E X T R AC TA B LE S A N D LE AC H A B LE S
S T U DY PR O G R A M S
•
Container closure systems (CCS), including
combination products
•
Single-use manufacturing equipment, including
the BPOG protocol
•
Implantable medical devices and infusion systems
•
Drug delivery via all routes of administration
E X T R AC TA B LE S A N D LE AC H A B LE S
S T U DY S E RV I C E S
•
Material selection for pharmaceutical container closure
systems (CCS) and medical devices
•
Customized E&L study designs developed according
to the latest industry best practices (PQRI and USP)
•
Complete method development and validation
programs, including unknown identification
•
Toxicological risk assessments
•
Development of E&L materials risk assessments and
strategy documents suitable for regulatory submission
•
Comprehensive materials characterization and
leachables risk evaluation according to ISO-10993
parts 12, 17, and 18
T A I L O R E D P H A R M A C E U T I C A L
T E S T I N G S O L U T I O N S
The safety of your drug product and patients is of utmost importance.
Our dedicated team of experts will partner with you to design extractable and leachable
studies to evaluate risk and provide solid supporting data for your product.
From materials assessment through extractables and leachables testing
and everything in between, Element supports leading healthcare brands in
establishing the safety of materials.
Learn more about our E&L and other Pharmaceutical testing solutions at e l e m e n t . c o m
E N S U R E P A T I E N T S A F E T Y
