Extractables and Leachables
Expertise in E&L to support you from early stages of development through the full lifecycle of your product.
Resolian’s dedicated Extractables and Leachables (E&L) team provide the data to allow assessment of the safety and compatibility of your product with its selected storage and delivery devices, as required by regulators. This analytical data will enable you to profile extractables from the primary packaging or device materials, and target leachables in the final product.
We deliver tailored study design for E&L in line with the latest regulatory guidelines, including FDA/EMA, BPSA, PQRI, and ISO-10993, USP 1663/1664, 665/1665, and following BPOG & ELSIE best practices.
Tailored solutions to your Extractable and Leachable requirements supporting you from early stages of development through the full lifecyle of your product.
Extractable and leachable (E&L) testing provides vital information concerning the potential for impurities deriving from container closure systems, drug delivery devices and manufacturing processes.
This contamination can present a risk in terms of both patient safety and product efficacy.
Our tailored Extractables and Leachables Testing Services
Resolian offers extensive expertise in assessing extractables and leachables testing, including:
Pharmaceuticals
Expert E&L testing for pharmaceutical products using state-of-the-art instrumentation.
Comprehensive analyses ensure safety and compliance for container closure systems of injectables, ophthalmics, topicals, and inhaled products, while maintaining product integrity.
Medical Devices
Resolian analyzes both whole products and components for biocompatibility to detect extractables.
Tailored studies compliant with ISO‑10993 enable chemical characterization of the material, exhaustive and exaggerated extraction of wound dressings, catheters, implants, and other devices.
Biopharmaceuticals
Comprehensive E&L testing for biopharmaceuticals, including pre-filled syringes and single-use systems, aligned with USP <665>, <1665>, and
ISO-10993.
State-of-the-art analytical platforms ensure compatibility and safety of transfer systems (IV bags, tubing, connectors) and process contact materials, following
BPOG & ELSIE best practices.
Process-equipment related leachables
Product contact manufacturing components pose a risk of releasing process-equipment-related leachables (PERLs), impacting the efficacy and safety of biopharma products.
Resolian excels in E&L study design and execution for single-use systems (SUS), multi-use systems (MUS), and container closure systems, aligned with USP <665>, <1664>, <1665>, ICHQ3E, and BPOG & ELSIE best practices.
Consumer Healthcare
E&L testing for container closure systems, including plastic and glass bottles, laminated tubing, and stoppers, following USP, ISO,
and ICH guidelines.
Extractable analysis for creams, ointments, toothpaste, and shampoo ensures compliance
with global regulatory standards
for safety and efficacy.
Electronic Nicotine Delivery Systems (ENDS)
Specialized E&L testing for ENDS device components and e-liquid container closure systems.
Identification and quantitation
of components with the potential to migrate into e-liquids or vapors under ISO- 10993. Comprehensive analysis ensures compliance with FDA, TPD,
and other regulatory standards.
Comprehensive E&L Testing Services for
Risk Assessment, Method Validation, and Product Safety
Bespoke Study Design
Tailored to your unique needs, the carefully considered study design, in line with the latest regulatory guidelines, will provide you with the data to support a regulatory submission, change of manufacturing process, device component or supplier.
Characterization of Unknowns
We specialize in characterizing unknown compounds, providing you with a complete understanding of potential extractables and leachables.
Accelerated Leachable Studies
Can be utilized to provide you with timely results and insights into potential leachables throughout the shelf life and to define the testing requirements of stability trials.
Toxicological risk assessment
The data generated by Resolian’s E&L studies can be used for toxicological assessment of any specific compounds as part of a human health risk assessment package. We partner with one of Europe’s leading chemical hazard and toxicology risk consultants to provide this service to our customers.
E&L Screening Studies
Delivering specialized methods and workflows that leverage innovative microsampling technology at the pre-clinical, clinical, and bioanalytical levels.
Validation of Leachable Assay Methods
Our team specializes in the development and validation of robust assay methods for target leachables. These methods enable precise monitoring of leachables throughout stability trials or the product’s shelf life, helping to ensure product safety.
