Introduction
Extractables and Leachables (E&L) Testing in Infusion Bags is one of the most important safety processes in the pharmaceutical field. It helps identify chemical compounds that may move from infusion bag materials into drug solutions. This testing is essential because it protects patients and ensures that medical products meet strict regulatory standards before reaching the market.
At ResolveMass Laboratories Inc., we provide detailed and regulatory-compliant E&L testing services. Our expertise supports pharmaceutical companies, medical device makers, and CRO partners. Since infusion therapies go directly into the bloodstream, even small traces of harmful substances can be risky. Working with a trusted lab like ResolveMass helps manufacturers stay compliant, reduce risks, and speed up approval timelines.
This complete guide explains definitions, processes, regulations, costs, and benefits of E&L testing in infusion bags.
Quick Summary of This Guide
- Definition: Identifies extractables and leachables that may move from infusion bags into drug formulations.
- Importance: Protects patients from chemical risks and ensures compliance with USP <1663>, <1664>, and ISO 10993-18.
- Process: Includes extraction studies, advanced analytics, toxicological evaluation, and reporting.
- Challenges: Material complexity, sensitivity needs, and changing regulations.
- Solutions: Partnering with labs like ResolveMass ensures accuracy and cost efficiency.
- Applications: Used for infusion bags, medical devices, biologics, and combination products.
What Is Extractables and Leachables (E&L) Testing in Infusion Bags?
E&L testing in infusion bags focuses on identifying and measuring chemical substances that might migrate from the bag’s material into a drug solution. These compounds can include stabilizers, plasticizers, or additives.
- Extractables are released under extreme lab conditions, such as heat or solvent exposure.
- Leachables are compounds that migrate under real-world storage and use conditions.
By testing both, manufacturers ensure infusion bags remain safe during storage and during patient use. This process protects drug stability and patient safety. Learn more in our FAQs on E&L testing.
Why Is E&L Testing Critical for Infusion Bags?
Infusion bags deliver medicine directly into a patient’s bloodstream. Unlike oral drugs, the body has no natural filter to block contaminants at this stage. Because of this, even small amounts of harmful compounds can cause serious side effects. Possible risks include:
- Toxic reactions ranging from mild irritation to severe health issues.
- Loss of drug effectiveness due to chemical interactions.
- Non-compliance with regulations, leading to costly recalls.
- Slower approval timelines if risks are detected late.
That’s why agencies like the FDA, EMA, USP, and ISO require thorough E&L studies. At ResolveMass, we provide rigorous and cost-effective solutions that help clients meet these standards. See our affordable E&L testing services.
The Process of Extractables and Leachables (E&L) Testing in Infusion Bags
A proper E&L program follows a structured workflow to ensure nothing is missed:
Controlled Extractables Study
This step uses harsh lab conditions such as high heat or strong solvents. It reveals potential “worst-case” chemical risks. See our controlled extractables study guide.
Leachables Study
Conducted under real storage and clinical conditions, this study shows the actual level of patient exposure.
Analytical Evaluation
Using advanced tools like LC-MS, GC-MS, ICP-MS, and NMR, compounds are detected even at very low concentrations. Learn more about analytical techniques for E&L testing.
Toxicological Assessment
Each compound is reviewed against safety thresholds such as the Analytical Evaluation Threshold (AET). Learn more about AET in E&L Testing.
Regulatory Submission
Final results are compiled and presented according to USP, ISO, and ICH guidelines. ResolveMass supports clients with complete regulatory submissions.
This method ensures complete safety evaluation and builds regulatory confidence.
Key Regulatory Standards for Infusion Bags
| Regulation | Focus Area | Relevance to Infusion Bags |
|---|---|---|
| USP <1663> & <1664> | Extractables & Leachables studies | U.S. requirements for packaging safety |
| ISO 10993-18 | Chemical characterization of devices | Ensures infusion bag material safety |
| EMA & FDA Guidelines | Safety of parenteral drugs | Required for global approvals |
Our ISO 10993-18 E&L testing services help manufacturers meet global standards and achieve faster approvals.
Applications of E&L Testing Beyond Infusion Bags
While Extractables and Leachables (E&L) Testing in Infusion Bags is the main focus, the same principles apply across healthcare:
- Medical Devices → See E&L testing for medical devices
- Biologics & Injectables where protein-based drugs are more sensitive.
- Combination Products like prefilled syringes and auto-injectors.
- Drug-Device Interactions to confirm compatibility.
ResolveMass provides multi-matrix E&L testing, covering all these applications in one service.
Cost Considerations in E&L Testing
The cost of E&L testing depends on factors like material complexity, study design, number of test methods, and toxicology needs. See our E&L testing cost guide.
For urgent projects, ResolveMass also offers fast-track E&L testing services, helping clients meet deadlines without sacrificing quality. Choosing the right study design early reduces time and costs.
Why Choose ResolveMass Laboratories for E&L Testing in Infusion Bags?
- Experience: Deep knowledge of infusion bags and medical device testing.
- Expertise: State-of-the-art instruments and validated methods.
- Authority: Recognized for global regulatory submissions.
- Trust: Transparent, ISO-compliant, and cost-effective processes.
Our team works closely with clients to create tailored studies that balance product safety with regulatory needs. Learn more about our custom E&L study design services.
Conclusion
Extractables and Leachables (E&L) Testing in Infusion Bags plays a critical role in protecting patients, ensuring drug safety, and achieving regulatory compliance. By working with ResolveMass Laboratories, companies gain access to advanced analytical tools, expert guidance, and affordable solutions that accelerate approvals.
Start your E&L testing project today by visiting our Contact Page.
Frequently Asked Questions (FAQs)
Extractables are chemical compounds that come out of infusion bag materials when exposed to harsh lab conditions like high heat or strong solvents. Leachables, on the other hand, are compounds that migrate into the drug solution under normal storage and usage conditions. Both need to be studied to ensure patient safety and drug stability.
E&L testing is important because infusion bags are used to deliver medicines directly into the bloodstream. Unlike oral medications, there is no natural filtering process before the drug reaches the body. Even tiny amounts of harmful substances can cause side effects or reduce drug effectiveness, making E&L testing essential for safety.
Several international standards govern E&L testing, including USP <1663> and <1664>, ISO 10993-18, and guidance from the FDA and EMA. These regulations ensure that infusion bags meet strict safety and compliance requirements. Following them also helps manufacturers avoid costly delays in approvals.
Safety thresholds are determined using the Analytical Evaluation Threshold (AET). This benchmark helps scientists decide which compounds need further toxicological review. By comparing detected compounds with AET values, only the substances with possible health risks are taken into account.
Yes, both extractables and leachables studies are required by regulators. Extractables testing identifies potential risks under extreme conditions, while leachables testing shows what actually migrates into the drug solution during real-world use. Together, they provide a complete safety profile.
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/
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