ISO Class 8 Cleanroom

ISO Class 8 cleanroom is one of the most popular cleanroom applications used in many industries, such as aerospace, automotive, pharmaceutical and research. Prior to the International Standards Organisation’s (ISO) adoption of global cleanroom standards and classification, the US FS209E was applicable worldwide.

FS209E features six classes, while the ISO 14644-1 added two cleaner and one dirtier standard. Class 1 is the cleanest cleanroom in FS209E, while Class 9 is the dirtiest. Classification is based on the amount of specific sized particulates per cubic metre. ISO Class 8 equals Class 100,000 under FS209E.

Particulate contamination changes over time, from the moment of construction, installation of equipment and use of the facility. ISO has three cleanroom standards: as built, at rest and operational.

Modular Cleanroom Benefits

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

ISO Class 8 Cleanroom particle count

The micrometre (µm) is the basis of any cleanroom standard, referring to the size of particles to be filtered from the cleanroom. As stated previously, cleanroom classifications are based on the size and quantity of particles per volume of air.

Some classifications (such as an ISO Class 8 cleanroom) do not require certain particle sizes to be tested, either because concentration levels are too high or low to be tested, but it cannot be zero. For ISO Class 8, particles smaller than 0.5 µm aren’t considered. The concentration of particles that are ≥0.5 µm should be below 3,520,000.

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

ISO Class 8 Cleanroom industry requirement standards

Cleanroom performance requirements are delineated at three levels of condition for testing and characterisation of performance.

As built: This refers to an empty cleanroom with the filter system running. There is no equipment or workers present in the room. The cleanroom has never been used and is at its cleanest in this state.

At rest: Once equipment and products are added to the cleanroom, it is then referred to as ‘at rest’. Humans have entered the room, but it hasn’t been tested. The room is not as clean as ‘at built’ and may be rated ISO 6.

In operation: Once the cleanroom has been tested for performance requirement, benchmarked and documented, the cleanroom rises to ‘at operational’. Now, the cleanroom is used for the purpose it was created, with human traffic and equipment present within. Humans and processes contaminate the cleanroom environment, so this the dirtiest time for a cleanroom. Corrective steps will be taken if contamination in the operational state is not in compliance with ISO Class 8 requirements.

Air change rates for ISO Class 8 Cleanrooms

Air change per hour (ACH) is a critical factor in cleanroom design. It describes the number of times that filtered air replaces the existing volume in the cleanroom. Depending on the usage and classification, ACH occurs from 10 to 600 times per hour.  For ISO Class 8 cleanrooms, ACR is 5 to 48 times per hour.

It is the major factor that determines ISO cleanliness standards. Subsequently, ACR must be properly measured and controlled to meet optimal standards.

There is some confusion at present, as the ISO appendix only addresses the application for microelectronic facilities from ISO Classes 6 to 8. It doesn’t contain ACR standard for healthcare, pharmaceutical or biotech applications that also require higher ACR regulations.

Total Clean Air specialists can advise the right ACR range to use for cleanliness classification. To do so, we take into account the number of cleanroom personnel, frequency of access, internal equipment, the effectiveness of garbing protocol and cleanroom application. This helps us determine the best way to keep out contaminants and control any contamination generated inside the cleanroom.

Correct gowning procedure for ISO Class 8 Cleanroom

Gowning protocol is dependent on cleanroom application and class. Proper cleanroom gowning supply is essential to contamination control. The requirements for ISO Class 8 cleanrooms include:

  • Woven gloves: gloves must cover the cuff of the sleeve
  • Inner suit
  • Hair cover
  • Hood: ensure neck/face seal are not exposed when putting a hood over the mask
  • Frock
  • Powered headgear
  • Barrier gloves
  • Face cover: bend nosepiece for mask to fit on the face
  • Coverall: make sure upper garment and sleeves do not touch any objects when stepping into a coverall
  • Boot cover: place over legs of coveralls
  • Shoe covers: place over the entire shoe
  • Special footwear

After each day’s usage, of gowns and garments should be disposed upon exit and entry for the cleanest cleanrooms. This applies twice a week for those with non-stringent requirements. When exiting the cleanroom compounding area, all garbs – with the exception of washable cleanroom gowns – must be disposed of properly.

Call us today for your ISO Class 8 Cleanroom, equipment and garments

Total Clean Air is a leading UK expert in the design and construction of ISO Class 8 cleanrooms. We offer an extensive range of hardwall cleanrooms, softwall cleanrooms, cleanroom equipment, consumables and furnishing.

phillip.godden
Phillip Godden

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

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