Extractables & Leachable for Medical Devices (Chemical Characterization)
Chemical Characterization for Materials
Extractables and leachables (E&L) are important considerations in the development and safety assessment of medical devices. These terms refer to substances that can be extracted from a material (extractables) or released into a product (leachables). Understanding and controlling these elements are crucial to ensuring the safety and efficacy of medical devices.
As part of the evaluation of medical devices, it is important to evaluate the potential for various chemicals to migrate from the container, container closure system or other materials used for a device. We are able to detect every leachable substance in your product that you must know of. Testing is conducted in accordance with ISO 10993-18.
While analytical methods and concepts are consistent with extractables and leachable studies for containers and closure systems, quick and affordable solutions are demanded for the comparison of medical device products after design and material changes, change of raw material production lot or ageing.
No matter what the geometry, material or consistency of your medical device, Product Safety Labs will find a way to prepare, extract and analyse your product in full compliance with ISO 10993-18.
- Chemical Characterization of Material (ISO 10993-18, 19)
- Identification and Quantification of Degradation Products (ISO 10993-13, 14, 15)
- Determination of Tolerable Intake for Extractable Substances (ISO 10993-17)
Risk Assessment & Toxicological Assessment
MDTL will help you to perform risk and toxicological assessments to help understand the safety profile of the medical device product. Such profiles can be used to drive additional analytical testing for further investigations of unknown entities, to drive biocompatibility program strategies or it can be combined with pre-clinical data for a comprehensive risk assessment. These assessments are based on ISO 10993-17 to identify and critically evaluate any existing toxicity and human exposure data on the final medical device product, on individual chemical compounds, additives, colorants, processing aids and potential leachables.
Extractables and leachable rubber (products) medical devices
Extractables and leachables are significant considerations when it comes to rubber products used in medical devices. Rubber materials can contain various additives, processing aids, and residual substances that may be extracted or leached under certain conditions. Here are some key points to consider in the context of rubber products for medical devices:
Types of Rubber Materials: Medical devices often use different types of rubber, such as silicone rubber, natural rubber, synthetic rubber, or elastomers like polyurethane. Each type may have specific considerations regarding extractables and leachables.
Potential Extractables: Extractables from rubber products may include substances like plasticizers, antioxidants, vulcanizing agents, stabilizers, lubricants, and residual monomers or oligomers from the manufacturing process.
Leachables in Medical Devices: Leachables can migrate from rubber materials into the drug, biologic, or body fluids that come into contact with the medical device. This can include substances like degradation products, additives, or residual chemicals.
Material Characterization: Manufacturers conduct comprehensive material characterization studies to identify and quantify extractables from rubber compounds. This involves subjecting the material to various conditions that simulate its use to encourage the release of potential extractables.
Accelerated Aging Studies: Rubber materials may be subjected to accelerated aging studies to simulate the effects of time, temperature, and environmental conditions. This helps in identifying potential degradation products and leachables.
Biocompatibility Testing: Biocompatibility testing, as outlined in standards such as ISO 10993, is essential to assess the impact of extractables and leachables on the biological response when the rubber product comes into contact with living tissues.
Risk Assessment: A risk-based approach is often employed to evaluate the potential impact of extractables and leachables on patient safety. Risk assessments consider factors such as the intended use, duration of contact, and patient population.
Regulatory Compliance: Compliance with regulatory standards and guidelines, such as ISO 10993 and FDA requirements, is crucial. Manufacturers must provide comprehensive documentation on the assessment of extractables and leachables as part of regulatory submissions.
Material Selection and Processing: Careful selection of rubber materials and manufacturing processes is essential to minimize the presence of harmful extractables and leachables. Choosing materials with a history of use in medical devices can simplify regulatory assessments.
