5 Must-Have Features in a iso5 cleanroom

How to make sure your industrial cleanroom is built on-time, on-budget and meets your cleanroom classification needs.

Link to EZONG

Figure 1. Class modular cleanroom for industrial manufacturing

Cleanroom Design Tip #1

Make sure you get the right cleanroom classification for your needs.

Most companies justify spending on a cleanroom for one of following reasons:

• Higher Yield &#; manufacturing in a cleanroom results in less bad product. The manufacturing savings pay for the cleanroom. A good example of this is in the semiconductor manufacturing industry where class 100 / ISO5 cleanrooms are industry standard.
• Customer requirement &#; if your company supplies the defense industry or medical device industry, they typically specify the classification of the  cleanroom your product must be manufactured in to ensure you meet their sterility, cleanliness, or quality requirements.
• Regulatory requirements &#; government or industry agencies such as FDA, NSF, DOD, or USP specify that certain products be manufactured to government. For example, USP797 compounding must be done in ISO7 cleanroom.

Knowing what cleanroom classification is required for your application and building just to that level will save you money. Setting too high of a cleanroom classification will drive your cost up unnecessarily.

Figure 2. Air conditioning for manufacturing cleanroom

Cleanroom Design Tip #2

Make sure you get enough cleanroom air conditioning. 

Your cleanroom is typically a year around net heat generator and it requires a dedicated air conditioner. Sizing your cleanroom air conditioner correctly requires taking into account cleanroom characteristics like process heat load, exhaust cfm, and HEPA fan filter unit heat load. Designing the cleanroom AC system is very different than standard industrial air conditioning and should be done by a cleanroom specialist.

Figure 3. Modular cleanroom walls

Cleanroom Design Tip #3

Make sure you choose the correct modular cleanroom wall type for your cleanroom application.

Depending on your cleaning regimen, you may need a chemical resistant wall surface. Electronic applications often choose static dissipative walls. However, if you don&#;t have special needs then a basic modular cleanroom wall material will result in the lowest cost.

Cleanroom Design Tip #4

Cleanroom flooring must be durable, easily cleaned and not give off particles.

For pharmaceutical cleanrooms and medical device cleanrooms, heat welded vinyl floors with integral cove are very popular due to their ability to withstand cleaning with strong chemicals required to maintain cleanroom sterility. Static dissipative cleanroom vinyl flooring is common for electronic cleanrooms like semiconductor where electrostatic discharge ESD can damage the cleanroom product.

Cleanroom Design Tip #5

Make sure you get enough cleanroom doors

Cleanroom doors are used for personnel entry, material transfer, equipment installation and emergency exits. Gown room doors for personnel are typically single doors. Material transfer doors can be cart pass thru&#;s, double doors, or motorized roll up doors. Cleanroom equipment doors are rarely used large double doors that go directly into cleanroom. Emergency exit doors are typically rarely used single doors with panic bars. For frequently used internal cleanroom doors &#; hands free motorized sliding doors can be used. The advantage of modular cleanroom construction is the ability to easily add doors after construction by swapping standard panels for door panels.

For more iso5 cleanroominformation, please contact us. We will provide professional answers.

The author Anthony Chien has worked at American Cleanroom Systems for the past 10 years. He has more than 40 years of cleanroom experience. Anthony has a BS and MS in Electrical Engineering specializing in semiconductor manufacturing from the University of Illinois. American Cleanroom Systems is a design-build modular cleanroom manufacturer based in Rancho Santa Margarita CA. ACS is an expert in ISO-5 thru ISO-8 (class 100 to class 100k) modular cleanrooms for pharmaceutical cleanrooms, medical device cleanrooms, and industrial cleanrooms.

What is ISO Class 5 Cleanroom? &#; Its Classification and Standards

Cleanrooms classified as ISO 5 are extremely clean. The cleanroom must have less than 3,520 particles larger than 0.5 microns per cubic meter and 250-300 HEPA filtered air changes per hour. In other words, the equivalent FED class is 100 particles per cubic foot.

ULPA filtration is 99.% effective at 0.12 microns. Common purposes are semiconductor manufacturing and pharmaceutical packing areas.

The following industries frequently use ISO class 5 cleanrooms:

To reach ISO Class 5 air cleanliness in a classified room, one must pass through an ISO 8 (anteroom), an ISO 7, and then an ISO 6 before entering the ISO class 5 cleanroom.

However, you can reach ISO 5 cleanrooms with two or three airlocks. When designing a cleanroom layout, many factors must be considered. For example, the number of people working inside, how much heat the room will generate, and the size of the room.

Moreover, ISO 5 or class 100 cleanrooms need unidirectional airflow. Compared to non-directional airflow cleanrooms, unidirectional airflow cleanrooms use much more air. The whole ceiling is covered in high-efficiency filters.

Filtered air sweeps down the room in a unidirectional manner, at a velocity between 0.3 m/s and 0.5 m/s, with GMP A/B (EU GMP grade standard) also looking at 5.0µ before exiting through the floor, removing all airborne contamination. Cleaning areas that use unidirectional airflow are more expensive compared to directional counterparts. Still, they can comply with rigorous classifications such as ISO 5 or lower.

To achieve ISO Class 5, monobloc and hardwall cleanroom construction is the best option. For example, monobloc is an ideal solution for companies striving for GMP standards and regulations. It accommodates features such as coved floors and interlocked doors.

If you want to learn more, please visit our website sliding doors for clean room.