As a typical representative of the national class III pharmaceutical packaging materials, aluminum cover is widely used in the pharmaceutical industry. Although it has a variety of classification methods, its production process is not complicated. In order to effectively block, inhibit and protect the deterioration of solid or liquid medicines in bottles, it is necessary to twist, seal and coat the aluminum cover. The basic physical performance indicators of moisture resistance are analyzed in detail, and the overall physical properties of the aluminum cover are improved from the details, which will play an important role in the aluminum cover manufacturer, the pharmaceutical company or the quality inspection organization.
The medicine packaging material is the abbreviation of the materials and containers for pharmaceutical packaging. The classification must be formulated and released by the State Drug Administration and is divided into three categories. Class I drug packaging materials refer to materials and containers for pharmaceutical packaging that are directly in contact with drugs and used directly, such as butyl rubber stoppers, PVC rigid tablets, etc. Class II drug packaging materials refer to direct contact with drugs, but are easy to clean, in actual use. In the case of drugs, packaging materials and containers that need to be sterilized and sterilized after cleaning, such as infusion bottles and antibiotic bottles; Class III drug packaging materials refer to materials and containers for pharmaceutical packaging that may directly affect the quality of drugs, such as Class I and II. Such as aluminum cover.
Below, we will focus on the detailed analysis and elaboration of the aluminum cover of Class III drug packaging materials.
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With the rise of domestic environmental protection and the concept of resource recycling, the production of aluminum covers has become more and more environmentally friendly in recent years. The production process of environmentally-friendly aluminum cover is not complicated. It only needs to be stamped by a punching machine for stamping. The raw material for production is aluminum alloy plate, but the environmentally-friendly aluminum cover of different specifications needs to be produced with aluminum alloy plates of different specifications. According to the difference of the number of flowering spots, the environmental protection aluminum cover can be divided into two points of flowering, three points of flowering, etc.; according to different flowering methods, it can be divided into inner flowering and outer flowering; 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; depending on the mold, it can be divided into a stretched aluminum cover and a cut-off aluminum cover. These different specifications and different types of environmentally-friendly aluminum covers will cause them to have different physical properties, which will directly affect the later use effect.
First, the torque
The torque is the moment applied when the material is subjected to torsional deformation. In addition to its own structure and type, the more important factor affecting the torque value of the aluminum cover is the force applied from the outside. In short, if the torque of the aluminum cover itself is stable, it can be opened without the user having to use too much power. The cap, which can save a lot of time to open the cap to a certain extent. However, there is still a problem that causes headaches for manufacturers. It is how to ensure that the aluminum cap needs to have a small breaking force and is easy to open, while ensuring its sealing performance and blocking the threat of the external environment to endogenous drugs. The balance of internal drugs, the balance between the two needs to be determined through professional scientific tests and specific test data.
For the method of measuring the torque of the aluminum cover of the III type drug packaging material, the GB/T 17876 "Packaging container plastic anti-theft bottle cap" standard can be referred to , and the testing equipment is the " NJY-20 torque tester " developed by Jinan Saicheng . The specific method is as follows:
- Place the instrument on the table smoothly while measuring;
- If the display shows that the value is not zero, press the zero key to reset it to zero;
- Rotate the large nut on the right side of the instrument, adjust the appropriate width, use a wrench to loosen the rubber clamp, and adjust it to the proper position so that it just clamps the object under test;
- Twist the object to be tested, and after the object is unscrewed, press the “Peak†button to record the test data (unit: Nm). After each measurement in the normal state, you need to press the clear button to make the next measurement. Note: The torque data is displayed as a negative value that only represents the direction of the measurement, not invalid data.
- After the operation is completed, turn off the power and remove the attachment or the object to be tested from the fixture.
The test results are shown in Figure 1. ( The test data is for reference only )
Different specifications | Sample 1 | Sample 2 | Sample 3 | Sample 4 |
Torque force value | 4.271 | 4.289 | 4.311 | 4.352 |
Note: Sample 1 is a stretchable outer flowering aluminum cover; sample 2 is a stretchable inner flowering aluminum cover; sample 3 is a ring-cut outer flowering aluminum cover; sample 4 is a ring-cut inner flowering aluminum cover;
Through the analysis of the above test data, we can generally conclude that the stretched aluminum cover is relatively simple in process, and is higher in the material utilization rate and the opening work efficiency than the cut ring aluminum cover, and the difference between the two mainly comes from The unevenness of the aluminum cover is different; while the inner flowering aluminum cover is slightly higher in the torsion than the outer flowering aluminum cover, but the overall difference is not large. From this it can be concluded that the factors affecting the torque of the aluminum cover are mainly derived from the stretching and cutting process.
- Sealing
The sealing of the medicinal aluminum cover is also one of the indicators that the manufacturer needs to monitor at all times, and its performance is also slightly different from the production process. If the above-mentioned torque test of the aluminum cover is carried out, many small and small manufacturers can also make a rough measurement by a simple "three-finger method", then the test of the sealing index cannot be tested by some conventional methods, and must rely on the package. The professional sealing tester for the material testing industry can be achieved.
For the method for determining the tightness of the aluminum cover of the class III drug packaging material, reference may be made to GB/T 15171-94 "Test method for sealing performance of flexible packaging parts", and the testing equipment is " MFY-0 2 sealing tester " developed by Jinan Saicheng . The specific method is as follows:
1. Put an appropriate amount of distilled water in the vacuum chamber, fix the sample on the sample holder, and immerse it in water. At this time, the distance between the tip of the sample and the water surface must 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 vacuum chamber sealing cover, close the exhaust pipe valve, and then open the vacuum pipe valve to evacuate the vacuum chamber. The degree of vacuum is adjusted from 30 to 60 s to one of the following values: 20, 30, 50, 90 kPa, and the like. When a certain degree of vacuum is reached, the vacuum is stopped and the vacuum is maintained for 30 s. (Note: The adjusted vacuum value is determined according to the characteristics of the sample (such as the packaging materials used, sealing conditions, etc.) or the relevant product standards. However, the internal or external pressure difference of the sample should not be too large to cause the sample to crack or seal. Cracking)
- The leakage of the sample during vacuuming and vacuum holding was observed, depending on whether or not continuous bubbles were generated. A single isolated bubble is not considered a sample leak.
4. Open the inlet pipe valve, open the vacuum chamber to the atmosphere, open the sealing cover, take out the sample, wipe the surface water, and open the seal to check whether there is test water infiltration inside the sample.
The test results are shown in Figure 2. ( The test data is for reference only )
Different specifications | Sample 1 | Sample 2 | Sample 3 | Sample 4 |
Sealing | There is a single bubble without water seepage | There is a single bubble without water seepage | No bubbles, no water seepage | No bubbles, no water seepage |
Note: Sample 1 is a stretchable outer flowering aluminum cover; sample 2 is a stretchable inner flowering aluminum cover; sample 3 is a ring-cut outer flowering aluminum cover; sample 4 is a ring-cut inner flowering aluminum cover;
Through the analysis of the above test data, we can generally conclude that the stretched aluminum cover is not as good as the cut ring aluminum cover because of the simple process, but only a single bubble appears in the test process, and no continuous bubbles are generated. According to the standard, it is not considered as a leak, that is, it also conforms to the standard; while the inner flowering and the outer flowering mode of the aluminum cover have substantially no effect on the overall sealing effect. From this it can be concluded that the main source factor affecting the tightness of the aluminum cover is still the difference between the stretching and the cutting of the production process.
Conclusion
In addition to the torque and sealing test indicators, the aluminum cover of the class III drug packaging material is the basis for the physical property detection index of the tension and the moisture permeability of the coating film. Due to space limitations, only the torque and sealing are used here. The two indicators were professionally elaborated and analyzed. Through the testing and analysis of the performance of these basic physical indicators, it can provide a reference basis for the manufacturer and the direction of improvement and improvement, which has positive significance to the society.
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