Stability Testing (Shelf-Life Determination) in Medical Devices and Healthcare Products
Stability testing, also referred to as shelf-life determination, is crucial for ensuring medical devices and healthcare products remain safe and effective throughout their intended lifespan. By evaluating a product’s physical, chemical, microbiological, and functional characteristics under specific environmental conditions, stability testing reveals whether a product deteriorates over time and if it retains its efficacy and safety. This process helps protect user safety and ensures compliance with regulatory standards.
Stability testing determines whether products maintain their safety, efficacy, and specifications over the proposed shelf life. It is essential for:
Ensuring Product Safety and Quality
Evaluating Product Performance
Meeting Regulatory Requirements
Gaining Market Acceptance
Stability tests simulate various conditions that products may face during their shelf life. The primary categories include:
Real-Time Stability Testing
Accelerated Stability Testing
Stress (Extreme) Condition Testing
Microbiological Stability Testing
Stability tests are carried out with a defined protocol, adhering to specific standards and guidelines:
Sample Selection and Preparation
Defining Storage Conditions
Planning the Testing Timeline
Conducting Analyses
Evaluation and Reporting
Stability testing follows national and international regulatory guidelines. Prominent references include:
At TTS Laboratory Services, we offer stability testing solutions for medical devices and healthcare products in accordance with international standards:
Physical, Chemical, and Microbiological Testing
Accelerated and Real-Time Stability Testing
Regulatory Compliance Support
Fast and Reliable Reporting
Stability testing is a crucial process to ensure that medical devices and healthcare products maintain safety, efficacy, and quality throughout their designated shelf life. It is also necessary to meet regulatory obligations and protect user safety.
At TTS Laboratory Services, we perform your stability tests professionally and provide internationally recognized reports.
As TTS Laboratory Services, we stand by your side with our accredited analysis scope to support your testing requirements.
Stability testing of medical products consists of a series of tests to evaluate whether a product retains its properties and effectiveness over a period of time. These tests are essential for determining the shelf life (lifetime) of a product and stating it on the label.
Stability tests are as follows:
1. **Real Time Stability Test**: This test is performed to determine how long the product will actually remain stable under recommended storage conditions and packaging. This is a test in which the product is stored for its full shelf life.
2. **Accelerated Stability Test**: In this test, the product is stored at high temperature (usually higher than the real-time storage temperature). This is done to obtain stability information in a short time, potentially reducing the stability of the product rapidly. However, the results from this test cannot replace real-time stability testing and are for predictive purposes only.
3. **Cyclic Temperature Test**: This test is done to evaluate how the product responds to temperature changes (hot-cold cycles).
4. **In Vitro Stability Test**: Stability is evaluated in in vitro environments, especially for biological products.
During the test, changes in the physical, chemical, microbiological and therapeutic properties of the product are measured at certain time intervals. These changes include colour, odours, solubility, pH, potency, microbiological contamination, amount of active substance and biological activity.
Determining the shelf life is necessary to ensure the effectiveness, safety and quality of the product. The product must maintain its stated properties throughout its shelf life. These tests are critical, especially for drugs, biologics, medical devices, and other critical healthcare products.
Stability tests should be performed according to the guidelines and standards of international and national regulatory agencies (eg FDA, EMA, ICH). The ICH (International Conference on Harmonization) has made some recommendations specifically for drugs, such as the Q1A-R2: Stability Tests guide.