Aseptic Manufacturing using an Automatic Filling Line

Short description

You will work with an aseptic filling machine in a class A/B cleanroom. Before entering the classified areas, you will learn all about cleanroom procedures and correct behavior in a GMP environment. A gowning qualification is part of the program.

In a production run, we simulate filling with water so that you can familiarise yourself with the operational aspects of the automatic filling machine and common interventions.

We will use a visual inspection qualification batch in order to gain a good understanding of the size and type of particles you could encounter in your own vials.

The environment in cleanrooms has an critical impact on the quality of the pharmaceutical products. That’s why the aspects of environmental monitoring play a central role during this aseptic filling course, for example by performing case studies and risk assessments.

Goals

• Gain experience in working with an automatic filling line

• Understand the impact of the environment on aseptic manufacturing of pharmaceutical products

• Be able to relate microbiological monitoring to operations at an aseptic filling machine.

• Gain in-depth understanding of environmental monitoring.

• Know which critical parameters are covered in a filling line validation and understand why these parameters are important.

Target group

• Operators who want to expand their production experience with more background knowledge of contamination factors.

• Operators who will be working with an automatic filling line and want to gain practical experience.

• Quality Assurance (QA) personnel who want to improve their understanding of critical parameters and contamination control factors in GMP production.