Validation of Clean Room Pass Boxes

🧪 Validation of Clean Room Pass Boxes

📌 What is a Pass Box?

A Pass Box is an enclosure fitted between two cleanroom areas or between a cleanroom and a non-cleanroom.
It allows transfer of materials while minimizing cross-contamination and maintaining cleanroom integrity.
Types:
- Static Pass Box – No air circulation inside.
- Dynamic Pass Box – Equipped with HEPA filter and air circulation to maintain cleanliness.

📌 Why Validate Pass Boxes?

Validation ensures that the design, installation, and operation of pass boxes comply with GMP requirements and consistently protect product quality.

📌 Validation Steps

1. Design Qualification (DQ)

Verify design meets cleanroom classification & regulatory standards.
Material of construction: SS 304/316, smooth, non-shedding, easy to clean.
Doors with interlocking system.
HEPA filter (for dynamic type) efficiency ≥ 99.97% for 0.3 μm.

2. Installation Qualification (IQ)

Check installation as per design.
Verify interlocking system (only one door opens at a time).
Ensure proper sealing, finishes, and calibration of instruments (differential pressure gauges, timers).
Verify electrical connections & alarms.

3. Operational Qualification (OQ)

Test interlocking function.
Air velocity and air change rate verification (dynamic type).
HEPA filter integrity (DOP/PAO test).
Recovery test (time taken to return to specified class after door opening).
Particle count inside pass box (meets ISO 14644 class).
Noise level and light intensity checks.

4. Performance Qualification (PQ)

Simulate actual material transfer.
Check microbial contamination using settle plates/swab samples.
Verify cleaning & sanitization procedures are effective.
Monitor performance under routine use.

📌 Revalidation Criteria

Annually or as per SOP.
After major maintenance/repair (e.g., HEPA replacement, interlock failure).
After relocation or modification.

✅ Documentation

Protocol (DQ, IQ, OQ, PQ).
Test results & deviations.
Summary report with approval.

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