Designing a Custom Cleanroom: Key Factors to Consider

Designing a Custom Cleanroom: Key Factors to Consider

For businesses in industries like biotechnology, pharmaceuticals, medical devices, and life sciences, cleanrooms are essential for maintaining product quality and regulatory compliance. If your company is planning to design a custom cleanroom, several key factors need to be taken into account to ensure that the space meets your operational needs, complies with industry standards, and supports the growth of your business. Below are the critical considerations to guide you through the design process of your custom cleanroom.

1. Understanding Cleanroom Classifications

The first step in designing a custom cleanroom is determining the level of cleanliness your processes require. Cleanrooms are classified based on the number of particles allowed per cubic meter of air, according to ISO standards. These classifications range from ISO Class 1 (the cleanest) to ISO Class 9 (the least stringent).

The classification you choose will depend on the sensitivity of your operations. For example, medical device and pharmaceutical manufacturing often require a higher level of cleanliness, such as ISO Class 5 or 7, while less stringent processes, like packaging, may only require ISO Class 8. Understanding the appropriate classification ensures that your cleanroom is equipped to meet regulatory and operational needs.

2. Airflow Design

One of the most important aspects of cleanroom design is airflow control. Cleanrooms typically use either laminar airflow (unidirectional) or turbulent airflow (non-unidirectional) to maintain cleanliness by controlling the movement of air and particles.

• Laminar airflow is ideal for higher-class cleanrooms (ISO Class 1-5), as it directs air in a straight, uniform flow from the ceiling to the floor or walls, minimizing turbulence and preventing particles from settling on surfaces.

• Turbulent airflow is used in less stringent environments (ISO Class 6-8) and allows for greater flexibility in design and cost-efficiency.

Your airflow system should also incorporate High-Efficiency Particulate Air (HEPA) filters or Ultra-Low Particulate Air (ULPA) filters to capture and remove airborne particles. The choice between these two filters will depend on your required cleanliness level, with ULPA filters being more efficient but also more expensive.

3. Environmental Controls

Maintaining stable environmental conditions inside a cleanroom is critical for ensuring the integrity of your products. Key factors to control include:

• Temperature: Certain materials and processes are sensitive to temperature fluctuations. The cleanroom’s HVAC system should maintain a stable temperature to prevent contamination or product degradation.

• Humidity: High or low humidity can lead to particle buildup, static electricity, or condensation that could contaminate the product. Humidity control is especially important in industries like electronics or pharmaceuticals.

• Pressure: Positive or negative pressure differentials can prevent outside contaminants from entering or prevent hazardous materials from leaving the cleanroom. For instance, positive pressure is typically used in cleanrooms where product protection is essential, while negative pressure is employed in cleanrooms handling hazardous substances to protect personnel and the environment.

4. Material Selection for Surfaces

The materials used for walls, floors, and ceilings in a cleanroom must be easy to clean, resistant to microbial growth, and non-shedding. Common materials include:

• Vinyl or epoxy flooring: These materials provide a smooth, durable surface that can withstand frequent cleaning and prevent particle accumulation.

• Polymer or stainless steel for walls and ceilings: These non-porous materials prevent particle shedding and microbial growth while being easy to sanitize.

Your selection of materials will impact the longevity and maintenance requirements of your cleanroom, as well as the ease with which you can maintain cleanliness standards.

5. Modular vs. Permanent Design

Another decision to consider is whether your cleanroom should have a modular or permanent design:

• Modular cleanrooms are flexible and can be assembled or reconfigured quickly. This option is ideal for startups or companies that anticipate changes in their operational needs or for businesses with temporary cleanroom requirements.

• Permanent cleanrooms are more costly upfront but offer greater stability and durability for long-term use. If you require a highly customized, long-lasting solution, a permanent cleanroom might be a better choice.

6. Compliance and Regulatory Standards

Compliance with regulatory bodies like the FDA, EU GMP (Good Manufacturing Practices), or ISO is non-negotiable. These standards dictate everything from airflow and environmental controls to the materials used in construction. When designing your cleanroom, you must ensure that every aspect of the facility meets the appropriate regulatory requirements for your industry.

Working with cleanroom design experts who are familiar with these regulations is critical for avoiding costly delays, retrofits, or non-compliance issues.

7. Ergonomics and Workflow Efficiency

Beyond maintaining cleanliness, your cleanroom should be designed to support workflow efficiency and employee comfort. Poorly designed layouts can lead to inefficiencies and increase the risk of contamination. Consider how workers will move through the space, the placement of workstations, and the organization of materials.

• Zoning: Separate areas for gowning, material transfer, and high-sensitivity tasks can minimize contamination risks and streamline operations.

• Access control: Limit access to critical areas through controlled entry points, and ensure proper gowning and decontamination procedures are in place.

8. Scalability for Future Needs

Finally, consider your business's future growth when designing your cleanroom. As your company expands, you may need to increase the size of your cleanroom or upgrade its classification. Designing a scalable cleanroom ensures you won’t outgrow your facility too soon, saving time and money on future expansions.

Modular cleanrooms can often be expanded or reconfigured with minimal disruption, making them a good choice for businesses expecting rapid growth.

Conclusion

Designing a custom cleanroom requires careful consideration of classification, airflow, environmental controls, materials, and workflow. By focusing on these key factors, you can create a cleanroom that not only meets your current needs but also supports long-term growth and compliance. At ReadyStart CleanRooms, we offer tailored solutions to help you design a custom cleanroom that aligns with your business's specific requirements, ensuring your success in a regulated and competitive market.

Reach out to us today to discuss how we can help you design the perfect cleanroom for your business needs.