Testing Oxygen and Water Vapor Barrier Properties of Aluminum-Plastic Composite Pharmaceutical Packaging

Pharmaceutical packaging protects drug products from environmental factors that can compromise their safety, efficacy, and quality. Among various packaging materials, aluminum-plastic composite films are widely used, especially for moisture- and oxygen-sensitive medications like powders, due to their excellent barrier properties. Therefore, rigorous testing is necessary.

Oxygen and water vapor transmission are two key properties that must be controlled. Oxygen can cause oxidation of active pharmaceutical ingredients, leading to degradation and loss of potency. Moisture can similarly promote chemical degradation, alter physical properties, and encourage microbial growth. Therefore, evaluating the barrier performance of aluminum-plastic composite packaging against these elements is crucial for ensuring drug stability and extending shelf life.

Several standardized test methods exist for quantifying these barrier properties. Oxygen transmission rate (OTR) is typically measured using coulometric or pressure difference methods. Coulometric methods, as described in ASTM D3985 and ISO 15105-2, involve measuring the amount of oxygen that permeates through a sample film over a specific time period using an oxygen sensor. Pressure difference methods, such as those detailed in ASTM F1307 and ISO 15105-1, determine OTR by measuring the pressure change in a test chamber caused by oxygen permeation.

Water vapor transmission rate (WVTR) is commonly determined using gravimetric methods, also known as cup methods. These methods, outlined in ASTM E96 and ISO 2528, involve sealing a desiccant inside a test cup with the packaging material as a lid and measuring the weight gain of the desiccant over time due to absorbed moisture. Another method is the modulated infrared sensor method, described in ASTM F1249.

Labthink C406H Oxygen /Water Vapor Transmission Rate Test System is based on the testing principle of Coulometric oxygen sensor and infrared water vapor sensor. It is designed and manufactured according to ASTM D3985、ASTM F1249，ISO 15106-2 and other relevant standards to provide high precision and high efficiency oxygen and water vapor transmission rate tests for high and medium gas barrier materials. It is suitable for testing the oxygen and water vapor transmission performance of films, sheets and related materials in the fields of food, medicine, medical devices, daily chemicals, photovoltaic, electronic and many others.

Regular testing of oxygen and water vapor barrier properties according to these standards is essential for pharmaceutical manufacturers to ensure the quality and safety of their products throughout the supply chain and until the point of consumption. By maintaining robust quality control measures on packaging materials, manufacturers can effectively protect medications from degradation and maintain their therapeutic effectiveness.

As the demand for functional packaging grows, testing methods are evolving to ensure a more comprehensive evaluation of film materials. Labthink encourages collaboration with companies for quality control! Visit the website www.labthink.com to learn more!