SCHOTT TopLine Options for Superior Shelf Life

SCHOTT Vials DC (Delamination Controlled)

Glass delamination resulting in barely visible glass flakes has led to recalls of numerous injectable drug products over the past few years. In order to prioritize patient safety, the FDA has reacted to this phenomenon by emphazising the importance of container/drug compatibility testing in line with USP 1660.

SCHOTT Vials DC – An optimized manufacturing process combined with quantitative laboratory test procedures on delamination resistance has proven to significantly reduce the risk of glass delamination.

Properties:

Chemically homogenious inner surface thanks to cutting-edge hot forming technology
SCHOTT patented Quicktest to verify the reduced delamination risk of each production batch using a predefine quantitative limit value
Reproducibly improved chemical stability of container’s inner surface

Benefits:

Significantly reduced delamination risk
Applicable to all products already registered – hence no re-registration required
SCHOTT Delamination Quickest-related batch certificate
All manufacturing-related risk factors for delamination are covered by one single limit value
No delamination observed within accelerated screening study according USP 1660 with model buffer systems