Delivered a turnkey, GMP-compliant HVAC and environmental control system for Abbott's new sterile product manufacturing area. The project's core mission was to engineer a precision-controlled environment that guarantees product integrity, exceeds international cleanroom standards, and ensures full compliance with the Drug Regulatory Authority of Pakistan (DRAP).
Client
Abbott Laboratories (Pakistan) Ltd.
Location
Karachi, Pakistan
Year
2024
A Complex Engineering Puzzle
The project's primary technical challenge was to design and implement an HVAC system capable of achieving and consistently maintaining ISO 5 and ISO 7 cleanroom classifications. This required absolute control over airborne particulates, the management of precise air pressure cascades between zones to prevent any possibility of cross-contamination, and holding temperature and humidity within the exceptionally tight tolerances mandated for sensitive biological manufacturing.
Innovative & Efficient
Our solution was a fully validated, dedicated cleanroom HVAC system built around high-performance, hygienically designed Air Handling Units (AHUs). The system utilizes a multi-stage filtration process, including terminal H14 HEPA filters, to ensure air purity. Variable Frequency Drives (VFDs) were installed on all fan motors to allow for precise airflow and pressure control. The entire infrastructure is governed by a sophisticated Building Automation System (BAS) that provides 24/7 real-time monitoring, alarming, and continuous data logging of all critical parameters—temperature, humidity, pressure differentials, and particle counts—providing an unbroken audit trail for regulatory compliance.
Key Project Outcomes
Successfully achieved and validated ISO 5 & ISO 7 cleanroom classifications as per ISO 14644-1 standards.
Ensured 100% compliance with local DRAP and international Good Manufacturing Practices (GMP) guidelines.
Guaranteed product safety by creating a stable, contamination-free environment, eliminating the risk of batch loss.
Provided a comprehensive, automated data logging system via the BAS, significantly simplifying the process for regulatory audits and batch release validation.
“In our industry, the integrity of the manufacturing environment is as critical as the product itself. Their team exhibited an exceptional understanding of GMP and cleanroom engineering principles. They delivered a robust, reliable, and fully compliant HVAC system that serves as the foundation of our quality promise.”
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