How to Choose the Right Cleanroom for Your Industry

In industries where precision and product integrity are necessary—such as medical devices, biotechnology, electronics, and aerospace—controlling the environment is essential. Cleanrooms are highly controlled spaces designed to maintain specific levels of air quality, temperature, and positive pressure to prevent contamination.

Whether you’re manufacturing medical devices, semiconductors, or conducting research, choosing the right cleanroom can make all the difference in ensuring compliance with industry regulations and protecting the quality of your products. Selecting the right cleanroom is not a one-size-fits-all process.

Every industry has unique requirements and operating procedures that dictate the cleanroom’s design, classification, and maintenance protocols. This guide will walk you through the critical factors to consider when choosing the right cleanroom for your industry, ensuring you make an informed decision that aligns with both your operational needs and regulatory standards.

1. Understand Your Industry Requirements

The first step in choosing the right cleanroom is understanding your industry’s specific cleanliness and regulatory requirements. Different industries have different levels of sensitivity to contaminants, and each industry will have standards you must comply with. For example:

Biotech: These industries require stringent contamination control, as even the slightest particle or microbe can affect the safety and efficacy of the product. The cleanroom must meet standards set by regulatory bodies like the FDA, EMA, and ISO.
Semiconductor and Electronics: Manufacturing high-performance electronics requires cleanrooms that prevent dust, static electricity, and airborne particles from affecting delicate circuits.
Medical Devices: Medical device manufacturing requires strict contamination control to prevent infection risks and ensure the functionality of devices.
Aerospace: In the aerospace industry, contaminants can affect the integrity of components that will operate in extreme conditions.
Robotics: In robotics manufacturing, especially for precision robots and automated systems, maintaining an ultra-clean environment is critical to prevent contaminants from disrupting sensitive components and moving parts.

Understanding these specific requirements will guide you toward the right cleanroom classification and features for your business.

2. Familiarize Yourself with Cleanroom Classifications

The amount and size of particles permitted per cubic meter of air in a cleanroom determines its classification. The International Organization for Standardization (ISO) developed the ISO 14644-1 standard, which provides cleanroom classifications ranging from ISO Class 1 to ISO Class 9.

ISO Class 1: This is the cleanest classification and allows the fewest particles. It’s typically used in industries like nanotechnology and advanced semiconductor manufacturing.
ISO Class 5: Commonly used in electronics and biotechnology industries, where moderate cleanliness levels are required.
ISO Class 7 and 8: These classes are suitable for industries with less strict contamination control requirements, such as aerospace or automotive industries.

Choosing the right classification depends on your industry standards and the sensitivity of your processes to contaminants. Make sure to assess whether your cleanroom needs to comply with standards like ISO 14644-1 or the FDA’s cGMP (Current Good Manufacturing Practices).

3. Consider the Cleanroom Layout and Size

The layout and size of your cleanroom depend on the nature of your operations, the equipment used, and the number of personnel involved. Cleanrooms can range from small modular units to large custom-built spaces.

Modular Cleanrooms: These are engineered and prefabricated structures that can be installed quickly and customized to fit your operational needs. They’re often a cost-effective solution and can be expanded or relocated if necessary.
Custom-built Cleanrooms: These are designed specifically for your processes. They offer flexibility in terms of design and are easily designed for your specific requirements

Consider how much space you’ll need for equipment, workers, and product flow. Also, take into account whether you’ll need additional zones for gowning, sterilization, or material transfer.

4. Evaluate Cleanroom Construction Materials

The materials used to construct your cleanroom play a vital role in ensuring that the environment stays free from contaminants. Some important factors to consider include:

Walls and Ceilings: Materials like HDPE, aluminum, and FRP are often used because they are smooth, easy to clean, and resist particle build-up.
Floors: The flooring material should be non-porous and easy to clean. Vinyl or epoxy-coated flooring is often used because it minimizes dust accumulation and can withstand heavy foot traffic.
Windows and Doors: Cleanroom windows and doors should be solid and secure to maintain the required pressure levels and prevent contaminants from entering.

Choose materials that are compatible with the cleaning agents and disinfectants used in your industry. For instance, if you work in the pharmaceutical industry, your cleanroom materials should be resistant to harsh chemicals used for decontamination.

5. Understand HVAC and Air Filtration Needs

One component for a cleanroom is its HVAC (Heating, Ventilation, and Air Conditioning) system. The HVAC system controls airflow, temperature, and humidity, ensuring that the cleanroom environment remains stable and free from contaminants. Air filtration is also essential in maintaining a cleanroom’s classification level.

High-Efficiency Particulate Air (HEPA) Filters: These filters remove 99.99% of particles that are 0.3 microns in size or larger, making them suitable for most cleanroom applications.
Ultra-Low Penetration Air (ULPA) Filters: These filters remove 99.999% of particles 0.12 microns or larger and are used in environments requiring more stringent contamination control.

Ensure that your cleanroom’s HVAC and filtration system meets your industry’s requirements. Regular maintenance of filters and ventilation systems is also essential to maintain the cleanroom’s integrity.

6. Determine the Required Cleanroom Protocols

Maintaining cleanliness in a cleanroom involves more than just the room itself—it also requires stringent protocols for personnel, equipment, and material handling.

Gowning and PPE: Personnel entering a cleanroom must wear appropriate gowns, gloves, and masks to prevent contaminants from entering the environment. Some cleanrooms also require full-body suits or cleanroom-approved shoes.
Cleaning Procedures: Regular cleaning and disinfection are crucial for maintaining the cleanroom’s classification level. Ensure that the cleaning agents and procedures used are compatible with the materials in your cleanroom and the standards of your industry.
Material Transfer: Consider how materials and products will enter and exit the cleanroom without contaminating the environment. This may involve installing airlocks, pass-through chambers, or specialized containers.

By implementing the right protocols, you can maintain your cleanroom’s integrity and ensure that your products remain free from contamination.

7. Consider Energy Efficiency and Sustainability

Cleanrooms can be energy-intensive due to the constant need for temperature and humidity control, as well as the high-performance air filtration systems. When selecting a cleanroom, consider energy-efficient solutions that can reduce operational costs while maintaining compliance with industry standards.

Variable Airflow Systems: These systems adjust the airflow in the cleanroom based on the level of activity, helping to conserve energy when the room is not in use.
Energy-Efficient Lighting: LED lighting is often used in cleanrooms because it generates less heat, reducing the demand on the HVAC system.
Recyclable Materials: Some cleanroom materials are designed to be recyclable or reusable, contributing to a more sustainable operation.

8. Choose the Right Cleanroom Manufacturer or Supplier

Finally, selecting the right cleanroom manufacturer or supplier is crucial for ensuring that your cleanroom meets all regulatory and operational requirements. Look for a supplier with experience in your industry and a track record of successful installations.

Customization Options: Ensure that the manufacturer offers customization options to fit your specific needs, with modular options.
Compliance with Standards: Your supplier should be familiar with industry standards and able to provide cleanrooms that comply with ISO or other relevant regulations.
After-Sales Support: Look for a supplier that offers maintenance, repair, and support services to ensure that your cleanroom continues to operate efficiently.

Conclusion

Choosing the right cleanroom for your industry requires a comprehensive understanding of your operational needs, regulatory requirements, and the technical specifications of cleanroom systems. By carefully evaluating the cleanroom classification, layout, materials, HVAC systems, and carefully following the steps mentioned above, you can ensure that your cleanroom will maintain the desired level of cleanliness and compliance.

Take the time to consult with cleanroom experts and suppliers who can guide you through the selection process and help you build a cleanroom that meets the highest industry standards. Contact Modulus Cleanroom and we’ll be glad to assist you.