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Does your cleanroom flooring remain ISO 14644-1 compliant after 10 years in use?

The choice of materials when designing a cleanroom is critical. These materials (including flooring) must guarantee the stability of production parameters and meet regulatory requirements for cleanroom classification (GMP, ISO Class).

Among cleanroom materials, flooring plays an important role, and several parameters need to be considered.

Product

Cleanroom flooring requirements

Airborne particles control ISO 14644-1 

Depending on the class to which the cleanroom belongs, high standards must be applied in response to ISO 14644-1, which involves counting the number of airborne particles released per cubic metre of air. The flooring must release a minimum quantity of particles below the required ISO class depending on the state of the cleanroom: at rest or in operation. For example, for a cleanroom GMP A classified, the level of particles must not exceed ISO 5 in use. The flooring choice will therefore need to be at a minimum of ISO 5 one according to ISO 14644-1.

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Biocontamination control ISO 846 

In a cleanroom, especially in the pharmaceutical industry, the level of biocontamination (bacteria, fungi, etc.) must be constantly monitored to prevent any risk of micro-organisms proliferation. This is why the materials selected by manufacturers for controlled environments must not facilitate the development of any form of biocontamination.

In our case, cleanroom flooring must not allow micro-organism growth on the surface. It is therefore important to ensure that the flooring chosen is certified by a third-party laboratory according to the ISO 846 standard, which measures bacterial and fungal growth (number of CFU) on the flooring surface over a period of 28 days. Logically, the flooring should not allow bacterial or fungal growth during the test period.

Resistance and durability

During the life of a cleanroom, flooring will be exposed to a wide range of constraints, such as: High traffic (pedestrian or mechanical), operating risks such as impacts or floor scratches, chemicals attacks or aggressive decontamination products (such as H202 for example). It will be important to define the requirements to which the flooring will be exposed so that it is adapted to the conditions of use and so to choose accordingly.

Watertightness

To guarantee that your installation is watertight, flooring must have a perfect connection at the joints between the rolls (hot welding) and at the floor/wall joint (coving system). Some systems, such as WCS (Watertightness Control System), allow you to check the watertightness of your flooring as soon as it is installed and throughout the life of the flooring, so that you can make any necessary repairs if you detect weaknesses that are impossible to see with human eyes (due to impacts or deep cuts).

Maintenance / Repairs

Flooring repairs can be tricky in a controlled environment, whether at rest or in use. Unlike Epoxy or polyurethane resins, vinyl solutions enable rapid repairs (hot welding for small repairs such as cuts or impacts) or easy replacement of the areas to be renovated with no shut down of production.

ESD properties

In the cleanrooms of certain pharmaceutical or electronics industries, it is recommended to install ESD (Electrostatic Discharge) flooring, either to prevent the risk of electrostatic discharge that could impact the product (semiconductor, printed circuit board) or the process (machine, electronics), or to protect people against the risk of fire/explosion (example: ATEX areas).

Depending on the ESD problem being addressed, it will be important to choose the appropriate ESD standard (IEC 61340, ANSI S20.20, EN14041, etc.), and therefore the flooring that meets it.

laboratoire

The Mipolam Biocontrol Clean, the only solution guaranteed ISO 14644-1 over several years in use

All flooring used in cleanrooms are tested by independent laboratories when freshly built to assess their level of particle release. However, after several years of use, particle release can increase significantly, after regular wear and tear due to traffic, and no longer meet the level of requirements needed in the cleanroom in question. Flooring choices should therefore consider the ageing of the floor to ensure it remains at the expected level.

 

That's why Gerflor developed Mipolam Biocontrol Clean in order to meet the most demanding cleanroom standards: GMP class A (ISO 3 tested by the Fraunhofer Institute in accordance with ISO14644-1).  As this test was carried out when the flooring was new, we extended the experiment by simulating 10 years of regular wear and tear on this particular flooring (using the wheelchair test method in accordance with ISO 4918), and re-tested the particle emission level again.

 

After 10 years of constant abrasion, Mipolam Biocontrol Clean achieves ISO 4 and remains compliant with GMP Class A requirements.

 

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Discover the GERFLOR cleanroom flooring ranges

Gerflor, the flooring group

Gerflor creates, manufactures, and brings to market innovative, decorative and eco-responsible complete solutions for resilient floors, wall coverings, and accessories, from installation to finishings for commercial environments.

 

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