Mappings & climate distribution measurements
We carry out professional temperature and climate distribution measurements for you. Our service is designed to verify robust production, storage and transport conditions for you, as well as to comply with all GxP-relevant regulations and standards. On request, we can handle the entire risk-based qualification process for you.
Our expertise includes professional climate and temperature distribution studies of warehouses, cold rooms, and refrigerators, freezers and ultra-low temperature freezers. We carry out mappings of systems and equipment in process rooms. These include, for example, autoclaves, GT systems, sterilisers, hot air tunnels and depyrogenisation systems. We provide you with detailed evaluations according to your needs, in which we identify critical monitoring points as well as the ‘coldest’ and ‘hottest spots’, among other things.
Temperature and climate mapping
- Temperature and humidity measurements in refrigerated and ambient areas as well as deep-freeze and ultra-deep-freeze areas
- Scope of mapping and type of evaluation according to your requirements
- Identification of hot/cold spots and other critical areas
- Verification for GMP and GDP/GSP requirements
GDP/GSP-compliant qualifications
From individual temperature and humidity measurements to the complete qualification of your storage areas: we support you in accordance with GxP regulations in the pharmaceutical/medical technology sector with individual and pragmatic solutions and our audit-proof documentation format.
Sterilisation and cleaning equipment
- Temperature and climate mapping in accordance with EN ISO 17665 – Sterilisation with moist heat / EN ISO 15883 – Cleaning and disinfection devices / EU GMP guidelines Annex 15 – Qualification & validation / FDA 21 CFR Part 11 – Data integrity and electronic records
- Mappings as part of the validation of various types of equipment, such as: Steam sterilisers (autoclaves), hot air sterilisers and tunnels, cleaning and disinfection devices (CSD), depyrogenation ovens, GT systems, fermenters, separators, isolators, decontamination locks and washing systems for containers/plugs/tools.
Monitoring systems
- Calibration and qualification of your monitoring systems
- Definition of the positions of the monitoring sensors
- Computer system validation (CSV)
Success stories
Simon Hegele is an internationally active, highly specialised logistics and service provider. For customers in the pharmaceutical industry, a warehouse in Karlsruhe was converted to comply with GSP/GDP requirements – a project that required a great deal of GMP expertise. Testo Industrial Services provided the experts for calibration/qualification. An important part of the project involved intensive climate distribution measurements in the new warehouse, the establishment of a monitoring system for the warehouse and a total of 1,700 UTK freezers, and the validation of this system.
Simon Hegele Gesellschaft für Logistik & Service mbH
Would you like to implement your mapping, qualification or validation with a reliable and experienced service partner?
Benefit from the effectiveness, flexibility and expertise of our large service team – let's plan your next mapping together! My team and I will find the right solution for your requirements. I look forward to hearing from you.
