What is Combination Product Biocompatibility?
Combination product biocompatibility is the analysis of a combined container closure or delivery system with a pharmaceutical drug product when in contact with, or in, the human body. In many ways these investigations combine aspects of standard extractables and leachables and chemical characterization studies. Essentially, the drug component of the combination product adds additional chemical variables to the medical device profile which needs to be evaluated. Per the FDA, the ISO 10993 standards are referenced as guidance for these studies. EKG has written a thorough overview of ISO 10993.
These drug device combination products are among the most challenging products to submit to the FDA for review. As such, these combination medical devices require extensive risk assessment and planning for product testing and analysis.
Combination Product Chemical Characterization Testing at EKG Labs
EKG Labs leverages its knowledge of extractables, leachables, and ISO 10993 chemical characterization to help companies develop combination products and devices for FDA approval. Our team has years of experience working with a wide variety of combination devices, materials, and pharmaceutical products. This includes applying ISO 10993 biocompatibility testing criteria across many combination products. We also have a firm understanding of how to characterize common and novel medical device materials and flag any materials which need further toxicological evaluation or analysis. EKG Labs further supports combination drug device analysis through regulatory consulting services and can help you navigate the complex FDA regulatory process.
Combination Medical Device Material Expertise:
- Polymers including plastic, rubber, resins, bioabsorbables, swellable polymers, nylons, natural products, etc.
- Metals and alloys
- Composite materials
Combination Device Experience:
- Drug-eluting stents
- Intraocular lenses and implants
- Dental implants and adhesives
- Metered dose inhalers, nebulizers, and other novel inhalation technology
- Wound-healing devices
- Filler devices
- Pumps and other drug delivery devices
- Cardiovascular devices
- Pulmonary devices
- Miscellaneous devices in accordance with ISO 10993 testing
Combination Product Chemical Characterization Analytical Techniques
- Chromatographic Characterization – HPLC, LC/MS, GC/MS, GC/FID, GC/TCD, GPC/SEC
- Spectroscopy Characterization – ICP-MS, NMR, MS, PXRD, TF-XRD, UV-Vis, FTIR, Raman
- Microscopy – SEM, TEM, AFM, STM, LSCM
- Other- TGA, DSC, TOC, BET Surface Area/Pore Size Analyzer