Biological Safety Testing and Biocompatability
Chemical Characterization for Materials
As part of the biological evaluation of medical devices, PSL offers chemical characterization services, as outlined in ISO 10993 Part 18: Chemical Characterization of Materials.
While analytical methods and concepts are consistent with extractables and leachables studies for containers and closure systems, quick and affordable solutions are needed for the comparison of medical device products after design and material changes, as well as change of raw material, production lot or aging.
To achieve this we utilize the "GC/HPLC/ICP fingerprint", a standardized analytical service under consideration of existing material and production data leading to complete chemical characterization of medical device products.
In some situations a customized study outline is recommended to complete the characterization and the safety evaluation of the device.
Thanks to our expertise in both medical devices and pharmaceutical packaging areas, we will be able to support you in designing a tailored study protocol (extraction temperature and duration, simulants to be used, etc.) for the analytical evaluation of the extractables and their toxicological assessment.
Our chemical characterization services include:
- 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
Risk Assessment & Toxicological Assessment
We 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.
We offer the full range of biocompatibility testing required by the Medical Device Industry. In addition to conducting biological studies according to the matrix of ISO 10993, FDA Blue Book Memorandum, MHLW requirements, USP classification of plastics, including Class VI and other international guidelines, we offer a variety of cell-based alternative methods or models under GLP to examine the hazardous effects of medical devices. The suitable customized test strategy design is chosen depending on the material of the product, manufacturing methods and the aim of the study.
Our services include standard testing methods as well as alternative in vitro testing methods or comprehensive histopathological services. Listed below is a brief overview of our services. For a comprehensive list please click the link above.
- Genetic Toxicology
- Hemocompatibility (Static and Dynamic Studies)
- Irritation and Local Tolerance Tests
- Acute Systemic Toxicity
- Subacute, Subchronic and Chronic Toxicity
- Implantation in Combination with Systemic Toxicity
We are familiar with the commercial realities and requirements, from start-up to multinational Medical Devices Companies. Our clients can be sure, that PSL provides the best test strategy for your medical devices in touch with latest scientific trends.
PSL also conducts bridging studies to determine scientific background for the biological evaluation of a medical device.
These studies provide essential information for assessing risks and benefits as well as achieving the ethical conduct of the planned evaluation as required by the animal welfare regulation (i.e. ISO 10993-2). Biocompatibility is evaluated through expert reports based on material and literature data, along with actual study results.