Cleanrooms Standards

For a Cleanroom to be considered a secure environment, it must satisfy certain standards. For instance, it has to maintain exceptionally low levels of airborne organisms, dust, vapourised particles, and other particulates. In most sterile work environments, quality can make the difference between life and death. Because of this, regulatory compliance is important because it sets the standards for safe conditions.

Cleanrooms are classified according to the number and size of particles permitted per volume of air. The airborne contamination level of a given Cleanroom is dependent on the particulates in the room. If a room is empty, a very low particle concentration can be achieved which closely reflects the quality of air supplied by the high efficiency filter. If the room has production equipment in it and operating, there will be a greater particle concentration but the greatest concentrations will occur when the room is in full production.

At Total Clean Air, our Cleanrooms are built in compliance and strict adherence to Cleanroom standards both nationally and internationally. We only work with reputable manufacturers to provide certified equipment sure to meet any Cleanroom standards. Our Cleanroom solutions are ideal for addressing many of the industry’s manufacturing air quality challenges.

Modular Cleanroom Benefits

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

What Determines Cleanroom Standardisation and Classification

The equipment your facility needs is entirely dependent on the type of Cleanroom you are building. For some systems, only air filtration is necessary while others require an integration with security systems and climate control. Some Cleanrooms need bacteria and other micro-organisms to be contained, while others are looking to manage flammable dust and other materials.

The purpose of the Cleanroom also needs to be considered. For example, it is not necessary to achieve the same level of air tightness found in a semiconductor Cleanroom in a food processing Cleanroom. This is because activities in a semiconductor Cleanroom require working under positive pressure, as it is a zone where biological and chemical hazards can occur.

There are different standards Cleanrooms must follow which are set by different bodies. They include:

  • EU GMP classification: The guidelines here are stricter than others as they require Cleanrooms to satisfy particle counts when at rest (which is when there are no manufacturing processes being carried out) and at operation (which is when manufacturing is ongoing).
  • ISO 14698:2003 Cleanrooms and associated controlled environments—Biocontamination control Part 1 and 2 and ISO 14644 Part 1-15 Cleanrooms and associated controlled environments. These are standards developed by the International Organisation for Standardisation and they represent the highest form of standards in every industry.

The ISO 14644-1: 2015 is the latest standard for cleanroom classification and classifies cleanrooms into 9 different classes (ISO 1-9) which are determined by air particulate size and quantity allowed in a Cleanroom for each classification.

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

Ways to Maintain Cleanroom Standards

Modern Cleanrooms are becoming much more advanced due to advancements in airflow, monitoring, filtration, and other technologies. By utilising these technologies, Cleanrooms can easily achieve ISO standards and reduce potential damage caused by nanoparticles and microorganisms. Many particle sources and different product requirements are observed prior to planning a clean environment.

It is necessary to perform tests that demonstrate the absence of leaks in ceilings and walls, secondary barriers of the containment area, and to design with double sealing of all panels, utility, electrical and mechanical penetrations, light fixtures and filter assemblies. In addition, doors may require inflatable joints and drains may require hydraulic seals.

Cleanroom technology such as HVAC systems which control air quality, pressure, temperature and humidity should be employed. These functions have controlled parameters which must be met for the Cleanroom to function correctly. Air quality, temperature, and the presence of foreign objects can all be detected remotely, minimising efforts to maximise results.

Total Clean Air for a Guaranteed Secure Environment for Your Critical Processes

Insisting on high standards for your Cleanroom environment is a necessary step in order to achieve better results. At Total Clean Air, we are always seeking out ways to improve the standards of our controlled environments for the preservation of your critical processes and the safety of everyone involved.

Our Cleanroom solution reduces costs, increases efficiency, and enhances working conditions.

phillip.godden
Phillip Godden

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

Working Hours

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  • Tuesday 08:00 - 19:30
  • Wednesday 08:00 - 19:30
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  • Sunday 08:00 - 19:30