Special requirements apply to sterile packaging in the medicine or food sector.
To ensure certain degrees of product purity, production must take place in a room under controlled conditions. It is particularly important to remove particles from the air by means of filters. This type of enclosed space with controlled environmental conditions is called a clean room. Clean rooms are divided into different air purity classes according to DIN EN ISO 14644-1.
The cleanliness of the classes is defined by the maximum particle count of different particle sizes.
Four classes (A, B, C and D) are distinguished.
Class A is for high-risk activities, such as the production of aseptic compounds.
Class B describes the environment required to ensure class A.
Classes C and D are defined as work areas for the less critical processes.
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