RT Journal Article
SR Electronic
T1 A Multicompany Survey Study for Helium Leak Container Closure Integrity Test
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2021.012633
DO 10.5731/pdajpst.2021.012633
A1 Roman Mathaes
A1 Klaus Wuchner
A1 David Riesop
A1 Daniel Wagner
A1 Sascha Dreher
A1 Florian Woelfle
A1 Prudvi Raj Mudumala
A1 Debora Bonvin
A1 Christian Müller
A1 Kerstin Traub Hoffmann
A1 Henri Hebting
YR 2021
UL http://journal.pda.org/content/early/2021/11/15/pdajpst.2021.012633.abstract
AB All products labeled as sterile are required to be free of microbial contamination throughout their shelf life (obligatory CQA). Container Closure Integrity (CCI) needs to be addressed with a holistic lifecycle strategy comprising adequate primary packaging components selection and the assessment of critical unit operations and Critical process parameters (CPPs) according to quality by design (QbD) principals. The Helium leak method is currently the most sensitive CCI test method and preferably used for the initial container closure system (CCS) qualification and characterization studies. Currently, two different measuring principals are used in the pharmaceutical industry and no data is available in the public domain for typical method performance parameters such as accuracy, precision, intermediate-precision, and limit of quantification of the method. Furthermore, the performance of different types and sizes of artificial leaks as well as certified helium leak standards has not yet been characterized across different test laboratories. In this intercompany study, we prepared 17 artificially prepared leak samples using the most common types of artificial leaks in relevant nominal size ranges which are commercially available or can be easily prepared in a laboratory. Each participating lab did generate results according to their in-house methods applying their established test parameters as the aim of the round robin study was not to create a standard for Helium leak measurements, but to compare real world performance between different laboratories.