Can Our Plant Layout and Air Handling System Prevent Cross-Contamination?

Airborne cross-contamination continues to rank high among the most common reasons for regulatory inspection failure. The FDA demands that pharmaceutical manufacturers provide evidence of effective control through:

Validated HVAC systems

Appropriate pressure differentials

Physical separation of manufacturing space—particularly important for high-risk drugs such as hormones, beta-lactams, and cytotoxic agents

Key Questions to Evaluate Readiness:

Can we validate that our air handling system avoids cross-contamination?

When was the last time our HVAC validation was done or updated?

Are we regularly checking particulate and microbial contamination levels in classified spaces?

⚠ Warning:

Stale validation information or blind faith in physical barriers are major compliance hazards. FDA inspectors learn to scrutinize air handling systems, not only on paper—but in reality.

Make sure your validation reports are up-to-date, trending data is within limits, and physical and procedural controls function harmoniously to safeguard product integrity.