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Abstract

The architectural design of pharmaceutical manufacturing facilities presents a complex engineering challenge, requiring simultaneous compliance with Good Manufacturing Practice (GMP) containment standards and life safety egress codes. This research presents an applied methodology for integrated fire protection design in sterile pharmaceutical environments, demonstrated through a case study of a manufacturing complex comprising cleanroom production zones and high-bay storage warehouses with heights reaching 14.8 m. The study reconciles facility classification under the Egyptian Fire Code and NFPA standards by defining Occupancy Hazard Groups W-1 and W-2 (high- and moderate-hazard storage), while utilizing regulatory Code Tables C-1 and C-2 to calculate occupant load densities and risk parameters, considering stored solvent Maximum Allowable Quantities (MAQ).The proposed methodology is structured around a two-axis engineering evaluation matrix that correlates architectural spatial layout with fire safety performance. The first axis investigates the operational interaction between pressure-controlled production spaces (airlocks) and their fail-safe release mechanisms to facilitate egress and minimize Required Safe Egress Time (RSET). The second axis evaluates architectural principles governing dynamic smoke control in high-bay spaces through the integration of passive fire separation, active fire protection systems, and ventilation duct protection against toxic gas infiltration along evacuation routes. The findings demonstrate that adopting an integrated design approach transforms the architectural environment into a flexible and dynamic safety system. Standard analytical egress calculations yielded a maximum RSET of 2.94 minutes based on a conservative design load of N=250 total facility workforce distributed across three shifts (∼83 personnel per shift plant-wide, with a maximum simultaneous presence of ∼22 operators across key functional cleanroom zones), which aligns closely with empirical field evacuation testing (∼3.0 minutes). The framework confirms that intelligent coordination between HVAC, fire protection, and architectural zoning resolves the inherent conflict between pressure-controlled sterile containment and emergency life safety.

Keywords

Performance-based fire safety, Good Manufacturing Practice (GMP), Cleanroom egress, High-bay industrial warehouses, Occupancy hazard classification, Analytical RSET calculation, Maximum Allowable Quantities (MAQ)

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