OIT-004 · Controlled processing and protein recovery

OIT-004 · 1.0 · 10.09.2026

Scope

Process development and control; no recipe, temperature or time is supplied as a validated setting.

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. Document the process flow for the exact material and form: milling, wetting, mixing, heating, cooling, filtration and filling where applicable.

2. Define critical parameters from study of the specific process. Previous experience at another strength does not demonstrate process equivalence.

3. Measure actual product temperature, time and cooling conditions. Heating is not automatically sterilisation or allergen neutralisation.

4. For filtration/sieving document material, size, retention and residue composition. Removing solids may alter the delivered protein.

5. Relate input/output mass and volume to suitable analysis before and after critical stages. Total mass balance does not establish allergen balance.

6. Approve operating ranges, sampling and criteria before routine use. Do not compensate for protein losses by arbitrarily adding raw material.

Stop criterion

Related records

• F-002 · Master formulation record
• F-009 · Allergen process verification

Sources

• NAPRA — Guidance Document for Non-sterile Preparations
• Santos et al. — EAACI management guideline, DOI 10.1111/all.16345

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: __________