RT Journal Article
SR Electronic
T1 Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 170
OP 177
DO 10.5731/pdajpst.2024.012972
VO 79
IS 2
A1 Guglielmi, Massimo
A1 Arai, Satoshi
A1 Georges, Peggy
A1 Meysner, Amy
A1 Otton, Peter
A1 Panighello, Serena
A1 Rupertus, Volker
A1 Zhang, Jingwei
A1 Zuccato, Daniele
YR 2025
UL http://journal.pda.org/content/79/2/170.abstract
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.