Aseptic Manufacturing using an Automatic Filling Line

Experience operating an automatic filling line in a real pharmaceutical manufacturing environment. During this 2-day course you spend more than 50% of your time in a cleanroom experiencing all critical parameters at first hand.

Duration
2 days
Course fee
€ 1495 (excl. VAT)

Short description

You will work with an automatic filling line in a class A/B cleanroom. Before entering the classified areas, attention will be paid to cleanroom procedures and behavior in a GMP environment.

In the first production run, we will fill vials with water so you get to know the operational aspects of the machine. Then we get serious. The second production run is a media fill and requires routine interventions. A gowning qualification is part of the program. Using a visual inspection qualification batch, you gain a good understanding of the size and type of particles you could encounter in your own vials.

Naturally, the course focuses on environmental monitoring, for example by case studies and risk assessments. All results of media fill, environmental monitoring and visual inspection will be reported to the trainees.

Objectives

  • Gaining experience in working with an automatic filling line
  • Understanding the impact of the environment on aseptic processing
  • Being able to relate microbiological monitoring to operations around an automatic filling line.
  • Gaining in-depth understanding of particle monitoring.
  • Knowing which critical parameters are covered in a filling line validation and understanding why these parameters are important. 

Target group

  • Operators who would like to broaden their production experience with a better understanding of contamination factors.  
  • QA personnel who would like to get a better understanding of critical parameters and contamination factors in GMP production
  • Operators who will be working with an automatic filling line and want to gain practical experience.

Program

Day 1

 

Theory

Cleanroom behavior, aseptic manufacturing and environmental monitoring.

 

Practice

Gowning and procedures training. Mock automatic fill with water to get experience in behavior and procedures. Set-up environmental monitoring program risk-assessment based.

Day 2

 

Practice

- TSB media fill with routine interventions and environmental monitoring program.
- Gowning qualification.
- Practical visual inspection procedure using a qualification batch
- Case-studies with environmental monitoring results.

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Interested in signing up a group of people for this course?

Please contact our Business Development team:
info@biotechtrainingfacility.nl
+31 (0)88 2830100

Need help? Have a question or a suggestion maybe?

Drop us a line below or call us on
+31 (0) 88 283 01 00.

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