ISO Class 5 Cleanroom

What is a cleanroom?

The ISO defines a cleanroom as a room within which the number concentration of airborne particles is classified and controlled. The design, construction and operation must work to control the generation, introduction and retention of particles within the cleanroom.

It is a controlled environment where the concentration of airborne particles is reduced to the specified limits of the cleanroom’s classification. Contaminants are introduced or generated through the introduction of human, equipment and processes performed within the cleanroom.

It is impossible to prevent the release of all airborne particles in the cleanroom. Hence, an air system such as a HEPA filter or ULPA filters works to remove contaminants and airborne particles according to the required standard for classification.

Modular Cleanroom Benefits

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

What is a cleanroom classification?

Cleanrooms are classified based on the level of clean air inside the cleanroom. Cleanrooms are also classified based on the sizes and number of particles allowed per volume of air. Large numbers such as class 1000 or class 100 refer to FED-STD-209W and describe the number of particles of sizes not larger than 0.5um per cubic foot of air.

There’s been an increased trend of change in the past few years to ISO classification systems in ISO 14644-1 from the previous systems used.

The cleanroom classification depends on several factors such as the type of industry, size of particles to be filtered out, sources of contamination and the amount of air in circulation to filter out contamination.

The primary authority in the UK is the ISO classification system 14644-1. It includes the cleanroom class ISO 5. Prior to the ISO, the US Federal Standard 209 was used but withdrawn in 2001. There was a need for a new international standard. The ISO set up several working groups and a technical committee to define its own set of standards. Cleanrooms in the UK must comply with EU gGMP, national and industry-specific standards.

FS209E comprises six classes and ISO 14644-1 adds one dirtier standard and two cleaner standards. Class 1 is the cleanest cleanroom in FS209E and class 100,000 is the dirtiest. ISO class 5 equals 100 in FS 209E. References to FS209E remain in use among certain brands and industries.

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 5 cleanroom classification

Organisations usually measure micron sizes 0.5U and 0.3 for ISO class 5 cleanroom. Required air changes per hour are 240-580 and EU GMP is A/B.

ISO class 5 cleanrooms are at the critical end of the cleanroom class and require more filtration levels to achieve the desired level of cleanliness. ULPA filtration of 99.9995% efficient at 0.12 micron should be considered.

Monobloc and hardwall cleanroom constructions are the best for achieving an ISO class 5 environment. Companies working towards GMP grades should consider monobloc as a solution because it accommodates required features like coved floors and interlocked doors.

Total Clean Air has designed ISO class 5 cleanrooms for a range of organisations in industries such as aerospace, engineering, healthcare laboratory and more. Our modular hardwall cleanrooms are ideal for clients who want to expand their operations to offer more products and services to their customers.

Your ISO class 5 cleanroom is also ideal for carrying out scientific testing and analysis, especially for processes where contamination compromises the results. Total Clean Air can build a mini-environment to change your existing cleanroom from a class 7 or class 8 to a class 5.

We consider future expansion needs in our cleanroom design to ensure that you enjoy the flexibility of adapting the existing cleanroom space to fit future needs. Our engineers design a dedicated area for each process, ensuring it meets the requirements. We can build a custom installation for you that features a control system that allows you to control your ISO class 5 cleanroom through a touchscreen interface.

We offer a fully managed service that includes planning, budgeting, design, manufacture, installation, validation and training of cleanroom personnel. Your hardwall cleanroom could include custom fitting such as benching, LFU areas, laminar flow areas, a goods and change area, air conditioning, transfer bench, integrated Trespa benching with lab sinks and gowning area to ensure compliance with ISO class 5 protocols

Cleanroom classification particle count

The size of particle counts to be filtered out is one of the most crucial factors to consider when constructing an ISO class 5 cleanroom. As earlier stated, the classification of cleanrooms depends on the cleanliness of the air based on the size and quantity of particles per volume of air.

For instance, if you need less than 100 particles per square foot, they determine a classification of an ISO 5 or class 100 cleanroom. If you do not consider the size of the particle to be filtered out, issues might arise.

phillip.godden
Phillip Godden

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

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