What to Look for in an E&L Testing Company: A Comprehensive Guide

Extractables and Leachables (E&L) testing is a critical aspect of ensuring product safety and regulatory compliance in the pharmaceutical, medical device, and packaging industries. Choosing the right E&L testing company is essential for accurate, reliable, and timely results. With increasing scrutiny from regulatory agencies such as the FDA, EMA, and ISO, identifying a trusted partner for E&L testing can be a challenging task.

This comprehensive guide will outline what to look for in an E&L testing company, including key expertise, certifications, technology, and service quality. We’ll also discuss why E&L testing is important and highlight how a good testing company can positively impact your product’s safety and success in the market.

Why E&L Testing is Essential

E&L testing is performed to detect harmful chemicals that could migrate from materials or packaging into a product, posing risks to patient safety and efficacy. This is particularly crucial for industries such as:

• Pharmaceuticals: Protects the safety of drug formulations.
• Medical Devices: Ensures biocompatibility and sterility.
• Food Packaging: Prevents contamination of consumables.

E&L testing evaluates two primary components:

1. Extractables: Compounds that can be extracted from a material under aggressive conditions.
2. Leachables: Compounds that migrate into the product under normal usage conditions.

For example, regulatory guidance such as the ICH Q3E (Impurities: Assessment and Control of Extractables and Leachables) underscores the importance of minimizing patient exposure to harmful substances

Key Factors to Consider in an E&L Testing Company

1. Regulatory Expertise

An E&L testing company must have an in-depth understanding of global regulatory requirements, including:

• FDA guidelines (e.g., USP <1663> and <1664> for pharmaceuticals).
• EMA standards for biocompatibility testing in medical devices.
• ISO 10993 for medical devices’ biological evaluation.

Look for companies that demonstrate a history of compliance and can provide detailed reports tailored to regulatory submission needs. Their ability to adapt testing protocols to meet international regulations is critical for global product launches.

---

2. Advanced Analytical Techniques

State-of-the-art analytical techniques ensure the detection of even trace levels of contaminants. An ideal E&L testing company should offer:

• Gas Chromatography-Mass Spectrometry (GC-MS) for volatile compounds.
• Liquid Chromatography-Mass Spectrometry (LC-MS) for non-volatile and semi-volatile compounds.
• Inductively Coupled Plasma Mass Spectrometry (ICP-MS) for elemental impurities.
• Nuclear Magnetic Resonance (NMR) for structural elucidation of unknowns.

These technologies ensure precise identification and quantification of extractables and leachables in line with ISO and pharmacopeial standards.

---

3. Comprehensive E&L Study Design

A competent company should provide end-to-end solutions, including:

• Material Screening: Identification of potential risks during the early stages of product design.
• Simulation Studies: Replication of real-world usage conditions to evaluate leachables.
• Toxicological Risk Assessment (TRA): Ensures safety by comparing detected compounds against toxicological thresholds.

For instance, a robust TRA involves the calculation of Threshold of Toxicological Concern (TTC) for each compound

4. Customization and Flexibility

Every project has unique requirements. The best E&L testing companies offer tailored testing protocols based on factors such as material type, product lifecycle, and intended use. Whether you’re testing a single-use medical device or a parenteral drug packaging system, flexibility is key.

---

5. Speed and Turnaround Time

Timely results are essential to meet development timelines. Evaluate whether the company has the capacity and resources to deliver accurate results within your required timeframe without compromising quality.

---

6. Experience and Reputation

Look for companies with a proven track record in E&L testing. Factors to evaluate include:

• Years in the industry.
• Client testimonials and case studies.
• Accreditations and partnerships with regulatory agencies.

---

7. Accreditations and Certifications

Ensure the testing company operates under internationally recognized standards, such as:

• Good Laboratory Practices (GLP).
• ISO/IEC 17025: General Requirements for the Competence of Testing and Calibration Laboratories.

---

8. Transparent Reporting

The final test report should include:

• Clear and detailed results with methodologies.
• Identification of all detected extractables and leachables.
• Risk assessments and recommendations for next steps.

Transparency is critical for regulatory submissions and future audits.

---

9. Customer Support and Communication

An ideal E&L testing company should prioritize customer communication throughout the project. Regular updates, quick responses to queries, and post-testing consultations are signs of a customer-centric approach.

---

Benefits of Choosing the Right E&L Testing Company

1. Regulatory Approval: Ensures smooth submission and approval of your products.
2. Product Safety: Protects end-users from harmful contaminants.
3. Cost Savings: Early detection of risks reduces the likelihood of costly recalls or regulatory penalties.
4. Market Reputation: Demonstrates a commitment to quality and compliance, enhancing brand credibility.

---

The Future of E&L Testing

The field of E&L testing is evolving with advancements such as:

• AI-Driven Analysis: Improving the speed and accuracy of data interpretation.
• Green Chemistry: Reducing the environmental footprint of testing processes.
• Predictive Toxicology: Leveraging computational models to assess toxicological risks without extensive laboratory testing (DOI: 10.1016/j.tiv.2019.03.015).

---

Why ResolveMass Laboratories Inc. is Your Ideal E&L Testing Partner

At ResolveMass Laboratories Inc., we combine regulatory expertise, advanced technology, and exceptional customer support to deliver industry-leading E&L testing services.

• Regulatory Compliance: Adherence to FDA, EMA, and ISO standards.
• Cutting-Edge Technology: Equipped with the latest GC-MS, LC-MS, and ICP-MS systems.
• Expert Team: Highly experienced scientists and toxicologists.
• Tailored Solutions: Custom protocols to meet your unique needs.

REFERENCES

1. Scatena A, Toth S, Chenevert K. EXPLORING EXTRACTABLE AND LEACHABLE TESTING STRATEGIES FOR PARENTERALS.
2. Crawford M. STRESSED TESTING: The pandemic has resulted in unprecedented levels of demand for device testing with requests for rapid turnaround times. Medical Product Outsourcing. 2021 Mar 1;19(2):38-46.