendulum length) Since M1=M2, Pr=Qlsinα, P=(Ql·sinα)/r Because of the radius r, the pendulum length l and pendulum weight Q are constant so Ql /r is also a constant. Let c = Ql/r be P = c · sinα, that is, the pull force P is proportional to the sine of the pendulum tilt angle. According to this relationship, a dial can be established to indicate the size of the pull force.
3. Electronic tensile testing machine: The force applied to the deformation of the sample of the electronic tensile machine is converted into an electrical signal through the resistance strain gauge attached to the elastic element in the force sensor and preamplified to the x axis of the XY recorder. The small deformation uses a differential transformer as a sensor, and the large deformation utilizes a synchro-synthesizer. After the measurement signal is amplified, it is input to the Y-axis of the XY recorder, so that the load deformation curve can be automatically drawn on the recorder. The differential transformer is mounted on the extensometer and the extensometer is connected to the sample. With the deformation of the specimen, the core of the differential transformer also has a corresponding displacement. After this displacement is converted into an electrical signal lightly, the deformation of the specimen can be recorded on the recorder. The measurement of large deformation is that when the cross beam connecting the lower holder is displaced, the gear box connected with the screw is driven by a certain gear ratio to send the synchro-synthesizer to rotate through the sending autosynthesizer and the XY recorder. The rotary transformer consists of follow-up lines to determine the elongation. The speed of the lower gripper movement is controlled by a complete set of servo systems. The synchronous motor drives the Synchro machine to rotate at a certain speed through a speed change gear. The receiving selsyn machine is connected with the main unit wheel box. The main gear drives two high-precision ball screws to rotate, and the cross beam rises and falls accordingly. If the cross beam moving speed is not corresponding to the sending selsynthetic machine, two self-steering angles are achieved. The machine has an angular difference. After the signal is amplified, the voltage of the SCR is supplied to the AC motor so that the cross beam can obtain a stable speed. This kind of system makes the beam displacement speed change with the sending autogenerator. Change the gear mesh of the gear box and get different speeds.
4. Automatic tensile testing machine: This testing machine is a fast automatic measurement testing machine. The tester has a conveyor belt with automatic conveying patterns, a metering device, an extension tracking device, a pneumatic ejector device for automatically removing the sample, and an electronic computer. The computer is used to indicate and calculate test results. The tester can automatically mark the sample with different colors, white or other colors, and measure the thickness of the sample. After the job is completed automatically, the sample is clamped by the pneumatic gripper and sent to the tensile device for tensile test. The machine's stretching speed is 500mm/min or 50mm/min. The machine can be automatically operated for 4-5 hours continuously, and the test results are finally printed out by a computer or saved as punched cards.
Second, the pharmaceutical aluminum foil and PVC heat sealing strength test This test at the speed specified in the tensile machine, the sample is applied on the adhesive surface of the vertical uniform tension, 180 ° peel the sample, when the measurement of aluminum foil and PVC hard film peeling The average strength required. Test equipment: automatic recording tensile tester, lever-type heat sealer, and standard test piece cutter.
1. Sample Preparation Requirements: 1 Sampling: Cut 100mm×100mm test pieces in finished aluminum foil, meet the requirements of GB5663 for medical use PVC hard sheets 100mm×100mm test pieces; 2 Heat sealing conditions: Lever type heat sealing The temperature of the instrument is 150-160°C, the pressure is 0.2×104Pa, and the time is 1s. 3 Operation: The adhesive layer of the sample is laminated with the PVC sheet, inserted into a heat sealer for heat sealing, and cut into 15mm width with a standard cutter. For the sample, take the middle three for testing.
2. Test methods and procedures: 1 Adjust the tensile tester and make the recorder pointer “zeroâ€. "Zero" adjustment: When the test pointer is in the "zero" position, the pendulum should be vertical. Increase or decrease the weight on the fact that the "zero" remains unchanged. If you find that the "zero point" is inaccurate, identify the reasons for adjustment in time. The general “zero point†should not have the following phenomena: a. The heavier the twist, the greater the value of the pointer. The most obvious is between the empty swing bar and the maximum squat. Cause: The position of the balance pole is incorrect, causing the swing bar not to be vertical. Adjustment method: adjust the balance é“Š to increase the maximum é“Š and no increase é“Š indicate the same value. b. The heavier the crown is, the smaller the indicator value is, and the most obvious is between the empty swing bar and the largest pole. Cause: The position of the balance pole is incorrect, causing the swing bar not to be vertical. Adjustment method: Adjust the balance in the opposite direction from the previous item, until the maximum value is the same as the value without the indicator. c. Regardless of which one is added, the pointer will not indicate zero, but the position will not change. Cause: The initial position of the indication gear is incorrect. Adjustment method: Adjust the ball until the pointer points to zero. 2 set the tensile speed is 200mm/min, the PVC in the sample is clamped on the upper clamp of the tester, the aluminum foil in the sample is clamped on the lower clamp of the tester, the standard peeling angle is 180°, and the sample is peeled off, the test The automatic recording device records the peeling load and the peeling length, and draws the peeling load curve.
3. Test results: 1 The average value of the curve drawn by the automatic recorder is the heat seal strength value (unit: N/15mm width); 2 The heat seal strength can be expressed by the formula: Q=k·L/b Medium: K-peel curve on the load unit represented by the load coordinate unit length N
Length of the load coordinate in the effective peel length on the L-peel curve mm
B—the width of the sample bonding layer mm
When L is calculated by a planimeter method, it should be accurate to 0.1 cm. If the peeling strength fluctuates beyond 15% of the average peel strength in the effective peel length, the test data of the sample is invalidated. Calculate the average value of each group of samples should take two significant figures, and apply the formula to calculate the standard deviation.
Third, the pharmaceutical aluminum foil and PVC heat seal strength test factors:
1. Bonding area: The heat-sealing strength of aluminum foil and PVC are expressed by the force per unit area. In the test, the size of the bonding area has influence on the bonding strength; the bonding area is too small, and the preparation of the sample is not easy. Accuracy, the relative error of the bonding measurement is also larger, the increase in the bonding area, the probability of bonding defects increases, so the determination of the heat sealing strength should be prepared according to the required width of the length of the sample.
2. The clamping method of the sample: At present, the adhesion performance of PVC and aluminum foil is generally determined by a pendulum pulling machine. According to the force measuring principle of the pendulum pulling machine, the force measured by the testing machine can be introduced as the force in the direction of the lead weight of the sample. If the direction of the force received by the sample deviates from the vertical direction, the measured force is The component force in the vertical direction is therefore smaller than the actual force applied to the sample. In other words, if the line of action of the force exerted by the specimen deviates from the vertical line passing through the center of the fixture, the test result will be low. Therefore, the center line of the fixture, the line of action of the force applied to the specimen, and the vertical The three lines coincide.
3. The tensile speed of the testing machine: the tensile speed of the testing machine is different from the selected value. The test results are different. With the increase of the tensile speed, the heat seal strength value increases. Therefore, the tensile speed of the tensile force must be specified as 200mm/min. (Author's Unit Shandong Pharmaceutical Packaging Institute Bai Bing)
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