Medical-Device Analysis:
Drug Coating Characterization, Defect and Failure Testing, Dimensional and Surface Metrology Services

Physical, Chemical, and Performance Data — ready for regulatory submission.


Chemical and Material Composition Analysis


Drug coating inconsistencies, microscopic cracks, alloy mix-ups, or trace-metal contamination can derail a 510(k) or spark a costly recall. Our lab pinpoints these issues with a full array of techniques and expertise — so you can fix them before the FDA asks. Get results in as little as 24 hours!

Areas of Expertise:

Test Category Typical Methods What the Data Prove
Chemical & Material Composition • FT-IR / Raman
• Thermal analysis: DSC / TGA
• X-ray Powder Diffraction (XRPD) — phase ID
• SEM-EDS — microstructure & inclusions
• ICP-MS/OES — elemental impurities 		Confirms resin grade, alloy or ceramic phase, and detects contaminants that could drive biocompatibility risk assessments.
Extractables / Leachables & Residuals • Headspace GC/MS & LC/MS for organic profiles
• ICP-MS for trace metals 		Shows that patient-contact devices (catheters, wearables, drug-device combos) will not release harmful chemicals during their use life.
Particulate & Cleanliness • Non-volatile-residue gravimetry
• SEM-EDS/XPS for particle ID
• Light microscopy / ICC particle counting 		Verifies that manufacturing debris, machining oil, or residue remain within accepted limits and identifies particulate & cleanliness failures during production or packaging. Identify contaminants.

 

Figure 1. SEM-Failure Image – micro-crack across a stent strut after fatigue cycling.


Device Analysis Techniques:

Technique What you get Typical Use-cases
SEM metrology (20 nm resolution) Surface-defect imaging, dimensional checks (± 0.05 µm) Stent strut cracks, catheter-balloon wrinkles; verifying critical tolerances
EDX elemental mapping Alloy verification, plating-thickness, foreign-particle ID Nitinol/titanium homogeneity, solder inclusion
ICP-MS trace-metals Quantitation to ppb; USP <232>/<233> style Ni, Cr, Co leachables; contamination audits
GC/MS, LC/MS, LC-MS/MS Sensitivity to low-ppb; structural confirmation via MS/MS; broad organic coverage Detects plasticizers, antioxidants, oligomers, residual monomers in extractables/leachables studies
XRPD phase ID Crystal-structure & polymorph identification; amorphous vs crystalline quantitation Detects phase changes in drug-eluting coatings; verifies ceramic phases in orthopedic implants; confirms lot-to-lot raw-material consistency
FT-IR infrared spectroscopy Chemical-bond fingerprint; functional-group verification Rapid polymer/resin ID, silicone-residue confirmation, monitoring oxidation or cross-linking of catheter materials



Drug-Coated Medical Device Analysis

Comprehensive characterization, stability & release profiling for drug-eluting stents, balloons, catheters, and combination products. We have extensive experience in analyzing material deposition and consistency.

Stay compliant—and competitive

Regulators expect robust, multi-technique evidence that your coating is uniform, adherent, chemically intact, and releases its payload at the intended rate. Triclinic Labs pairs advanced surface, structural, and compositional analyses with cGMP data packages to keep your submission on track and your product performing in the field.

Test Category Typical Methods What the Data Prove
Coating Uniformity & Thickness • Scanning Electron Microscopy (SEM)
• Energy-Dispersive X-ray Spectroscopy (EDX)
• Optical/Confocal Profilometry		 Is the drug layer continuous? What is the thickness distribution along critical features?
Drug Identity & Crystalline Form • X-ray Powder Diffraction (XRPD)
• Micro-Raman & FT-IR Spectroscopy
• Differential Scanning Calorimetry (DSC)		 Has polymorphic form changed during processing or sterilization?
Drug Loading & Content Uniformity • HPLC/UPLC with UV or MS detection
• LC-MS/MS quantitation
• ICP-MS (for metallic APIs or excipients)		 How much API is truly on each device—and is it consistent lot-to-lot?
Stability & Compatibility
• Accelerated aging (ICH Q1A)
• Forced degradation analysis - LC-MS
• Extractables/Leachables by GC-MS & LC-MS 		Shows manufacturing debris, machining oil or residues are within accepted limits.

Figure 2. Drug-Coated Balloon Catheter (macro) – high-magnification surface showing uniform micro-beads.

 

Regulatory Alignment

  • FDA Quality System Regulation (21 CFR 820) traceability

  • USP <232>/<233> elemental impurity requirements

  • Zero Form 483 observations in all FDA audits (most recent 2024)