Extractables & Leachables (E&L) Testing – ISO 10993-18
Protect patient safety and satisfy regulatory requirements with advanced chemical characterization. We identify and quantify potential chemical risks before they reach the patient.
Extractables and Leachables (E&L) testing is a sophisticated analytical process used to identify potentially harmful chemical substances that could migrate from a medical device, drug delivery system, or packaging into a patient. Under the modern ISO 10993-18 standard, chemical characterization is the preferred first step in biological evaluation, often reducing the need for lengthy in vivo animal testing.
Understanding Extractables vs. Leachables
To ensure comprehensive safety, we analyze chemicals under both extreme and routine conditions:
- Extractables: Chemicals that can be „pulled out” of a device under exaggerated conditions (elevated temperature, aggressive solvents, and extended time). This identifies the worst-case scenario of potential contaminants like plasticizers, antioxidants, surfactants, and residual monomers.
- Leachables: Chemicals that migrate spontaneously from the device, packaging, or processing equipment under normal conditions of use and storage. Leachables are typically a subset of extractables and are critical for assessing long-term stability and patient exposure.
Why E&L Testing is Critical for Patient Safety
The presence of unintended chemicals can compromise both the product and the patient:
- Toxicity & Carcinogenicity: Identifying harmful impurities that could cause systemic or long-term health issues.
- Immunogenicity: Preventing leachables from interacting with proteins or altering the drug formulation.
- Product Stability: Ensuring that chemicals do not cause oxidation, aggregation, or changes in the potency and color of a drug substance.
- Regulatory Compliance: Meeting the strict requirements of ISO 10993-18 and MDR 2017/745.
Advanced Analytical Technologies at EBI
Our laboratory utilizes a suite of high-resolution instruments to detect organic and inorganic contaminants at trace levels.
| Compound Class | Common Methodologies | Qualitative | Quantitative |
|---|---|---|---|
| Volatile Organic (VOC) | Headspace GC-MS | Yes | Yes |
| Semi-Volatile (SVOC) | GC-MS | Yes | Yes |
| Non-Volatile (NVOC) |
UPLC/HPLC-MS/MS UPLC/HPLC-MS/HRAM UV-VIS |
Yes | Yes |
| Elemental Impurities | ICP-MS | n/a | Yes |
From Data to Safety: Toxicological Risk Assessment
Data alone is not enough. Once we identify chemical components, our qualified toxicologists calculate the Analytical Evaluation Threshold (AET) or Total Element Exposure (TEE).
- AET Calculation: This threshold determines which extractables must be reported and assessed.
- Risk Mitigation: If a compound exceeds safety limits, we provide a comprehensive Toxicological Risk Assessment to gauge the level of risk posed to the patient and determine if further biological studies are necessary.
Standards & Regulatory Framework
EBI conducts all E&L studies in accordance with international quality and safety benchmarks:
- ISO 10993-18: Chemical characterization of medical device materials within a risk management process.
- ISO 10993-17: Establishment of allowable limits for leachable substances.
- USP <1663> & <1664>: Assessment of extractables and leachables associated with pharmaceutical packaging/delivery systems.
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: Common Questions about E&L Testing
When should I choose E&L testing over traditional animal tests?
Regulatory bodies (FDA, Notified Bodies) now prefer chemical characterization as the primary data source. If E&L data shows the device is chemically safe, you may be able to waive several in vivo tests, such as systemic toxicity or genotoxicity.
What solvents do you use for extraction?
Depending on the device’s nature, we use a range of polar, semi-polar, and non-polar solvents (e.g., water, isopropanol, hexane) to ensure all potential chemical classes are captured.
What is the „Analytical Evaluation Threshold” (AET)?
The AET is a limit based on the Dose-Based Threshold (DBT). Any chemical found above this concentration must be identified and evaluated by a toxicologist for potential patient risk.
When should I choose E&L testing over traditional animal tests?
Regulatory bodies (FDA, Notified Bodies) now prefer chemical characterization as the primary data source. If E&L data shows the device is chemically safe, you may be able to waive several in vivo tests, such as systemic toxicity or genotoxicity.
What solvents do you use for extraction?
Depending on the device’s nature, we use a range of polar, semi-polar, and non-polar solvents (e.g., water, isopropanol, hexane) to ensure all potential chemical classes are captured.
What is the "Analytical Evaluation Threshold" (AET)?
The AET is a limit based on the Dose-Based Threshold (DBT). Any chemical found above this concentration must be identified and evaluated by a toxicologist for potential patient risk.
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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