Quality Management and Production oral exam from the Pharmaceutical Sciences Master FS24

Eric Meier asked the questions, Barbara Herzog listened quietly.


Started by asking me what i know about the Zone Concept with an example of an aseptic process.

I talked about the levels (A-D), Isolators, Environmental Monitoring, Sterilisation, Pressure differences for airflow and Gowning.

He asked about gowning; wanted to know if we protect operator or product with Gowning.

Operator Protection was correct.

He asked which Environmental factors are measured and why.

I said: Temp, Humidity, particles in the air, pressure differences.

He asked about difference between viable and non viable particles.

I had no clue, correct would have been: viable carry microbials so they are measured and controlled differently.

He also wanted to know the size of particles, i didnt know, he said it doesnt matter its just a detail.

Lastly he asked about designing a clean room and what should be considered.

I said, airlocks, pressure differences, placement of monitoring systems, rounded edges for easy cleaning.


Overall they were very nice and even let me go a bit early because he had no more questions.