Case Study

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. 
December 10, 2020

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. 

A clinical supply manufacturer was adding a new integrated filling operation to its aseptic filling capabilities. The new pilot lab area provides a Grade C background environment with adjacent Grade D transition airlocks for material and personnel.

The traditional sanitization/disinfection used by the site included the routine use of hydrogen peroxide/peracetic acid ready to use (RTU), 70% isopropyl alcohol (IPA), and hot Water for Injection (WFI).

The site explored disinfection products currently available and utilized at the adjacent affiliated commercial sites after realizing the limited cleaning effectiveness of the established regimen. As the site strategized to determine the revised regimen, the need for a global approach was considered to synergize all related activities. 

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