Delta Sterile Injectables & Biologics Facility

Project Overview

A specialized sterile pharmaceutical manufacturing facility dedicated to biologics and freeze-dried vials. The facility conforms to cGMP, ISO 14644-1 (Class 5 / Grade A filling zones), and Egyptian EDA regulations. RE Consultant spearheaded the HVAC air conditioning, clean utilities, and electrical infrastructure engineering.

Technical Solution

• Cleanroom HVAC Architecture: Deployed dedicated once-through and recirculating air handling units equipped with terminal gel-seal H14 HEPA filters providing 45 air changes per hour (ACH) in critical filling suites.
• High Purity Water Systems: Designed 316L orbital-welded stainless steel distribution loops for Purified Water (PW) and Water for Injection (WFI) operating under continuous ozone and thermal sanitization cycles at 85°C.
• SCADA / BMS Environmental Monitoring: Centralized 21 CFR Part 11 compliant building management system monitoring temperature (20±2°C), relative humidity (45±5%), differential pressures, and non-viable particle counts.

Commissioning & Validation

DQ/IQ/OQ/PQ documentation protocols executed with zero critical deviations during facility validation and client production qualification.