OIT-003 · Allergen segregation and staff protection

OIT-003 · 1.0 · 10.09.2026

Scope

Storage, weighing, processing and cleaning of allergenic materials.

Roles and prerequisites

Responsible pharmacist: approves implementation and release. Trained operator: performs and records work. Reviewer: verifies critical items. Specialist clinician/analytical partner: as specified.

Before implementation complete local document IDs, named roles, suitable equipment, specific specifications and acceptance criteria. Check the applicable framework in your country.

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.

Stop criterion

Related records

• F-004 · Equipment and cleaning record
• F-007 · Deviation, CAPA and recall

Sources

• NAPRA — Guidance Document for Non-sterile Preparations
• AEMPS PN/L/PG/002/00 — Indumentaria

These sources inform the original editorial synthesis. Their publishers do not adopt or endorse this SOP.

Local approval

Local version: __________ Effective date: __________
Author: __________ Reviewer: __________ Pharmacist approval: __________
Signatures / dates: __________ Next review: __________