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The Role of Stability Testing in the Pharmaceutical Industry


The world depends on the safety and reliability of pharmaceutical drugs. In fact, about 66% of adults in the U.S. alone take prescription drugs. To keep up with this overwhelming demand, pharmaceutical companies must subject their products to environmental testing in a stability test chamber. Stability testing simulates real-world conditions that help determine the effects of temperature, pressure, humidity, and more on a product. The results collected during pharmaceutical testing determine how the products will behave over time through manufacturing, transportation, and storage.


Real-Time Stability Testing Uses

Stability testing is a critical part of the drug development and approval process. Pharmaceutical companies use stability chambers for several purposes to meet safety and quality standards

Accelerated Aging Studies

Determining a drug’s long-term stability in a short time frame is essential. Through accelerated stability testing, companies can learn more about how a product will react to extreme environmental conditions, including high temperatures and humidity levels. The data that is collected during the accelerated aging study provides estimations of long-term outcomes and evaluations of temporary excursions from label storage conditions.

Quality Assurance Testing

It’s important to verify that no changes have been introduced in the drug formulation or manufacturing process. This is where quality assurance testing comes in. Through stability testing, pharmaceutical companies can conduct quality control tests that ensure conditions are not negatively affecting the stability of the product. Data collected on different active and inactive ingredients can provide insight into how the drug is reacting and assist companies in developing a drug with higher efficacy.

Integrity of Packaging

Transportation and storage can have a big impact on pharmaceutical products. Humidity and temperature can cause exposed products to have altered chemical compositions, physical properties, and more. That’s why testing the durability of pharmaceutical packaging is so important. With a stability chamber, companies rely on fans, compressors, and heaters to test how the packaging and its shelf-life withstand erratic environmental changes. 

Stability chambers are used for various purposes besides packaging, quality assurance, and accelerated aging. Depending on the company’s end goal, they can test a drug’s potency, purity, consistency, light resistance, or microbial count. A range of features can support further pharmaceutical testing and analysis. 

How AES Can Support the Future of Pharmaceuticals  

At Associated Environmental Systems (AES), we provide high-quality environmental test chambers, including stability testing chambers. Our LH-Series includes three innovative chamber models with temperature and humidity-controlled capabilities. These models come in three different volumes: 1.5, 5, and 10 cubic foot test chambers, which are either benchtop or floor model chambers. Our benchtop LH chamber can be stacked to double the testing capacity while maximizing lab space. 

As global regulations change and consumers demand new products, AES is here to provide innovative solutions. Across the pharmaceutical industry, trends point to increased drug molecule complexity, shortened development and delivery timeframes, and decreased batch sizes. Throughout landscape changes, AES will work tirelessly to ensure each pharmaceutical company is ready and confident to bring a product to market. Together, we can provide assurance and safety to consumers around the world. Chat with an AES sales engineer today to learn more about our pharmaceutical testing services!