Pharmadidact Practical Course: Sampling and Analytics in Cleaning Validation

Pharmadidact Practical Course: Sampling and Analysis in Cleaning Validation

"Is there a practical PTS seminar on sampling in cleaning validation? A seminar where I receive practical guidance on how to properly collect samples, and learn which analytical methods to apply?" These questions hit the mark with the young woman: Wouldn't a seminar focusing solely on the specifics of sampling and analytics in cleaning validation be useful? A seminar that combines theory and practice?

PTS took up the suggestion, with Friedrich Günnewig from Rottendorf Pharma GmbH and Cornelia Wawretschek taking on the professional moderation, and a suitable partner was found in the College of Sartorius Stedim Biotech GmbH. Thus, a circle of interested participants gathered in Göttingen.

Swabbing – Rinsing - Spiking

After a theoretical introduction, practical work began in the college's laboratory area. Focused and with great commitment, the participants engaged with the tasks. For the first task – "Retrieval from the swab material" – several swab materials were available. Their suitability was to be tested. In the task "Retrieval on the material surface," the participants learned the technique of spiking (adding analyte). Afterwards, they could choose between different swab methods and rinse techniques and try them out.

What you have in black and white, you can confidently take home

During the practical work, each participant prepared "their" test protocol. The results obtained were also recorded here. Prior to this, they had received instructions for each task. The afternoon began with a lecture from Mr. Günnewig on sampling plans, methods, and their validation. Subsequently, the results obtained in the morning were needed, as calculations and evaluations were the focus of another workshop.

As always, when theoretical and practical work alternate, the seminar day flew by. Here are some comments from the participants
… that I can take a lot away
… the practical part (of the seminar) to improve understanding of cleaning test methods
… the proximity to practice
… practical application
… comprehensive and practice-oriented

The next seminar will take place on November 14, 2012.