The right cleanroom clothing for every cleanroom class
Depending on the cleanroom class, it is advisable to use cleanroom clothing suitable for the respective class in the cleanroom. When cleanroom garments are offered, the recommendations for which cleanroom class these garments are suitable are usually included. The following article deals with the question of how a suitable garment concept can be developed for the respective cleanroom.
Cleanroom classes
Cleanrooms are divided into different classes depending on the maximum permissible particle concentration (perm3), with different class systems depending on the industry. The so-called GMP class system is used in particular for cleanrooms in the pharmaceutical, medical technology and cosmetics industries, while the ISO class system is used for cleanrooms in the semiconductor and aerospace industries, for example.
The ISO classes are set out in the “DIN EN ISO 14644-1:2015” standard. The GMP classification can be found in “Annex 1 to the EC Guide to Good Manufacturing Practice”.
The GMP system recognizes four classes, which are designated A, B, C and D:
| Particles ≥ 0.5 μm (idle state) | Particles ≥ 5.0 μm (idle state) | Particles ≥ 0.5 μm (operating state) | Particles ≥ 5.0 μm (operating state) | |
| Class A | 3520 | 20 | 3520 | 20 |
| Class B | 3520 | 29 | 352 000 | 2900 |
| Class C | 352 000 | 2900 | 3 520 000 | 29 000 |
| Class D | 3 520 000 | 29 000 | not specified | not specified |
The ISO system recognizes nine classes, which also differ in terms of the maximum permissible particle concentration (perm3).
The following table provides an overview of the different ISO classes:
| Particles ≥ 0.1 μm | Particles ≥ 0.2 μm | Particles ≥ 0.3 μm | Particles ≥ 0.5 μm | Particles ≥ 1.0 μm | Particles ≥ 5.0 μm | |
| ISO 1 | 10 | |||||
| ISO 2 | 100 | 24 | 10 | |||
| ISO 3 | 1000 | 237 | 102 | 35 | ||
| ISO 4 | 10 000 | 2370 | 1020 | 352 | 83 | |
| ISO 5 | 100 000 | 23 700 | 10 200 | 3520 | 832 | |
| ISO 6 | 1 000 000 | 237 000 | 102 000 | 35 200 | 8320 | 293 |
| ISO 7 | 352 000 | 83 200 | 2930 | |||
| ISO 8 | 3 520 000 | 832 000 | 29 300 | |||
| ISO 9 | 35 200 000 | 8 320 000 | 293 000 |
Cleanroom clothing for cleanrooms
Which garments are best suited to a particular cleanroom depends on the cleanroom in question, the industry and the specific use of the cleanroom. This also applies to the question of how often cleanroom garments need to be changed. If garments are indicated for which cleanroom class they are suitable, this is always only a recommendation.
What is a garment concept for a cleanroom?
To ensure that the permissible particle concentration for a particular cleanroom is not exceeded, a clothing concept should be drawn up for the activity carried out in the cleanroom in question. Such a cleanroom clothing concept is an individual and internal specification that is directed at those employees and visitors who enter the cleanroom in question.
How do you create a concept for cleanroom garments?
In order to create a suitable garment concept for a specific cleanroom, you first need to know in which industry the cleanroom will be used. This determines which classification system is used, i.e. GMP (e.g. for the pharmaceutical, medical technology or cosmetics industry) or ISO (e.g. for the semiconductor and aerospace industry).
It is then necessary to decide to which class in the respective system the cleanroom is assigned, which depends on how sensitive the product is that is manufactured or processed in the respective cleanroom.
Possible clothing concept according to GMP classification:
- Cleanroom jacket: GMP D, C
- Cleanroom coverall: GMP B, A
- Intermediate garments: GMP B, A
- Fleece hood: GMP D, C, B, A
- Full protection hood: GMP B, A
- Beard protection: GMP D, C
- Face mask: GMP D, C
- (sterile) face mask: GMP B, A
- Nitrile gloves: GMP D, C
- Sterile gloves: GMP B, A
- Arm protectors: GMP D, C
- Sterile arm protector: GMP B, A
- Socks: GMP C, B, A
- Cleanroom shoes: GMP D, C, B, A
- Sterile overboots: GMP B, A
Possible clothing concept according to ISO classification:
- Cleanroom jacket: ISO 9, 8, 7
- Cleanroom coverall: ISO 7, 6, 5, 4
- Intermediate garments: ISO 7, 6, 5, 4
- Fleece hood: ISO 9, 8, 7
- Full protection hood: ISO 6, 5, 4
- Beard protection: ISO 8, 7
- Mouthguard: ISO 7, 6, 5, 4
- Gloves: ISO 9, 8, 7, 6, 5, 4
- Cleanroom shoes: ISO 9, 8, 7, 6, 5, 4
- Overshoes: ISO 9, 8, 7
- Overboots: ISO 6, 5, 4
In addition to assigning the respective cleanroom garments to the correct cleanroom classes, a cleanroom garment concept also includes determining how often the respective garments need to be changed. As a rough guide, it can be said that cleanroom garments in classes ISO 9 to 7 and classes GMP D and C should be changed once or twice a week.
In ISO class 6, a change three times a week is recommended. In class ISO 5 (GMP A/B), a daily change should be sufficient, whereas in class ISO 4 (GMP A), fresh cleanroom garments should be put on each time the cleanroom is entered.
abovo advises you on the creation of a clothing concept
When creating the garment concept for the respective cleanroom, the specific requirements that the cleanroom must fulfill must be taken into account. The abovo team will advise you free of charge on the development of a suitable garment concept.
In addition, the experts at abovo can give you an initial price estimate of what the implementation of your clothing concept would cost. Contact abovo without obligation by e-mail or telephone.