Extractables and Leachables
Smither provides comprehensive extractables and leachables (E&L) testing services to help manufacturers identify, quantify, and evaluate chemical compounds that may migrate from medical device or drug delivery materials into a drug product or patient.
Our laboratories offer a broad range of analytical techniques to support E&L studies across the product lifecycle — from early risk assessments and material screening through to full regulatory submission studies.
Extractables vs Leachables
Extractables
Compounds that can be released from a material under exaggerated laboratory conditions using aggressive solvents — used to characterise the worst-case leachable profile.
Leachables
Compounds that actually migrate into a drug product under normal conditions of use or accelerated storage — the primary safety concern for regulatory submissions.
Regulatory Compliance
Our E&L studies are designed to meet current regulatory expectations including:
- ICH Q3E Guideline on Extractables and Leachables
- USP <661> Plastic Packaging Systems and Their Materials of Construction
- USP <1663> and <1664> Assessment of Extractables and Leachables
- ISO 10993-18 Chemical Characterization of Medical Device Materials
- EU MDR Annex I General Safety and Performance Requirements
- FDA Guidance for Industry — Container Closure Systems
Extractables and Leachables Study Programmes
We can design and execute tailored E&L study programmes based on your product type, regulatory pathway, and timeline, including:
- Extraction studies with multiple solvent systems
- Analytical identification and quantification
- Threshold of Toxicological Concern (TTC) evaluations
- Correlation studies between extractables and leachables
- Migration modelling and worst-case simulations
Routine Risk Assessments
Extractables and leachables risk assessments are carried out with safety and efficacy in mind. Our approach complies with safety concern thresholds (SCTs) and qualification thresholds (QTs) for both organic and inorganic compounds, and includes toxicological risk assessment where required.
Sample Support
Our team can advise on suitable sample types for your extractables and leachables study, drawing on experience across materials including elastomers (e.g. nitrile, silicone), plastics (e.g. PVC, polyethylene), adhesives, coatings, and metal alloys.
Expert Support
In addition, our team is able to advise on the range of extractables and leachables studies available. In general, you can use our E&L consultancy support to meet your needs.
