Total Clean Air products are reliable, safe, and of outstanding quality. Our ISO certification backs up our service delivery standard and provides strong performance credibility.
The primary authority on clean room classification standards is the International Organization for Standardization (ISO), which is the global representation of national standard bodies. The ISO is a non-governmental group with its headquarters in Geneva.
ISO implies equal representation by member nations and is made up of more than 160 countries, with each represented by its standard body. The United Kingdom Accreditation Service (UKAS) is the standard body representing the UK.
To decide on best practices, ISO’s member subject experts come together to form a committee. After two sessions comprising a draft standard and a draft vote, a FDIS (Final Draft International Standard) is then created. If the FDIS is approved from the central secretariat, it is then published as an official international standard.
Modular Cleanroom Benefits
- Modular Construction
- Quick Assembly Time
- Airflow Control
- Inexpensive Modifications
ISO and Cleanrooms
Cleanrooms are built to meet cleanliness classification levels, dependent on the industry in question. It’s important to match industry type to a specific cleanroom model. This is because different industries work with different levels of air purity.
Manufacturing and assembling electronic components within the electronic industry depends critically on cleanrooms. Biotech and Pharmaceutical companies deploy ISO Class 5 to ISO Class 8 to avoid particulate contamination. Medical companies work with ISO Class 7 and ISO Class 8 to avoid surface contamination. Food industries ultimately depend on secure cleanroom environments for food safety.
Cleanroom industry requirements fall under ISO 14644-5:2004 – an ISO category that lists the basic requirements for cleanroom operations.
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
How To Determine A Cleanroom Classification
Cleanrooms are classified based on the level of air cleanliness. Cleanroom classes cover the range of ISO 1 to ISO 9. An ISO 1 is the cleanest, whereas an ISO 9 is the dirtiest status for cleanroom standards.
Analysis shows there are about 500,000 to 1 million particles per cubic feet of air. To measure contaminants found in the cleanroom, the standard deployed is a micron or micrometer (μm) Micron measurement represents the cleanroom standard size for contaminants.
A micron is equivalent to one-millionth of a metre. A micron is smaller than a living cell and can only be seen by a powerful microscope. A dust particle is about 60 microns, while the size of a bacterium is roughly 2 to 10 microns.
Modular Cleanroom Services
- Design & Build
- Free Site Survey
- Free Design Service
- Cleanroom Planning
- Construction and Installation
- CNC Engineered
- Training & Support
- Discounted Service Contracts
- Remedial Works
- Panel Repairs
- BMS Management
- Cleanroom Certification
- Differential Pressure Qualification
- Servicing Testing Validation
- Smoke Testing
- DOP Testing
Particle size within a Cleanroom
A cleanroom is categorised based on the level of air cleanliness within its space. This categorisation is measured on particle size and quantity per air volume (number of air contaminants per cubic metre). It must be determined whether a specific size of the contaminant particle or various particle sizes need to be filtered from the cleanroom.
If there is a request for less than 100 particles per square foot in a cleanroom, the ISO classification will be an ISO 5 (or Class 100). The former Federal Standard 209 featured class numbers which are still being used. It is abbreviated to FS 209. Find below ISO classifications and equivalent FS 209 class numbers.
- ISO 3 represents class 1
- ISO 4 represents class 10
- ISO 5 represents class 100
- ISO 6 represents class 1,000
- ISO 7 represents class 10,000
- ISO 8 represents class 100,000
ISO classes are represented in cubic metres of air, while cubic feet are the unit calculation for FS 209.
- ISO 4-9
- ISO 14644
- Low Power Consumption
- Environmentally Friendly
- HEPA Filters
- Air Filtration
- Fan Filter Units
- Cleanroom Ceiling System
- Temperature Control
- Access Control
- Inter Lock Door Systems
- Air Showers
- Unidirectional Airflow
- Desiccator Cabinets
- Horizontal Flow Wall Modules
- Horizontal Laminar Flow Clean Benches
- Laminar flow cabinets
- Laminar Flow Canopy
Source of Contamination
There are three sources of cleanroom contamination:
Contamination brought into the Cleanrooms by workers: personnel still bring small amounts of contaminants into the cleanroom. Cosmetics are not encouraged in the cleanroom, as they can be responsible for contaminant particles of silicon or sodium. There should be strict enforcement of cleaning procedures – especially for the ISO 7 cleanroom classification. An ISO Class 5 is designed not to tolerate more than 3,520 particles equal or larger than 0.5 microns per cubic metre of air. Notebooks and pens specially made for cleanrooms should be used only to reduce contaminants.
Industry type work Process: contamination caused by the ongoing industry work process (manufacturing, health or pharmaceutical) also affects airflow.
Cleanroom operational layout is important: the placement of systems and equipment can affect airflow, with poor positioning of filtration systems leading to a build-up of contaminants, which in turn can bring about poor ISO classification; for instance, ISO classification depreciation from an ISO 7 to ISO 8 and an ISO 8 to an ISO 9.
ISO classifications and FFM ceiling space allocations
There is a direct relationship between ISO classification and Fan Filter Modules (FFMs) housed in cleanroom ceilings. Additional FFMs improve ISO classifications.
An ISO Class 8 has roughly 5 to 15% of its ceiling space made up of FFMs. Introduce additional FFMs that have 15 to 25% ceiling space for an improvement to an ISO 7 Class. Introduce more FFMs with a 25-40% ceiling space allocation and an ISO Class 6 is created.
FFM allotment for ISO classes include:
ISO Class 1
Electronic and life science industries utilise ISO Class 1. Industrial processes make use of ultra-fine particles and nanotechnology. FFM ceiling coverage in an ISO class 1 is 80 to 100%.
ISO Class 2
A ceiling FFM space coverage of 80 to 100% is required.
ISO Class 3
ISO Class 3 requires FFM space coverage of 60 to 100%.
ISO Class 4
A ceiling FFM coverage of 50 to 90% is required.
ISO Class 5
A room FFM ceiling coverage of 35 to 70% is required.
ISO Class 6
An FFM ceiling coverage of 25 to 40% is required for an ISO Class 6.
ISO Class 7
A ceiling FFM of 15 to 25% is required for an ISO Class 7.
ISO Class 8
An FFM ceiling coverage of 5 to 15% required for ISO Class 8
For more information
Reach out to Total Clean Air today to discuss your needs.
We have experienced Technical Sales Representatives who are available 24/7 to answers your queries.