Root Cause Analysis of Color Change in Aqueous Drug Product
An aqueous drug product failed inspection due to discolorations of both the drug solution and the vial wall. CPG identified the cause of the discolorations using microscopy and elemental analysis, enabling release of the production hold on the drug product. View PDF View Short Version
Several syringes on a blue background. Vaccinations.
Root Cause Analysis in Cracked Polycarbonate Syringes
A client requested a root cause analysis of cracks and haziness that appeared in polycarbonate (PC) syringes during accelerated aging as part of a shelf-storage study. The results of the study were unexpected and revealed a few issues with the manufacturing line. View Full PDF View Short Version
Failure Analysis in Catheters
A client presented catheter hubs that appeared to be cracking during their manufacturing process. Cambridge Polymer Group isolated the root cause and proposed an alternative manufacturing strategy that the client adopted. View PDF
Artificial Lens Hazing Root Cause Analysis
A client of Cambridge Polymer Group had concerns over hazing that was occurring in a new formulation of lenses during manufacture. CPG traced the cause of the cloudiness to a poorly controlled reaction process resulting in microcavitation within the lens during the swelling process as the lens hydrated. View PDF