What Is A Cleanroom? The ISO series defines a cleanroom as a room within which the concentration of airborne particles is controlled and classified, and which is designed, constructed and operated in a manner to control the introduction, generation and retention of particles inside the room". There are 9 ISO classifications, ISO 1, ISO
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The ISO series defines a cleanroom as a room within which the concentration of airborne particles is controlled and classified, and which is designed, constructed and operated in a manner to control the introduction, generation and retention of particles inside the room.
There are 9 ISO classifications, ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8, and ISO 9. ISO 1 is considered the cleanest while ISO 9 is considered the dirtiest. ISO provides us with a series of tables showing the maximum permittable particles at varying sizes for each ISO classification. The particles are categorized in number of micron (μm) particles per m3 of air.
ISO -1: Table 1. Please feel free to download.
In the validation of an ISO 7 cleanroom a light scattering particle counter is used to sample the air at numerous points to ensure that that the air contains less than 352 000 particles equal to or greater than 0.5 micron per cubic meter and 2,930 particles equal or greater than 5 micron per cubic meter. An anemometer is also used to record that the room is achieving 30-60 HEPA filtered air changes per hour.
Some industries still refer to the old American Federal Standard 209E and so you might hear an ISO 7 cleanroom be referred to as class 10,000.
The EU GMP Annex 1 Class C classification is equivalent to ISO Class 7.
An important and often overlooked piece of work that should be thoroughly exhausted before specifying a cleanroom is to determine what size and number of particles can negatively affect your experiment, procedure or production.
ISO 7 Cleanrooms are used in almost every industry. Electronics manufacturers, advanced engineering, particularly those working with composites, Medical device manufacturing, for example, are all extremely sensitive to sub-micron particles.
The Pharmaceutical industries might use a GMP Class C or ISO 7 cleanroom for the filling of products or preparation of solutions that are unusually at risk of contamination.
The ISO 7 Cleanroom is the most commonly used classification. As it requires a lower number of air changes it is not as expensive to build and requires less energy to run when compared to the classifications below.
It requires an airlock at any entry point, control of both the air in and also the air out so as to be able to control the internal pressure which should be around +25 to +30 pascal. An ISO 7 cleanroom will go through 30-60 air changes per hour. An ISO 7 cleanroom can use numerous construction materials, hard wall, monobloc, PVC, Glass etc the main feature of these materials being that they are smooth and resilient to the most common detergents and so easy to clean.
Maintaining an ISO 7 Cleanroom requires extensive care. This is usually done with:
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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, well specifically focus on ISO 7 cleanrooms and their features, requirements, applications, and more.
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:
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.
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ISO 7 Cleanroom RequirementsTo 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, well 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 HourA 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 FiltrationA 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.
Airflow ControlIn 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:
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, its important to customize each cleanroom for its intended use.
If youre 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.
If you are looking for more details, kindly visit class 6 cleanroom.