GMP Pharmaceutical Cleanroom Design & Construction | ISO 14644 Compliant

With years of experience in pharmaceutical cleanroom engineering, we understand the critical challenges facing pharmaceutical companies in the Middle East and Southeast Asia. The core requirement is clear: facilities must strictly adhere to GMP regulations and ISO 14644 international standards. However, they must also be engineered to withstand extreme regional climates while ensuring construction efficiency and ease of maintenance.

Many local companies make the mistake of choosing generic designs. Some fail regulatory audits due to non-compliant layouts, while others ignore local climate factors, leading to frequent system failures, production downtime, and wasted budget. Boben Modular Cleanroom Manufacturers specializes in the global pharmaceutical sector. We deeply understand the regulatory landscape and climate nuances of the Middle East and Southeast Asia, helping numerous clients achieve dual-standard compliance (GMP & ISO) with reliable, stress-free solutions.

1.The Foundation: GMP Compliance & ISO 14644 Standards

A successful pharmaceutical cleanroom stands on two pillars, neither of which can be compromised:

• GMP (Good Manufacturing Practice): Focuses on “Safety.” It mandates the prevention of cross-contamination and microbial growth to ensure drug safety.
• ISO 14644 Standards: Focuses on “Cleanliness.” It defines air cleanliness classifications based on particle concentration.

For the pharmaceutical industry, ISO Class 8 (Grade D) and ISO Class 7 (Grade C) are the most common standards. Our designs strictly control airborne particulates (≥0.5μm) within these specified limits, forming the baseline for all our engineering projects.

2.Climate-Adaptive Engineering: The Boben Advantage

A standard design cannot fit every climate. Boben Modular Cleanroom Manufacturers distinguishes itself by tailoring solutions to regional environments:

• For the Middle East (High Heat & Dust): The challenges here are extreme temperatures and sandstorms. We optimize the HVAC system with high-efficiency cooling and dehumidification units. We reinforce the cleanroom’s sealing and thermal insulation to prevent heat and dust infiltration. This ensures the facility maintains GMP-required conditions (Temperature: 20-24°C, Relative Humidity: 45%-60%) regardless of the harsh outdoor environment.
• For Southeast Asia (High Humidity & Rainfall): The challenge here is mold and corrosion. We integrate advanced moisture barriers and select corrosion-resistant, easy-to-clean enclosure materials. We utilize Epoxy Self-Leveling Flooring and Flush Sandwich Wall Panels to eliminate crevices where dust and mold could accumulate. Furthermore, we optimize the exhaust air system to accelerate humidity removal, balancing cleanliness with moisture control.

3.Precision Construction: Modular & Efficient

Execution is just as critical as design. To avoid costly rework, every step must adhere to strict protocols.

• Modular Speed: We utilize modular assembly methods, which can reduce construction time by 40% compared to traditional methods—ideal for companies needing rapid deployment.
• Strict Sequence: We follow a “Top-Down, Inside-Out” protocol: installing technical mezzanine piping first, followed by ceilings, walls, and flooring.
• Quality Control:

a.Gap Control: Wall panel joints are controlled within 0.5mm and tested for light leakage.

b.HEPA Integrity: After installation, every HEPA filter undergoes DOP/PAO leak testing to ensure 100% seal integrity.

c.Validation: Upon completion, we commission third-party agencies to generate ISO 14644 test reports, ensuring you pass GMP audits smoothly.

4.One-Stop Service: From Design to Validation

Many clients come to us after failed attempts with other suppliers—complaining of unstable humidity levels or rough workmanship that failed inspections.

Boben Modular Cleanroom Manufacturers eliminates these headaches. We provide a full Turnkey Solution that covers:

1. Site Survey & Conceptual Design
2. HVAC & Modular System Installation
3. DQ/IQ/OQ/PQ Validation Support
4. Operational Maintenance Training

Whether in the Middle East or Southeast Asia, the core needs of pharmaceutical companies remain the same: Compliance, Efficiency, and Reliability.

Designing a GMP cleanroom is not just about erecting walls; it is a comprehensive solution integrating standards, climate adaptation, and operational workflow. We stick to the bottom line of GMP and ISO 14644, using professional engineering to build facilities that boost your product quality and market expansion.

Choose Boben Modular Cleanroom Manufacturers. Stop compromising between international standards and local adaptation. Get a compliant, world-class pharmaceutical production space today.