Verein Deutscher Ingenieure

Cleanroom technology - Cleanliness of process media
 N VDI 2083 BLATT 7

Annotation

The cleaning of process media is an element of clean processing. The level of cleanliness of process media depends on a multitude of potential contamination sources. This part of the guideline VDI 2083 primarily assesses the influence of particulate contamination.

Particulate contamination of products manufactured in clean rooms is not subject of this guideline.

Note 1: The Annex of this guideline applies logical to the sterile production in the pharmaceutical industry.

The technical objective is to ensure that a predefined limit value of contamination in total is not exceeded at the measurement point in question. Bearing in mind this objective, process materials, containers, installations and filters are designed and are qualified in respect to their suitability. This guideline contains a classification of the cleanliness of process media. Beyond the cleanliness of liquid and gaseous media, this classification can basically also be applied to complete systems, i.e. including particles released by installations.

Note 2: Compatibility of equipment or air-handling components with the required cleanliness is dealt with in the guideline VDI 2083 Part 9.1.

For the purpose of qualifying particulate cleanliness, this guideline describes standardised measurement procedures and provides indications for assuring the required cleanliness conditions. The application of these measurement techniques is carried out by means of inspecting installations for process media supply, see also VDI 2083 Part 10 of this guideline, as well as for the qualification of commercial products. In respect to ensuring particulate cleanliness of process media at the point of use, equipment, operation and test procedures of microfiltration are considered.