📌 HEPA Filter Uses in Pharmaceutical Manufacturing

🔬 What is a HEPA Filter?

• High Efficiency Particulate Air (HEPA) Filter removes ≥ 99.97% of airborne particles ≥ 0.3 microns.

• Essential for cleanroom design and controlled environments.

✅ Uses in Pharmaceutical Manufacturing

1. Cleanroom Classification & Control

   • Maintains ISO/GMP cleanroom grades (A, B, C, D).

   • Ensures particle-free environment for sterile manufacturing.

2. Aseptic Processing & Sterile Area

   • Provides unidirectional airflow (LAF, RLAF, Biosafety Cabinets).

   • Prevents contamination of sterile injectables, ophthalmics, biologics, etc.

3. HVAC Systems in Pharma

   • Installed in Air Handling Units (AHU) for terminal filtration.

   • Ensures clean, filtered air supply to manufacturing and packing areas.

4. Sampling & Dispensing Booths

   • Protects product and operator during handling of APIs, powders, and raw materials.

5. Microbiology & QC Labs

   • Used in biosafety cabinets and clean benches for aseptic testing.

6. Containment of Hazardous Substances

   • Prevents release of toxic dust or potent drug particles (oncology, hormones).

7. Regulatory Compliance

   • Required by US FDA, EU GMP, WHO TRS, and ISO 14644 for sterile drug manufacturing.

📌 In Summary

HEPA filters are critical barriers in pharmaceutical manufacturing for contamination control, aseptic processing, operator protection, and regulatory compliance.