What is an ISO 7 Cleanroom? What You Need to Know

What is an ISO 7 Cleanroom? What You Need to Know

Understanding cleanrooms and their ISO classifications can be confusing. Simply put, cleanrooms limit airborne particles in order to prevent contamination. Each ISO class only differs in the number and size of particles allowed. In this guide, we&#;ll specifically focus on ISO 7 cleanrooms and their features, requirements, applications, and more.

With competitive price and timely delivery, EZONG sincerely hope to be your supplier and partner.

What is an ISO 7 Cleanroom?

An ISO 7 cleanroom, as defined by ISO -1 standards, is a controlled environment that limits airborne particles to no more than 352,000 particles (0.5 micrometers or larger) per cubic meter. These cleanrooms require 60 to 90 air changes per hour and can use a combination of unidirectional and non-unidirectional airflow. They are commonly used in industries such as pharmaceuticals, biotechnology, and electronics manufacturing.

Per cubic meter, they allow a maximum of the following:

• 352,000 particles for sizes 0.5 micrometers or larger
• 83,200 particles for sizes 1 micrometer or larger
• 2,930 particles for sizes 5 micrometers or larger

ISO -1 cleanroom classifications.

As you can see from the chart above, ISO Class 7 cleanrooms only target particles that are 0.5 micrometers or bigger. They do not focus on smaller particles, such as those between 0.1 and 0.3 micrometers. This is because, in general, smaller particles have less impact on the work done in these rooms. ISO classifications are selected based on the sizes of particles that cause the most trouble.

Are ISO Class 7 Cleanrooms the Same as Class 10,000 Cleanrooms?

ISO 7 cleanrooms directly correspond to Class 10,000 under the older Federal Standard 209E. This older standard used particles per cubic feet for measurement. The ISO -1 standard, on the other hand, uses particles per cubic meter, and has replaced Fed Standard 209E.

Although the Federal Standard 209E is no longer in use, the terms &#;Class 10,000,&#; &#;Class 1,000,&#; etc., are still commonly used for ease of reference.

Both ISO 7 and Class 10,000 cleanrooms allow less than 352,000 particles bigger than 0.5 micrometers in each cubic meter of air, so we can say that they are the equivalent, or the same.

ISO 7 Cleanroom Requirements

To keep particles below required levels, these cleanrooms have special requirements. They achieve this by frequently changing the air, using efficient filters, and managing airflow. In this section, we&#;ll cover key requirements such as air changes per hour, HEPA filtration, and airflow control.

An industrial cleanroom with air handling units, insulated ductwork, and modular walls to control particle levels.

Air Changes per Hour

A high number of air changes per hour (ACPH) helps cleanrooms stay clean. This metric tells us how often the air in a room is completely changed with new air in one hour.

In ISO 7 cleanrooms, the air is replaced 60 times each hour. This means that every minute, the air inside is entirely renewed.

For some perspective, the American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE) suggests that a typical home should have a minimum of 0.35 ACPH to ensure good indoor air quality.

In other words, these cleanrooms are significantly cleaner than a typical house.

HEPA Filtration

A high-efficiency particulate air (HEPA) filtration system is necessary for filtering out particles in an ISO 7 cleanroom.

These filters are highly efficient, trapping 99.97% of particles 0.3 micrometers or larger. As a result, they are able to capture almost all airborne particles of this size and larger.

Want more information on class 7 cleanroom standards? Feel free to contact us.

Airflow Control

In ISO Class 7 cleanrooms, how airflow is designed is just as important as filtration.

In most cases, turbulent air flow is sufficient to meet the standard. However, in special cases, you may need unidirectional or laminar flow, where air moves in a single direction at a consistent speed.

Unidirectional airflow sweeps particles away from critical areas towards air returns in the lower walls or floor, preventing turbulence that may push particles back into the air.

The combination of HEPA filtration and carefully designed airflow patterns minimizes the overall risk of contamination in sensitive areas.

What are Some Applications of ISO 7 Cleanrooms?

These cleanrooms are used in many sectors and are important for both making safe products and meeting regulations.

For example, in making medicines, they stop contamination during important steps like product filling. These cleanrooms also serve in the production of sterile drugs, the construction of spacecraft parts, and the preparation of food.

Other industries that commonly use these cleanrooms include:

• Biotechnology
• Electronics
• Optical manufacturing
• Medical devices manufacturing
• Automotive manufacturing

A hallway in a modular cleanroom.

Understanding ISO 7 Cleanroom Variability

While ISO 7 cleanrooms are designed to meet strict standards, factors such as size, layout, specific industry requirements, and individual customer needs can greatly influence their design. Given these differences, it&#;s important to customize each cleanroom for its intended use.

If you&#;re considering an ISO 7 cleanroom, we recommend contacting our engineers at Allied Cleanrooms. They can guide you through the options and help design a cleanroom that perfectly fits your requirements.

Cleanrooms are classified according to the number and size of particles permitted per volume of air. ke "ISO-7" refers to the ISO -1 Cleanroom Standards and denote the number of particles of size 0.5 µm or larger permitted per cubic meter of air. ISO-7 cleanroom classification would have <352,000 particles >05.micron/cubic meter and minimum of 60 air changes per hour.

FAQs About ISO-7 Cleanrooms

Q: What is the Difference Between an ISO-7 and an ISO-6 Cleanroom?

A: An ISO-7 cleanroom is allowed a maximum of 2,930 particles/m3 greater than 5 microns and less than 352,000 particles/m3 greater than 0.3 um. An ISO-7 cleanroom must have at least 60 air changes per hour. An ISO-6 cleanroom is allowed a maximum of 293 particles/m3 greater than 5 micron and less than 35,200 particles/m3 greater than 0.3 um. An ISO-6 cleanroom must have at least 180 air changes per hour. An ISO-7 cleanroom classification is closest to Class 10,000 Fed Std 209E . An ISO-6 cleanroom classification is closest to Class Fed Std 209E.

Q: What is an ISO-8 Cleanroom?

A: An ISO-8 cleanroom is allowed a maximum of 29,300 particles/m3 great than 5 microns and less than 3,520,000 particles/m3 great than 0.3 microns. An ISO-8 cleanroom must have at least 20 air changes per hour. An ISO-8 cleanroom classification is closest to Class 100,000 cleanroom classification.

Q: What Does the Term ISO-4 Cleanroom Mean?

A: An ISO-4 cleanroom is allowed no particles greater than 5 microns, less than 352 particles/m3 greater than 0.5 um and less than 1,020 particles/m3 great than 0.3 microns. ISO-4 cleanrooms have between 500 to 600 air changes per hour. An ISO-4 cleanroom classification is closest to class 10. ISO-4 cleanrooms typically use ULPA filters and have 100% ULPA filter ceiling coverage.

Q: What are Cleanroom Requirements?

A: Cleanroom requirements typically refer to cleanroom classification, length, width, height, wall type, air flow of either recirculating or one pass, temperature, humidity, and room pressure. Other requirement can be related to exhaust, chemical resistance, biohazard, electrical discharge, or light frequency.

Q: What is an ISO-5 Cleanroom?

A: An ISO-5 cleanroom is allowed 29 particles/m3 greater than 5 microns, less than 3,520 particles/m3 greater than 0.5 um and less than 10,200 particles/m3 great than 0.3 microns. An ISO-5 cleanroom must have more than 300 air changes per hour and typically has at least 70% HEPA filter ceiling coverage. An ISO-5 cleanroom classification is closest to class 100.

Q: What is the Highest-Class Cleanroom?

A: ISO-9 is considered the high ISO cleanroom classification. The particle counts correspond to room and is roughly 10x as dirty as ISO-8. Class 100k is the highest FED Std 209E cleanroom classification. Class 100k is closest to ISO-8.

Q: What are the Classes of Cleanrooms?

A: The Fed Std. 209E cleanroom classifications are class 100,000 (class 100k) , class (class 10k), class and class 100. The ISO cleanroom classifications are ISO-5, ISO-6, ISO-7 and ISO-8.

Q: What is an ISO-7 Cleanroom?

A: An ISO-7 cleanroom is allowed a maximum of 2,930 particles/m3 greater than 5 microns and less than 352,000 particles/m3 greater than 0.5 um. An ISO-7 cleanroom must have at least 60 air changes per hour, have ceiling mounted HEPA fan filter units and low all air returns.

Q: What ISO Class is a Cleanroom?

A: The ISO class of cleanroom is defined by how many particles per cubic meter and how many air changes per hour with hepa filtered air.

Q: How are Cleanrooms Classified?

A: Cleanrooms are classified by particle count and HEPA filtered air changes per hour. Particle counts range from 0 to 29,300 particles/m3 greater than 5 um, and air changes from 20 to 300 air changes per hour. For example, a ISO-8 cleanroom is allowed 29,300 particles/m3 greater than 5 microns, 3,520,000 particles/m3 greater than 0.3 microns and minimum 20 air changes per hour. Fed Std 209E cleanroom classifications are also by particle count and HEPA filtered air changes per hour. However, the particle counts are by feet3.

Are you interested in learning more about linear bar diffuser? Contact us today to secure an expert consultation!