PT  - JOURNAL ARTICLE
AU  - Guglielmi, Massimo
AU  - Arai, Satoshi
AU  - Georges, Peggy
AU  - Meisner, Amy
AU  - Otton, Peter
AU  - Panighello, Serena
AU  - Rupertus, Volker
AU  - Zhang, Jingwei
AU  - Zuccato, Daniele
TI  - Evaluation of extreme depyrogenation conditions on the surface hydrolytic resistance of glass containers for pharmaceutical use
AID  - 10.5731/pdajpst.2024.012972
DP  - 2024 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2024.012972
4099  - http://journal.pda.org/content/early/2024/11/23/pdajpst.2024.012972.short
4100  - http://journal.pda.org/content/early/2024/11/23/pdajpst.2024.012972.full
AB  - This paper is the result of a round robin activity run by the Technical Committee TC12, Pharma Packaging, of the International Commission on Glass (ICG). The study was motivated by a concern about the risk that the depyrogenation treatment of glass vials, when performed in an abnormal way that deviates from the usual procedure, may have a negative impact on the hydrolytic resistance of the container inner surface. The study was executed by using 10 ml clear type I Borosilicate glass vials representing four different compositions. For the applied depyrogenation process extreme parameters were chosen to with maximum temperature up to 400°C, exposure times up to 72 hours and different amounts of residual water inside as starting conditions. Those treated samples were tested in seven different laboratories as a round robin test.. A large amount of data was obtained, which clearly indicate that the hydrolytic resistance performance of the Type I Borosilicate glass vials is not affected even by such extreme depyrogenation conditions (e.g. 400°C, 72hours and not perfect dried inside). This is an important and useful result, both for glass and pharma companies, based on the 12.000 analytical data collected during the interlaboratory activity.