Before diving into the details… here’s what you need to know: FILTR Revolution air purification system serves as a critical backup solution for compounding labs facing HVAC disruptions – ensuring compliance in unforseen moments. This allows labs to maintain USP standards, avoid costly shutdowns, and ensure continuous operation without compromising safety or regulatory requirements.
Compounding pharmacies operate under strict USP <797> and <800> guidelines that mandate specific air quality parameters. According to USP requirements, sterile compounding facilities must maintain controlled environments with specific air change rates (ACH), pressure differentials, and filtration standards.
| Area | ISO Class | ACH | Particle Size of Concern | Pressure Differential |
|---|---|---|---|---|
| Storage Area | N/A | 12 | 0.5µm & 5.0µm | |
| Ante Room | 8 | > 30 | 0.5µm & 5.0µm | ≥ +0.02 in. w.c. vs. Unclassified Areas |
| Buffer Area | 7 | > 30 | 0.5µm & 5.0µm | +0.02 to +0.05 in. w.c. vs. Ante Room |
| HD Buffer Room (Hazardous) | 7 | > 30 | 0.5µm & 5.0µm | -0.01 to -0.03 in. w.c. vs. Ante Room |
| Ante Room (Hazardous) | 7 | > 30 | 0.5µm & 5.0µm | ≥ +0.02 in. w.c. vs. Unclassified Areas |
FILTR Revolution has 99.99996% Removal Efficiency of 0.5µm and above at 500 CFM.
HVAC systems and fan filter units (FFUs) form the backbone of cleanroom environments, but they represent a significant vulnerability. When these systems require maintenance, experience failure, or need repair, compounding labs face an immediate crisis. Without proper backup systems, facilities must halt operations, potentially experiencing significant revenue loss. According to industry standards, even brief interruptions in controlled airflow can necessitate extensive remediation before operations can resume.
Fan Speed | w/ Carbon Filter | w/o Carbon Filter |
|---|---|---|
Low Speed | 160 CFM (425m3/hour) | 215 CFM (5093/hour) |
Medium Speed | 260 CFM (4253/hour) | 360 CFM (8493/hour) |
High Speed | 390 CFM (8503/hour) | 500 CFM (1,8893/hour) |
Features | |
|---|---|
Filtration: | Pre Filter, Activated Carbon Filter, HEPA (98 sqft media), Bi-Polar Ionization |
EN 1822 classification for HEPA: | HEPA Class H13 |
HEPA Efficiency: | 99.97% Removal Efficiency of 0.3µm of 500 CFM 99.99996% Removal Efficiency of 0.5µm at 500 CFM |
Ultra-Fine Particle Efficiency: | 99.97% Removal Efficiency of 0.023µm of 500 CFM |
Total System Efficiency: | 99.995% (Cert Supplied with every unit) |
Ozone Emissions: | None / CARB Certified |
Onboard Sensors: | Particle Mass (PM2.5) | VOC | Temperature, Humidity |
Housing: | Reflective White Powder Coated Aluminum |
Control: | Local Switch or Remote Via WiFi and Phone App |
Sound Power Levels: | Low 51dB Medium 56dB High 59dB |
Fan Speeds: | 3 Fan Speeds (Low, Medium, High) |
Power Requirements: | 100-120 volts 60 Hz/2.0 amps or 220-240 volts 50/60 Hz/1.1 amps |
Dimensions and Weight: | Height: 30.5” Width: 15.3” Weight: 39 lbs |
When HVAC challenges arise, compounding labs need solutions that can be rapidly deployed without infrastructure modifications. Portable air purification systems have emerged as a critical strategy for maintaining operations during primary system disruptions. FILTR Revolution specifically addresses this need by providing supplementary air filtration that maintains required air changes per hour.
Compounding facilities must consider how any backup solution integrates with USP standards. Buffer rooms, anterooms, and hazardous drug areas each have specific requirements for air quality, pressure relationships, and filtration efficiency. An effective backup system must support these varied requirements while being adaptable enough for rapid deployment where needed.
Delivers up to 50% more clean air at the same sound level as competing units, ensuring communication and workflow aren't disrupted in sensitive compounding environments
Every unit undergoes comprehensive particle leakage testing, ensuring the entire system-not just the filter media-maintains integrity during operation
Ducting capabilities enable the unit to support positive pressure environments for non-hazardous compounding or negative pressure requirements for hazardous drug areas
No HVAC modifications or installation required-the portable design allows for immediate positioning where airflow challenges emerge
FILTR Revolution delivers performance metrics that align with stringent compounding lab requirements. Its filtration efficiency captures 99.997% of particles at 0.3 microns and 99.77% at 0.024 microns, exceeding standard HEPA efficiency requirements for pharmacy cleanrooms. This level of filtration meets and surpasses the requirements for both non-hazardous and hazardous compounding environments.
FILTR is not only a corrective solution — it’s a critical component in preventative contamination control strategies. By continuously supplementing facility air quality, FILTR helps pharmacies stay ahead of environmental risks, particularly in high-risk areas, common areas, and transitional zones. Preventative applications include:
With FILTR, pharmacies can build resilience into their cleanroom strategy — ensuring consistently clean air and reinforcing compliance before problems arise.
When compounding environments fall out of compliance due to elevated particle counts, contamination events, or HVAC system inadequacies, FILTR Air Purification serves as a rapid and effective corrective action solution. FILTR units can be deployed to restore controlled environments while primary systems are repaired, recalibrated, or upgraded. By introducing our four-stage approach to clean air at the source of concern, FILTR helps to:
FILTR allows pharmacies to maintain operations during corrective periods while demonstrating a proactive response to quality and regulatory expectations.
The FILTR Revolution serves multiple roles within a comprehensive compliance strategy:
Schedule HVAC maintenance without operational shutdowns by deploying FILTR units to maintain required air changes and pressure relationships
Keep FILTR units as ready reserves for unexpected HVAC failures or contamination events
Address areas with marginal compliance by boosting air changes without costly HVAC modifications
Create compliant temporary workspaces when needed for overflow production or during facility renovations
Implementing FILTR Revolution as part of your compliance strategy delivers measurable financial benefits. A single day of operational shutdown can cost thousands in lost revenue and wasted materials. By maintaining continuity during HVAC disruptions, labs protect both their bottom line and their reputation for reliable service.
The journey to sustained compliance in compounding facilities requires proactive planning for inevitable infrastructure challenges. FILTR Revolution serves as a critical component in this strategy-providing the flexibility, performance, and reliability needed to maintain operations through HVAC disruptions.
By incorporating portable air purification into your compliance toolkit, you create resilience against disruptions that would otherwise halt production and compromise patient care.
Knowledge Center
Stay in the Know!
Get the scoop on new products, the latest tech papers, webinars and more…
