What Common Mistakes Should You Avoid in Cleanroom Design?

 

Designing a cleanroom is a complex process that requires careful planning, precise execution, and adherence to international standards. A cleanroom is a controlled environment where contaminants such as dust, airborne microbes, and chemical vapors are kept at minimal levels. These spaces are crucial in industries like pharmaceuticals, biotechnology, electronics, aerospace, and food production. However, even small mistakes during cleanroom design can lead to inefficiency, compliance issues, and significant financial losses.

In this article, we will discuss the most common mistakes to avoid in cleanroom design and how you can ensure your facility meets industry standards and performs at its best.

1. Ignoring Cleanroom Classification Requirements

One of the first steps in cleanroom design is determining its ISO classification or GMP grade. Each industry has specific standards that dictate the number of particles allowed per cubic meter of air.
A common mistake is to build a cleanroom without considering these classifications or over-designing the space to achieve a higher classification than necessary. This leads to unnecessary costs in HVAC, filtration, and ongoing energy consumption.

Tip: Work with a cleanroom expert to define the right classification based on your process requirements (ISO 14644-1, EU GMP guidelines, or other relevant standards).

2. Poor Airflow Design

Airflow is the heart of a cleanroom. The goal is to ensure that airborne contaminants are removed efficiently. Many facilities make the mistake of using improper air change rates, turbulent airflow patterns, or insufficient HEPA/ULPA filtration coverage.

Improper airflow can create dead zones where particles accumulate or lead to contamination flowing from dirty to clean areas.

Solution: Use computational fluid dynamics (CFD) simulations during the design stage to model airflow patterns and ensure proper laminar flow and pressure differentials.

3. Lack of Proper Zoning and Pressure Differentials

Cleanrooms are usually divided into zones with varying cleanliness levels. A common mistake is failing to create proper pressure cascades between zones. This allows contaminants from less clean areas to infiltrate critical spaces.

Best Practice:

• Maintain positive pressure in clean areas relative to adjacent spaces.

• Design airlocks and gowning rooms to act as barriers.

• Include pressure monitoring systems to detect leaks or imbalances.

4. Overlooking Material and Personnel Flow

The movement of people and materials can introduce contaminants if not properly managed. Many cleanroom designs neglect to provide separate entry/exit points for personnel and materials, resulting in unnecessary cross-contamination risks.

Key Considerations:

• Create dedicated gowning rooms with clear SOPs for donning and doffing cleanroom attire.

• Use pass-through chambers or pass boxes for material transfer.

• Design unidirectional flow of personnel and products to avoid backtracking.

5. Choosing the Wrong Building Materials

Not all materials are suitable for a cleanroom environment. A common mistake is using porous, particle-shedding, or difficult-to-clean materials for walls, ceilings, or floors. These surfaces can harbor microbes, release fibers, or deteriorate over time.

Recommended Materials:

• Seamless, non-porous wall panels (PVC-coated, stainless steel, or epoxy-painted).

• Vinyl or epoxy flooring with coving to eliminate sharp corners.

• Cleanroom-compatible ceiling tiles that do not shed particles.

6. Inadequate HVAC System Design

The HVAC system controls temperature, humidity, and air cleanliness. Many projects fail due to under-designed HVAC systems, resulting in unstable conditions, excessive energy usage, or inability to meet cleanroom classifications.

Important Factors:

• Correctly size air handling units for required air changes per hour.

• Maintain optimal temperature and humidity for both product and personnel comfort.

• Ensure energy efficiency by integrating variable airflow control and heat recovery systems.

7. Neglecting Cleaning and Maintenance Needs

Some cleanroom designs look good on paper but are difficult to clean or maintain. Poorly placed equipment, hard-to-reach corners, or lack of space around air diffusers can complicate cleaning routines.

Solution:

• Choose a layout that allows easy access for cleaning and maintenance.

• Minimize horizontal surfaces where dust can settle.

• Include adequate space for equipment servicing without disrupting operations.

8. Forgetting About Future Expansion

Many companies design a cleanroom only for their current production needs, ignoring future scalability. Later, when they need to expand capacity, they face costly redesigns and downtime.

Pro Tip:
Design your cleanroom with modularity in mind. Consider demountable walls, flexible HVAC systems, and space allocation that allow for easy expansion or reconfiguration.

9. Insufficient Monitoring and Control Systems

Modern cleanrooms require continuous monitoring of parameters such as particle counts, differential pressure, temperature, and humidity. Skipping real-time monitoring systems can make it difficult to prove compliance during audits.

Best Practice:
Install an automated environmental monitoring system (EMS) that provides real-time alerts, data logging, and trend analysis.

10. Not Consulting Cleanroom Experts Early

One of the biggest mistakes is not involving cleanroom design specialists early in the project. Many issues arise because companies try to adapt standard building designs rather than working with experts who understand cleanroom dynamics.

Solution:
Engage experienced cleanroom designers, engineers, and validation experts from the planning stage. This ensures compliance, efficiency, and cost-effectiveness throughout the project.

11. Underestimating Training and SOP Development

Even the best-designed cleanroom will fail if personnel are not properly trained in gowning procedures, behavior protocols, and contamination control.

Action Step:
Develop Standard Operating Procedures (SOPs) and train staff before commissioning the cleanroom. Include regular refresher training and audits to maintain compliance.

Final Thoughts

Designing a cleanroom is not just about building a controlled space—it’s about creating an environment that consistently protects your processes and products from contamination. Avoiding common mistakes such as poor airflow design, inadequate zoning, wrong material selection, and lack of monitoring systems can save you time, money, and regulatory headaches.

Reference Link(OriginallyPosted):https://medium.com/@ziebaq/what-common-mistakes-should-you-avoid-in-cleanroom-design-a08c17f41196