- Research Article
- 10.5731/pdajpst.2026.26131
Designing a CCS that Focuses on Materials Transfer into Cleanrooms, RABS, and Isolators: Poster Presented at PDA Microbiology Conference 2025.
- Feb 28, 2026
- PDA journal of pharmaceutical science and technology
- James Polarine
This seminar will cover utilizing a contamination control strategy with a risk-based approach to materials transfer into cleanrooms, RABS, isolators, and BSC's. There will be a focus on how to control hard to kill fungal spores such as Aspergillus and Penicillium as well as bacterial spores and viruses. Recent case studies from the past few months in ATMPF facilities and compounding pharmacies will be discussed in relation to materials transfer. Published data will also be mentioned to convey effective methods in control bioburden utilizing VHP, sporicidal chemistries, and disinfectants into the APA. This presentation will be a holistic approach to controlling bioburden from entering cleanrooms, BSC Hoods, RABS, and Isolators. New industry case studies in disinfectant field trials will also be covered and discussed in detail based on recent industry publications.
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