Extractable and Leachable Testing
Extractable & Leachable evaluations have become increasingly more vital to successful product development and regulatory submissions. Recently, many E/L and chemical characterization guidelines, as well as standards, have been revised to better address patient safety considerations in the pharma/biotech and medical device industries, including USP standards and FDA guidance. These heightened requirements necessitate manufacturers to seek out experts who are aware of the industry trends and changes in the regulatory landscape for medical device evaluations and container qualification, as it pertains to final fill, intermediate storage, and manufacturing systems including Single Use Systems.
Whitehouse Labs, as a subsidiary of AMRI, understands the strategic vision needed to compliment the spectrum of services already offered to our customers, including but not limited to: drug discovery, chemical development, analytical services, small and large scale API and drug product GMP manufacturing, product stability testing, drug delivery device safety testing, container closure integrity, packaging validations, etc.
To meet this increased demand, Whitehouse Labs has furthered its efforts towards gaining access to more and more E&L expertise. Within Albany Molecular Research, Inc. (AMRI), additional scientific staff has been dedicated to testing services for addressing Extractables/Leachables & Impurities. Along with added personnel, critical instrumentation has been added to the E&L group. Moreover, additional instruments have been identified to further develop novel solutions in meeting customers’ E&L needs.
Most Importantly, AMRI has assembled industry leading experts to be a resource to our global customers trying to navigate the evolution of FDA Extractables & Leachables expectations. Many of these experts, who started with E&L testing when first recommended by PQRI, and as outlined by ISO 10993-18 include material scientists, analytical chemists, biomedical engineers, toxicologists, and biocompatibility specialists, often educate regulators and participate in developing the standards or guidelines related to this multidisciplinary science known as Extractables & Leachables.
EXTRACTABLE AND LEACHABLE SERVICES
- Development of a Tailored Extractable and Leachable Study Design
- Development of optimized protocols based on pertinent guidelines
- Controlled Extraction Studies
- Extractable Profiling and Identification
- Simulation Studies
- Leachable Studies on Drug Product over Shelf Life and/or Accelerated Stability Program
- Extractable and Leachable Method Development, Validation,and Routine Testing
EXTRACTABLE AND LEACHABLE INSTRUMENTATION
Whitehouse Laboratories uses state-of-the-art instrumentation to produce high-quality data and submission-ready results when conducting your Extractable and Leachable Studies. Our instrumentation ranges from general analytical equipment to specialized systems for E&L Testing.
- HPLC-MS, UPLC-MS, HPLC-MS/MS, HPLC-High Resolution MS
- HPLC-UV/CAD/ELSD, UPLC-UV/CAD/ELSD
- HS-GC-MS, GC-MS, GC-FID, GC-ECD
- ICP-OES, ICP-MS, IC
- FTIR, NMR
- TGA, DSC
PRODUCTS WE TEST:
- Medical Devices
- Container Closure systems
- Raw materials
- Single use systems
- Manufacturing components including rubber closures for parenteral products
- Primary and secondary packaging
Whitehouse Labs, a division of AMRI, offers comprehensive analytical services providing support for manufacturing from development to market. From analytical chemistry and material qualification to packaging optimization, Whitehouse Labs is the testing partner for the world’s leading pharmaceutical, biotechnology, medical device, life sciences and consumer products organizations.
Please contact us at Whitehouse labs to better understand how we can guide you through the process in meeting your Extractables & Leachables needs.