SCHOTT TopLine Options for Superior Shelf Life
SCHOTT EVERIC™
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 EVERIC™ – 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
Sizes:
2R - 30R (50R in development) ISO formats using improved Type I FIOLAX® Borosilicate glass – FIOLAX® CHR. Customization available on request.
More information: Dr. Bernhard Hladik from SCHOTT breaks down the delamination phenomenon and describes how pharma manufacturers can effectively fight back.
