OIT-006 · Microbiology, packaging and stability

OIT-006 · 1.0 · 10.09.2026

Scope

Developing a justified use period for the exact allergenic matrix.

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 risks from raw material, water, equipment and handling. A food origin does not exclude microbial burden.

2. Select suitable microbiological tests and criteria with an analytical partner for the product and use. Demonstrate preservative neutralisation in testing where needed.

3. Study the exact packaging and repeated opening/withdrawal. Refrigeration and high sugar alone do not validate preservation.

4. Combine microbiological evidence with chemical/physical stability, protein, redispersibility and delivery. One passing test does not establish the entire BUD.

5. Assign a period and conditions only after reviewing all evidence. Do not transfer the period of another medicine or another nut.

6. Define handling of temperature excursions, transport and opening. Do not give generic refreezing or reheating instructions without specific evidence.

Stop criterion

Related records

• F-005 · Sampling and QC results
• F-006 · Stability and BUD rationale

Sources

• NAPRA — Model Standards for Pharmacy Compounding of Non-sterile Preparations (2018; clarification 2022)
• NAPRA — Guidance Document for Non-sterile Preparations

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: __________