prSRPS EN ISO 13408-4:2026

Aseptic processing of health care products — Part 4: Cleaning processes for surfaces used within a critical processing zone

Scope

This document specifies the general requirements for, and offers guidance on, the qualification, validation, operation and control of cleaning processes for surfaces used within a critical processing zone in an aseptic processing area for the manufacture of a health care product. The requirements and guidance encompass clean-in-place, automated and manual cleaning processes. A risk-based approach is adopted to establish the suitability of a cleaning process within a contamination control strategy and as an essential prerequisite to disinfection or sterilization of surfaces. The principles and information in this document are applicable to the processing of products covered by ISO 18362. This document is not applicable to cleaning processes conducted in a washer-disinfector as described in the ISO 15883 series.