UEI LUAKV3T8KSV5
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NAICS 621999
50-Day Delivery
Mobile Pharmacy Trailer — USP797/800 Compliant, CETA-Certifiable
Odulair manufactures mobile compounding pharmacy trailers compliant with USP797/800 standards. Features include ISO Class 5 Biological Safety Cabinet (BSC Type A2), negative pressure environment, 30 air changes per hour (ACPH), HEPA filtration, and CETA-certifiable design. WOSB manufacturer. CAGE 6L2X9. 30ft minimum platform. 50-day delivery.
USP797 and USP800 — Built Into the Trailer
Mobile compounding pharmacies must comply with USP Chapter <797> (sterile compounding) and USP Chapter <800> (hazardous drug handling). These standards govern HVAC design, air pressure, filtration, surface materials, and equipment specifications. At Odulair, compliance is engineered before production — not retrofitted after delivery.
USP797 Requirements (Sterile Compounding)
- ISO Class 5 Primary Engineering Control (PEC) — Laminar Airflow Workbench (LAFW) or Biosafety Cabinet for sterile preparation
- ISO Class 7 Buffer Area — surrounding the PEC; HEPA-filtered, positive pressure for non-hazardous sterile compounding
- ISO Class 8 Ante-Area — personnel gowning and material transfer zone
- HVAC isolation — buffer area HVAC must not recirculate to general areas
USP800 Requirements (Hazardous Drug Compounding)
- ISO Class 5 BSC Type A2 — required for hazardous drug manipulation; exhausts to exterior
- Negative pressure — hazardous drug compounding area must be negative relative to adjacent spaces
- 30 ACPH minimum — air changes per hour in the hazardous drug compounding area
- Dedicated exhaust — 100% exhaust, no recirculation of hazardous drug area air
- Surface materials — non-porous, cleanable, chemical-resistant surfaces throughout
USP800 requires that hazardous drug compounding areas maintain negative air pressure of at least -0.01 to -0.03 inches water column relative to all adjacent areas. Odulair trailers are pressure-tested prior to delivery. CETA CAG-003 certification is achievable on Odulair’s 30ft+ pharmacy trailer platform.
Platform Requirements — 30ft Minimum
A compliant mobile compounding pharmacy requires a minimum 30ft trailer platform to accommodate the ISO Class 5 BSC, ISO Class 7 buffer area, ISO Class 8 ante-area, HVAC mechanical space, and dispensing/storage zones in a compliant spatial configuration. The 30ft platform provides approximately 300 sq ft of clinical space — the minimum footprint for a CETA-certifiable mobile pharmacy layout.
40ft and 53ft platforms support larger compounding volumes or combined pharmacy + dispensing configurations for health system outreach programs.
CETA Certification
CETA (Controlled Environment Testing Association) certifies that cleanroom and controlled environment equipment meets the applicable ISO and USP standards. Odulair mobile pharmacy trailers are designed to support CETA CAG-003 certification by a CETA-accredited certifier. Odulair does not perform the CETA certification — that is performed by an accredited third-party certifier retained by the buyer. Odulair provides the engineering documentation required for the certification process.
For buyers who need CETA pre-certification review, Odulair can coordinate with ARES (720-283-0177, ext. 2) for ophthalmic CSSD CETA review. Other CETA-accredited certifiers are available for pharmacy configurations.
Frequently Asked Questions
What HVAC standard applies to a mobile compounding pharmacy trailer?
Mobile compounding pharmacy trailers must meet USP797 and USP800 HVAC standards: 30 air changes per hour (ACPH) minimum in the hazardous drug compounding area, negative pressure of at least -0.01 to -0.03 inches water column, ISO Class 5 BSC Type A2 for hazardous compounding, and 100% exhaust (no recirculation) of hazardous drug area air. Odulair trailers are engineered to these specifications before production.
What is the minimum trailer size for a USP800-compliant mobile pharmacy?
A minimum 30ft trailer platform is required for a USP800-compliant mobile compounding pharmacy. This accommodates the ISO Class 5 BSC, ISO Class 7 buffer area, ISO Class 8 ante-area, HVAC mechanical space, and dispensing zones in a CETA-certifiable configuration.
Can Odulair’s mobile pharmacy trailer be CETA certified?
Yes. Odulair mobile pharmacy trailers are designed to support CETA CAG-003 certification. CETA certification is performed by a CETA-accredited third-party certifier retained by the buyer. Odulair provides the engineering documentation required for the certification process. The 30ft+ pharmacy trailer platform is the Odulair configuration designed for CETA certification.
What type of BSC is required for USP800 hazardous drug compounding in a mobile trailer?
USP800 requires a Class II, Type A2 Biological Safety Cabinet (BSC Type A2) for hazardous drug compounding. The Type A2 BSC exhausts a minimum of 30% of cabinet air to the exterior via a dedicated exhaust connection, maintaining the required negative pressure in the compounding area. Odulair’s 30ft pharmacy trailer includes an ISO Class 5 BSC Type A2 as standard for USP800 configurations.
Specify Your USP797/800 Mobile Pharmacy Trailer
ISO Class 5 BSC Type A2. Negative pressure. 30 ACPH. CETA CAG-003 certifiable. 30ft minimum platform. 50 days from signed order.