Annex 1 mandates automation of lyophilizer loading and unloading as much as possible. However, very few projects for retrofits have been presented so far.

The presentation will show such a case study of retrofitting an existing cleanroom for lyo vial unloading from manual to automated unloading in just 1 year in 2024.

First, the former cleanroom layout and material flows will be displayed. Current Annex 1 requirements will then be discussed to show Vetter's decision path to retrofit this cleanroom.

Subsequently, the challenges as well as our corresponding solutions of the project phase will be discussed in detail, among other things:

Concept of automation
Concept of construction while commercial production
Reduction of timeline to reduce impact on supply chain
Impact on aseptic process simulation concept, etc.

The successful implementation in just one year was mainly driven by setting up a technical twin next to use proven technology. Key learnings of the success of this project will be discussed.

Arne Schröder, PhD

Lead Expert Aseptic Production / Production Systems, Vetter Pharma International GmbH

Appearances