OIT-003 / SOP v2.0
Allergen segregation and staff protection
Storage, weighing, processing and cleaning of allergenic materials.
Procedure
- Assess worker exposure and contamination of other preparations. Select a dedicated area and equipment where the assessment requires it.
- Keep separately labelled containers and tools for each allergen. Do not rely solely on colour coding without written identification.
- Control dust with suitable engineering containment. Avoid dry sweeping and compressed air that disperse residues.
- Select task-appropriate PPE and organise safe removal, clothing changes and waste handling. Specifically assess workers with relevant sensitisation.
- Demonstrate cleaning using a method suitable for the specific allergen and surface. ATP testing or simple disinfection does not establish allergen removal.
- Define an acceptable residue and verification plan with scientific justification. Release the area for other work only after the required checks.
Edition-specific detail
Cleaning assessment uses recovery from actual surfaces and an allergen-suitable method. Report not detected with LOD/LOQ, surface area and acceptance criterion; it does not mean zero allergen. If shared equipment cannot be demonstrably cleaned, use dedicated equipment or refer the work.
Stop criterion
Inadequate containment or unproven cleaning of shared equipment: do not use.
Related forms
Sources and references
- 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
- Santos AF et al. EAACI guidelines on the management of IgE-mediated food allergyAllergy. 2025;80:14–36; online 2024Abstract and published guideline recommendations; DOI 10.1111/all.16345Specialist clinical recommendations; not stability evidence for local syrups or suspensions2026-09-12
- FDA — PALFORZIA prescribing informationUS prescribing information, July 2024 revision, accessed 2026-09-12Sections 1, 2.3, 4, 5 and 16Specific authorised product only; no equivalence with pharmacy-made peanut preparations2026-09-12
- NAPRA — Guidance Document for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 5, 6 and 7; master/batch records, delivery, qualityQuality-system implementation; historical BUD table not substituted for 2022 USP revision2026-09-12