Introduction
Developing safe and compliant medical devices, pharmaceuticals, and biologics requires a strong focus on risk management. One of the most critical parts of this process is the use of Custom E&L Study Design Services. Extractables and leachables (E&L) testing ensures that no harmful chemicals move from packaging, manufacturing systems, or devices into the final product. At ResolveMass Laboratories Inc., we provide tailored E&L study design and method development in line with strict global regulations. This approach protects patients, preserves product quality, and helps speed up the approval process. By combining scientific accuracy with regulatory expertise, we deliver studies that are both efficient and reliable.
Summary of Key Takeaways
- Custom E&L Study Design Services provide targeted testing strategies for specific medical devices, pharmaceuticals, and packaging materials.
- Method development makes sure that both extractables (seen under stressed lab conditions) and leachables (seen in real use) are accurately detected.
- ResolveMass follows ISO 10993-18 and USP guidelines to support worldwide regulatory submissions.
- Well-planned study designs reduce costs, save time, and build regulator confidence.
- Risk assessment, advanced analytics, and expert review ensure meaningful, high-quality results.
- Working with an experienced CRO like ResolveMass ensures compliance, accuracy, and smooth project outcomes.
Custom E&L studies are not just about meeting minimum requirements. They also anticipate regulatory needs in advance, helping manufacturers avoid unexpected delays and support faster product launches.
Why Custom E&L Study Design Services Are Essential
Every product carries unique risks depending on its materials, production methods, and clinical use. This makes Custom E&L Study Design Services a vital part of product safety. Generic testing approaches often miss important variables, which can increase the chance of non-compliance. A tailored study, however, ensures alignment with:
- Product materials such as plastics, elastomers, or coatings.
- Intended use cases, from short-term contact to implantable devices.
- Regulatory standards including FDA, EMA, Health Canada, ISO 10993, and USP.
By customizing study designs, manufacturers can prove product safety, avoid costly setbacks, and build stronger trust with regulators. This type of forward-looking E&L strategy also helps set products apart by showing that patient safety is prioritized from the earliest stages. Learn more about our Custom E&L Testing.
Core Components of a Custom E&L Study Design
Creating a sound E&L study requires careful planning and clear execution. The key components include:
| Component | Description |
|---|---|
| Material Selection | Identifying polymers, adhesives, metals, coatings, or solvents. |
| Extraction Conditions | Using worst-case scenarios based on ISO 10993-18 and USP standards. |
| Analytical Techniques | GC-MS, LC-MS, ICP-MS, NMR for organic and inorganic compound detection. |
| Toxicological Assessment | Connecting results with Analytical Evaluation Thresholds (AET values). |
| Method Development | Custom validation for sensitivity, reproducibility, and regulatory fit. |
| Reporting & Compliance | Structured documentation for FDA, EMA, and ISO submissions. |
These components ensure accurate data, lower risk of variability, and strong scientific credibility during regulatory review. ➡ Explore our ISO 10993-18 E&L Testing services.
Method Development in E&L Testing
Importance of Custom E&L Study Design Services in Method Development
Method development is central to achieving accurate and repeatable E&L testing results. Each study often needs custom extraction methods, solvents, and advanced techniques to capture both major and trace-level chemicals.
- Chromatography (GC-MS, LC-MS) detects volatile and semi-volatile compounds with high sensitivity.
- Spectroscopy (FTIR, NMR) provides detailed insights into molecular structures.
- Elemental analysis (ICP-MS) identifies and quantifies heavy metals with precision.
A strong method development plan reduces false negatives, improves quantitation, and produces data that can stand up to regulatory evaluation. This process not only strengthens patient safety but also helps accelerate approvals in global markets. Discover our Analytical Techniques for E&L Testing.
Benefits of Partnering with ResolveMass Laboratories Inc.
Working with ResolveMass gives manufacturers a partner that combines technical skill with regulatory knowledge:
- ✅ Extensive experience with E&L testing for medical devices, packaging, and pharmaceuticals.
- ✅ Expertise in ISO 10993, USP <1663>/<1664>, and global regulatory requirements.
- ✅ Proven track record with successful global submissions and published case studies.
- ✅ Clear reporting that supports compliance and builds confidence with regulators.
Partnering with ResolveMass reduces risks, improves success rates, and ensures products reach the market smoothly. Read our E&L Compliance Case Study.
Applications of Custom E&L Study Design Services
E&L testing applies to many industries and product categories:
- Medical Devices → E&L Testing for Medical Devices
- Single-Use Systems (SUS) → SUS E&L Testing
- Pharmaceutical Packaging → vials, syringes, stoppers, blister packs.
- Biologics Manufacturing → tubing, filtration systems, bags, connectors.
Each use case comes with its own risks, so Custom E&L Study Design Services ensure the right strategy is applied for each product type. This comprehensive approach supports safety and global regulatory approval.
Cost Considerations in Custom E&L Studies
The cost of E&L studies can change depending on:
- Product complexity.
- Number of materials tested.
- Type of regulatory submission.
- Analytical techniques used.
Early planning with a tailored E&L strategy helps reduce unnecessary costs and prevents redesigns or delays later in development. Learn more about Cost of E&L Testing.
Extractables vs. Leachables: Understanding the Difference
- Extractables → Compounds released under extreme laboratory conditions.
- Leachables → Compounds that migrate into the product under normal usage.
Understanding the difference is critical for manufacturers and regulators. Extractables testing highlights potential risks, while leachables testing confirms real-world patient exposure. Together, they create a complete risk profile. Read our full guide: Extractables vs Leachables.
Conclusion
Custom E&L Study Design Services are vital for ensuring medical devices, pharmaceuticals, and biologics meet strict international safety and compliance standards. At ResolveMass Laboratories Inc., we design studies and develop methods that are both defensible and regulatory-ready. By working with our team, manufacturers can move through complex regulations with confidence, protect patient health, and achieve faster, more reliable approvals worldwide.
➡ Ready to get started? Contact ResolveMass today.
FAQs on Custom E&L Study Design Services
Every product has different materials and intended uses, so a one-size-fits-all approach can miss risks. Customization ensures the study is accurate, reliable, and accepted by regulators.
Costs depend on factors like material type, number of samples, and analytical techniques required. Strategic planning can help optimize expenses.
E&L data refers to the information collected during extractables and leachables testing. It includes the list of identified compounds, their concentration levels, and toxicological risk assessments that demonstrate product safety.
The Analytical Evaluation Threshold (AET) is the reporting level above which all detected compounds must be identified and assessed. It helps ensure that no chemical present at levels of potential concern is ignored during safety evaluations.
Extractables and leachables usually come from product materials, manufacturing equipment, or packaging. Common sources include plastics, elastomers, adhesives, coatings, and solvents that may release chemicals into the product.
References
- 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/
- 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
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