Device Change Management For Inhaled Products: Loy Britto, Ph.D. Glaxosmithkline
Device Change Management For Inhaled Products: Loy Britto, Ph.D. Glaxosmithkline
Device Change Management For Inhaled Products: Loy Britto, Ph.D. Glaxosmithkline
Management for
Inhaled Products
Loy Britto, Ph.D.
GlaxoSmithKline
ISAM Congress Munich 2015
Topics to be covered
Components
Inhaled
Formulation Drug Methods
Product
Processes
Location
Around the nozzle block of
the actuator
On top of the can
Counters and Indicators
Ex-Device dose
Throat Impact on
deposition Patient Material filling
Delivered dose Handling changes
Changes in
process
Studies Electrostatics
deposition on Valve Extractables
CI stages function
Overages Counter
robustness
Upper Stem
Body
Lower Stem
Spring