For GMP facilities, aseptic drug manufacturing, biosafety laboratories and hospital operating rooms where air cleanliness demands are extremely stringent, Yiran® provides complete solutions from pre-filtration to ULPA ultra-high efficiency filtration, strictly complying with EN 1822, ISO 14644 international standards and Chinese GMP regulations to ensure product quality and patient safety.
Air cleanliness in pharmaceutical manufacturing directly impacts drug quality and patient safety. GMP regulations impose strict quantified requirements on cleanroom airborne particles, microorganisms, temperature, humidity and pressure differentials. A failed filtration system can result in entire production batches being rejected.
Global drug regulatory agencies (NMPA/FDA/EMA) have increasingly stringent requirements for cleanroom environments and HVAC purification system validation. Filters must be supported with complete DQ/IQ/OQ/PQ documentation, particle count reports and leak test records. Any missing documentation can lead to GMP certification failure or warning letters, causing product launch delays and significant losses.
In multi-product shared production lines, cross-contamination of Active Pharmaceutical Ingredients (API) is the greatest risk. ISO 14644 requires strict pressure differential gradients and airflow patterns. HEPA/ULPA filter leakage, poor sealing or return air entrainment can cause cross-contamination, leading to drug recalls and patient safety incidents.
Aseptic preparations (injectables, ophthalmic products, etc.) require core filling zones to achieve ISO 5 (Class 100/GMP Grade A). Controlling particles in millions of cubic meters of air to single-digit levels demands terminal HEPA filters achieving H14 (≥99.995%) or U15 (≥99.9995%) ultra-high efficiency, and terminal HEPA installation seals must be 100% leak-free.
Regulations require DOP/PAO leak testing on every HEPA/ULPA filter after installation, with periodic retesting during operation. Meanwhile, filter pressure drop changes, service life prediction and preventive replacement planning are key to continuous GMP compliance. Without scientific lifecycle management, unplanned downtime or premature filter failure will occur.
Yiran® pharma cleanroom solution uses a four-stage pre-medium-subHEPA-HEPA/ULPA cascade configuration, with optional chemical filtration stages for VOCs and disinfectant vapors.
| Product Series | Model Example | Efficiency Rating | Standard Size (mm) | Rated Airflow (m³/h) | Initial Resistance (Pa) | Applicable Class | Filter Media |
|---|---|---|---|---|---|---|---|
| ALG Non-Woven Pre | ALG-592-G4 | G4 / ISO Coarse 85% | 592×592×46 | 3400 | 55 | — | Synthetic Non-Woven |
| EFL Bag Medium | EFL-592-F7 | F7 / EN 779 | 592×592×381 | 2850 | 110 | — | Synthetic Fiber |
| VCP Compact Sub-HEPA | VCP-592-F9 | F9 / ISO ePM1 85% | 592×592×292-4V | 3400 | 85 | — | Ultra-Fine Glass Fiber |
| SEP H13 HEPA | SEP-610-H13 | H13 ≥99.95% | 610×610×78 | 1700 | 100 | ISO 7-8 / GMP C-D | Ultra-Fine Glass Fiber |
| SEP H14 HEPA | SEP-610-H14 | H14 ≥99.995% | 610×610×78 | 1500 | 125 | ISO 5-6 / GMP A-B | Ultra-Fine Glass Fiber |
| ULP U15 ULPA | ULP-610-U15 | U15 ≥99.9995% | 610×610×78 | 1200 | 145 | ISO 4-5 | PTFE/Glass Fiber |
| CGD Chemical Filter | CGD-592-KMnO4 | H₂O₂ ≥95% | 592×592×96 | 2000 | 80 | — | KMnO₄ Impregnated Alumina |
| CAC Activated Carbon Panel | CAC-592-C | VOCs ≥90% | 592×592×46 | 2500 | 60 | — | High-Iodine Activated Carbon |
Four-stage filtration configuration example for aseptic injectable filling facility (GMP Grade A / ISO 5)
Based on EN 1822 MPPS method testing, 610×610×78mm, rated airflow 1500m³/h
| Comparison Parameter | Yiran® SEP H14 | Leading Intl Brand A | Leading Intl Brand B | Yiran® Advantage |
|---|---|---|---|---|
| Overall Filtration Efficiency (MPPS) | ≥99.997% | ≥99.995% | ≥99.995% | Better Penetration Control |
| Initial Pressure Drop (Rated) | 125 Pa | 135 Pa | 130 Pa | 5-10Pa Lower |
| Leak Test (PAO/DOP @100% Flow) | Zero Leakage | Zero Leakage | ≤0.01% | Equivalent/ Superior |
| EN 1822 Full-Efficiency Scan | Per-Unit Scan | Per-Unit Scan | Per-Unit Scan | Equivalent |
| Frame Strength (Aluminum) | 6063-T5 Al Profile | Standard Al Profile | Standard Al Profile | Premium |
| Sealing Method | Two-Component PU | Hot Melt | Polyurethane | Continuous Seal |
| Validation Package (DQ/IQ/OQ/PQ) | Complete | Complete | Upon Request | Standard Complete |
* Test conditions: EN 1822-4 MPPS method, DEHS aerosol, scan speed per standard. Data are laboratory typical values.
Key Results:
Key Results:
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