A specialized HVAC system upgrade for the Active Pharmaceutical Ingredient (API) production block at Sami Pharmaceuticals. This critical project involved engineering a high-containment environmental control system to ensure operator safety, prevent cross-contamination, and guarantee the stability and purity of potent compounds, all in strict adherence to international GMP and local DRAP regulations.
Client
Sami Pharmaceuticals (Pvt.) Ltd.
Location
Karachi, Pakistan
Year
2023
A Complex Engineering Puzzle
The primary challenge was to design and implement an HVAC system that provides stringent containment for the handling of potent APIs. This required creating precisely controlled negative pressure environments to prevent the escape of any airborne particles, while simultaneously protecting the product from external contaminants. The system had to be exceptionally reliable, as any deviation could compromise both product batches and personnel health.
Innovative & Efficient
We engineered a dedicated, single-pass (100% fresh air) HVAC system with specialized Air Handling Units (AHUs) for the API block. The design centered on creating a pressure cascade, with the most critical processing areas held at the strongest negative pressure relative to adjacent corridors. To ensure safety, the system included safe-change (bag-in/bag-out) HEPA filtration on the exhaust air stream. A comprehensive Building Automation System (BAS) was implemented to continuously monitor and maintain these critical pressure differentials, providing instant alarms and detailed data logs for regulatory compliance and batch records.
Key Project Outcomes
Successfully established and validated a high-containment environment, ensuring full operator and environmental safety.
Achieved 100% compliance with GMP guidelines for API manufacturing and passed all DRAP facility audits.
Eliminated the risk of cross-contamination between different product lines within the facility.
Provided a robust, automated monitoring and data-logging system that simplifies compliance and ensures continuous quality control.
“Handling potent APIs requires a level of precision and safety that is non-negotiable. Their engineering team demonstrated a masterful understanding of containment and GMP requirements. They delivered a system that not only protects our people and our products but also gives us the validated data we need to operate with absolute confidence.”
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