Why the E&L Testing Case Study Matters for Product Safety
Ensuring patient safety is a top priority in the pharmaceutical world. At ResolveMass Laboratories, our E&L Testing Case Study highlights how important extractables and leachables testing is in protecting consumers and meeting health authority standards. This study shows how careful analysis during product development can help avoid risks and support regulatory success.
Our testing experts use proven techniques and adapt to each client’s needs. By focusing on early detection of potential threats, this E&L Testing Case Study proves how strong testing protocols can guide better decisions, improve safety, and make the path to approval faster and smoother.
🔬 Visit our core service page on Extractables and Leachables Testing to understand our comprehensive capabilities.
Background of the E&L Testing Case Study
This case centers around a company developing a nasal spray for people with long-term respiratory conditions. In early trials, the team noticed a chance of contamination from the container or packaging materials, which could affect the medicine.
To solve this, the pharmaceutical company chose ResolveMass Laboratories to build a custom E&L testing plan. The main goal was to identify any harmful chemicals that could be released from materials in contact with the drug. Thanks to early testing, they could make better choices in both formulation and packaging before any serious issues occurred.
👉 Learn more about our Custom E&L Testing services.
Project Goals: Aligning with Global Regulations
The objectives of the study included:
- Testing materials from the container closure system (CCS) under stress.
- Finding possible leachables in both real-time and accelerated storage conditions.
- Making sure all results meet safety guidelines from ICH, FDA, EMA, and USP <1663>/<1664>.
By addressing extractables and leachables early, the company could feel confident about the product’s safety. Combining toxicological reviews with solid data helped them get ready for regulatory submission without delays.
📘 Check out E&L Testing and Patient Safety to understand how safety evaluation is integrated into testing strategies.
Methodology Used in the E&L Testing Case Study
Material Selection and Risk Evaluation
ResolveMass began by carefully reviewing every component that touched the drug. Special attention was given to plastics and other materials used in inhalation products. A risk-ranking system was applied to decide which items needed more testing, based on exposure risk and material properties.
Extraction Testing Under Worst-Case Scenarios
To find possible extractables, we used a range of solvents:
- Water-based
- Organic
- High temperatures (40°C and 60°C)
These testing conditions helped uncover a wide range of potential extractables. Using strong methods ensures we catch anything that might be harmful before the product hits the market.
🔗 Dive into the FAQs about E&L Testing for more on solvent choice and extraction conditions.
Advanced Analytical Techniques
Our team used advanced tools to get accurate results, such as:
- Gas Chromatography-Mass Spectrometry (GC-MS)
- Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS)
- Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
- Headspace GC for checking volatile compounds
Over 50 compounds were identified. Out of those, 12 were flagged for further toxicological study because they raised safety concerns. Each was compared against safety limits to make sure the product stays within health guidelines.
Leachables Testing with Stability Studies
To mimic real use, leachables testing was done alongside stability studies. This helped determine what substances actually migrate into the product during its shelf life.
These tests are not just useful during launch but also support long-term safety. This careful approach builds trust with regulators and protects patients.
📚 See how we optimize E&L Testing Services for complex formulations.
Results and Impact of the E&L Testing Case Study
During testing, two unexpected leachables were found. These were linked to adhesives in the secondary packaging. As a result:
- The company switched to a safer adhesive approved for pharmaceutical use.
- The new packaging improved the product’s safety margins and met required limits.
- The regulatory file was strengthened, helping avoid submission delays.
This case shows how E&L testing done early in development helps avoid bigger problems later and ensures the medicine is safe for use.
Why Choose ResolveMass Laboratories for E&L Testing
Working with ResolveMass gives you access to skilled scientists and deep regulatory knowledge. Our services include:
- Validated and ISO-compliant testing protocols
- Customized test plans for every product batch
- Complete documentation for health authority submissions
- Expert toxicological reviews
We support all kinds of drug delivery systems—nasal sprays, injections, eye drops, and more. Every project is tailored to match the product’s risk profile and market requirements.
Explore our dedicated service page: E&L Testing for Inhalation and Nasal Drug Products
E&L Testing Case Study and Product Lifecycle Success
E&L testing isn’t just for product development. It’s a vital part of the full product lifecycle. Any changes in packaging, materials, or processes can introduce new risks.
This E&L Testing Case Study shows that regular testing, especially after changes, helps keep the product safe long-term. Working with experienced labs like ResolveMass makes it easier to stay compliant and ready for audits or re-approvals.
🧪 Wondering about the cost of extractables and leachables testing? We offer transparent pricing models that scale with your needs.
Key Takeaways from the E&L Testing Case Study
- Start risk assessments early to avoid delays
- Don’t overlook packaging materials, even secondary ones
- Toxicological insights help build safer drug formulations
- Ongoing testing supports quality after launch
Using strong science and careful planning, ResolveMass helps companies deliver safe products while meeting all regulatory expectations.
Learn more about our E&L testing costs and how we optimize your ROI.
Final Thoughts: Partnering with ResolveMass for E&L Testing
The E&L Testing Case Study clearly shows the value of thorough, early-stage testing. It helps ensure product safety, reduce risks, and simplify approval steps.
ResolveMass Laboratories supports pharmaceutical companies at every step—from development to post-launch. Our expert-led services ensure that your product meets all the necessary safety standards. Trust ResolveMass to help you achieve regulatory success and protect patients with confidence.
👉 Start here: Extractable and Leachable EL Services
📞 Contact us today to begin your E&L testing journey.
📧 Need custom solutions? Get in touch with our scientific advisors.
📍 Local or global – we’re here to help.
FAQs: Extractables & Leachables Testing
E&L testing is essential for industries like pharmaceuticals, biotechnology, and medical devices. It is especially important for drug products delivered through nasal sprays, injectables, inhalers, and eye drops. Any product that comes in contact with packaging or delivery systems can benefit from E&L evaluation.
Extractables are compounds that can be pulled out of a material when exposed to aggressive lab conditions like heat or solvents. Leachables, on the other hand, are chemicals that actually migrate into the drug product under real storage or usage conditions. Both need to be assessed to ensure full safety.
Yes, E&L testing is a regulatory requirement for many drug products, especially combination products, inhalation therapies, and injectables. The FDA requires this data as part of the Chemistry, Manufacturing, and Controls (CMC) section. It proves that your product is safe from contamination caused by packaging or device components.
Our toxicologists review each detected compound and compare its level to safety limits like Permitted Daily Exposure (PDE) or Threshold of Toxicological Concern (TTC). This helps determine whether the compound poses a risk to patients. Based on this, we offer expert guidance on whether any action is needed.
ResolveMass customizes each testing plan based on the product type, materials used, and the intended route of administration. We follow international guidelines like USP <1663>/<1664> to ensure regulatory compliance. Our approach ensures the testing is not only thorough but also relevant to your specific product.
