Disinfection

Details

Disinfection reduces, by an irreversible action, the number of microorganisms on a surface or object to a level appropriate for the intended use (EU GMP Annex 1 glossary); it does not eliminate surviving organisms as sterilisation does, so in cleanroom control disinfection is one layer of the contamination control strategy rather than a substitute for sterilisation. Annex 1 §4.33 requires cleaning to remove surface contamination before disinfection and residues of disinfectant to be removed, requires more than one disinfectant with different modes of action so that both bacteria and fungi are covered, requires a sporicidal agent to be included periodically, and requires the effectiveness of the disinfection programme and the emergence of resistant strains to be monitored regularly. §4.34 requires the disinfection process to be validated for the way it is actually used and for the surface materials, with the in-use shelf life of prepared solutions supported; §4.35 requires disinfectants and detergents used in Grade A and B areas to be sterile before use. Inspections cite sporicidal agents not used, dwell times shorter than the contact time on the label, non-sterile disinfectants and wipes used in Grade A and B, and the absence of disinfectant rotation and effectiveness verification.

Related sections

Related terms

Real inspection findings

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

1. For example, your firm has not validated the cleaning and disinfection processes for your ISO (b)(4) cleanroom or ISO (b)(4) where your product is manufactured.

   FDA · FDA Warning Letter · 2026-09-22

2. Specifically, an operator removed the outer packaging of stoppers in the ISO 7 area and the inner bag was then transferred from the ISO 7 area into the ISO 5 LAFW without surface disinfection.

   FDA · FDA Warning Letter · 2026-05-12

3. At the time of the inspection, your written procedure for cleaning and disinfection of (b)(4) was inadequate in that it did not include a description in sufficient detail of the cleaning schedules, methods, equipment, and materials to be used in cleaning the facility.

   FDA · FDA Warning Letter · 2022-06-28

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