Today we are going to meet Tran The Hung, our Cleanroom Engineering Expert at Archetype Vietnam. With over 14 years of experience, he specializes in designing high-performance cleanroom environments for industries such as pharmaceuticals, food and beverages, and healthcare
In this edition, we explore the science behind cleanroom design, focusing on the technical complexities and challenges involved in creating and maintaining contamination-free environments that meet the highest standards of safety, efficiency, and reliability.
As a cleanroom engineering expert, you’ve worked on a variety of high-standard projects across industries. To start, could you share which international standards or guidelines you frequently work with beyond ISO 14644?
While ISO 14644 forms the foundational framework for cleanroom classifications, it is far from the only standard guiding our work. Depending on the project type and location, we also work with:
- WHO GMP (Good Manufacturing Practices): Governs global pharmaceutical production, especially in pharmaceutical and biotechnology projects.
- EU GMP Annex: Sets out detailed guidelines for the manufacture of sterile medicinal products.
- PICS GMP: Harmonizes GMP compliance requirements across multiple countries and regulatory bodies.
- HACCP (Hazard Analysis and Critical Control Points): A widely used risk management standard in the food and beverage industry.
- FDA cGMP (21 CFR Part 210 and 211): Critical for US-based pharmaceutical projects, ensuring compliance with US regulations.
- VDI 2083: A German engineering standard providing technical guidance on air cleanliness, particle control, and performance benchmarks in cleanrooms.
- JACA B 9920: A Japanese cleanroom standard issued by the Japanese Air Cleaning Association, tailored to local industry needs.
For industries that rely on cleanrooms, contamination control is critical. What are the biggest risks of improper cleanroom design or maintenance?
Poor cleanroom design or maintenance carries serious risks, from product contamination and regulatory non-compliance to downtime and financial loss. A common issue is misalignment between the cleanroom design and its actual process requirements. The design must clearly reflect the intended function, cleanliness classification, and operational parameters such as airflow rates, temperature, humidity, and pressure zoning.
Regulatory compliance is non-negotiable. Standards such as ISO, EU GMP, and FDA require up-to-date knowledge and rigorous application. Engaging a multidisciplinary team, particularly experienced HVAC engineers, is critical to ensure effective air filtration, airflow patterns, and the correct use of HEPA systems.
Pressure control is another critical factor. Cleanrooms must maintain precise pressure differentials to prevent cross-contamination, supported by real-time monitoring, alarms, and regular testing.
Material selection also plays a key role. Non-porous, chemical-resistant, and easy-to-clean materials are essential. Cost-driven compromises often lead to contamination risks and higher long-term remediation costs.
Finally, realistic budgeting is essential. Cleanroom projects involve specialized systems and materials, so cost planning must account for design, construction, and ongoing maintenance, with contingency allowances informed by experienced architects, engineers, and cost consultants.
How do you balance meeting strict contamination control requirements while ensuring the cleanroom remains efficient and cost-effective for clients?
Cleanrooms are energy-intensive due to strict requirements for air filtration, pressure control, and environmental stability. However, efficiency can be significantly improved through smart design and advanced technologies without compromising performance.
Key strategies include optimizing air change rates using dynamic airflow systems such as VAV, demand-controlled ventilation, and smart BMS platforms, combined with pressure cascade zoning to reduce airflow in less critical areas. High-efficiency HEPA and ULPA filters with low pressure drop, along with variable-speed fan filter units, help lower fan energy consumption when properly maintained.
Energy performance is further enhanced through smart HVAC solutions, including heat recovery systems, efficient dehumidification, and chiller plant optimization integrated into BMS. Efficient equipment and lighting such as VFD-driven motors, LED lighting with sensors, and automated power management reduce operational loads. Water efficiency is addressed through ultrapure water recycling, low-flow fixtures, and real-time monitoring, supporting both sustainability and long-term cost control.
If you had to highlight one key lesson learned from projects that you have worked on, what would it be?
One key lesson from projects such as ACE and the Medochemie Factory is the critical importance of early, cross-disciplinary coordination. Aligning MEPF, Process Engineering, Architecture, and Civil teams from the outset through dedicated coordination meetings ensures that technical and regulatory requirements are clearly understood and integrated early.
Late design changes such as resizing MEP shafts or relocating airlocks often lead to costly revisions. Clear definition of client requirements, project scope, and applicable standards before detailed design is essential. Misapplying standards, for example designing to ISO 14644 when EU GMP is required, can result in regulatory rejection.
Common risks also include inadequate HVAC and pressure cascading, which may cause cross-contamination, and inappropriate material selection. Using unsuitable wall finishes or insulation materials in high-grade cleanrooms can significantly increase contamination risks.
