Boxed gloves not for the cleanroom – only gloves in PE film
Latex or nitrile gloves from the dispenser box do not belong in the cleanroom, as the cardboard packaging alone releases too many particles. The right solution for the cleanroom are nitrile gloves or gloves made of another material such as latex, which are double-packed in PE protective bags, i.e. protected from contamination by polyethylene film.
Cleanroom classes are based on the particle concentration
A cleanroom is defined as one in which special measures are taken to minimize the amount of airborne particles. Cleanrooms are divided into different classes depending on the maximum permissible particle concentration per cubic meter.
However, depending on the industry, there are different systems for defining the respective classes: the GMP class system and the ISO class system.
The so-called GMP class system for classifying cleanrooms is primarily used in the pharmaceutical, medical technology and cosmetics industries. According to this system, there are four classes, which are indicated as GMP A, GMP B, GMP C and GMP D. In some cases, there are also from-to indications, such as GMP C-D, which indicates that the product in question is suitable for both GMP C and GMP D cleanrooms.
The GMP classification is regulated in “Annex 1 to the EC Guide to Good Manufacturing Practice”.
In addition to the GMP classification system, there is also the ISO classification system. The ISO system is used to classify cleanrooms in the semiconductor and aerospace industries, for example. There are 9 ISO classes, some of which also include from-to specifications, such as ISO 4-9. In the latter case, the product labeled in this way would be suitable for cleanrooms of classes ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9. The ISO classification is also regulated in writing, namely in “DIN EN ISO 14644-1:2015”.
You can find a tabular overview of the different cleanroom classes of the GMP and ISO system in our article “The right cleanroom clothing for every cleanroom class“.
Nitrile gloves from the box not suitable for the cleanroom
Disposable latex or nitrile gloves are not only sold individually removable in dispenser boxes in retail outlets such as drugstores. Even for professional applications, disposable gloves are still supplied in cardboard dispenser boxes. One example of this is the popular
The packaging box alone can release particles into the gloves and the environment, which can cause contamination that is undesirable in the cleanroom. Repackaging these gloves from the cardboard box into cleanroom-compatible plastic bags is not sufficient unless the gloves are sufficiently cleaned.
The release of particles is even greater if the gloves are then removed from the paper box or cardboard box before actual use.
Cleanroom nitrile gloves double-wrapped in polyethylene
Cleanroom gloves should only be used if the gloves meet the corresponding particle specifications for the cleanroom according to the GMP or ISO classification systems commonly used in Switzerland. Contamination of products manufactured in the cleanroom can damage people’s health or even cost their lives. Contamination in the cleanroom can also lead to expensive production downtime or the devaluation of products manufactured there.
As a general rule, gloves for the cleanroom should be double-wrapped in polyethylene (PE) film to minimize contamination by particles and microorganisms – such as bacteria, viruses and fungi. Only double-wrapped gloves should be brought into the cleanroom.
Although there are also gloves made of other materials for cleanrooms, such as latex gloves, the trend in cleanroom gloves is towards nitrile gloves.
Related article: Nitrile gloves vs. latex gloves – why the trend is towards nitrile
The CELOS Gl ove 1.10 nitrile glove, for example, is packaged twice in PE film, with 100 gloves in a PE protective bag, which in turn are packaged in PE bags. This means that the CELOS Glove 1.10 nitrile glove is double underpacked for cleanroom use; sealed under vacuum. This CELOS glove is recommended for cleanroom classes ISO 4-9 or GMP C-D.
CELOS is a brand of pure11 GmbH, which is abovo’s cleanroom partner from Germany.
Buy cleanroom gloves online at abovo
You can buy double-wrapped cleanroom gloves in the abovo online store. In addition to the double-wrapped nitrile glove “CELOS Glove 1.10“, you will also find other suitable cleanroom gloves at abovo, such as the nitrile gloves PUREZERO HG3 from the manufacturer HALYARD, which are also available as sterile versions and, above all, in large quantities.
If you have any questions about gloves for cleanrooms, simply contact our experts by e-mail or phone– free of charge and without obligation, of course.
