GDP-compliant deep-freeze storage of pharmaceutical products
Conversion of a warehouse at Simon Hegele Gesellschaft für Logistik und Service mbH in Karlsruhe
Testo Industrial Services provided support with GMP consulting services, qualifications and mappings. In just 4 weeks, 1,700 sensors were calibrated and installed in UTK freezers. Our GxP Services team also took on the validation of the monitoring system.
Simon Hegele was founded in 1920 and is now an internationally active, highly specialised logistics and service provider with over 50 locations worldwide. The company offers customised logistics services for customers in the pharmaceutical, healthcare, industrial and retail sectors.
A warehouse at the Karlsruhe site was to be converted to GSP/GDP standards for customers from the pharmaceutical industry. Such a specialised conversion requires a great deal of GMP expertise. This was a new field of activity for Simon Hegele, which is why the company sought out experienced partners: Testo Solutions and Testo Industrial Services.
Your advantage: Our expertise
- Conceptualisation and consulting on GDP-relevant topics such as calibration, qualification and validation
- Comprehensive project management taking into account initial calibration, warehouse qualification and computer system validation
- Flexible & efficient GxP services team on site
- Carrying out the installation qualification of the hall areas including the ventilation system
- Carrying out warehouse qualification including empty chamber mappings (OQ mappings) and mappings in summer and winter in a loaded state (PQ mappings)
- Conceptualisation of a recalibration strategy for the installed sensors
- Introduction of the holistic test equipment management system PRIMAS
A high level of commitment to the project on the part of all those involved, as well as a broad range of technical expertise, flexibility, speed and a trusting collaboration at eye level were the basis for the very successful project implementation and achievement of objectives. We are therefore happy to continue this collaboration.Markus Henn
Head of Central Project Management
Simon Hegele Gesellschaft für Logistik & Service mbH
Our partner in this project was Testo Solutions GmbH.
Find out more about the complete solution testo Saveris 1, the fully automated environmental monitoring system.