Inside The Cleanroom: Disinfectant Validation Demystified With Neil Simpson
Establishing a robust disinfectant validation protocol is a critical requirement for maintaining cleanroom integrity, yet many facilities struggle with when and how to update their data. While manufacturer efficacy data serves as a foundational backbone, it cannot replace site-specific validation. Regulatory expectations now lean heavily toward justifying the continued use of products through periodic reviews. Significant changes—such as facility expansions, increased personnel density, or modified manufacturing setups—necessitate a formal revalidation or, at minimum, a documented justification.
Beyond chemical efficacy, professionals must evaluate the synergy between disinfectants and their application tools. Testing should reflect real-world usage, incorporating specific mops, wipes, and the actual porosity of facility surfaces to ensure compliance with Annex 1 standards. For a deeper look into navigating these complex regulatory expectations and optimizing your contamination control strategy, watch the full interview in this episode of Inside the Clean Room.
Get unlimited access to:
Enter your credentials below to log in. Not yet a member of Pharmaceutical Online? Subscribe today.