Gute Hygiene-Praxis bei der Behandlung von Pharma-Verschlüssen
Dipl.-Ing. Martin Düblin
Y-Tec GmbH, Oberwil (Schweiz)
Corresponding author: Dipl.-Ing. Martin Düblin, Y-Tec GmbH, Hohestrasse 134, 4104 Oberwil (Schweiz), e-mail: Martin.Dueblin@y-tec.ch
Good Hygienic Practice for the Treatment of Pharma Closures
The requests, the process technics and examples of solutions of the equipment for the treatment of any closures are presented within this article, based on the good hygienic practice.
Closures may be treated, transferred and put onto the primary packings in different ways. Not only the equipment for the treatment but as well the concept for the whole production chain, from delivery to filling, the number of different closures and its requested capacities and as well the situation of the building have to be considered.
To review the solution, it is essential to execute an economical analysis as well. It is unfortunate to analyse the investment only by disclaiming the analysis of the operating costs. Only the overall evaluation allows an objective decision and has lead meanwhile to very interesting solutions.
It is clearly understood, that the basics as a reliable system, the entire qualification and validation activities and an adequately control system have to be fullfilled.
Key words Aseptische Fertigung • Gute Hygiene-Praxis • Sterile Fertigung • Stopfen • Verschlüsse