Qualifying fully automated deep-freeze storage systems presents unique challenges for the pharmaceutical industry. In this presentation, we demonstrate how we successfully qualified a highly automated logistics facility together with a globally operating life sciences company. The facility comprises more than 16 high-bay warehouses, 35 deep-freeze and ultra-low temperature freezers, as well as GMP-compliant sampling cabins.
What made this project special: Neither the customer nor the qualification system in use had comparable templates for automated storage logistics of this complexity. We broke new ground together – under tight time constraints with a fixed partial go-live scheduled for summer 2025.
This presentation guides you through our end-to-end approach to qualification and temperature validation. We begin with the systematic creation of a complete documentation package covering all GMP-relevant disciplines: URS, FMEA, functional and test specifications, control plans, as well as DQ, IQ, OQ, and PQ protocols. Regulatory requirements such as 21 CFR Part 11 were also taken into account.
A key aspect is the temperature mapping with more than 70 data loggers deployed simultaneously over a 14-day measurement period. The size of the storage areas and temperatures down to –70 °C required creative solutions for device placement and data transmission. By implementing adapted transmission technology, reliable monitoring of all storage areas was ensured.
We also highlight interdisciplinary coordination as a critical success factor. From technical site management for the sampling cabin to alignment between construction, engineering, automation, and GMP documentation – we show how close collaboration enables fast, solution-oriented responses even when unexpected interface issues arise.
The presentation concludes with the concrete project results: successful completion of all qualification phases, on-schedule partial go-live, and – particularly valuable – the transferability of the developed qualification structure as a reusable template for future projects.
