ISO Class 6 Cleanroom

For a cleanroom to be considered ISO class 6 in terms of air cleanliness, users of the room need to access it via an ISO 8, then pass through an ISO 7, before entering the ISO 6 environment. The anteroom will serve to preserve pressurization differentials between areas that possess dissimilar cleanliness class. The number of airlocks needed before being able to enter the ISO 6 clean room will be determined by the size and dimensions of the room.

Sensitivity of the process taking place within the cleanroom as well as number of equipment and people in the room, and other related factors, will also be taken into consideration. In order to reach ISO 6 classification, unidirectional airflow may be recommended. This must deliver 90 to 180 air changes per hour. For an ISO 7 or ISO 8 cleanroom, 30 to 60 air changes per hour and 15 to 25 air changes per hour respectively will be required. This is in line with ISO 14644-1 Cleanroom Standards

Modular Cleanroom Benefits

  • Modular Construction
  • Quick Assembly Time
  • Versatility
  • Reconfiguration
  • Airflow Control
  • Inexpensive Modifications

What is cleanroom classification?

Cleanliness level of the air within a cleanroom is what is used to determine classification of the room. Cleanroom class is what level of cleanliness has been attained and is being maintained in the room. This is determined by size and quantity of particles per volume of air in the cleanroom.

ISO 14644-1 is the ISO classification system typically referred to in the US and Canada. This standard dictates cleanroom classes from ISO 1 to ISO 9. According to this system of classification, ISO 9 is the “dirtiest” class while ISO 1 is the “cleanest”. Even though ISO 9 is considered to be the “dirtiest”, it is still cleaner than a regular room. Cleanroom class found in operation in most industries are ISO 7 and ISO 8.

Asides from these general standards, a cleanroom’s cleanliness also has to be in accordance with applicable regional and industry-specific standards. For instance, USP (795, 797 and 800) specifically applies to compounding pharmacies, and EU GGMP (A-B-C-D) applies to pharmaceutical products.

Cleanroom Design, Build & Validation

  • Budgeting and planning
  • Engineering, design & layout
  • Airflow and filtration design
  • Construction and Installation
  • Full Certification of our product
  • Industry-specific equipment installation
  • Validation

Considerations for ISO class 6 cleanrooms

Among all the cleanroom types, Hardwall Cleanrooms are the most effective for achieving the standards required for ISO class 6. Our Modular cleanrooms can also help with achieving this.

In order to achieve ISO class 6, the use of HEPA (High Efficiency Penetration Air) Filters are also recommended. This is because a HEPA filter can help you achieve 99.99% filtration at 0.3 microns.

Using HEPA Filters to Achieve an ISO class 6 cleanroom

HEPA (high-efficiency particulate air) filters are the most popular option in terms of filter choices. They filter out 99.99% of particles 0.3µm or larger. When maintained properly and in the right environment, these filters can last for 7 years or more before they need replacing.

How frequently a HEPA filter should be replaced will vary from cleanroom to cleanroom. Some of the factors that will influence the lifespan of a HEPA filter are temperature, humidity, and air pressure levels in the cleanroom.

It is important that a filter be tested at least once every two years for leaks. If significant leaks are found, the filter may be repaired. Where repair is impossible, the filter will have to be replaced.

At Total Clean Air, we install, manage and repair HEPA filters. We also run tests to ensure the filters are working efficiently. If during the test the filter is found to be below specified efficiency standards, Total Clean Air engineers can restore your filter onsite.

DOP Testing to Keep Your HEPA Filter at Optimal Performance

When it comes to maintaining an ISO 6 class cleanroom environment, air cleanliness is measured by using a particle counter to take count of airborne particles. A smaller particle amount means cleaner air which in turn points to a higher class cleanroom.

Filter integrity testing or Dispersed Oil Particulate (DOP) testing is a form of assessment that is used to verify the integrity and performance of an installed HEPA filter. The testing involves constantly introducing particulates to the HEPA filter and measuring the output.

During the test, oil is dispersed into the upstream flow of the filter media as an aerosol. The amount of particles occurring in the downstream flow will then be measured with the aid of a calibrated photometer.

Contact Total Clean Air for Your ISO Class 6 Cleanroom

At Total Clean Air, our priority is the success of your cleanroom project. We are ISO 9001:2015, ISO 14001:2015, and OHSAS 18001:2007 accredited, which means our CTCB-i trained and qualified engineers are more than capable of designing, installing and maintaining your ISO Class 6 Cleanroom.

phillip.godden
Phillip Godden

Phillip Godden is the Founder & Chief/Executive Officer at Total Clean Air.

Working Hours

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