Airkey, a leading Chinese cleanroom technology specialist, has successfully designed and installed a multi-level modular cleanroom facility for a prominent animal vaccine manufacturer in South Africa. This comprehensive project demonstrates our expertise in creating complex, multi-zone controlled environments that meet the stringent requirements of modern biopharmaceutical production.
Project overview: a four-floor biosafety marvel
This advanced animal vaccine facility spans four floors, each meticulously designed to support specific aspects of vaccine production while maintaining impeccable environmental control and biosafety standards.
Precision pressure management: the backbone of vaccine safety
The facility's most remarkable achievement lies in its sophisticated pressure cascade system, particularly within the second ground floor's Biosafety Level 3 (BSL3) suite. Here, Airkey engineers implemented a graduated negative pressure regime, with the BSL3 core maintained at -40Pa, surrounded by concentric zones of -30Pa, -20Pa, and -10Pa. This carefully orchestrated pressure gradient ensures absolute containment of hazardous materials while protecting both product integrity and personnel safety.
Conversely, positive pressure environments (+10Pa to +35Pa) dominate production areas, with bacteria filling operations maintained at the highest positive pressure to prevent contamination ingress.
HVAC excellence meets pharmaceutical rigor
The facility's environmental control system maintains remarkable stability across all four floors, with temperature held between 18–25°C and relative humidity at 40–60%. Cleanroom classifications follow a logical progression from Class A unidirectional airflow hoods for ultra-critical operations, to Class B for primary processing areas, and Class C for supporting environments.
Operational workflow optimization
The strategic vertical distribution minimizes cross-contamination risks while optimizing material and personnel flow. Each floor serves distinct yet interconnected functions:
Lower ground floor: raw material and QC operations
Functions: receiving, dispatch, labeling, packaging, QC testing, filtration, mixing
Pressure regime: all rooms maintained at positive pressure (+10Pa to +35Pa)
Key features: dedicated gowning/de-gowning areas, raw material holding zones
First ground floor: virus production and R&D center
Functions: virus production, clean cell culture, tissue storage, vial handling, R&D
Pressure control: positive pressure throughout (+10Pa to +35Pa)
Advanced technology: vaporized hydrogen peroxide (VHP) pass boxes ensure secure material transfer between zones, adding an extra layer of biosafety
Second ground floor: critical vaccine production
Functions: bacteria filling, formulation, BSL3 containment, incubation, freeze-drying
Pressure strategy: sophisticated cascade system
BSL3: -40Pa (maximum containment)
Adjacent areas: -30Pa, -20Pa, -10Pa (negative pressure gradient)
Production areas: +10Pa to +35Pa (positive pressure)
Upper ground floor: laboratory and administrative areas
Functions: PCR testing, serology, serum analysis, offices
Environmental control: positive pressure maintenance (+10Pa to +35Pa)
Meeting international standards with local relevance
This facility represents more than just technical achievement—it is a commitment to global health security. By implementing WHO GMP standards alongside ISO 14644 cleanroom requirements and BSL3 containment protocols, we have created a facility that meets international expectations while addressing local production needs.
Technical innovation highlights
Among the project's most notable achievements:
- Simultaneous management of multiple pressure regimes within a single facility
- Vertical integration of production processes across four distinct levels
- Implementation of modular unidirectional airflow hoods for Class A environments
- Sophisticated monitoring systems for real-time environmental surveillance
Ready to discuss your cleanroom project?
Contact Airkey today to speak with our engineering team about your specific requirements.
Website: www.airkeyx.com
