What are the typical ISO classifications for hardwall clean rooms?

Exploring ISO Classifications for hardwall Cleanrooms

By Deiiang™ with design contributions from Deiiang Jason.peng

What is a Hardwall Modular Cleanroom?

A hardwall modular cleanroom is a type of controlled environment constructed with rigid panels, such as tempered glass, acrylic, or other solid materials. Unlike softwall Cleanrooms that utilize flexible curtains, hardwall Cleanrooms offer superior airtight seals and enhanced particulate control. Their durable construction is ideal for applications requiring strict environmental conditions as they better support advanced HVAC systems vital for maintaining specific air cleanliness levels.

ISO Classifications

ISO classifications set the standard for Cleanroom cleanliness, dictating the maximum number of particles permissible within a space. These classifications are crucial in ensuring compliance and operational standards across industries.

ISO Cleanroom Classes

ISO Class 8: Generally used for lower-demand applications such as warehousing and some assembly operations, this class can be achieved with non-unidirectional airflow. It permits 3,520,000 particles per cubic meter, each sized 0.5 microns and larger.
ISO Class 7: Suitable for environments like compounding pharmacies, ISO Class 7 accommodates 352,000 particles per cubic meter, needing moderate control and typically employing non-unidirectional airflow.
ISO Class 6: Equivalent to Class 1,000 from the older Federal Standard 209E, frequently using unidirectional airflow to manage 35,200 particles per cubic meter. It is ideal for environments requiring high levels of particle control.
ISO Class 5: Known as Class 100 under the Federal Standard 209E, this level requires stringent control with a limit of 3,520 particles per cubic meter and often mandates unidirectional airflow for strict contamination control.
ISO Class 1-4: While challenging due to their rigorous requirements, these classes are achievable in hardwall cleanrooms by leveraging advanced construction and state-of-the-art HVAC systems, necessary for extremely clean environments in sectors like Semiconductor manufacturing.

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Cleanroom GMP Classification A, B, C, D

In pharmaceutical manufacturing, cleanrooms are also classified into Grades A, B, C, and D, each defining the acceptable particle and microbial levels required for different processes. These grades correlate with ISO classifications but incorporate additional specifications for microbial control.

Federal Standard 209E

Although superseded by ISO standards globally, Federal Standard 209E was once the guiding classification system in the United States, categorizing cleanrooms into classes like 100, 1,000, 10,000, and 100,000 based on particle counts.

Softwall vs. Hardwall Cleanrooms: Choosing the Right Option

When deciding between softwall and hardwall cleanrooms, consider factors such as budget, cleanliness requirements, and flexibility. Hardwall cleanrooms provide better contamination control and are suited for higher classification needs, while softwall options are cost-effective and adaptable to changing requirements within less demanding applications.

Feature	Hardwall Cleanroom	softwall Cleanroom
Construction	Rigid panels (tempered glass, acrylic)	Flexible curtains or panels
Contamination Control	Superior airtight seals, high particulate control	Moderate control, suitable for lower classifications
Cost	Higher initial investment	More cost-effective
Flexibility	Less adaptable to quick changes	Highly adaptable to changing needs
Ideal Use Cases	Pharmaceuticals, biotechnology, electronics	Warehousing, low-demand assembly, temporary setups

Conclusion: Ensuring Perfect Cleanroom Environments

Choosing the right ISO classification for your cleanroom is essential for fostering the precise conditions necessary for specific applications. Deiiang™, with guidance from Deiiang Jason.peng, leads in designing innovative solutions that meet and exceed industry standards, facilitating efficient, compliant, and safe operations in cleanroom environments.

Common Questions and Solutions

❓ What makes hardwall cleanrooms more suitable for higher ISO classifications?

Their robust construction and advanced environmental controls make hardwall cleanrooms ideal for stringent cleanliness requirements, achieving higher ISO classifications seamlessly.

❓ How do ISO classifications differ from Federal Standard 209E classifications?

ISO standards are internationally recognized and more widely adopted, offering a unified approach compared to the dated and U.S.-specific Federal Standard 209E.

References

International Organization for Standardization. (2015). ISO 14644-1:2015 – Cleanrooms and associated controlled environments.
United States Federal Standard 209E.

By aligning cleanroom environments with suitable ISO classifications, industries can ensure they achieve optimal performance, regulatory compliance, and product quality across various operational settings.