Extractables and Leachables Testing SupportE&L Testing Support
E&L and chemical characterization support for medical devices, pharmaceutical packaging, combination products, containers, closures and patient-contact materials.
What this category can include
Study design
Extraction conditions, solvent selection, sample surface area, device/material configuration and analytical method route planning.
Analytical screening
GC-MS, LC-MS, ICP-MS, IC and related screening routes depending on material and target compounds.
Toxicological support inputs
Chemical data organized for toxicological risk assessment, biological evaluation and regulatory response needs.
Mapped around accepted industry expectations
E&L planning should be risk-based and linked to patient exposure, material type, contact duration, extraction conditions and the intended regulatory use of the data.
| Area | Industry route | Client output |
|---|---|---|
| Medical device chemistry | ISO 10993-18 chemical characterization and ISO 10993-17 toxicological risk assessment principles | Chemical characterization and TRA input package |
| Pharma packaging | Container closure, single-use system and process contact material expectations | Extractables/leachables study scope and report support |
| Analytical route | Volatile, semi-volatile, non-volatile and elemental impurity screening methods | Analytical data package coordination |
What to send before testing
- Material composition and device or packaging drawings
- Patient or product contact route and duration
- Sterilization and manufacturing process details
- Target standard, regulator question or buyer requirement
- Sample quantity and available prior chemical data
Typical deliverables
- E&L study design outline
- Sample preparation and extraction condition checklist
- Analytical report coordination
- TRA or biological evaluation input summary
A practical path from requirement to report package
1. Requirement intake
Product category, target market, intended use, test objective and deadline are captured.
2. Scope mapping
Relevant standards, methods, sample quantity, report format and documentation gaps are mapped.
3. Quote-ready package
The enquiry is structured so technical and commercial review can move faster.
4. Report follow-up
Reports, certificates and supporting documents are organized for business or submission use.
FAQ for this service
When is E&L testing needed?
It is commonly considered for long-contact devices, implants, packaging systems, combination products, new materials and regulator questions on chemical safety.
Which instruments are used?
Common routes include GC-MS, LC-MS, ICP-MS and IC, selected according to target compound classes and material risk.
Does E&L replace biological testing?
No. It can reduce uncertainty and support toxicological assessment, but the final strategy depends on the full biological evaluation.
Need a structured testing plan?
Send your product details and target geography. We will help convert the requirement into a cleaner service scope and documentation checklist.