Sporicidal Agent

Details

The EU GMP Annex 1 glossary defines a sporicidal agent as one that destroys bacterial and fungal spores when used at a sufficient concentration for a specified contact time, and it fills the gap left by ordinary disinfectants, which act on vegetative bacteria and fungi but not on spores. Annex 1 §4.33 requires a cleanroom disinfection programme to use more than one disinfectant with different modes of action, to include a sporicidal agent periodically, and to monitor the effectiveness of the programme and the emergence of resistant strains; §4.35 requires disinfectants used in Grade A and B areas to be sterile before use. If disinfection is the whole business of reducing microorganisms, the sporicidal agent is the one within that programme charged with spores. FDA warning letters and 483s repeatedly cite sporicidal agents not used at all or used too rarely in ISO 5 aseptic processing areas, application for less than the contact or dwell time the label requires, and non-sterile sporicides and wipes used in Grade A.

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Related terms

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

1. Your firm also stated that moving forward, a detergent and sporicidal agent will be used to clean the interior of the (b)(4) .

   FDA · FDA Warning Letter · 2022-02-08

2. Your firm failed to ensure an adequate contact time for your sporicidal agent used to disinfect your aseptic processing areas.

   FDA · FDA Warning Letter · 2024-10-22

3. You failed to evaluate whether the recovery of spore-forming organisms indicated a need for more frequent application of a sporicidal agent as part of your routine disinfection program.

   FDA · FDA Warning Letter · 2021-02-09

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.