USP 797/800 Pharma Cleanroom in Saudi Arabia
Project Highlights
1. Compliant with Biopharmaceutical Standards (USP 797 & 800)
Designed in strict accordance with international pharmaceutical standards, this modular cleanroom features dedicated personnel anterooms and material buffer zones. Differential pressure gradients are established between areas of varying cleanliness levels—maintaining positive pressure for sterile drug preparation and negative pressure for hazardous drug preparation. This zoned preparation setup effectively prevents cross-contamination. Fully compliant with Middle Eastern pharmaceutical standards, this project serves as a fully operational, localized USP 797 & USP 800 modular cleanroom in Saudi Arabia.
2. Custom HVAC System for Precise Climate Control
In line with Saudi pharmaceutical manufacturing regulations, the cleanroom maintains conditions of <20°C and< 60% RH to minimize bacterial growth risks while providing a comfortable environment for operators wearing cleanroom protective suits. Equipped with a custom HVAC system, it achieves constant temperature and humidity control, satisfying both local Saudi codes and international pharmaceutical standards.
3. Customized Double-Tier Pass Boxes
To comply with sterile manufacturing practices requiring materials to be staged before cleanroom entry, we designed custom double-tier pass boxes for this project. These units segregate material transfers to prevent cross-contamination while maximizing space efficiency inside the workshop.
4. Compliant Positive & Negative Differential Pressure Gradients
The cleanroom maintains a minimum positive pressure differential of 0.020 in.w.g.(5Pa) between clean zones. All positive and negative pressure differentials were pre-configured and precisely calibrated in our factory prior to shipment, fully meeting Saudi pharmaceutical requirements and USP international standards.
5. Rigorous Factory Acceptance Testing & Verified Performance
Before export to Saudi Arabia, the modular cleanroom underwent complete pre-assembly and full-scope testing at our factory. All technical parameters passed inspection with 100% compliance, ensuring reliable, compliant, and stable performance for our client overseas.