OIT-005 · Uniformity, redispersibility and dosing device

OIT-005 · 1.0 · 10.09.2026

Scope

Demonstrating consistent concentration in the finished product and delivery device.

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. Define quality attributes: measured protein/analyte, uniformity, particles and the amount delivered by the dosing device.

2. Design sampling at different vessel locations and beginning/middle/end of filling as justified by the study. Do not sample only the easiest location.

3. Study settling and redispersibility after representative standing periods. Define shaking that a user can realistically perform.

4. Assess delivered-volume accuracy, clogging, dead volume and adsorption in the chosen syringe/adapter. Do not assume all dosing devices are equivalent.

5. Use analysis suitable for the final matrix and low concentrations. Record detection/quantification limits and uncertainty where critical.

6. Compare results with predefined criteria. Check in-use behaviour and performance toward the proposed BUD.

Stop criterion

Related records

• F-005 · Sampling and QC results
• F-009 · Allergen process verification

Sources

• NAPRA — Guidance Document for Non-sterile Preparations
• Santos et al. — EAACI management guideline, DOI 10.1111/all.16345
• FDA — PALFORZIA: product information and package insert

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: __________