Our work
Patients undergoing treatment with any drug product or medical device can be exposed to small amounts of “leachable” chemicals. These can migrate from contact with processing equipment, packaging or delivery systems, and subsequently become part of the administered dose.
It is critical for all parties that such leaching does not occur at a level that presents a significant safety or quality issue. Extractables and leachables (chemical characterisation) studies play a critical role in this quality control and monitoring.
The E+L process
