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Common Problems of Pharmaceutical Packaging Quality Inspection

Sep 18,2022

Source: Link Testing Instruments Co.,Ltd.

Pharmaceutical Packaging

How to monitor the barrier performance of blister packaging?


Blister packaging is a common form of medicine packaging. The medicines in each blister are independent of each other. Taking out the medicine in one blister will not affect the sealing and barrier properties of the medicines in other blisters, so the quality of the medicine is guaranteed. better. The barrier properties of blister packaging mainly include barrier properties to oxygen and water vapor to prevent oxidation of active ingredients in medicines and deliquescence of medicines.

The oxygen barrier property is verified by the oxygen transmission test, and the principle of the isobaric method is used. The sample is clamped on the testing equipment through a special fixture, and then the blister package and the fixture are covered with a sealing structure. On the inner and outer sides of the blister package, one side is filled with oxygen, and the other side is passed through, etc. Under the action of the concentration difference, the oxygen permeating to the nitrogen side through the blister package is carried by the flowing nitrogen to the sensor for analysis, so as to obtain the oxygen permeation rate of the blister package. The referenced standard is GB/T 31354-2014.

The water vapor barrier property is verified by the water vapor transmission test. The available detection methods include infrared method and electrolysis method. The processing and clamping process of the sample is similar to the oxygen transmission test, the difference is that on both sides of the blister package, one side is dry high-purity nitrogen, and the other side is high-purity nitrogen with a certain humidity. , Under the action of humidity difference, water vapor will penetrate from the high-humidity side through the blister package to the low-humidity side, and be carried by the nitrogen gas on the low-humidity side to the sensor for analysis, thereby obtaining the water vapor transmission rate of the blister package. The standard that can be referred to when using the infrared method is GB/T 31355-2014, and there is no relevant standard for the electrolytic method to test the water vapor transmission capacity of the container.

How to ensure that the medical packaging roll film is not easy to break the bag when filling the bag?


For many pharmaceutical products in bags, the packaging film is usually heat-sealed into bags by pharmaceutical product manufacturers, and then used for packaging of pharmaceutical products. Since the time interval between the packaging heat-sealing bag-making operation and the product filling operation is very short, almost at the same time, during the filling process, the temperature at the heat-sealing part of the packaging bag has not yet cooled to room temperature, and the adhesive fastness of the sealing It is still lower than the heat sealing strength of the package after cooling. If the adhesive fastness at this time is too low to withstand the weight of the packaged pharmaceutical product or the impact force generated, the heat seal will easily be broken during the filling process of the product. The packaging is broken.

The adhesion fastness of the package when the heat sealing temperature has not cooled to room temperature is expressed by the hot tack strength. Under different heat sealing parameters (heat sealing temperature, heat sealing pressure, heat sealing time), the hot tack strength of the package is different. By setting a series of heat-sealing parameters on the heat-adhesion tensile testing machine, the corresponding hot-sealing strength of the package under the set heat-sealing parameters is tested, so as to obtain the heat-sealing parameter range corresponding to the appropriate hot-sealing strength, which is used to guide the medical products. Packaging process to prevent bag breakage during product filling. The verification test process can refer to the American standard ASTM F1921, and the corresponding national standard is being formulated.

How to ensure that the plastic bottle for tablet packaging has good sealing performance and is easy to open?

Plastic bottles are commonly used packaging forms for tablet medicines. The rotational torque and sealing performance of such packaging bottles have always been the concerns of enterprises. If the rotation torque of the bottle cap is small and the overall sealing performance of the package is poor, the oxygen in the environment will penetrate into the package along the bottle mouth, affecting the quality of the packaged drugs; if the rotation torque of the bottle cap is too large, it may It affects the patient's medication process, increases their anxiety, and is not conducive to the recovery of the body.

The opening performance and sealing performance of the tablet medicine plastic bottle can be verified by the rotation torque test and the sealing performance (negative pressure method) test respectively. If the packaging requires both sealing performance and opening performance, the rotation torque of the bottle mouth can be controlled by a torque meter. , and then use the sealing tester to test the sealing performance of the packaging under different rotational torques, so as to ensure that the packaging is easy to open the bottle cap under the premise of good sealing performance.

What are the reasons for the change of nitrogen content in nitrogen-filled infusion bags?

Leak Tester LTY-01

Quality issues:

The nitrogen content in nitrogen-filled infusion bags changed greatly with the prolongation of storage time.

Cause Analysis:

(1) Packaging materials

l Poor barrier properties - including poor barrier properties to air or oxygen in the environment, and poor storage capacity for nitrogen inside the package, resulting in a large amount of gas exchange inside and outside the package, resulting in a decrease in the nitrogen content inside the package.

(2) Finished product packaging and processing

l Poor sealing - if the packaging bag body is creased or damaged during storage or circulation, it is easy to cause air leakage or leakage in the packaging; in addition, if the heat sealing effect of the heat seal is poor, poor heat sealing or heat sealing may occur. Excessive conditions, etc., will easily lead to the problem of slow air leakage from the heat seal of the package.

Expert advice:

——Pay attention to the monitoring of main performance such as air (oxygen) transmission, nitrogen transmission, headspace gas content analysis, heat sealing strength, and sealing performance (negative pressure method) of the packaging.

——Adjust the parameters of the heat sealing machine to improve the quality of heat sealing; choose packaging materials with high barrier properties or improve the quality of existing packaging materials.

Typical quality case:

——Test sample: infusion bag sample (customers report that the nitrogen content in the infusion bag decreases after storage for a period of time).

- Targeted inspection items: oxygen transmission, nitrogen transmission, sealing performance (negative pressure method), heat sealing strength.

——Test results: The oxygen permeability of the sample is 831.4716cm3/(m2•24h•0.1MPa), and its barrier property to oxygen is low; the nitrogen permeability is 215.0168cm3/(m2•24h•0.1MPa), which is not suitable for the interior of the package. The storage capacity of nitrogen is low; the heat sealing strength of the sample is 34.175N/15mm, and the heat sealing effect is good; in the sealing performance test, the sample has no air leakage under -90KPa, and the sealing performance is good. Therefore, the barrier property of the infusion bag is low, and the amount of gas interpenetration inside and outside the package is large, which is an important reason for the reduction of nitrogen content inside the package.

What are the factors that affect the tear performance of aluminized composite films for granule packaging?


Tear performance is a basic performance of packaging materials and an important factor related to the opening performance of packaging bags. The surface of the granulation drug packaging bag is often provided with easy tearing openings to improve the tearing performance of the packaging, such as serrated easy tearing openings, easy tearing gaps, easy tearing lines, etc. Rationality and the nature of the packaging bag itself will affect the tear performance of the packaging.

Taking the aluminum-coated composite film commonly used in granules as an example, the factors that affect the tearing performance of the easy tearing opening include the depth and angle of the tearing opening, the peel strength of the composite film, and the adhesion fastness of the aluminized layer on the surface of the film. Generally speaking, on the basis of a certain cut angle, the depth of the cut is small, and the tearing difficulty of the package increases; while the peel strength of the composite film and the adhesion fastness of the aluminized layer to the film surface are small, the The tearing process is prone to delamination, and each single-layer film is likely to be stretched to varying degrees under the action of the tearing force, which increases the tear strength of the composite film. The tearing properties of the aluminized composite film materials for granule drug packaging can be verified by right-angle tearing force or pants-type tearing and peeling strength tests.

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