Which gloves can be used to control contamination risks in the cleanroom?

Cleanroom gloves are one of several measures to control the risk of contamination in the cleanroom. Contamination can result in damage to health, but also to the economy.

The following article explains what you should look out for when selecting gloves to control the risk of contamination in the cleanroom.

What is contamination?

Contamination is defined as impurity caused by a foreign element, such as a particle, a microorganism or a chemical.

The particles that can contaminate the cleanroom are dust particles, skin flakes or fibers from employees’ clothing, for example. Particle contamination in the cleanroom is a question of how high the particle concentration of particles of a certain size is. The classification of the cleanroom into cleanroom classes, either according to the GMP or the ISO system, depends on this.

Microorganisms, another possible source of contamination, include bacteria, fungi, viruses and algae, for example. However, contamination by decay products of bacteria, known as endotoxins, must also be avoided.

Another type of contamination can be caused by chemical elements down to the molecular level. Chemical contamination can occur as particles but also, for example, as aerosols or gases.

ESD, i.e. electrostatic discharge, is not a harmful substance. Nevertheless, ESD is considered a contamination factor. This is because electrostatic discharges can damage or even destroy electronic components. But electrostatic discharges can also have further damage potential. For example, sparks caused by electrostatic discharges can ignite flammable or explosive substances.

You can also read our technical article: “How ESD disposable gloves work and what types are available“

Sources of contamination in the cleanroom include the employees, the environment, the furniture, the equipment and the materials and substances brought in, as well as other sources.

How can the risk of contamination be controlled?

In order to control the risk of contamination in the cleanroom, the right clothing is crucial, as is the correct way to wear cleanroom clothing. The use of cleanroom gloves is one element in keeping contamination in the cleanroom as low as possible. Depending on the application, doublegloving is even recommended.

In cleanrooms, nitrile gloves are used in particular, but there are also cleanroom gloves made from other materials such as latex, neoprene or vinyl.

You may also be interested in the following specialist article: “Nitrile gloves vs. latex gloves – why the trend is towards nitrile“

Standards for the evaluation and testing of gloves, for example

There are a large number of norms and standards that regulate the evaluation and/or testing of gloves. You will find a list of these standards below:

Regulation (EU) 2016/425
EN ISO 374-5:2016
EN 16523-1:2015 (replaces EN ISO 374-3)
DIN EN 455-3:2015-07
EN ISO 21171:2006
DIN EN ISO 11137-1:2020-04
EN ISO 10993-10:2013
DIN EN 16350:2014-07
IEST-RP-CC005.4
ASTM D6978-05(2019)

Choosing the right cleanroom glove

When choosing the right cleanroom glove, you should consider the following selection criteria, among others:

Recommended cleanroom class
Degree of cleanliness
Technical properties
Physical properties
Protective properties

Depending on the planned application, you need cleanrooms that fulfill a certain cleanroom class. The appropriate gloves for the required cleanroom class must be selected accordingly.

As cleanroom gloves should release as few particles as possible, they must not be powdered.

If it is necessary to wear sterile cleanroom gloves for the respective application, you should ensure that the cleanroom gloves have achieved a sterility assurance level (SAL) of 10-6 in accordance with ISO 11137-2:2015 during sterilization, as per the manufacturer’s guarantee.

When it comes to cleanliness, you should also make sure that the cleanroom gloves have an endotoxin content of < 20 EU/pair of gloves in accordance with EN 455-3:2015.

The packaging of the cleanroom gloves must also meet the requirements for the respective cleanliness level.

If you have applications where ESD protection is required, you must ensure that the cleanroom gloves you choose meet the requirements for the necessary ESD protection.

If gloves are intended to protect the wearer, you should look at the AQL value, where AQL stands for Acceptable Quality Level. To determine the AQL value, a water or air penetration test is carried out to detect micro-holes in the glove. The lower the AQL value, the higher the protection provided by the glove.

To ensure that the wearer is properly protected, you should also make sure that the gloves are long enough so that no skin remains visible between the gloves and clothing.

In principle, the equipment that forms part of the personal protective equipment (PPE) must meet the requirements of Regulation (EU) 2016/425.

Also read our product presentation “Halyard gloves for cleanrooms in focus: Purezero nitrile gloves“.

Advice on cleanroom gloves

If you require further information on gloves for controlling the risk of contamination in cleanrooms, you are welcome to consult our experts at abovo, the Swiss specialist wholesaler for cleanroom and ESD products. We can also help you select the right cleanroom gloves for your application.

The best way to contact our experts for cleanroom and ESD products is by telephone or e-mail: