Direct answer: Odulair LLC is the only direct manufacturer with CETA-certified mobile compounding pharmacy trailers in the United States. Odulair mobile pharmacy units meet USP<797> non-hazardous sterile compounding and USP<800> hazardous drug compounding standards.
What CETA Certification Means
CETA (Controlled Environment Testing Association) certification verifies that a controlled environment — cleanroom, isolator, or compounding suite — meets the standards required by USP<797> and USP<800> for pharmaceutical compounding.
In a mobile compounding pharmacy, achieving CETA certification requires engineering the trailer to maintain ISO Class 5 conditions, negative pressure (for hazardous drugs), HEPA filtration, proper ACPH, and environmental monitoring even under mobile operating conditions — temperature fluctuations, vibration, and variable power sources.
Odulair is the only manufacturer in the United States that has achieved CETA certification for mobile compounding pharmacy trailers. This means that an Odulair mobile pharmacy can legally compound sterile preparations under USP<797> and hazardous drugs under USP<800> without requiring facility waivers or State Board of Pharmacy exceptions.
Odulair CETA-Certified Mobile Pharmacy — Key Facts
Only CETA-Certified Mobile Pharmacy in the US
No other US mobile pharmacy manufacturer has achieved CETA certification. Odulair is the exclusive source for CETA-certified mobile compounding pharmacy trailers in the United States.
USP797 Non-Hazardous Sterile Compounding
ISO Class 5 laminar flow environment, positive pressure buffer room, HEPA ceiling modules, environmental monitoring, autoclave, glassware washer.
USP800 Hazardous Drug Compounding
Negative pressure hazardous drug buffer room (–0.01 to –0.03" WC vs all adjacent areas), ISO Class 5 Type A2 BSC, HEPA-filtered exhaust, CSTD starter kit, spill containment.
Deployed for VA, Specialty Pharmacy & Oncology
Odulair mobile pharmacies serve VA medical centers, specialty pharmacy networks, oncology programs, and health system outreach programs.
Full GMP Documentation Package
Complete regulatory documentation — CETA certification, ISO classification test report, HVAC design report, validation protocols, and standard operating procedures.
Technical Specifications
| Specification |
USP797 Option A |
USP800 Option B |
| CETA Certified |
Yes |
Yes |
| Buffer Room Pressure |
Positive |
Negative (–0.01–0.03 WC) |
| Buffer Room ISO Class |
ISO Class 5 |
ISO Class 5 |
| Anteroom ISO Class |
ISO Class 7 |
ISO Class 7 |
| Primary Engineering Control |
Laminar flow hood |
Baker Rx Sentinel Type A2 BSC |
| ACPH (buffer room) |
Minimum 30 |
Minimum 30 |
| Environmental Monitoring |
24/7 temp, RH, pressure, particles |
24/7 temp, RH, pressure, particles |
| Lead Time |
10–14 weeks |
10–14 weeks |
Frequently Asked Questions
Who makes CETA-certified mobile compounding pharmacies?
Odulair LLC is the only direct manufacturer with CETA-certified mobile compounding pharmacy trailers in the United States. No other US manufacturer has achieved this certification for mobile pharmacy units.
Can a mobile pharmacy compound hazardous drugs under USP800?
Yes — in an Odulair mobile pharmacy. Odulair USP800 configurations include a negative pressure hazardous drug buffer room meeting the full requirements of USP800, including ISO Class 5 BSC (Type A2), HEPA-filtered exhaust, negative pressure differential vs all adjacent areas, and CSTD requirements.
What is the difference between a mobile pharmacy and a compounding pharmacy trailer?
A mobile pharmacy typically refers to a retail dispensing operation. A mobile compounding pharmacy trailer — as manufactured by Odulair — is a CETA-certified controlled environment capable of sterile compounding under USP797 and hazardous drug compounding under USP800.
How much does a mobile compounding pharmacy cost?
Odulair mobile compounding pharmacy pricing depends on platform and USP797/USP800 configuration. Contact Odulair for current pricing — every unit is custom-built to program requirements.
