In today’s fast-paced pharmaceutical and medical device world, E&L Testing and Patient Safety are closely linked. Materials used in packaging and drug delivery like inhalers, syringes, or vials can release unwanted substances. These substances can affect a drug’s safety. That’s why labs like ResolveMass Laboratories in Canada are essential. They specialize in precise Extractables and Leachables (E&L) testing, helping manufacturers avoid risks and keep patients safe.
With more than a decade of lab experience, ResolveMass ensures that every E&L test follows international safety standards. Their accurate methods help companies reduce harmful exposure risks and support product safety from start to finish.
To understand how this process works and why it matters, check out our detailed Extractables & Leachables Testing service page.
What Is E&L Testing and Why It Matters for Patient Safety?
E&L Testing and Patient Safety go hand in hand. This testing helps find and measure harmful substances that may move from a product’s packaging into the drug or the body. Without this process, these substances could go unnoticed, potentially leading to serious health risks. By identifying them early, manufacturers can make safer products and meet regulatory requirements more easily. These substances fall into two types:
- Extractables: Chemicals that come out when materials face extreme conditions.
- Leachables: Chemicals that slowly move into the product under real-world use, like during storage or injection.
ResolveMass designs custom testing plans to reduce patient exposure to harmful materials. Their goal is to identify risks early and stop them before the product is released.
Explore our broad range of E&L Testing Services that ensure your product meets all safety requirements.
How E&L Testing Supports Patient Health
The main aim of E&L testing is to protect patients from unsafe exposure. Here are three reasons this process is crucial:
- Avoiding Toxic Substances
Harmful materials like phthalates or heavy metals can build up in the body. E&L testing helps find these threats early. - Keeping Drug Quality Intact
If leachables affect the drug, it may lose strength or even become unsafe. Testing ensures the medicine stays effective. - Meeting Regulatory Standards
Agencies like the FDA, EMA, and Health Canada require solid E&L data. Good testing prevents delays and boosts approval chances.
E&L Testing and Patient Safety: ResolveMass’s Approach
ResolveMass Laboratories uses science-backed strategies to ensure reliable E&L testing results. Their service stands out for several reasons:
- High-End Tools
Instruments like GC-MS, LC-MS/MS, and ICP-MS help detect even the tiniest traces of harmful chemicals. - Global Compliance
Testing plans follow guidelines from ICH, USP <1663>/<1664>, PQRI, and ISO 10993. - End-to-End Support
From the first call to the final report, ResolveMass guides clients through the full process with custom advice and solutions.
Every study is tailored based on the product type, use method, and exposure risk—making sure no detail is missed.
Every study is tailored based on the product type, use method, and exposure risk—making sure no detail is missed. Learn more about our full E&L capabilities here.
Custom E&L Testing for Different Drug Delivery Systems
ResolveMass provides detailed E&L studies for various drug delivery formats, each with its own safety concerns:
- Inhalers and Nasal Sprays
These touch the lungs and nasal tissues, so testing checks materials under use-like conditions to spot any leachables.
These touch the lungs and nasal tissues, so testing checks materials under use-like conditions to spot any leachables. Learn more about our inhalation and nasal product testing.
- Injectable Products
Testing includes vials, syringes, and other parts, whether single-use or multi-use. All materials are checked thoroughly. - Eye Drops and Skin Patches
These products contact sensitive areas like eyes or skin. Strict limits are used to make sure they stay safe.
ResolveMass ensures that every test addresses the exact risks that come with each delivery system.
Understanding the Regulations Behind E&L Testing
Health authorities are becoming stricter about E&L data. ResolveMass keeps clients ahead by following all key standards, such as:
- FDA’s container and closure system guidance
- EMA’s quality documents for combination products
- USP <1663>/<1664> for extractables and leachables
- ISO 10993 for biocompatibility
- ICH Q3D for elemental impurities
See how our E&L Testing Services comply with global regulations.
With cost transparency and expert help, ResolveMass helps companies complete their studies efficiently and affordably.
With cost transparency and expert help, ResolveMass helps companies complete their studies efficiently and affordably.
Real Results: Reducing Leachables in a Nasal Spray
One client needed help with a nasal spray that might release harmful chemicals from its rubber tip. ResolveMass ran two types of tests—one under tough conditions and one under normal use. They found trace amounts of aryl amines, but the levels were below danger limits. Because the testing was well-documented, the product passed inspection without delays. This shows how E&L Testing and Patient Safety are deeply connected.
Transparent Pricing, High Quality
ResolveMass believes in top-quality science and honest pricing. Their easy-to-use online cost calculator lets clients get clear estimates upfront. That way, companies can plan properly while still meeting the highest safety standards. There are no hidden fees or unexpected charges, making budgeting straightforward and stress-free. This level of transparency builds long-term trust and supports efficient decision-making throughout the testing process.
Conclusion: E&L Testing and Patient Safety Cannot Be Ignored
E&L testing is now a must in drug development, not just a nice-to-have. It plays a vital role in protecting patient health and securing product approval. ResolveMass Laboratories leads the way by combining solid science, regulation knowledge, and client care. Their E&L Testing and Patient Safety services help bring safer, more trusted products to market. By identifying risks early, they help avoid costly delays and support a smoother path to global compliance. As regulations evolve, ResolveMass remains a reliable partner for staying ahead in safety and innovation.
To request a quote or begin your testing journey, visit ResolveMass Contact Page. Their team is ready to assist with expert advice.
FAQs on E&L Testing and Patient Safety
Without E&L testing, harmful substances could go undetected and enter the body, potentially causing toxicity or allergic reactions. These compounds may also affect the stability or performance of the drug. E&L Testing and Patient Safety are closely linked because this process ensures the product remains safe and effective throughout its lifecycle.
E&L testing is essential for a wide range of drug-device combination products. This includes inhalers, injectables, IV systems, eye drops, nasal sprays, and transdermal patches. Any product where the drug interacts with packaging or delivery materials should undergo E&L testing to protect patient safety.
Regulatory agencies like the FDA, EMA, and Health Canada require strong E&L data. Guidelines such as USP <1663>/<1664>, ICH Q3D, and ISO 10993 provide the framework for acceptable study design and testing limits. Compliance with these standards is essential for smooth product approvals and risk mitigation.
Safety thresholds are based on toxicological risk assessments using values like TTC (Threshold of Toxicological Concern) and SCT (Safety Concern Threshold). These help determine if the levels of detected substances pose any risk to patients. Setting proper thresholds is a core part of maintaining product safety.
Yes. Advanced non-targeted analysis methods allow ResolveMass to detect and identify unknown chemicals that were not originally expected. Once identified, these compounds are evaluated for their toxicity and potential impact, which is essential for full compliance and patient protection.
In most cases, yes. For drug-device combination products, regulatory bodies often require validated E&L testing data. Missing or incomplete studies can delay or even prevent market approval. That’s why investing in proper E&L testing is crucial for both compliance and patient safety.
You can visit resolvemass.ca/contact to speak directly with a scientist or request a custom quote. ResolveMass offers clear pricing, expert guidance, and tailored E&L studies designed to ensure regulatory readiness and safeguard patient health.
