Aseptic Manufacturing using an Automatic Filling Line

Aseptic filling is a crucial process during the manufacturing of pharmaceutical products. Participants will operate an automatic filling machine in a real pharmaceutical manufacturing environment and experience all critical parameters at first hand.

Duration
2 day training course
Course fee
€ 1895 (excl. VAT)

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. 

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
  • Not the Aseptic Manufacturing training you were looking for? Take a look at the following courses that may be of interest :

    Aseptic Techniques in a Downflow Cabinet
    Microbial Control in Pharmaceutical Manufacturing

    or go back to the complete training overview: All Training Courses

Program

Day 1

 

•Introduction in GMP in aseptic processing
•Behavior in cleanroom A/B
•Cleaning and disinfection
•Pharmaceutical microbiology
•Environmental monitoring techniques
•Tour and demo utilities (HVAC, water)
•Production facility: D-C-B zone - preparations of equipment and
materials for aseptic manufacturing
•Training of gowning and cleanroom procedures.

Day 2

 

•Theory media fill and quality aspects
•Execution of a TSB Media fill with aseptic operations
(including environmental monitoring, interventions, documentation batch records)
•Visual inspection
•Case studies
•Workshop

  • Keep me up to date

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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.

Thanks