Clean Room

1. The intended use of the clean room?

Knowing the intended use is fundamental. Different applications require different levels of particle control and air quality. For instance, a pharmaceutical manufacturing clean room may require different specifications than an electronics manufacturing cleanroom. Determine the required level of particle control, air changes per hour (ACH), temperature, and humidity levels that will be needed for the space.

2. Class or Grade of Cleanliness is required?

Classified by specifying the maximum number of microorganisms and particulate matter in a given cubic meter of air within the cleanroom. The International Organization for Standardization (ISO) is the primary industry organization that sets the standards for cleanroom environments. Classifications range from ISO Class 1 (the cleanest) to ISO Class 9 (the dirtiest). Determining the proper classification by your industry standards can help ensure your cleanroom performs per your product and process requirements.

3. Size should the clean room be?

Determining the size of the cleanroom can be tricky as the area size depends on the application and equipment used. The number of personnel working in the clean room and the equipment, furniture, and fixtures required in the room will likewise determine its size. Consult a professional who will be able to determine the size requirements necessary to accommodate the procedures and equipment to be utilized in the room.

4. Required air system specifications?

Cleanrooms require air systems that offer precise control over air supply, distribution, and evacuation. The air system must provide constant directional airflow, control room temperature, and maintain the required humidity. It is important to consider the air system when designing the room’s layout – air supply diffusers typically should not be located over equipment or personnel, nor should they allow contaminated air from adjacent spaces to enter the cleanroom.

5. Type of construction materials should be used for the cleanroom?

The type of construction materials you utilize will impact its function and ease of maintenance. The wrong materials can generate contamination, corrode, or become difficult to clean over extended periods, reducing efficiency. Aluminum components, easy clean wall panels and ceiling tiles, and antimicrobial paints are common clean room construction materials. You might also consider the composition of your furnishings, flooring materials, and equipment.

6. Who is responsible for maintaining the cleanroom?

Most cleanrooms require ongoing management and maintenance for optimized performance. Clear SOPs, training programs and maintenance schedules, and procedures ensure the proper functioning of equipment and procedures. You should establish a training protocol with your contractor or supplier to ensure your staff receives appropriate training for maintaining the space’s cleanliness.

7. What are the regulations governing cleanrooms?

Various regulatory requirements govern design and function, such as the Federal Basic Standard used in the United States. The applicable regulatory requirements differ between industries, but they are necessary for ensuring the clean room meets specifications for the product and process being conducted within the space.

8. How do I ensure the clean room meets my expectations?

Building a clean room is an investment, and you want to ensure it performs to your specific needs. It is essential to work with a supplier or contractor experienced in designing and manufacturing clean rooms, ensuring it is engineered for your application and industry standards. Factory acceptance testing (FAT) provides the ability to verify the equipment and systems meet performance requirements before being packed and shipped, and installation qualification (IQ) and process qualification (PQ) provides the ability to troubleshoot issues before operations begin.

So what Class is the room you require?

There are many classes from
ISO Class 8 ,ISO Class 7 (10,000); ISO Class 6 (1,000); ISO Class 5 (100); or ISO Class 4 (10). We can help you determine what class you require.

What are the dimensions you would like your room?

The Width, the Length,  and the inside ceiling height are valuable pieces of information.

Would you like a gown room? How about gowning benches or gowning racks?

Will any existing walls be utilized? That can reduce the price and needs to be considered in the layout.

Do you need anti-static or standard vinyl curtains?

Are there any overhead obstructions?

How many doors will you need?

Is a pass-through needed?

Are pre-wired outlets needed?

Would you prefer a clear span interior or are internal posts acceptable??

Would you prefer standard or energy efficient HEPA filters?

Are you interested in Static Neutralizing Equipment?

As we discuss your project there may be more questions but knowing the answers to these questions will really help to get started.

In conclusion, designing and buying a clean room requires careful consideration and planning to ensure its successful implementation.

As you determine your room’s size, specific application requirements, construction materials, and air handling capabilities, involve technical experts with experience designing and manufacturing clean rooms. A structured design approach, including FAT, IQ, and PQ, ensure the clean room equipment and systems meet performance requirements to deliver functionality that meets your expectations.