Tests involved product formulations prone to delamination recalls
SCHOTT Vials DC demonstrate resistance against delamination in new screening study
A new series of studies has once again demonstrated the effectiveness of SCHOTT Vials Delamination Controlled (DC). These pharmaceutical vials have a particularly high chemical durability and are therefore less susceptible to delamination.
SCHOTT has had this property confirmed in various storage studies. First, substances were used that have already caused product recalls due to delamination. In a second series of studies, the question of how effectively buffer systems can be stored in the new bottle was examined more closely.
The result: if the respective substances were stored in SCHOTT Vials DC, the vials remained stable and no glass delamination was observed. A detailed presentation of results was published in the November/December 2016 issue of the PDA Journal.
The delamination studies were conducted in accordance with USP1660 using two different types of formulations: a 15-percent potassium chloride solution and a 10-percent sodium thiosulfate solution for which recalls due to delamination had been announced.
Nevertheless, established buffer or formulations that are often used to develop drugs were also tested, for instance ultrapure water, citrate buffer, phosphate buffer, sodium bicarbonate buffer and EDTA (ethylendiamintetraacetic acid).
“Both series of studies clearly show that switching to SCHOTT Vials DC as primary packaging materials significantly reduces the risk for pharmaceutical manufacturers to experience delamination recalls”, says Product Manager Florence Buscke.
Thanks to SCHOTT Vials DC, pharmaceutical companies now have an interesting alternative course of action against the “phenomenon of delamination” i.e. the detachment of flakes from the inner glass surface due to interaction of the formulation with the pharmaceutical vials.
SCHOTT Vials DC are based on established hot forming principles without any additional post process steps and can therefore replace the packaging that is already being used with approved drugs without causing expensive re-registration.
The vials are available in the ISO sizes 2R to 10R. SCHOTT has also already produced larger sizes to meet individual customer needs, for example, a large-scale 50 ml vial for a biotech company based in the United States.