Author: Alex, Indoor Air Quality (IAQ) & Health Specialist (8 Years Experience) Lead HVAC & Cleanroom Designer: Wayne Luo, Senior HVAC & Cleanroom Designer (Specializing in: Pharmaceutical engineering, hospitals, BSL/PCR laboratories, and high-standard manufacturing facilities) Approved by: Danny Chen, Building Air Quality Team Leader at Guangzhou Airwoods Environment Technology Co., Ltd.
We recently completed a cleanroom design and equipment supply project for an Oral Solid Dosage (OSD) pharmaceutical manufacturing facility. The workshop spans 600 square meters and houses the complete solid dosage production line, including material weighing, blending, fluid bed drying, coating, cutting, and blister packing.
The Challenges
The client needed to establish an ISO 8 (Class D) compliant production environment while meeting strict regulatory and operational constraints. Their primary challenges included:
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LFDA Compliance: The facility layout had to smoothly pass the approval process of the Libyan Food and Drug Authority (LFDA), which enforces extremely strict standards regarding cross-contamination.
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Precise Environmental Control: Solid dosage production is highly sensitive to humidity. To prevent powders from clumping during production, the indoor environment had to be stably maintained at 20–24°C with a relative humidity (RH) of 50%–60%.
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Tight Project Timeline: The client urgently needed to accelerate construction. Using the traditional model of finding scattered local design firms and multiple equipment subcontractors usually takes 4 to 6 months or more, which would severely delay their product launch.
Our Engineering Solutions
1. Layout Optimization to Ensure LFDA Approval
In OSD manufacturing, illogical personnel and material flow is the leading reason regulatory bodies reject manufacturing licenses. Our engineering team conducted a rigorous evaluation and optimization of the client's initial factory floor plan.
To ensure a smooth LFDA audit, we implemented three critical design adjustments:
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Separated Access Flows: We mapped out independent access routes for personnel, raw materials, and finished goods to prevent mix-ups at the source.
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Segregated Waste Flow: We established a strictly isolated transit route for waste, ensuring it never crosses paths with the clean production areas to eliminate contamination risks.
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Strict Differential Pressure Cascades: We designed a precise cascade pressure system, ensuring the air pressure in clean corridors is higher than in the core processing rooms. This forces air to flow toward areas with lower contamination risks, keeping suspended powders firmly contained within their respective processing rooms.
2. Customized Purification HVAC and Control System Integration
The core of solid dosage production is constant temperature and humidity. To maintain the precise 20–24°C and 50%–60% RH environment, we discarded standard commercial air conditioning and provided a specialized, pharmaceutical-grade purification HVAC equipment package:
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DX Air Handling Unit (AHU): A customized unit delivering 16,000 m³/h of airflow and a 90kW cooling capacity, equipped with powerful temperature regulation and deep dehumidification capabilities.
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Outdoor Condensing Unit: Uses a high-efficiency inverter compressor (R410A eco-friendly refrigerant, heat pump type) that automatically adjusts its output based on the workshop's actual thermal load, ensuring energy-efficient and stable system operation.
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Smart PLC Control System: Equipped with a centralized PLC control cabinet featuring an all-English touch screen. This allows facility managers to monitor and record historical temperature and humidity metrics in real-time, fully meeting the mandatory data-tracking requirements for GMP audits.
3. Rapid Preparation and Professional Installation Within 2–3 Months
Addressing the pain point of a tight schedule, we provided an integrated end-to-end solution from design to equipment supply. Compared to the traditional local subcontracting cycle of over 4 to 6 months, we not only completed the entire cleanroom engineering design and core HVAC equipment delivery within 3 months, but also leveraged our highly responsive capabilities to complete all preliminary preparations and mobilize a professional construction team for on-site system assembly within just 2 to 3 months. This closed-loop approach helped the client cut their project execution cycle by nearly half.
Project Outcomes
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Factory License Secured: The optimized personnel and material flow plan smoothly passed the Libyan Food and Drug Authority (LFDA) review on the first attempt, allowing the project to break ground on time.
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Perfect System Compatibility: Delivering the cleanroom enclosure design and the specialized DX AHU purification system as a unified package completely eliminated the common issue of installation conflicts between wall panels and ductwork during on-site construction.
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Fully Ready for Production: The entire workshop is now fully capable of conducting solid dosage manufacturing under strict ISO 8 / Class D regulations. Upon final validation, this compliant facility will help the client successfully export their pharmaceutical products to the global market.
Post time: May-29-2026
