Why Laminar Flow Matters in Compounding Pharmacies
The U.S. Pharmacopeia USP <797> requires ISO Class 5 air for sterile compounding. Laminar flow hoods achieve this by delivering air with less than 100 particles ≥0.5 µm per cubic foot.
Horizontal vs. Vertical Laminar Flow
- Horizontal: Air exits the HEPA filter toward the operator—ideal for non‑hazardous preparations.
- Vertical: Air flows downward, protecting the operator from cytotoxic aerosols; recommended for hazardous drugs per USP <800>.
Key Performance Metrics
| Parameter | USP Requirement | Best‑in‑Class Hood |
|---|---|---|
| Air Velocity | 0.45 m/s ± 20% | 0.47 m/s (±10%) |
| HEPA Efficiency | >99.97% @ 0.3 µm | 99.995% @ 0.12 µm |
| Noise Level | <68 dB(A) | 55 dB(A) |
Best Practices for Microbial Handling
- Disinfect work surfaces with 70% IPA every 30 minutes during compounding.
- Change pre‑filters monthly; clogged filters raise particle counts by up to 300%.
- Perform smoke‑pattern tests semi‑annually to visualize airflow integrity.
- Use UV‑C decontamination cycles overnight to achieve a >4‑log reduction in surface bioburden.
Common Pitfalls
Placing paperwork upstream of critical work areas can increase colony‑forming units (CFU) by 15–20 CFU/plate in settle‑plate tests. Always keep non‑sterile items downstream of product flow.
Conclusion
Well‑maintained laminar flow hoods reduce contamination events by 98%, safeguarding patient safety and pharmacy reputation.
References: USP <797> (2024 Revision); International Journal of Pharmaceutical Compounding 2023, 27(4): 312‑318.