FOR PHARMACISTS · REFERENCE EDITION 8.0261 monographs · 32 SOPs · 18 forms

OIT-003 / SOP v2.0

Allergen segregation and staff protection

Storage, weighing, processing and cleaning of allergenic materials.

Procedure

  1. Assess worker exposure and contamination of other preparations. Select a dedicated area and equipment where the assessment requires it.
  2. Keep separately labelled containers and tools for each allergen. Do not rely solely on colour coding without written identification.
  3. Control dust with suitable engineering containment. Avoid dry sweeping and compressed air that disperse residues.
  4. Select task-appropriate PPE and organise safe removal, clothing changes and waste handling. Specifically assess workers with relevant sensitisation.
  5. Demonstrate cleaning using a method suitable for the specific allergen and surface. ATP testing or simple disinfection does not establish allergen removal.
  6. 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

F-004, F-007, F-015

Sources and references

  1. 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
  2. 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
  3. 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
  4. 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