Drug-delivery devices release a drug product over time into the human body. Depending on whether the product is intended to be submitted as a medical device or as a pharmaceutical drug product, the ...

Extractables and Leachables (E&L) testing is a crucial process in the development and manufacturing of pharmaceutical packaging and medical devices. Contrary to many other methods of laboratory ...

In this interview, AZoM talks to Dr Mark Jordi, President of Jordi Labs, about extractables and leachables, and how they relate to the pharmaceutical industry. What are Extractable and Leachables?

CARPINTERIA, Calif.--(BUSINESS WIRE)--Freudenberg Medical, a global contract manufacturer of medical device components and pharmaceutical tubing, announces the completion of extractables testing on ...

Medical tubing maker AvantaPure has completed its BioPhorum Operations Group standardized extractables testing on three of its silicone and thermoplastic elastomer tubing products. Testing is complete ...

The International Council for Harmonization (ICH) has released a draft Q3E guideline that offers a harmonized framework for assessing and controlling extractables and leachables (E&L) in ...

Extractables and leachables assessment is a critical facet of biopharmaceutical development and quality control, ensuring that medicines remain safe, effective and uncontaminated by substances ...

Every medical device requires an evaluation of its overall biocompatibility profile prior to its release to market. The overarching standard that covers the framework and guidance on how to approach ...

Each supplier of single-use technology products has an implicit obligation to characterize the materials of construction used in the manufacture of its products and to share that information with its ...

SOUTHAMPTON, Pa.—AvantaPure has completed its BioPhorum Operations Group standardized extractables testing on three of its silicone and thermoplastic elastomer tubing products. Testing is complete on ...