RT Journal Article
SR Electronic
T1 Multisite Qualification of an Automated Incubator and Colony Counter for Environmental and Bioburden Applications in Pharmaceutical Microbiology
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2022.012742
DO 10.5731/pdajpst.2022.012742
A1 Hans Joachim Anders
A1 Daniel Mannle
A1 William Carpenter
A1 Wolfgang Eder
A1 Ivana Heckel
A1 Tobias Gotzen
A1 Corinne Oechslin
A1 Cedric Joosen
A1 Maria Eugenia Giribets Parra
A1 Jason Rose
A1 Vaishali Shah
A1 David L Jones
YR 2022
UL http://journal.pda.org/content/early/2022/11/15/pdajpst.2022.012742.abstract
AB Traditional microbiological techniques have been used for well over a century as the basis for contamination testing of pharmaceutical products and processes. With more recent focus on faster product release and concerns around integrity of the test data, new technologies have been implemented to detect and enumerate organisms faster and provide paperless processes to minimize data integrity issues. Manual colony counting technologies, where incubation is performed in a standard incubator and the plate manually transferred to the colony counter for a single read at the end of incubation, have been used for many years to reduce the potential for human error, however, they pose validation challenges due to poor counting accuracy. Colony counters that automatically perform both the incubation and enumeration functions (multiple enumeration calculations through the incubation phase) have recently been implemented for QC laboratory analytical processes, supporting a cGMP environment. This paper summarizes the findings of eight companies demonstrating the qualification of an automated colony counter technology to perform the majority of microbial tests required for QC, environmental monitoring, bioburden for in process, bulk drug substance and water system testing. Comparable analytical performance and time to result data generated during individual studies at all companies allows the system to be qualified and implemented for cGMP processes while reducing data integrity risks.