Understanding Chemical Characterization Testing
The purpose of this testing is to determine a baseline to the extractable amount of chemical compounds present in and on a medical device and utilize extraction conditions similar to those utilized in biocompatibility determination of similar devices.
Chemical Characterization Techniques
- Gas Chromatography/Mass Spectrometry (GC/MS): Analyzes the extract samples for Volatile Organics Compounds (VOC) and Semi-Volatile Organic Compounds (SVOC)
- Liquid Chromatography/Mass Spectrometry (LC/MS): Analyzes the extract samples for target Non-Volatile Organic Compounds (NVOC).
- LC Chromatogram: Utilizing a UV detector to determine the presence of peaks corresponding to non-target NVOC.
- Inductively Coupled Plasma (ICP): Analyze the extract samples for metals.
For “borderline products”, some container/closure systems may either be considered as a pharmaceutical container or as a medical device. For medical devices, appropriate testing according to the ISO 10993 Standard series should be performed.
- ISO 10993 – Part 3: Tests for Genotoxicity, Carcinogenicity, Reproductive Toxicity
- ISO 10993 – Part 4: Selection of Tests for Interactions with Blood
- ISO 10993 – Part 5: Tests for In-Vitro Cytotoxicity
- ISO 10993 – Part 6: Tests for local Effects after Implantation
- ISO 10993 – Part 10: Tests for Irritation and delayed-type Hypersensitivity
- ISO 10993 – Part 11: Tests for Systemic Toxicity
- OECD 471: AMES testing (Mutagenicity)
- ISO 10993 – Part 18 Chemical Characterization
Toxikon’s Expertise in Chemical Characterization
Toxikon provides analytical services applicable to all phases of product development. This includes characterizing raw materials for container/closure and disposable systems, conducting material comparisons, providing ongoing QC validation support for manufacturing residuals, and testing for byproducts of sterilization.