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For Purchasing Managers & Technical Directors who demand FDA/CE‑compliant air quality without the premium price tag.
Get Free Quote in 24 h1. Excessive Replacement Costs – Average filter lifespan in US hospitals is 6 months, leading to $12,000 + annual spend per OR.
2. Inconsistent Filtration Efficiency – Many “medical‑grade” filters only achieve 85% particle capture, falling short of ISO 14644‑1 Class 5 requirements.
3. Regulatory Risks – Non‑CE or non‑FDA‑listed filters can trigger compliance penalties of up to $250,000.
4. High Pressure Drop – A 0.4 inH₂O pressure drop raises HVAC energy consumption by 12%, inflating operating expenses.
5. Lead Times Over 8 Weeks – Delays jeopardize surgical schedules and increase overtime costs.
| Parameter | Standard Model | Custom Option |
|---|---|---|
| Filtration Efficiency | ≥99.99% @ 0.3 µm | Up to 99.9995% (ULPA) |
| Media Type | HEPA (Glass Fiber) | Electrostatic, Activated Carbon |
| Max Flow Rate | 5 m³/min | Custom up to 20 m³/min |
| Pressure Drop | ≤0.4 inH₂O | ≤0.2 inH₂O (low‑drop design) |
| Operating Temperature | ‑20 °C ~ +50 °C | ‑40 °C ~ +70 °C |
| Certifications | FDA, CE, ISO 9001, RoHS | Additional FDA 510(k), ISO 13485 upon request |
| Warranty | 12 months | 24 months (OEM) |
Operating Room – NewYork General Hospital – Replaced legacy filters with our 0.2 inH₂O low‑drop design. Result: 15% HVAC energy saving and zero infection spikes over 12 months.
Cleanroom – PharmaTech Inc. – Customized carbon‑infused filter for VOC removal. Outcome: Achieved ISO 14644‑1 Class 5 within 3 weeks, cutting validation cost by $45,000.
All stock filters are CE‑marked, FDA‑registered, ISO 9001 and RoHS compliant. OEM projects can include FDA 510(k), ISO 13485, and ISO 14644‑1 certifications upon request.
Yes. Our engineering team offers OEM/ODM design services for dimensions, media composition (HEPA, ULPA, activated carbon), and pressure‑drop targets. Turn‑around time for prototypes is 7‑10 days.
Stock items ship within 5 business days. For OEM orders, standard production is 2 weeks after artwork approval; expedited 10‑day service is available for an additional 10% fee.
We work with UPS, DHL, and FedEx for DDP (Delivered Duty Paid) shipping. All export documentation (CO, packing list, CE/FDA certificates) is provided to ensure smooth customs clearance.
All filters come with a 12‑month (24‑month for OEM) warranty covering material defects. Our technical support team is available 24 h via phone, WhatsApp, and email.
Supply your facility with FDA‑approved, low‑drop medical air filters within 5 days – risk‑free.
Request Free Sample Email Sales TeamOffer expires 30 days from your first inquiry. Stock limited.
Emily R., Purchasing Manager, West Coast Medical Center
“The free sample performed exactly as promised – zero pressure drop and flawless HEPA efficiency. We placed a 10,000‑unit order within a week.”
Michael T., Technical Director, CleanAir Labs
“Customization was a breeze. The engineered carbon‑layer removed 99.7% of VOCs, helping us pass ISO 14644 audit on the first try.”
Dr. Susan L., Head of Facility Management, Sunshine Hospital
“Fast 5‑day delivery saved us from a critical surgery postponement. The warranty and 24‑hour support gave us confidence.”
Alex Chen, Senior Product Engineer – Air Filtration Division
Over 15 years in medical HVAC design, former Lead Engineer at a US‑based cleanroom consultancy, and certified ISO 9001 auditor. Alex has authored three industry white‑papers on HEPA performance and regularly contributes to *Medical Facility Management* magazine.
Contact: hebeilixin2011@hblxmed.com | +86 156 3318 3151
Trusted By Leading Healthcare & Cleanroom Brands
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Certifications & Compliance – CE Mark, FDA 510(k), ISO 9001, ISO 13485, ISO 14644‑1, RoHS, VDE, GS, CB, HACCP/GMP, IPPC.
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