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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