Clean Room Start Up: Evaluation of a Combined Sanitization Regimen Using Ready-To-Use (RTU) Quaternary Ammonium and RTU Hydrogen Peroxide/Peracetic Acid
A clinical supply manufacturer was adding a new integrated filling operation to its aseptic filling capabilities. As the site strategized to determine the revised regimen, the need for a global approach was considered to synergize all related activities.
2020-12-10
Key Takeaways:
- A combined regimen of RTU quaternary ammonium and RTU hydrogen peroxide/peracetic acid effectively reduced bioburden in a new Grade C/D cleanroom to ISO-14644 compliance.
- A phased sampling strategy (T=0, T=1, T=2) demonstrated progressive microbial reduction, targeting Gram-positive cocci, Gram-negative rods, and mold.
- Environmental monitoring (EMPQ) validated efficacy without requiring additional in-house testing.
- Routine procedures were data-driven, including weekly quaternary disinfection, monthly sporicidal application, and shutdown residue removal using hot WFI and 70% IPA.
- The protocol supports the global use of compatible, low-residue disinfectants across multiple application methods.
