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SOP-022 / 2.1

Cleaning verification for actives and allergens

Shared equipment and surfaces at risk of residue carryover.

Collection and scientific editing: Stasinos Chr. SikaliasContent edition: 2.1Record editorial review date: 2026-10-14

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Procedure

  1. Select worst-cleaning substances and locations using toxicity, dose, solubility, adhesion and geometry.
  2. Set a scientifically/toxicologically justified residue limit for the next use. Do not adopt universal 10 ppm or zero without method and rationale.
  3. Verify swab or rinse recovery from actual surface materials, suitable LOQ and cleaning-agent interference.
  4. Perform the approved method and record exact cleaner, dilution, time, mechanical action and rinsing.
  5. Assess visual inspection together with required analytical results. ATP or disinfection does not establish removal of allergens or potent drugs.
  6. Release the area only after acceptance. Failure requires investigation, justified recleaning or dedicated equipment, with assessment of previous batches.

Additional detail

A drug-residue limit from a toxicological model is not automatically safe for a food allergen. A not-detected report includes LOD/LOQ, area, recovery and the specific acceptance criterion. If shared equipment lacks a defensible limit/method, use dedicated equipment or refer the task.

Stop criterion

Failed limit or unsuitable method: no subsequent shared use.

Related forms

F-015, F-004, F-007

Sources and references

  1. 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
  2. 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 certification2026-10-14
  3. EMA — Guideline on Allergen Products: Production and Quality IssuesEMEA/CHMP/BWP/304831/2007; adopted 20 November 2008; effective 20 May 2009; remains current effective quality version on EMASections 2, 4.1.1, 4.2.4.4, 4.4.3–4.4.5; document pp. 4–13Industrial biological-allergen quality guidance; principles adapted explicitly, not a compounding authorisation or a food-OIT recipe2026-10-14
  4. EMA — Guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populationsEMA/161669/2025; adopted 10 June 2025; effective 1 January 2026Sections 2, 4 and 4.1 (Type I allergy quality aspects); pp. 4–6; section 8.4 for food-allergy endpointsIndustrial allergen development and quality guidance; complements 2008 guideline. Section 4.2 Type IV patch-test exceptions are not transferred to food OIT.2026-10-14