Our Social

Why internationally recognised cleanroom standards matter

The cleanroom industry is controlled by international standards and certifications that govern environmental cleanliness – to operate successfully in the sector, understanding and conforming to these regulations is critical

Conversations with our customers in different geographical regions highlight the complexity and depth of regulations that apply to the cleanroom sector.

As strict cleanliness levels are required for the manufacture of products such as pharmaceutical, or sensitive electronic items, global and local standards have emerged to meet this demand.

Without internationally recognised cleanroom standards such as ISO 14644, it would be impossible for different organisations across multiple regions and industries to work together and maintain the required cleanliness levels.

Our Q+ cleanroom wipes, robot covers, face masks, and protection products help to secure clean environments. Q+ consumables have been developed to protect the integrity of the cleanroom from sources of potential pollutants and particles brought into the environment by human operators – and (like other players in the cleanroom industry), we rely on internationally recognised standards to do this effectively.


The US federal standard FED-STD-209E is focused on the measurement of airborne particles in clean environments and classification of different cleanliness levels. This was officially cancelled in November 2001 by the General Services Administration and superseded by ISO 14644, which was defined by the International Standards Organisation (ISO).


The older FED-STD-209E standards for cleanroom environments are aligned with the ISO Classification. For example: ISO Class 5 cleanroom according to ISO 14644-1, aligns perfectly with Class 100 of FED-STD-209E classification. For particles bigger than 0,5µm, both permit a maximum of 3,520 particles/m3, which corresponds to 100 particles/cubic foot. This is the same for all cleanroom classifications across FED-STD-209E/ ISO 14644, allowing a simple comparison and transition between the new and superseded standards.

The ISO 14644 series of standards covers all aspects of the cleanroom environment, from design, construction and validation through to operations and the classification of different contaminants in the space.

Today, even if ISO 14644 are the only officially, globally recognised standards – US FED-STD-20E cleanroom grades are still used and referred to by some in the cleanroom industry.

ISO vs FED STD 209 standards
A chart to show how the differing international standards are aligned


The Good Manufacturing Process (GMP) standards focused on pharmaceuticals manufacturing. These are regulated/edited by the European Medicines Agency in the EU and the Food and Drug Administration in the US.

Further examples of standards that have emerged regionally and also to cover specific industries are Japanese standards, JIS B9920. The global semiconductor industry cleanroom standards, SEMI F21 and United States Pharmacopeia (USP) standards for medicine, food and dietary supplements.

IEST-RP-CC004.4, published by the Institute of Environmental Sciences and Technology details recommended practice and describes methods for evaluating cleanliness and functionality of wipes used in cleanrooms and controlled environments.


Gekatex Q+ cleanroom consumables are designed, engineered and controlled in Europe and manufactured to ensure minimum contamination. The entire process takes place in-house – this means that our products are both, fully customisable and fully traceable. Extensive quality control allows us to supply most products with a certificate of analysis, ensuring product cleanliness.

Our cleanroom wipes are produced in three cleanliness levels, and are tested using a liquid particle counter according to IEST-RP-CC004.4, section 7. There is no existing standard advocating wipes cleanliness to be used in any specified cleanroom level. Our expertise enables us to advise our customers on the following specifications:

ISO 7/6 – EU GMP B

ISO 4/5 – EU GMP A

ISO 3/4 – EU GMP A

We provide wipes for cleaning and disinfection procedures and our on-site ISO 14644, ISO 7 certified cleanroom – means we can work with you to create on-demand solutions, including using your own chemicals in bespoke presaturated wipes. Our mops can be used to clean all of the larger surfaces and our swabs are ideal for cleaning hardly accessible place, or taking samples for biological analysis.

Find out more about our Q+ cleanroom consumables here

Contact us to speak to one of our experts!

Our Social