Targeted Analysis: Extractables & Leachables (ISO 10993-18)
Chemical characterization is a mandatory part of the biological safety evaluation for most medical devices. Targeted analysis identifies and quantifies specific chemical substances—known as Extractables and Leachables (E&L)—that could potentially migrate from the device into the patient’s body.
EBI provides high-resolution analytical screening to ensure your device meets the rigorous requirements of ISO 10993-18.
The Goal of Chemical Characterization
The primary objective of targeted analysis is to establish the „worst-case” chemical release profile of your device. This data is essential for:
- Demonstrating Chemical Equivalence: Proving that changes in manufacturing or suppliers do not alter the device’s safety.
- Risk Management: Providing the necessary input data for the Toxicological Risk Assessment (TRA).
- Screening for Impurities: Detecting manufacturing residues, cleaning agents, or degradation products.
Analytical Methodology: VOC, SVOC, NVOC, and Elements
We utilize a suite of advanced chromatographic and spectroscopic techniques to cover the full spectrum of potential migrants:
- Volatile Organic Compounds (VOC): Analyzed via Headspace GC-MS (Gas Chromatography-Mass Spectrometry).
- Semi-Volatile Organic Compounds (SVOC): Analyzed via GC-MS using various extraction solvents.
- Non-Volatile Organic Compounds (NVOC): Analyzed via LC-MS (Liquid Chromatography-Mass Spectrometry) for high-molecular-weight substances.
- Elemental Impurities: Analyzed via ICP-MS (Inductively Coupled Plasma) to detect heavy metals and catalysts at parts-per-billion (ppb) levels.
Sample Requirements and Turnaround Time
Proper sample preparation is vital to avoid external contamination in chemical analysis.
- Sample Quantity: Minimum of 3–9 finished devices (depending on surface area and device size).
- Surface Area Requirements: Generally 120 cm² or more to ensure adequate detection limits.
- Standard Turnaround Time: 10–16 weeks (includes extraction, analysis, and data interpretation).
Compliance and Standards
All targeted analysis at EBI is performed according to:
- ISO 10993-18: Chemical characterization of medical device materials.
- ISO 10993-12: Sample preparation and reference materials.
- USP <1663> & USP <1664>: Guidelines for assessment of extractables and leachables.
How We Work
Discovery & Insight
We begin with an in-depth consultation to understand your needs, challenges, and objectives. This helps us define the right strategy and scientific approach for your project.
Design & Development
Our experts translate your vision into actionable plans — combining innovative research, data, and technology to build precise and reliable solutions.
Delivery & Support
We implement the solution with full transparency and ongoing communication. After delivery, we stay involved — supporting you with optimization, updates, and future improvements.
FAQ: Extractables & Leachables
What is the difference between an Extractable and a Leachable?
Extractables are compounds that can be pulled out of a device under aggressive laboratory conditions (solvents, high heat). Leachables are compounds that actually migrate into the patient under normal clinical use.
Which solvents do you use for extraction?
Per ISO 10993-18, we typically use a range of solvents with varying polarities, such as purified water (polar), ethanol/water mixtures (semi-polar), and hexane (non-polar), to ensure all potential chemicals are captured.
What is the difference between an Extractable and a Leachable?
Extractables are compounds that can be pulled out of a device under aggressive laboratory conditions (solvents, high heat). Leachables are compounds that actually migrate into the patient under normal clinical use.
Which solvents do you use for extraction?
Per ISO 10993-18, we typically use a range of solvents with varying polarities, such as purified water (polar), ethanol/water mixtures (semi-polar), and hexane (non-polar), to ensure all potential chemicals are captured.
Contact with us
We’re open to collaboration and research partnerships. Fill out the form — our team will respond as soon as possible.
Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
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