Single-use bioprocessing technologies are changing the way modern biopharmaceuticals are made. They provide flexibility, reduce cleaning requirements, and improve production efficiency. However, these systems also introduce risks from extractables and leachables (E&L). That is why E&L Testing Single Use Systems is essential to confirm product safety, regulatory compliance, and reliable manufacturing. At ResolveMass Laboratories Inc., we deliver complete E&L testing solutions designed specifically for single-use materials. With advanced technology expertise, we help manufacturers minimize risks and meet strict international standards.
🔹 Summary of Key Insights
E&L testing safeguards the quality, safety, and compliance of single-use bioprocessing systems.
- Extractables are compounds released under extreme laboratory stress, while leachables migrate during real manufacturing or storage conditions.
- Testing reduces contamination risks, protects patients, and supports regulatory approvals.
- Multiple analytical tools such as LC-MS, GC-MS, and ICP-MS ensure accurate compound detection.
- ResolveMass provides tailored services aligned with international guidelines.
- Understanding cost factors, regulatory needs, and case studies supports better decisions.
- A structured checklist improves study design and avoids costly mistakes.
E&L testing is not just a requirement—it is a proactive step to build trust in product safety. With regulatory agencies tightening global standards, a strong testing strategy lowers risks of delays in product launches while ensuring both scientific accuracy and operational success.
What is E&L Testing Single Use Systems?
E&L testing investigates whether chemical compounds from plastics, polymers, and elastomers in single-use materials migrate into drug products. Extractables are identified under aggressive lab simulations, while leachables are those that appear under actual storage or processing conditions.
This testing is vital for patient protection, product purity, and compliance with strict global drug development rules. Without it, undetected leachables could compromise product stability and effectiveness. E&L studies also help manufacturers select the best materials at an early stage, lowering risk of adverse interactions with biologics.
👉 Learn more in our E&L FAQs resource.
Why is E&L Testing Important for Single-Use Systems?
Single-use systems rely heavily on plastics, adhesives, and elastomers. These materials can release compounds that:
- Affect drug stability and quality.
- Endanger patient safety.
- Cause regulatory delays and added costs.
At ResolveMass Laboratories Inc., we perform controlled extractables studies to identify risks before clinical or commercial production begins. This proactive approach supports faster approvals and avoids last-minute regulatory surprises. Early E&L Testing Single Use Systems also streamlines material selection and secures long-term process reliability.
Extractables vs Leachables in Single-Use Systems
| Parameter | Extractables | Leachables |
|---|---|---|
| Definition | Compounds released under exaggerated lab conditions | Compounds migrating under real process/storage |
| Purpose | Predict potential risks | Confirm actual patient exposure |
| Importance | Early risk screening | Regulatory and safety compliance |
📌 Read our detailed guide: Extractables vs Leachables in Medical Devices.
This difference is critical because extractables give predictive insights, while leachables confirm real-world exposure. A complete testing strategy includes both studies, ensuring no harmful compounds reach patients and that regulators have a reliable safety profile to review.
Analytical Techniques for E&L Testing Single Use Systems
Modern analytical tools provide high confidence when evaluating risks from E&L. At ResolveMass, we follow USP <1663>/<1664> and ISO 10993-18 standards, applying a mix of techniques such as:
- LC-MS & GC-MS: For volatile and semi-volatile compounds.
- ICP-MS: For trace metal detection with high sensitivity.
- Spectroscopy: For polymer identification and unknown compound characterization.
👉 Explore more: Analytical Techniques for E&L Testing.
By combining different methods, our scientists ensure accurate coverage across a wide chemical spectrum. Orthogonal testing approaches give a deeper understanding of risks, supporting stronger and faster regulatory submissions.
Regulatory Framework for E&L Testing
Global regulators like the FDA, EMA, and Health Canada require E&L data in submissions. Key frameworks include USP <1663>/<1664>, ISO 10993-18, and PDA Technical Reports.
ResolveMass supports clients with:
- ISO 10993-18 compliant testing.
- USP-based regulatory studies.
- PDA Technical Report–aligned protocols.
Following these standards smooths approval pathways and minimizes the risk of regulatory setbacks. A strong compliance strategy also builds trust with stakeholders, investors, and healthcare providers.
Cost Considerations in E&L Testing
The cost of an E&L study depends on:
- The type of study design (controlled vs simulated).
- The number of tested materials.
- The regulatory scope and requirements.
At ResolveMass, we provide transparent pricing so clients know exactly what to expect: Cost of E&L Testing.
Investing early in robust testing helps prevent costly delays, reformulations, or regulatory failures. Collaborating closely with testing experts also ensures cost-effective and efficient strategies.
How to Conduct an E&L Study
A well-structured E&L study at ResolveMass includes:
- Material Review – Evaluating polymers, additives, and manufacturing details.
- Controlled Extractables Study – Testing with solvents, heat, and time conditions.
- Leachables Study – Simulating real-world use with drug formulations.
- Data Evaluation – Comparing outcomes against Analytical Evaluation Thresholds (AET).
👉 Full guide: How to Conduct an E&L Study.
This approach reduces errors and ensures no compound of concern is missed. By assessing both extractables and leachables, manufacturers get a complete safety profile for global regulatory submissions.
Case Studies and Real-World Applications
Our E&L compliance case studies showcase successful global submissions, demonstrating how our tailored testing accelerates product approvals and improves patient safety.
Real-world examples also show how early assessments prevent costly reformulations or production setbacks. These case studies provide confidence to manufacturers by highlighting proven results backed by science and regulatory success.
Conclusion
E&L Testing Single Use Systems is a vital step in ensuring safety, compliance, and reliability for bioprocessing materials. At ResolveMass Laboratories Inc., we combine state-of-the-art technology with deep regulatory knowledge to deliver accurate and dependable results. Partnering with us means gaining confidence in product safety, patient protection, and smooth regulatory approvals.
👉 Contact our team to get started:
🔹 Frequently Asked Questions (FAQs)
The main goal of E&L testing is to confirm that no harmful compounds from plastics or polymers migrate into the drug product. This ensures patient safety while meeting strict global compliance requirements.
Single-use materials often include plastics, adhesives, and elastomers. These components can release compounds under heat, pressure, or contact with formulations, increasing the need for proper testing.
Authorities such as the FDA, EMA, and Health Canada require E&L data. Standards like USP <1663>/<1664> and ISO 10993-18 provide structured methods to achieve compliance.
Techniques like LC-MS, GC-MS, ICP-MS, FTIR, and NMR are commonly used. Each method captures different types of compounds, giving a complete chemical safety profile.
Yes, E&L testing is a key part of ISO 10993 biocompatibility evaluations. It provides essential data for medical device safety and regulatory acceptance.
References
- Rozio, M. G. (2025). Correcting detection and quantitation bias in extractables and leachables testing. Journal of Pharmaceutical Sciences, 114(4), 1234–1245. https://doi.org/10.1016/j.xphs.2025.01.001
- Balfour, H. (2022, April 29). Advancing extractables and leachables testing. European Pharmaceutical Review. https://www.europeanpharmaceuticalreview.com/article/170814/advancing-extractables-and-leachables-testing/
- Eckford, C. (2024, January 22). Single-use systems to drive E&L testing market growth. European Pharmaceutical Review. https://www.europeanpharmaceuticalreview.com/news/196367/single-use-systems-to-drive-el-testing-market-growth/
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2025). ICH Q3E: Extractables and leachables (Step 2 draft guideline). ICH. https://database.ich.org/sites/default/files/ICH_Q3E_EWG_Step2_DraftGuideline_2025_0704.pdf
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