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Materials Testing
Medical Device Materials Characterisation
Chemical analyses are an under exploited resource in the medical device industry. They can save costs in product development and avoid QA problems in production or worse in the field. Materials characterisation is used to define products chemically. Then when a process or minor design change is made a repeat chemical analysis can be used to compare new and old production. This reduces the need for repeat toxicity testing.
Our analytical services are equally applicable for testing pharmaceutical containers to ICH guidelines and USP monographs.
Chemical analyses provided by MET include:
- Assessment of processing residuals
- Batch to batch verifications
- Cleaning fluid analysis
- ISO 10993-18 materials characterisation
- Goods inwards materials identification
- Measurement of extractable and leachable materials from medical devices
- Measurement of extractable and leachable materials from pharmaceutical containers
- Verification of process changes
The biocompatibility testing during new product development can also be minimised by chemical analysis. This has been agreed by all major regulatory authorities:
FDA Guidance May 1, 1995 Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
'Some devices are made of materials that have been well characterized chemically and physically in the published literature and have a long history of safe use. For the purposes of demonstrating the substantial equivalence of such devices to other marketed products, it may not be necessary to conduct all the tests suggested in the FDA matrix of this guidance.'
EN/ISO 14971 requires that 'relevant characteristics that could affect safety are listed and, from these, possible hazards are identified. For a biological safety assessment, the first step comprises characterisation of materials. Data relating to formulations, additives, processing aids, degradation products, effects of processing, residue levels, etc. allow the chemical nature of the material(s) to be fully characterised. Toxicological hazards can be identified from a knowledge of the toxicity of the chemicals or materials listed.'
MHRA Guidance 5 EC MEDICAL DEVICES DIRECTIVES GUIDANCE ON THE BIOLOGICAL SAFETY ASSESSMENT Updated February 2011
'Biocompatibility test data should (therefore) be used to complement an assessment based on materials characterisation, rather than as a replacement for it.
It may not be necessary to perform tests suggested by the standard (ISO 10993) in all cases. Where the proposed materials have already been extensively used or tested, little or no biological testing may be necessary to judge the biological safety of the device.' Brackets added by MET.
