Designed, supplied, and validated a state-of-the-art, GMP-compliant HVAC and Building Management System (BMS) for Piramatec's new sterile manufacturing wing. The project's critical objective was to establish and maintain precise environmental conditions (temperature, humidity, and pressure) for ISO-7 and ISO-8 cleanroom classifications.
Client
Piramatec Pharmaceuticals (Pvt.) Ltd.
Location
Karachi, Pakistan
Year
2024
A Complex Engineering Puzzle
The primary challenge was the stringent requirement for air quality and environmental control in a pharmaceutical cleanroom. The HVAC system had to guarantee specific air change rates, maintain strict differential pressure cascades between zones to prevent cross-contamination, and achieve filtration levels down to 0.3 microns using HEPA filters, all while being fully compliant with international GMP (Good Manufacturing Practices) and local DRAP (Drug Regulatory Authority of Pakistan) standards.
Innovative & Efficient
Our team engineered a dedicated cleanroom HVAC system with multiple Air Handling Units (AHUs) featuring multi-stage filtration (pre-filters, fine filters, and terminal HEPA filters). We implemented a sophisticated BMS to continuously monitor and control temperature, humidity, and differential pressures, providing real-time data logging for validation and compliance. The system was designed with 100% fresh air intake for critical zones and integrated with variable frequency drives (VFDs) for energy efficiency without compromising compliance.
Key Project Outcomes
Achieved 100% compliance with GMP, ISO 14644, and DRAP standards for sterile manufacturing.
Successfully validated all cleanroom zones (ISO-7 & ISO-8), meeting all required particle count and air change rate specifications.
Maintained precise and stable environmental control, with temperature controlled to ±1°C and humidity to ±5% RH.
Provided a comprehensive data logging and validation package, crucial for regulatory audits and batch record-keeping.
“In pharmaceuticals, the HVAC system isn't just for comfort; it's a core part of the manufacturing process. Their team's deep expertise in GMP and cleanroom engineering was evident throughout the project. They delivered a world-class, fully validated system that is the foundation of our new sterile facility's success.”
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