Extractables & Leachables

Definition of Extractables and Leachables

• Extractables are substances which could be potentially released from polymeric, metallic or glass material of medical device using extraction solvents and/or extraction conditions into the patient or consumer; such as dyes, catalysts and plasticizers.
• Leachables are substances which do migrate from a medical device into the patient under intended use conditions, typically a subset of those identified in the extractables analysis.

Many compounds are intentionally added during the manufacture of a device, including colorants, plasticizers, impact modifiers, and processing aids. Extractables and Leachables (E&L) testing is performed to identify and quantify the potentially harmful chemical compounds which could migrate from medical device into patients.

Standard for Extractables and Leachables

• ISO 10993-12
• ISO 10993-18:20

STEMart offers Extractable & Leachables testing service utilized modern analytical techniques and instrumentation, following the ISO 10993 standard for medical devices. Medical device manufacturers can use it to show that materials of concern do not migrate from the device into the patient.

Extractables and Leachables Testing Service for Medical Device

• Gathering of chemical data to include materials and manufacturing processes;
• Material review and risk analysis with method verification;
• Specific study design and protocol using validated methods;
• Method development;
• Sample extraction;
• Comprehensive analysis of extracts and leachables with a wide range of analytical techniques;
• Gas Chromatography (GC) / Mass Spectrometry (MS) Headspace, GC and GC- MS for Volatiles, Semi-Volatiles and Organics
• Liquid Chromatography (LC)/MS for Non-Volatile Chemicals
• GC-FID/MS for Fingerprinting
• Spectrophotometry by UV/Vis/FL
• High Performance Liquid Chromatography (HPLC) for Identification / Concentration / Purity / Stability
• Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES) for Heavy Metals and Elemental Analysis
• Fourier Transform Infrared (FT-IR) Spectrophotometry for Determination of Chemical Fingerprint
• Protein Content and Characterization
• SEC-LLS for Size and MW characterization
• Karl Fisher for Moisture Determination
• Osmolarity Determination
• Conductivity
• pH
• Polarimetry
• Total Organic Carbon (TOC)
• Viscosity Measures
• Gravimetric Determination of Extractables
• Instrumentation Details
• Toxicological risk analysis.

Combining the rich experience in method development for controlled extractables studies with vast knowledge of leachable compounds, STEMart provides comprehensive extractables and leachables testing service to help medical device manufacturer to verify product safety and efficacy. If you have additional questions about Extractables & Leachables or would like to find out more about our services, please feel free to contact us.