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

Reminder of the essential flooring properties to be taken into consideration in cleanroom environments.

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 materials, flooring play 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 release per cubic meter 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 be at minimum an 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-organisms growth on their 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 flooring surface over a period of 28 days. Logically, the flooring should not allow bacterial or fungal growth during the test period.

Particular decontamination ISO 4628-1 &-2

70% of residual airborne particles in the air end up on the floor (after air treatment). This means that the floor must be easy to clean and decontaminate towards particles to avoid any risk of biocontamination.

It is therefore critical to ensure that the flooring selected has no residual particles on its surface after cleaning. Riboflavin test according to ISO 4628-1 & -2, done by a third party laboratory, provides proof that flooring top layer can be easily cleaned of particles.

One of the leading worldwide institute for cleanrooms certification devices.

Cleanroom Certification - Fraunhofer IPA

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 polyurethan 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 (Electro Static 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.

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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 choice 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 / 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 constant abrasion, Mipolam Biocontrol Clean remains ISO 4 and so compliant with GMP Class A requirements.

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