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Temperature and humidity testing in the pharmaceutical industry

Abstract: 在制药行业,环境条件对产品质量尤为重要,因此温湿度测试是确保药物及其包装在不同环境下稳定性的关键。恒温恒湿箱广泛用于模拟极端湿度条件,以评估药品包装的耐久性和标签的稳定性。虽然药物本身难以测试,但包装和标签必须能够承受湿度的影响,不会因湿度而失去附着力或印刷清晰度。同时,高温环境测试同样重要,因为温度升高可能导致填料释放颗粒,影响药物的稳定性。热风炉在这种测试中常用于评估药物在高温下的行为,并广泛应用于干法灭菌过程。

Environmental conditions may directly affect the quality of the product. Temperature and humidity mapping verification can be performed by installing different machines to verify operability. This includes Incubators, constant temperature and Humidity Chambers, freezers, etc.

However, at some point, the manufacturer loses control of the situation. He can manage the conditions of the laboratory, the manufacturing unit, his warehouse. But for retailers, transporters or users, he has no control to this extent. What he can do is make his products withstand different conditions.

In the pharmaceutical industry, you can't test products because they are drugs, but you can certainly test packaging. Whether they are sustainable under different conditions. In addition to the packaging, it is important that the labels are able to withstand environmental conditions. 

Humid Environment Test

Constant temperature and Humidity Chambers are widely used in the pharmaceutical industry to evaluate the behavior of products and their packaging under extreme humidity. Testing is not performed on every product. In contrast, testing is an ongoing, simultaneous process during research.

It is important to know if there is any ingredient interference due to humidity, whether it will cause some dangerous results or remain neutral or unaffected.

The second important thing to know is the packaging behavior in wet conditions. Take blister packaging, for example. The lower film is bonded to the plastic cover with an adhesive. If this adhesion is affected by humidity? Labels affixed to the package and labels printed on the package shall not be torn off due to moisture in the air.

High temperature environment test

It is always recommended to store medications in a cool, dry place. The reason behind it is due to the uncertainty of the drug and its packaging due to exposure to high temperature. Some polymer fillers tend to release particles due to increased temperature. These are usually non-reactive fillers, but due to drug sensitivity, such contamination cannot be tolerated. This can disrupt the overall composition. This is why the filler is tested for any change in properties due to ambient temperature. Hot Air Ovens are common in the pharmaceutical industry. In addition to testing products, they are also widely used in dry sterilization processes.

Temperature and humidity test in the pharmaceutical industry with picture 1

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