Aseptic Manufacturing using an Automatic Filling Line

Short description

What can you expect from this Aseptic Filling Training Course?

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 the first production run, we will fill vials with water so you will get to know the operational aspects of the filling machine. The second production run is a real media fill which will teach you more about frequently occurring 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.

All results of the media fill, environmental monitoring and visual inspection will be reported to and discussed with the trainees.

Objectives

• 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 particle monitoring.
• Know which critical parameters are covered in a filling line validation and understand why these parameters are important.
• Reviews form participants: "Very infomative course", "Great for people looking to upskill" , "Trainers were approachable and had lots of experience". 

Target group

Who should follow this Aseptic Filling Training?

• 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