Dokumentation von Reinraum-Mopps – eine Checkliste für die GMP-Audit-Bereitschaft
A practical 20-item checklist to prepare cleanroom mop documentation for FDA, MHRA, and GMP audits. Covers COA, Certificate of Irradiation, particle test reports, batch traceability, and change control records that auditors expect to see. Free downloadable checklist available.
Leitfaden zur Lagerung und Handhabung von Reinraum-Mopps — Verhinderung von Kreuzkontaminationen in GMP-Anlagen
How cleanroom mops should be stored, dried, and handled between uses to prevent cross-contamination in GMP facilities. A practical guide covering drying validation, container selection, FIFO rotation, storage room environmental requirements, and an audit-ready storage checklist.
Reaktion auf verschüttete Wischmopps im Reinraum – Ein Protokoll- und Werkzeugleitfaden für GMP-Einrichtungen
Spill response in a cleanroom is a distinct cleaning event from routine mopping — it requires faster response, containment before cleaning, dedicated spill kit tooling (separate from routine cleaning mops), additional documentation (spill incident report linked to cleaning records), and specific operator training. A facility that treats spills as “just clean it up” has an undocumented gap in its contamination control program. This protocol and tooling guide provides a step-by-step framework that GMP facilities can implement directly, including a spill kit contents specification and a spill incident report template.
