Double glass component delamination

Glass delamination occurs when thin, flexible fragments – lamellae or flakes – become detached from the surface of the containment solution. When selecting a containment solution, it is important to identify the potential for delamination issues early on and provide the relevant documentation for regulatory submission.

Terminal sterilization, glass chemistry, and solution chemistry are the key factors in the generation of glass flakes. Dissolution of silica may be an effective indicator that delamination will occur with a given liquid stored in glass. Finally, delamination should not be defined by the appearance of visible glass particulates.

Delamination of the glass surface occurs when sodium and other ions leach out of the glass surface into the solution. This leaves a predominantly silica surface layer, which may become detached from the glass and enter the solution as a thin flake. This is known as lamella, which is characteristic of delamination.

Delamination effects are still possible in molded glass, typically affecting the whole surface and not just certain risk areas, which needs to be considered in any glass change assessments due to delamination. However, molded glass is for a variety of other reasons often less favorably used compared to tubing glass.

The combined results of phase I and II showed depyrogenation does not play a significant role in delamination. Terminal sterilization, glass chemistry, and solution chemistry are the key factors in the generation of glass flakes. Dissolution of silica may be an effective indicator that delamination will occur with a given liquid stored in glass.

gradients due to hot forming are the most extreme. The highest risk for delami-nation is located there. A second area is located close to the shoulder of the vial. But the effect is less pronounced due to the lower glass temperature and the shorter time used for the forming process.