Test and analysis of the physical properties of the base of the aluminum cap of the third kind of drug packaging materials

As a typical representative of national class III drug packaging materials, aluminum cap is widely used in the pharmaceutical industry Although it has many kinds of classification methods, its production process is not complicated In order to effectively block, inhibit and protect the deterioration of solid or liquid drugs in bottles, it is necessary to analyze the basic physical performance indexes of the aluminum cap, such as torsion, sealing and moisture resistance of the film, so as to improve the overall physical performance of the aluminum cap from the details All these will affect the aluminum cap manufacturer Family, pharmaceutical enterprises or quality inspection institutions play an important role Drug packaging material is the abbreviation of materials and containers for drug packaging Its classification must be formulated and issued by the State Drug Administration, and it can be divided into three categories Class I drug packaging materials refer to the materials and containers directly used for drug packaging, such as butyl rubber stopper, PVC hard disk, etc.; class II drug packaging materials refer to the materials and containers directly used for drug packaging, such as infusion bottles, antibiotic bottles, etc.; class III drug packaging materials refer to the materials and containers other than class I and class II, which need to be sterilized after cleaning in the actual use process Packaging materials and containers, such as aluminum caps, that may directly affect the quality of drugs Next, we will focus on the detailed analysis and elaboration of class III drug packaging aluminum cover With the development of domestic environmental protection and the concept of resource reuse, the production of aluminum cover is more and more environmental friendly in recent years The production process of environmental protection aluminum cover is not complicated, only the stamping die driven by the punch can be used for stamping The raw material for production is aluminum alloy plate, but different specifications of environmental protection aluminum cover need to be produced with different specifications of aluminum alloy plate According to the different purposes of flowering points, the environmental protection aluminum cover can be divided into two-point flowering, three-point flowering, etc.; according to the different flowering ways, it can also be divided into internal flowering and external flowering, etc.; according to whether the aluminum alloy plate is coated, it can be divided into ordinary aluminum cover, single coated aluminum cover and double coated aluminum cover; according to the different molds, it can be divided into stretch aluminum cover and cut ring aluminum cover These different specifications and different types of environmental protection aluminum cover will cause different physical properties, which will directly affect the later use effect I torque force torque force is the torque applied when the material produces torsional deformation In addition to its own structure and type, the most important factor affecting the torque force value of aluminum cap is the external force Simply speaking, if the torque force of aluminum cap is stable, the user does not need too much power to open the cap, which can save a lot of time to open the cap to a certain extent However, there is also a headache for manufacturers How to ensure the sealing performance of the aluminum cover, the threat of the external environment to the internal medicine and the leakage of the internal medicine while ensuring the low torque and easy opening of the aluminum cover? The balance between the two needs to be determined through professional scientific tests and specific test data For the method of measuring the torsion of the aluminum cap of class III drug packaging materials, please refer to GB / T 17876 plastic anti theft cap for packaging containers The testing equipment is njy-20 torque tester developed by Jinan Saicheng The specific methods are as follows: when measuring, the instrument should be placed on the table stably; if the display value is not zero, press the zero adjustment key to make it return to zero; turn the large nut on the right side of the instrument, adjust the appropriate width, loosen the rubber clamp with a wrench, adjust it to the appropriate position, and make it just clamp the measured object Rotate the tested object After the tested object is unscrewed, press the "peak value" key to record the test data (unit: N.m) In normal condition, after each measurement, press the reset key once to carry out the next measurement Note: the torque data shown as negative only represents the direction of measurement, not invalid data After the operation is completed, turn off the power supply, and remove the accessories or objects to be measured from the fixed fixture The test results are shown in Figure 1 (the test data is only for reference) sample 1, sample 2, sample 3, sample 4 of different specifications Torque value 4.271 4.289 4.311 4.352 Note: sample 1 is the tensile outer flowering aluminum cap; sample 2 is the tensile inner flowering aluminum cap; sample 3 is the ring cutting outer flowering aluminum cap; sample 4 is the ring cutting inner flowering aluminum cap Based on the analysis of the above experimental data, we can get the following conclusion: the stretching aluminum cover is relatively simple by virtue of its technology, and it is higher than the ring cutting aluminum cover in material utilization rate and opening force work efficiency, and the difference between them mainly comes from the difference of concave and convex points of the aluminum cover; while the inner flowering aluminum cover is slightly higher than the outer flowering aluminum cover in torsion, but the overall difference is not significant It can be concluded that the main factors affecting the torque of aluminum cover are drawing and ring cutting Sealing property: the sealing property of medical aluminum cover is also one of the key indicators that manufacturers need to monitor at all times, and its performance is also slightly different from the production process If we say that the above-mentioned torque test of aluminum cover can be roughly measured by simple "three finger method" by many small-scale manufacturers, then the test of sealing index can not be tested by some conventional methods, which can only be achieved by professional sealing tester in the packaging material testing industry For the method of measuring the sealing property of the aluminum cover of class III drug packaging materials, please refer to the standard of GB / T 15171-94 test method for sealing property of soft package The testing equipment is "mfy-02 sealing tester" developed by Jinan Saicheng The specific methods are as follows: 1 Put a proper amount of distilled water in the vacuum chamber, fix the sample on the sample fixture, and then immerse it in water At this time, the distance between the top of the sample and the water surface shall not be less than 25 mm (Note: as long as the leakage of each part of the sample can be observed during the test, two or more samples can be tested at a time) cover the sealing cover of the vacuum chamber, close the exhaust pipe valve, and then open the vacuum pipe valve to vacuumize the vacuum chamber Adjust the vacuum degree to one of the following values within 30-60s: 20, 30, 50, 90kpa, etc When a certain vacuum degree is reached, stop vacuumizing and keep the vacuum degree for 30s (Note: the adjusted vacuum value is determined according to the characteristics of the sample (such as packaging materials, sealing conditions, etc.) or relevant product standards However, the internal and external pressure difference of the sample shall not cause the sample to crack or crack at the seal) Observe the leakage of the sample during vacuumizing and vacuum holding, depending on whether there are continuous bubbles A single isolated bubble is not considered a sample leak 4 Open the intake pipe valve to make the vacuum chamber open to the atmosphere, open the sealing cover, take out the sample, wipe the water on its surface, and open the seal to check whether there is test water penetrating into the sample The test results are shown in Figure 2 (the test data is only for reference) sample 1, sample 2, sample 3, sample 4 of different specifications Sealing property: single bubble without water seepage; single bubble without water seepage; no bubble without water seepage; no bubble without water seepage Note: sample 1 is the tensile outer flowering aluminum cap; sample 2 is the tensile inner flowering aluminum cap; sample 3 is the ring cutting outer flowering aluminum cap; sample 4 is the ring cutting inner flowering aluminum cap Based on the analysis of the above test data, we can generally draw the conclusion that the stretching aluminum cover is not as good as the ring cutting aluminum cover in terms of tightness due to its simple process, but only a single bubble appears in the test process, and there is no continuous bubble generation, so it is not considered as leakage according to the standard, that is, it also conforms to the standard; while the internal and external flowering modes of aluminum cover have a basic effect on the overall tightness No impact It can be concluded that the main factor affecting the sealing performance of the aluminum cover is still the difference between the drawing process and the ring cutting process Conclusion: in addition to the torque and sealing test indexes, the tension and the moisture permeability of the coating film are the basic physical property test indexes Due to the limitation of space, only two indexes of torque and sealing are discussed and analyzed in this paper Through the test and analysis of the performance of these basic physical indicators, it can provide reference for manufacturers and the direction of improvement, which is of positive significance to the society.