Introduction
Multi-Matrix E&L Testing Services play a vital role in ensuring the safety, compliance, and overall performance of pharmaceutical packaging, medical device components, and manufacturing systems. At ResolveMass Laboratories Inc., we provide advanced multi-matrix extractables and leachables (E&L) testing solutions that help manufacturers meet strict global regulations, protect patient health, and speed up product approvals.
Even very small levels of extractables or leachables can affect drug stability, device safety, or patient well-being. By identifying these risks early, companies can prevent recalls, avoid delays in approvals, and strengthen trust with regulators and healthcare providers.
In this article, we explain what multi-matrix E&L testing involves, why it is so important for packaging, manufacturing, and device components, and how our validated methods ensure accurate, reliable results every time.
Summary at a Glance
- Multi-Matrix E&L Testing Services evaluate extractables and leachables across packaging, manufacturing, and medical device components.
- They detect chemical risks that may migrate into drugs, biologics, or devices.
- Global agencies like FDA, EMA, and USP require strong E&L data in regulatory submissions.
- ResolveMass provides expert study design, advanced analytical methods, and compliance with USP and ISO standards.
- Key benefits include safer products, reduced regulatory risks, and faster market entry.
- Our multi-matrix approach ensures full protection across all product contact points.
What is Multi-Matrix E&L Testing?
Multi-Matrix E&L Testing Services identify extractables—compounds released under controlled laboratory conditions—and leachables—compounds that migrate during actual use. These can originate from packaging, manufacturing materials, or device components.
In simpler terms, this testing answers: What chemicals might move from materials into the final product, and are they safe for patients?
This ensures:
- Regulatory compliance
- Reduced risks of contamination
- Better patient safety
- Long-term product integrity
A structured E&L program not only protects patients but also improves product reliability. By catching issues early, manufacturers design safer systems and minimize lifecycle risks.
👉 Learn more about Extractables and Leachables FAQs.
Importance of Multi-Matrix Testing in Packaging
Multi-Matrix E&L Testing Services in packaging confirm that containers, vials, syringes, and closures do not release harmful chemicals into pharmaceuticals. This is especially important for injectable drugs, where even trace contaminants can harm safety and effectiveness.
Key considerations include:
- Interaction between packaging polymers and drug formulations
- Organic compounds such as volatile or semi-volatile chemicals
- Heavy metals and inorganic leachables
- Container stability during storage and shipping
ResolveMass applies USP Extractables and Leachables guidelines to packaging studies, ensuring full compliance with global regulations. By simulating real storage and transport conditions, we help confirm that packaging remains safe throughout its shelf life.
Manufacturing System E&L Testing
In pharmaceutical manufacturing, materials like tubing, filters, gaskets, and bioreactors can introduce unwanted chemicals into the final product. These substances may come from polymer breakdown, solvents, or additives used during production.
Why it matters:
- Manufacturing processes involve many material contact points.
- Degradation products or lubricants may migrate into drugs.
- Non-compliance could trigger recalls or regulatory rejection.
ResolveMass provides controlled extractables study services that help manufacturers detect and control such risks. This proactive approach supports Good Manufacturing Practices (GMP), ensuring consistency and quality across every batch.
Device Component E&L Testing
Medical devices like catheters, implants, and combination products are some of the most complex cases for leachables. Since these devices often stay inside or in contact with the body, safety testing becomes critical.
Key focus areas include:
- Long-term implants requiring lifetime exposure assessments
- Biocompatibility testing following ISO 10993-18
- Potential release of chemicals from adhesives, coatings, or polymers
Our medical device E&L testing provides complete chemical characterization to ensure patient safety. This supports compliance with strict global rules and reduces long-term exposure risks for patients.
Regulatory Landscape for Multi-Matrix E&L Testing
Multi-Matrix E&L Testing Services are required by major global regulations, including:
- FDA guidance on packaging and device safety
- EMA directives for leachables in injectable products
- USP chapters <1663> & <1664> on extractables and leachables
- ISO 10993-18 for medical device compatibility
At ResolveMass, we create regulatory submission-ready reports designed for specific agencies. Our experts also guide clients through updates in global standards, reducing approval risks and shortening timelines.
Analytical Techniques in Multi-Matrix Testing
ResolveMass applies advanced analytical techniques to ensure thorough chemical identification:
| Technique | Application |
|---|---|
| GC-MS | Volatile organic compounds |
| LC-MS | Semi-volatile and non-volatile compounds |
| ICP-MS | Metals and inorganic leachables |
| FTIR | Material identification |
By combining multiple methods, we generate reliable and reproducible data that regulators can trust for decision-making.
Why Choose ResolveMass for Multi-Matrix E&L Testing?
- Experience: Proven success across pharma, biotech, and device industries.
- Expertise: Tailored custom study design for unique client needs.
- Efficiency: Fast-track E&L services for urgent projects.
- Affordability: Cost-effective testing without reducing quality.
- Trust: Transparent reports, GLP-compliant protocols, and strong regulatory alignment.
Choosing the right E&L partner is essential. At ResolveMass, we combine technical depth with efficiency to provide results that accelerate approvals and safeguard patients.
Conclusion
Multi-Matrix E&L Testing Services are essential to protect patients, comply with regulations, and achieve faster approvals. By evaluating packaging, manufacturing systems, and device components, ResolveMass Laboratories delivers results that ensure safety and support product success.
Our team is committed to providing regulator-ready studies, tailored to each client’s needs. Partnering with ResolveMass means lowering risks, saving time, and bringing safe products to market more efficiently.
FAQs on Multi-Matrix E&L Testing
Multi-matrix testing is important because different materials such as packaging, manufacturing systems, and device components can interact with drugs in unique ways. It ensures that no potential contamination risks are overlooked, providing complete safety coverage.
E&L testing detects harmful chemicals such as toxic, allergenic, or carcinogenic compounds before they can migrate into medicines or devices. This early detection ensures products remain safe, effective, and compliant with regulatory standards.
The extractables and leachables standard refers to guidelines such as USP <1663> and <1664>, which define how to identify and evaluate compounds that migrate from materials into products. These standards help ensure product safety and regulatory compliance.
Extractables may come from plastics, elastomers, adhesives, coatings, or processing aids used in packaging and manufacturing. Under stress conditions, these materials release compounds that may migrate into drugs or devices.
The main ISO standard is ISO 10993-18, which focuses on the chemical characterization of medical device materials. It guides manufacturers in assessing potential extractables and leachables to confirm product biocompatibility and safety.
The FDA provides guidance on container closure systems and medical devices to ensure they do not release harmful chemicals into pharmaceuticals. These recommendations help manufacturers design safe, compliant products for regulatory approval.
The safety concern threshold (SCT) is the level below which a leachable is not considered to pose a significant risk to patient health. It helps define acceptable reporting limits and ensures product safety evaluations are patient-focused.
References
- 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
- 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/
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