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Dichtheitsprüfanlagen zur integralen Messung an trocken oder flüssig befüllten Gebinden

Roland Koch

WILCO AG, Wohlen (Schweiz)

Qualification 100 % Leak Test Equipment for Integral Testing on solid or liquid filled containers

For the integrity testing on solid filled products a patented vacuum decay system is used and for liquid filled products the especially developed and also patented LFC system (Liquid Filled Containers) is applied. These test systems are not simply based on a yes/no decision but on actual numbers, thereby giving information on detected leak rates which can be correlated to physical leak sizes. The relevant testing data is sent via data transfer to the central processor, where it is constantly monitored and verified. These are necessary information to make qualification and validation of leak detection systems possible.
Any efficient equipment qualification requires an optimal co operation between supplier and end-user. This co-operation between both side’s experts will reduce costs significantly. A key issue for an efficient qualification is the detailed knowledge of the equipment by the expert in charge of qualification. Enough time and effort need to be provided to establish at the beginning of a project the “User Requirement Specifications”, after start and during the process of the project the “Functional Design Specifications” and the “Risk Analysis”. It has been shown that keeping these points in mind and with optimal cooperation between supplier and end-user a qualification can be processed in short time. For instance the whole qualification process of a 18 station equipment with a capacity of 120 vials/min (installation, putting into operation, installation qualification, operation qualification, Factory Acceptance Test, process qualification to the first production lot) could be completed in only 4 weeks.

Key words Anlagenqualifizierung · Dichtheitsprüfung