Future of disinfection testing: Aligning validation to regulation
Regulatory requirements and guidance for pharmaceutical industry now require Disinfectant Efficacy Testing (DET) to validate biocides to be even more prudent. The expectation is to validate with the minimum contact time, typical microbial flora and surface materials and specific manner in which a biocide is used for each facility.
The presentation summarises existing methodology for biocidal assessment and how it has been developed to better reflect use in pharmaceutical manufacturing environments. The most recent development of wipe efficacy assessment methods reflecting best practice techniques is discussed. It also explores validation beyond laboratory testing, with guidance and recommendation on in-situ, or ‘Phase III’ assessments.
• Examines current validation methodology and how it can and should be adapted
• Suggests strategies to rationalise validation plan such as bracketing of materials
• Shows how wipe layers, surface topography and wipe saturation can influence results
• Discusses how Phase III studies can inform your overall disinfection strategy