The complexity of multi-use injectors incorporates unique requirements, not least among them a need to be sterile throughout device usage. Microbial ingress testing can be a useful tool to ensure peak safety and effectiveness, but has its own challenges.
In this Pharma Matters Q&A, Cassidy Law, Study Director III—Supervisor, Microbiology & Microbial IDs, addresses these issues. Moreover, Law discusses the benefits of a risk-based approach in designing a microbial ingress validation study.