PT  - JOURNAL ARTICLE
AU  - Sven Deutschmann
AU  - Mousumi Paul
AU  - Marja Claassen-Willemse
AU  - Jonas van den Berg
AU  - Pieta IJzerman-Boon
AU  - Viviane Grunert da Fonseca
AU  - Ellen Brunbech
AU  - Lynn Johnson
AU  - Chris Knutsen
AU  - Lucile Plourde
AU  - Joanny Salvas
AU  - Philip Villari
AU  - Lisa Wysocki
TI  - Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to Their Evaluation, Validation and Global Implementation
AID  - 10.5731/pdajpst.2021.012672
DP  - 2023 May 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 211--235
VI  - 77
IP  - 3
4099  - http://journal.pda.org/content/77/3/211.short
4100  - http://journal.pda.org/content/77/3/211.full
SO  - PDA J Pharm Sci Technol2023 May 01; 77
AB  - The current compendial sterility test has a 14-day incubation time and is often the time-limiting step in the Assess and Release Process of pharmaceutical products. There is an ever-increasing number of technologies available on the market that have benefits in addition to faster Time to Result, such as standardization and automation of readout (eliminating analyst subjectivity) and improved data integrity (including eliminating the need for contemporaneous verification of the result by another analyst). Regulators have been encouraging the pharmaceutical industry to adopt these innovative systems; however, it has taken a considerable time before receiving the first approvals from various health authorities (including both the European Medicines Agency and Food and Drug Administration) for the use of an alternative and rapid sterility test for the release of sterile drug product lots. This article describes a systematic 9-step approach to the evaluation, equipment qualification, validation, and deployment of alternative sterility tests that can be applied by pharmaceutical companies wanting to take advantage of the numerous benefits of alternative sterility tests. Two case studies are presented to illustrate the validation and implementation approach, including statistical methods. Although most of the steps toward implementation are aligned, the validation and transfer have been approached differently for each of the case studies because of differences in the chosen technology as well as independent company internal decisions to comply with validation guidelines. However, both case studies show successful implementation of an alternative sterility test for sterile drug products with an ∼50% reduced incubation time.