PT  - JOURNAL ARTICLE
AU  - Guglielmi, Massimo
AU  - Arai, Satoshi
AU  - Georges, Peggy
AU  - Meysner, 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  - 2025 Mar 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 170--177
VI  - 79
IP  - 2
4099  - http://journal.pda.org/content/79/2/170.short
4100  - http://journal.pda.org/content/79/2/170.full
SO  - PDA J Pharm Sci Technol2025 Mar 01; 79
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 after filling with the drug product, for example, by increasing the release of leacheables and/or the propensity to delamination. 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 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, 72 hours, and not perfectly 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.