QUALIFICATION &
THERMAL MAPPING
Equipment and utilities qualification
Adeodata supports customers in all stages of qualification of equipment and utilities, ensuring full compliance with the requirements of EU GMP Annex 15: Qualification and Validation.
Thanks to a structured and quality-oriented approach, we ensure effective, traceable and regulatory-compliant interventions.
The approach we use is based on risk analysis (ISPE Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition), which allows us to define CQAs (Critical Quality Attributes), critical product quality attributes, and CPPs (Critical Process Parameters), critical process parameters, on which Commissioning & Qualification efforts should be focused.
This approach allows targeted testing, thus reducing effort and increasing efficiency right from the commissioning stages.
✔ HVAC Systems / Clean Rooms
✔ Utilities (Steam, PW, Compressed Gases…)
✔ Autoclaves / Depyrogenating Ovens / Lyostats
✔ Machines / Production and Packaging Lines
✔ Laboratory Equipment (Hoods, Refrigerators, Incubators…)
Thermal mapping
Thermal mapping is an essential qualification activity that aims to accurately track temperature and/or humidity trends within the environments to be examined, identifying critical points, i.e. the hottest and coldest areas of equipment and warehouses.Determining these critical points is crucial for the accurate positioning of continuous monitoring probes.
Our technicians are on the front line to support customers in the thermal mapping of warehouses, cold rooms, climatic chambers and freezers, and are at your disposal for any inspections and verifications.
Our services also include criticality analysis of alarms, not only related to environmental parameters, to understand which ones need to be monitored.
What sets us apart
Customised approach
We adapt each qualification to the customer's needs and the specific characteristics of the plant.
Specialised technicians
Our team is highly trained, ready to act with experience and precision.
Internal Equipment Fleet
Our in-house equipment is complete and regularly
calibrated.
Training
Our team follows internal continuous training
programmes.
Our services
CSV and Data Integrity
CONSULTING
Qualification
CONSULTING
Calibration
CONSULTING
Engineering
CONSULTING
Digital Innovation
CONSULTING
Project Management
CONSULTING
GMP Consulting
CONSULTING
In-house training
TRAINING
CSV and IT Audit
AUDITING
GMP Audit
AUDITING