Stability Test (Shelf Life Determination)
Medical Analyses

Stability Test (Shelf Life Determination)

    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.


    Purpose and Importance of Stability Testing

    Stability testing determines whether products maintain their safety, efficacy, and specifications over the proposed shelf life. It is essential for:

    1. Ensuring Product Safety and Quality

      • Verifies whether physical, chemical, and biological attributes remain stable throughout the shelf life
      • Protects user health and safety
    2. Evaluating Product Performance

      • Confirms if medical devices retain their functional properties over time
    3. Meeting Regulatory Requirements

      • Mandatory for adherence to standards set by organizations such as the FDA, ISO 13485, and EU MDR
    4. Gaining Market Acceptance

      • Stability test reports are required to prove product safety and efficacy for international markets

    Types of Stability Testing

    Stability tests simulate various conditions that products may face during their shelf life. The primary categories include:

    1. Real-Time Stability Testing

      • Products are stored under normal conditions (e.g., 25°C and 60% relative humidity) for the full intended shelf life
      • Most accurate method for predicting real-world product behavior
    2. Accelerated Stability Testing

      • Products are subjected to elevated stress factors (e.g., 40°C and 75% relative humidity) to simulate long-term storage in a short timeframe
      • Useful for estimating shelf life during product development
    3. Stress (Extreme) Condition Testing

      • Products are exposed to extreme environments such as freezing temperatures, high temperatures, or direct sunlight
      • Evaluates product durability under challenging conditions
    4. Microbiological Stability Testing

      • Assesses resilience against microbial contamination
      • Especially important for sterile products and those containing biological materials

    The Stability Testing Process

    Stability tests are carried out with a defined protocol, adhering to specific standards and guidelines:

    1. Sample Selection and Preparation

      • Final products from the production line are chosen for testing
      • Prepared according to the purpose and requirements of the test
    2. Defining Storage Conditions

      • Storage conditions reflect the climate of the target market
      • ICH Q1A guidelines are often referenced for pharmaceutical products
    3. Planning the Testing Timeline

      • The test duration is aligned with the product’s intended shelf life
      • For instance, a 24-month shelf life might be assessed at 6, 12, 18, and 24 months
    4. Conducting Analyses

      • Physical Tests: Checks properties like color, odor, viscosity, and fragmentation
      • Chemical Tests: Monitors the stability of active components
      • Microbiological Tests: Verifies the absence of microbial contamination
      • Functional Tests: Assesses whether device performance remains consistent
    5. Evaluation and Reporting

      • Test results are compared against product specifications and international standards
      • A detailed stability report documents findings and conclusions

    Standards and Guidelines for Stability Testing

    Stability testing follows national and international regulatory guidelines. Prominent references include:

    • ICH Q1A: Guidelines for planning and implementing stability testing of pharmaceutical products
    • ISO 13485: Quality management system requirements for medical devices
    • FDA Guidance: Requirements for shelf-life determination in medical products
    • EU MDR (Medical Device Regulation): Mandates stability and shelf-life testing for devices in the European Union

    Stability Testing Services at TTS Laboratory Services

    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

      • Comprehensive analyses to assess product stability
    • Accelerated and Real-Time Stability Testing

      • Evaluations under both expedited and long-term conditions
    • Regulatory Compliance Support

      • Guidance for aligning products with FDA, ISO, and MDR requirements
    • Fast and Reliable Reporting

      • Detailed stability reports to facilitate global market access

    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.