SOP-022 / SOP v1.0
Cleaning verification for actives and allergens
Shared equipment and surfaces at risk of residue carryover.
Procedure
- Select worst-cleaning substances and locations using toxicity, dose, solubility, adhesion and geometry.
- Set a scientifically/toxicologically justified residue limit for the next use. Do not adopt universal 10 ppm or zero without method and rationale.
- Verify swab or rinse recovery from actual surface materials, suitable LOQ and cleaning-agent interference.
- Perform the approved method and record exact cleaner, dilution, time, mechanical action and rinsing.
- Assess visual inspection together with required analytical results. ATP or disinfection does not establish removal of allergens or potent drugs.
- Release the area only after acceptance. Failure requires investigation, justified recleaning or dedicated equipment, with assessment of previous batches.
Stop criterion
Failed limit or unsuitable method: no subsequent shared use.
Related forms
Sources and references
- NIOSH — Managing Hazardous Drug Exposures: Information for Healthcare SettingsDHHS (NIOSH) 2023-130Risk assessment and activity-specific control table, printed pp. 27–33Exposure routes and hierarchy of occupational controls2026-09-12
- PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12
- EMA — Guideline on Allergen Products: Production and Quality IssuesEMEA/CHMP/BWP/304831/2007, 2008Sections 2, 4.1.1, 4.2.4, 4.3, 4.4.3–4.4.5; pp. 4–13Industrial biological-allergen quality guidance; principles adapted explicitly, not a compounding authorisation or a food-OIT recipe2026-09-12