Cleanroom classes according to DIN EN ISO 14644-1 and EC-GMP guidelines, Annex 1: A comprehensive overview
Introduction
Cleanrooms are essential in various industries where high levels of cleanliness are required, such as pharmaceutical production, electronics manufacturing or the food industry. The cleanroom classes according to DIN EN ISO 14644-1 and the EC-GMP guidelines, Annex 1, serve to uniformly classify cleanrooms and enable a clear delineation of the requirements for particle control. Below you will find a comprehensive overview of the cleanroom classes according to these standards, including practical overview tables with the relevant values.
Cleanroom classes according to DIN EN ISO 14644-1
DIN EN ISO 14644-1 is an internationally recognized standard that specifies the classification of clean rooms based on particle concentration. It defines different cleanroom classes, which are determined based on the maximum permissible particle size and particle concentration per cubic meter of air. The cleanroom classes range from ISO Class 1 (lowest particle concentration) to ISO Class 9 (highest particle concentration).
Overview table of cleanroom classes according to DIN EN ISO 14644-1
|
Maximum permissible number of particles per m³ |
||||||
|---|---|---|---|---|---|---|
|
CLASS |
≥ 0,1 µm |
≥ 0,2 µm |
≥ 0,3 µm |
≥ 0,5 µm |
≥ 1,0 µm |
≥ 5,0 µm |
|
ISO 1 |
10 |
|||||
|
ISO 2 |
100 |
24 |
10 |
|||
|
ISO 3 |
1.000 |
237 |
102 |
35 |
||
|
ISO 4 |
10.000 |
2.370 |
1.020 |
352 |
83 |
|
|
ISO 5 |
100.000 |
23.700 |
10.200 |
3.520 |
832 |
|
|
ISO 6 |
1.000.000 |
237.000 |
102.000 |
35.200 |
8.320 |
293 |
|
ISO 7 |
352.000 |
83.200 |
2.930 |
|||
|
ISO 8 |
3.520.000 |
832.000 |
29.300 |
|||
|
ISO 9 |
35.200.000 |
8.320.000 |
293.000 |
|||
Examples of cleanroom classes according to DIN EN ISO 14644-1
1. ISO Class 1:
- Manufacturing of semiconductors
- Production of optical devices
2. ISO Class 4:
- Assembly of electronic components
- Manufacturing of medical devices
3. ISO Class 7:
- Manufacturing of cosmetics
- Food packaging
4. ISO Class 9:
- General storage of products
- Assembly of simple electronic components
Cleanroom classes (purity classes) according to the EC GMP guidelines, Annex 1
The EC GMP guidelines, Annex 1, are an important set of rules for the production of medicinal products. It specifies detailed requirements for cleanrooms used in the pharmaceutical industry. The cleanroom classes according to the EC-GMP guidelines are based on the ISO classes, but contain additional requirements regarding microbiological contamination.
GMP stands for "Good Manufacturing Practice". GMP refers to quality guidelines and standards used in the pharmaceutical industry to ensure that drugs and other products are produced in a safe and controlled environment during the manufacturing process. GMP guidelines cover aspects such as the purity of raw materials, the validation of production processes, the documentation of manufacturing procedures and the implementation of quality controls. The aim of GMP is to ensure the quality, safety and effectiveness of the products manufactured and thus protect the health and well-being of consumers.
According to the EC GMP Guide, Annex 1, there are two main classes of cleanrooms:
1. Aseptic processing areas:
- Class A: The area where the most stringent requirements for particulate and microbiological contamination apply.
- Class B: The area where the requirements are slightly less stringent than Class A.
2. Other clean rooms where the microbiological load is lower:
- Class C: The area where the requirements are less stringent than Class B.
- Class D: The area with the lowest requirements for particulate and microbiological contamination.
Overview table of cleanroom classes according to the EC GMP guidelines, Annex 1
|
Maximum permissible number of particles per m³ |
||||||
|---|---|---|---|---|---|---|
|
CLASS |
At rest |
At rest |
Operating condition |
Operating condition |
||
|
A |
3.520 |
20 |
3.520 |
20 |
||
|
B |
3.520 |
29 |
352.000 |
2.900 |
||
|
C |
352.000 |
2.900 |
3.520.000 |
29.000 |
||
|
D |
3.520.000 |
29.000 |
not fixed |
not fixed |
||
Examples of cleanroom classes according to the EC GMP guidelines, Annex 1
1. Class A:
- Filling of sterile medicines
- Preparation of injection solutions
2. Class B:
- Production of sterile eye drops
- Production of parenteral solutions
3. Class C:
- Production of non-sterile tablets
- Filling of liquid medicines
4. Class D:
- Production of capsules
- Packaging of solid medicines
Conclusion
The cleanroom classes according to DIN EN ISO 14644-1 and the EC-GMP guidelines, Annex 1, offer a uniform classification of cleanrooms and serve as the basis for particle control and microbiological cleanliness. The overview tables give you a quick overview of the respective cleanroom classes and their specific requirements. Strict adherence to these classes is crucial to ensure optimal product quality and product safety in various industries.
The examples given show that the choice of cleanroom class depends on the type of products manufactured and the required cleanliness standards. It is important to consider the specific requirements of cleanroom classes and take appropriate contamination control measures to ensure product quality. Please note that these examples are general in nature and may vary by industry and company. A precise adaptation to individual requirements and regulations is therefore always necessary.