Pharmadidact practical course: Sampling and analytics during the cleaning validation to 31.05.2011 in Goettingen

An interview with Friedrich G�nnewig, gang village pharmaceutical GmbH gentleman G�nnewig, Sie a PTS practical course to sampling and analytics during the cleaning validation planned. What is for a practical course? In the PTS practical course we dedicate ourselves particularly to the sampling. It takes a central place during the cleaning validation. But it differs clearly from the sampling with basic materials or micro-biological sampling which is there so differently? That begins already with the usual sampling procedures, the Swab and the Rinse test. In both cases it concerns techniques, which must be required some exercise and trained accordingly. And then questions arise: With what do I make that at all, i.e. I need which aids in addition? And how do I find a suitable analysis method for arrears regulation? In the autumn the seminar cleaning and cleaning validation takes place. Wouldn't it be sufficient to hear your lecture in this seminar? In the seminar cleaning and cleaning validation we regard the topic fundamentally. As already said, here the participants have to acquire two days time around fundamental knowledge to cleaning and cleaning validation and to develop a concept to the cleaning validation. In addition belong the cleaning and their optimization, bases to the conception of a cleaning validation and the determination of the guidance substance, the Bracketing, the definition of limit values and much more besides. And the sampling and analytics? Sampling and analytics are natural also in this seminar a topic. I present to it usual methods like Swab and Rinse test just like alternatives to it. Also I demonstrate a multiplicity of sampling techniques and - tools. Here I over possible assigned analysis methods and the requirements speak to the validation of the analysis methods. Thus a purely theoretical meeting? A meeting, which links theory and practice with one another. Without a doubt is it comprehensive and learn intensive and by numerous Workshops and practical courses is enriched - nevertheless, in both days sufficient area for discussions and Erfahrungsaustausch.Und remains why is I the Pharmadidact practical course now to sampling and analytics during the cleaning validation to visit? Because this one-day practical course dedicates itself exclusive and intensively to the topics sampling and analytics. It constructs on contents of the seminar cleaning and cleaning validation and gives you in the laboratory the time to practice detached from the everyday life situation to. They can deepen their knowledge and use the sampling techniques and - tools practically. In addition the Spiken belongs of surfaces. They practice Swabben just like Rinsen. They determine the regaining rate of a surface, evaluate in the connection their results and compute the actual quantity of the remainder contamination on Anlage.Das practical course are part of the Pharmadidact row. What means that? With the Pharmadidact row the emphasis is clearly in it in the Workshops practical knowledge to mediate. In this case stand for the participants for this the areas, the devices and the equipment of the Sartorius Stedim Biotech GmbH to order whom would like you with this practical course to address? If you take samples to the cleaning validation, they should participate in the meeting. Coworkers the validation plans or sampling plans provide, concepts to the cleaning validation develop or convert, are likewise addressed. If you must develop analysis methods to the cleaning validation and compute arrears, you should participate in it. They engage themselves personally with both meetings. What provokes you at this task? Personally particularly it pleases me that in both meetings the lectures are linked with the practical activity. By the practical work we come with the participants more easily into contact, the atmosphere become looser. So a meeting lives also of discussions, which develop between us advisers and the participants. The participants discuss also among themselves over their experiences with cleaning validation. Everyone brings in completely own problems, already under the most different technologies, the analytic equipment and organisational structure in" seiner" Company. I like this exchange of experience and common looking for L�sungen.Das interview led Cornelia Wawretschek.

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