Excellence in aseptic handling in sterile production and filling

For operators in the aseptic production and filling of sterile medicinal products

Practical, process-oriented, tailor-made - the exact requirements and goal of the learning journey are defined in advance and the curriculum is individually adapted to your processes. The duration is flexible from 1 to 2 training days or more.

The training module takes place at your location. Your employees do not have to travel, you save working time and costs. Your production continues unhindered. Alternatively, we can invite you to one of our training centers, including a clean room.

Mindset and skillset for key moments in aseptic operation are sharpened.

Examples of key moments and learning objectives:

• Learners gain a deeper understanding of the essence of Good Manufacturing Practice (GMP) and the Contamination Control Strategy (CCS)
• They reflect on and sharpen their awareness of aseptic dressing and train their skills intensively
• They deepen their understanding of the principles of contamination prevention in sterile and non-sterile cleanroom areas
• Learners train in the use of aseptic techniques, particularly for activities in GMP class B and class A procedures
• In live simulations, they recognize the effects of their movements in the cleanroom
• The learners draw concrete conclusions for their behavior from impressive visualizations
• Backgrounds and methods of environmental monitoring are taught and the correct execution is trained in a practical manner

We work with you in advance in a process analysis workshop to develop a detailed selection of focal points and clear objectives. This coordination and a focused curriculum ensure that the learning solution reinforces the voice of your quality assurance and internal trainers.

Background

The manufacture of medicinal products in compliance with regulatory requirements (EU GMP guidelines, PIC/S documents, FDA Aseptic Guide etc.) leaves no room for uncertainty, especially when it comes to contamination control.