Estudo de Estabilidade de Produtos Médicos | Scitec

Stability testing of sterile packaging and medical devices is of utmost importance in healthcare. These tests aim to evaluate the ability of packaging to maintain sterility and the integrity of medical devices over time. By exposing the packaging and devices to actual storage and transport conditions, such as temperature, humidity, and light, it is possible to identify potential failures and take corrective action to ensure product quality and safety.

The sterility of medical devices is critical to avoid infection and other risks to patients. Therefore, ensuring package stability is essential for preserving the sterility of devices throughout their life cycle. Stability testing allows you to evaluate the packaging’s resistance under different environmental conditions, identifying potential problems such as material degradation or loss of sterility. With this information, manufacturers can make improvements in packaging design, materials, and methods to ensure product integrity.

In addition, stability testing is required by quality regulations and standards, such as Good Manufacturing Practices (GMP). These regulations aim to ensure the quality, safety, and efficacy of medical devices. Stability testing allows manufacturers to prove the compliance of their products, demonstrating that they have been subjected to rigorous conditions and have maintained their integrity and performance over time. As such, these tests play a key role in regulatory compliance and the confidence of healthcare professionals and patients in the medical products they use.

The stability study aims to assess the length of time a product retains, within specified limits and throughout its period of storage and use, the same properties and characteristics it had at the time of manufacture. 

Similar to pharmaceutical products, medical devices have a set of criteria for assessing stability such as:


Degradation, interaction with packaging and device interaction.


Physical characteristics, strength, manufacturing process, storage conditions.


Sterility, environmental control, antimicrobial efficacy, endotoxins, bioburden and cytotoxicity.

In addition to



MDRF – Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
ICH guideline Q series