1. Viral removal and viral inactivation steps shall be performed within their validated parameters.
2. Appropriate precautions shall be taken to prevent potential viral contamination from pre-viral to post-viral removal or inactivation steps. Open processing shall be performed in areas that are separate from other processing activities and have separate air handling unit.
3. The same equipment shall normally not be used for different purification steps. In those cases where the same equipment is used, the equipment shall be appropriately cleaned and sanitised before re-use.
4. Appropriate precautions shall be taken to prevent potential virus carry-over (e.g. through equipment or environment) from previous steps.
Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04
CitationArticle 75 of Commission Implementing Regulation (EU) 2025/2154 (LawPlayer, data as of 2026-07-04)
