What are Leachable and Extractable Studies?

What are Leachable and Extractable Studies?

Contents

    What Are Leachable and Extractable Studies?

    Leachable and extractable studies are critical analyses conducted to ensure product safety and quality, especially in medical devices, pharmaceuticals, packaging materials, and products that come into contact with food. These studies aim to identify harmful chemical substances that may originate from the product's environment.

    What is Extractable?

    Extractables are chemical substances that can be released from a product when it is exposed to a specific solvent or simulated conditions. This study is conducted to understand the potential risks contained within the product and is usually performed under more aggressive conditions.

    What is Leachable?

    Leachables are chemical substances that a product can release into the environment under normal usage conditions. This study simulates real-world usage scenarios and is highly important for end-user safety.

    Why Is It Important?

    • Patient Safety: In medical devices and pharmaceuticals, the risk of chemical substances leaching that could harm the human body is assessed.
    • Regulatory Compliance: Regulatory authorities such as the FDA, EMA, and ISO mandate the conduction of these studies.
    • Product Quality: Ensures that packaging or manufacturing materials do not affect the product’s stability and efficacy.

    Methods Used in Leachable and Extractable Studies

    • Mass Spectrometry (GC-MS, LC-MS)
    • Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
    • FTIR Analysis
    • HPLC and UPLC Techniques

    Which Products Are Tested?

    • Pharmaceutical Packaging
    • Medical Devices (e.g., catheters, syringes)
    • Food Packaging
    • Cosmetic Products

    Leachable and extractable studies are fundamentally important for ensuring the safe use of products and predicting their long-term effects. At TTS Laboratory Services, we are here to support your analysis needs with our accredited testing capabilities.