Temperature peaks in the manufacturing process are the main cause of delamination in tubular glass vials. This was discovered in a recent long-term study conducted by Gerresheimer AG and the Alfred University in New York. The Primary Packaging Glass Division took action directly: the new Gx ARMOR vials are equipped to withstand aggressive active ingredients, thereby reducing the delamination risk.
Experts were also surprised by the finding of the long-term study which confirmed that delamination in primary packaging for parenteral solutions is a temperature-induced phenomenon. It only affects vials made of tubular glass. And it is a phenomenon that occurs 98 percent of the time in the region of the vial base. Delamination is caused by too high temperatures in the forming process. It can also be exacerbated by the subsequent treatment of the vials with ammonium sulfate.
Study initiator Gerresheimer and the research team at New York's famous Alfred University invested three years in this project. It involved the meticulous testing of around 9000 samples. The Primary Packaging Glass Division has already responded to the study results with a new product line called Gx ARMOR vials which are specifically designed for parenteral solutions with aggressive active ingredients and specially equipped to prevent delamination. Gx ARMOR stands for Gerresheimer Advanced Risk Management and Operational Response.
The vials are manufactured in an optimized production process which limits and continuously adjusts the temperature of the burners. A camera system monitors the molding process for every single vial. Random samples are regularly taken from the production line and tested for their susceptibility to delamination with the new, in-house developed Gx THOR (Thermal Hydrolytic Optimization and Reduction) control process and the Gx FLASH test procedure. "The complex research and development work has paid off," summed up Carol Rea Flynn, Director of Technical Services. "We are now launching a brand new generation of optimized vials."
The delamination problem has become worse since the introduction of innovative biotech drugs. Monoclonal antibodies, which are active proteins, cause the glass to flake off the vials' surface when they are stored for long periods of time, causing corrosion and contamination. Solutions containing chelating agents or buffer systems, or solutions with a high pH value, can also cause delamination. Although it is such an inert material, Type I borosilicate glass is strongly affected by the phenomenon. In the USA, in particular, delamination has resulted in many product recall campaigns - generating significant losses in the pharmaceutical industry.
Source: Gerresheimer AG/gerresheimer.com