GMP and Pharmaceutical Flooring: Epoxy VS Vinyl?

GMP and Pharmaceutical Flooring: Epoxy VS Vinyl?
GMP and Pharmaceutical Flooring: Epoxy VS Vinyl?

Factories producing food, health, and pharmaceutical products are mandated to comply with all requirements announced in GMP (Good Manufacturing Practice) regulations. The purpose of complying with these regulations is to ensure the production of quality and healthy products and to protect consumer rights. In the GMP regulations, detailed instructions have been introduced by categorizing different parts of the factory based on the sensitivity of production operations in it, regarding production stages, building specifications, personnel coverage, equipment, etc. In GMP regulations, in the description of the characteristics of the suitable flooring for the pharmaceutical factory, these characteristics are specifically mentioned:

1- Floor covering complying with GMP regulations must be washable.
2- Floor covering complying with GMP regulations must have a completely smooth and non-porous surface.
3- Floor covering complying with GMP regulations must be without any seams and cracks and can be disinfected.

GMP regulations and pharmaceutical factory flooring: epoxy flooring or PVC flooring?

Today, the two main categories of epoxy flooring and PVC vinyl flooring (roll and tile) have become the main choices in these factories.

But what is the degree of conformity of these two floors with the specifications included in GMP?


Pharmaceutical Flooring Systems: epoxy and vinyl flooring

1- PVC roll and tile flooring

In recent years, the use of vinyl PVC flooring, mainly in roll form, has increased in pharmaceutical factories. Rolled vinyl floor coverings are produced in specific dimensions and are cut according to the room dimensions at installation time and attached to the floor using glue.

To create a seamless flooring the joints of the PVC flooring are welded. Also, by using plastic cornices the joint between the floor and the wall would be in curved form, and all the areas with the 90-degree angle will be removed. Therefore, despite the time-consuming installation and the need to use a skilled contractor familiar with GMP considerations, efforts are made to make this flooring comply with GMP standard requirements as much as possible.
However, according to these regulations, the surface of the flooring must be smooth (the surface of PVC roll flooring is textured) and also show proper chemical resistance against detergents and disinfectants. Despite of not having high chemical resistantce and having a textured surface, using PVC roll floors in areas with less sensitivity and light traffic is acceptable. But it is sometimes observed that roll flooring is used in production halls with forklift traffic and the possibility of heavy objects falling, as well as places that require regular daily washing due to its relatively reasonable prices.
Factors such as water penetration under the flooring and its glue dissolving, low mechanical strength against the heavy traffic load of the forklift, and lack of sufficient adhesion strength to the substrate in heavy applications (falling of objects) lead to PVC roll flooring torn and even separated from the substrate. These all can make health problems and maintenance costs.


2- Epoxy resin flooring for Pharmaceutical Facility’s Floor

Another product that is widely used in clean rooms, production halls, and even pharmaceutical warehouses is one type of resin flooring, epoxy flooring. The reason for using this product for various uses (both in terms of compliance with GMP and in terms of the variety of required strength) is its unique features and properties.
Epoxy flooring is applied in different layers and as a result different thicknesses. The final thickness of the flooring affects not only the price of the product but more importantly, its final strength. This product can be used as a waterproof floor covering in very light applications or as a multi-layer self-leveling floor (with a thickness of a few millimeters) in heavy applications (such as a warehouse).

Epoxy flooring is a two/three-component liquid product, that is applied to the substrate during installation after mixing the components. Therefore, this product does not have predetermined dimensions and creates a seamless surface. There is no need to use glue in the installation of this flooring, and the product forms the new floor of the building. Therefore, there is no space between the flooring and the underlying surface, and the possibility of accumulation of pollutants and pathogens in this space is eliminated. Also, at the junction of the floor and the wall, all ninety-degree angles have been removed, and there will be no need to use PVC cornices. Due to its chemical nature, epoxy flooring has desirable chemical resistance against a wide range of disinfectants, and due to its high wear resistance, it creates a dust-free and completely hygienic environment following GMP principles.

But why despite these positive features of epoxy flooring the use of this product in pharmaceuticals has been questioned?
The most important reason for the dissatisfaction of the technical experts of pharmaceuticals is the cracking of the epoxy floors used.

what factors cause cracking of the flooring, which is very common in heavy industrial applications due to its high strength?


Epoxy Flooring and Its Benefits in Pharmaceuticals

1- One of the most important reasons for this problem is the incompatibility of the end use and the service conditions with the type and amount of epoxy flooring materials used. In many of these cases, the amount of materials used and the thickness of the epoxy flooring did not fit with its final application; and as a result, the flooring (or its underlying surface) suffered cracks. The article "How to calculate and measure the proper thickness of epoxy flooring?" is suggested to read.
2- But another reason is building structure and infrastructure. Many pharmaceutical factories have suffered settlement due to the old structure. As a result of the settlement of the structure, the flooring, which is now a part of the building's flooring, has settled in some areas and due to the integrity of its surface, the flooring has cracks.

All in all, it can be concluded that the use of vinyl roll flooring in light traffic (people traffic) in parts of pharmaceutical factories where there is no need to wash the floor daily is possible under the condition of compliance with GMP considerations. Also, the use of various types of resin flooring (epoxy flooring) in heavier uses, careful examination of the flooring conditions and action to correct it before installing the flooring will ensure hygienic, durable, and GMP-compliant flooring.
  • Date of Release:8/10/2022
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