Introduction of medicinal aluminum-plastic blister packaging detection method
Introduction of medicinal aluminum-plastic blister packaging detection method planting bag grow planting bag grow Guangzhou Zhongzhinan Supply Chain Co.,Ltd. , https://www.gzzhongzhinan.com
Original: Jinan Languang Electromechanical Technology Co., Ltd.
Abstract: Blister packaging is the mainstream of solid pharmaceutical packaging in the future. This paper analyzes the testing requirements of blister packaging, and introduces the detection methods of specific indicators in combination with specific testing standards for pharmaceutical packaging materials.
Key words: blister, PTP, oxygen transmission rate, heat sealing strength, impact strength
Pharmaceutical blister packaging, also known as water-eye packaging, is PTP (Press Through Packaging) packaging technology, is one of the main forms of pharmaceutical packaging, suitable for mechanized packaging of solid preparations. It has obvious advantages, such as stable and reliable medicine, easy to realize less metering and series packaging, advanced technology, safe and hygienic, convenient to carry and use, long storage period, good adaptability and appearance, and has the functions of identification and anti-counterfeiting. At present, blister packaging accounts for about 30% of the global pharmaceutical market, and maintains a steady growth trend. In the future, it will become the mainstream in the packaging of tablets, capsules, pills, powders, powders and granules of western medicine. .
1. Detection requirements for blister packaging <br> The main packaging object for blister packaging is solid medicine. The packaging should separate the contained pharmaceutical preparation from the outside world, and prevent the active ingredients from volatilizing, escaping and leaking. The volatile pharmaceutical ingredient can be dissolved in the inner side of the packaging material and diffused to the other side under the action of osmotic pressure, such as a solid pharmaceutical preparation containing an aromatic component and containing a volatile active ingredient, and the active ingredient is volatile and penetrates a certain Some materials. On the other hand, it prevents the outside air, moisture, foreign matter, and microorganisms from entering and coming into contact with the drug. The air contains oxygen, moisture, large amounts of microbes and foreign particles, which can cause oxidation, hydrolysis, degradation, pollution and fermentation of the drug after it enters the package.
PTP aluminum foil and PVC hard sheet or PVC/PVDC composite hard sheet used in blister packaging will directly contact the medicine, so special attention should be paid to the detection of materials including appearance, barrier properties, tensile strength, impact strength and heat shrinkage. Rate and other mechanical properties, as well as health indicators, etc., have corresponding testing methods and standards (or corporate standards), the following highlights the key testing items for blister packaging.
2, barrier detection <br> Barrier testing is a key test item for blister packaging, including oxygen transmission rate detection and water vapor transmission rate detection. Although the standard does not mention the oxygen permeability detection of aluminum foil, However, since this index is closely related to the number of pinholes, if the number of pinholes of the aluminum foil can meet the standard requirements, the oxygen transmission rate can generally meet the requirements of use. Whether it is aluminum foil or PVC material, the material barrier property is high in actual use, so you should pay attention to selecting instruments with high detection accuracy when purchasing inspection equipment. Oxygen transmission rate and water vapor transmission rate detection technology have become more popular. Here, we will focus on the barrier detection technology for the entire blister.
At present, the overall barrier detection technology for packaging materials has matured, but since the overall size of the blister is very small, it is difficult to use the general packaging to detect the accessories as a whole, and the strength of the aluminum foil layer is weaker than that of the plastic, so the overall barrier detection technology It has not been used in blister packaging. However, in fact, due to the uniformity of the coating amount of the material binder, the problem of the heat expansion rate of the material, and the mechanical strength of the aluminum foil, the oxygen permeability and the water vapor transmission rate of the actual blister are compared. The calculated value obtained is large. We have tested some drugs on the market that use blister packs. Comparing the actual barrier properties of the packaged aluminum foil and PVC hard sheets or PVC/PVDC composite hard sheets obtained from some manufacturers, we found that despite the barrier properties of the packaging materials. The test data is very close, but the measured data of the blister can sometimes differ by tens of times.
When testing the overall barrier properties of the blister, the preparation of the blister sample is carried out through a special accessory, which is detected by the isostatic method in the oxygen transmission rate test and the sensor method in the water vapor transmission rate test. During the whole test, special attention should be paid to the adjustment of the flow rate to avoid a sudden change in the pressure of the gas inside the bubble cover, which will cause an impact on the sample state. In fact, the detection accessories used in the blister can also be applied to the detection of small hollow containers such as capsules, and it is convenient to widen the types of small samples that can be inspected.
In addition, the detection of volatile pharmaceutical ingredients can be referred to the organic gas permeability test method. At present, China has drafted the first international organic gas permeability test standard (including container test), which is believed to provide an effective method for the penetration of volatile drugs.
3, heat sealing strength test <br> As with other types of packaging, sealing is an important indicator of the practicality of blister packaging, and heat sealing strength is an important test item to reflect the sealing. For the blister packaging, there are heat sealing strength testing items in the detection of aluminum foil and PVC hard sheets or PVC/PVDC composite hard sheets.
The method for detecting the heat sealing strength is as follows: selecting a suitable heat sealing parameter according to a specific testing standard, and heat-sealing a PVC hard sheet or a PVC/PVDC composite hard sheet having a size of 100 mm×100 mm by a heat sealer (bonding layer of aluminum foil and The PVC sheet is superimposed), and then the sample is cut into 15mm width by a standard cutter, and the middle three strips are 180° peeled by a tensile machine (the peeling speed is performed according to the requirements of specific testing standards), and the necessary work for peeling off is Heat sealing strength.
4, heating expansion rate detection <br> Heating expansion rate is an important test item of PVC hard sheet or PVC / PVDC composite hard sheet, refers to the change of the size of the sample after a certain temperature in a certain period of time, the amount of change between the punctuation points The percentage of the ratio to the distance between the initial punctuation indicates that the test was carried out in accordance with the provisions of YBB00292004 "Heat-expansion rate measurement method".
Two square test pieces were cut from the hard piece, each side having a length of 120 mm ± 1 mm. At the center point position, cut through the blade, draw two perpendicular vertical lines AB and horizontal CD with a punctuation interval of 100mm±1mm, and then mark the tops of the two lines respectively to accurately measure each piece of AB and CD. The arithmetic mean is taken after the length of the line segment. The test piece should be placed flat on a glass or metal plate, and should not affect the free deformation of the test piece. It should be placed horizontally in a heating device at 100 ° C ± 1 ° C for 10 min, and taken out and cooled to room temperature. Then, the lengths of each of the AB and CD segments were accurately determined and the arithmetic mean values ​​were taken. The standard requires that the heat expansion rate should be within ±6%.
5, impact strength testing <br> Stamping is an important step in the manufacturing process of blister packaging, so testing the impact resistance of PVC rigid sheet or PVC / PVDC composite hard sheet is of great significance, you need to use the ball impact tester to complete Item test.
Take the appropriate amount of this product, take a length of about 150mm, a width of 50mm sample, five vertical and horizontal. The sample shall be placed in an environment of 23 ± 2 ° C, 50 ± 5% RH for more than 4 hours, and tested under the above conditions. The sample (the composite hard piece requires the PVDC layer to be upward) is fixed on the falling ball impact tester, the span is 100mm, and the steel ball and the falling ball height are selected according to the following table, so that the steel ball is freely dropped in the central part of the span, longitudinal and horizontal. There must be no more than two pieces of damage.
7. Summary <br> At present, China's standard construction in blister packaging has begun to take shape, but there is still a big gap compared with the standard regulations for pharmaceutical packaging materials in developed countries, mainly focusing on the low requirements and standards for testing indicators. The update is not timely, and the test method is backward. Standard requirements are a major way to guide the development of testing technology and improve the quality of packaging. Therefore, standard regulations on drug blister packaging should be improved and updated to promote the healthy development of the pharmaceutical blister packaging market.