FIRM FAILS TO ASSURE ADEQUATE USE OF SPORICIDAL AGENTS AND CLEANING SUPPLIES
Jubilant HollisterStier, Spokane, WA was audited by the FDA between April 15 and May 10, 2013. The FDA reviewed the firm’s response from May 30 and noted that sufficient corrections actions were lacking. The FDA also received additional correspondence dated July 12 and August 15, but believed that a Warning Letter was required. Two Observations, both related to microbiology, were subsequently issued. This Blog only discusses the second Observation. The first Observation was reviewed in an earlier Blog.
The second citation cited (21 CFR 211.42(c)(10)(v) focuses upon provisions to ensure adequate use of sporicidal agents and the use of mops and wipes. Observation 2(a) suggests that sporicidal agents are not required on aseptic filling line stainless steel, non-removable components, and the ISO 5 rigid barriers. Observation 2(b) focuses upon the questions of “visually soiled” vs. sterile. The FDA’s latest guidance on mops, disinfectants/sterilants, buckets, etc suggest that all of these items must be used as sterile when cleaning an Aseptic Processing Area (APA).
2. “Your firm failed to assure an adequate system for cleaning and disinfecting aseptic processing areas and equipment (21 CFR 211.42(c)(10)(v)).
a) For example, your firm’s SOP 101.74, “General Cleaning, Sanitization and Disinfection of Aseptic and Controlled Areas,” lacks provisions to ensure adequate use of sporicidal agents. According to SOP 101.74, sporicidal agents are not required on aseptic filling line stainless steel, non-removable components, and the ISO 5 rigid barriers. According to SOP 101.74, (b)(4) will be used to sanitize/clean stainless steel components in the aseptic or controlled areas.
In your response you state that SOP 402.12, “Controlled and Classified Area Out-of-Service Process” has been revised to include (b)(4) disinfection of aseptic fill-lines and non-removable ISO5 equipment and platforms when out-of-service activities require scrubs or street clothes. However, your response is inadequate because you failed to address the routine use of sporicidal agents.
b) Your firm’s SOP 101.74, “General Cleaning, Sanitization and Disinfection of Aseptic and Controlled Areas,” also lacks adequate details on how many times mops and wipes can be used.
Your response is inadequate because you did not provide scientific data that the corrective actions implemented in SOP 101.74, “General Cleaning, Sanitization and Disinfection of Aseptic and Controlled Area” are adequate. While this SOP instructs staff to replace mops, wipes, and other supplies when visually soiled, it is unclear whether this revision will provide for acceptable standards of sanitization and disinfection in the controlled area.”
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