Qualification
Temperature mapping of storage areas and cold rooms
Why warehouses, cold rooms and climatic chambers are mapped, how measuring points, duration and load are defined, and what EU GDP, EU GMP and WHO say.
· 8 min read
Cleanliness is a state. Without evidence, it remains a claim.
Additional service
Calibration of quality-relevant instruments and sensors for temperature, humidity, differential pressure and air velocity, mobile or permanently installed.
What it is about
A qualification result is only as reliable as the instrument that produced it. That is why we also calibrate quality-relevant instruments and sensors. The risk assessment shows which measuring points are quality-relevant. Our reference instruments are calibrated traceably by laboratories accredited by members of the European co-operation for Accreditation (EA).
We offer calibration as an additional service, usually in connection with qualification projects.
Reference instruments calibrated by laboratories accredited by EA members such as DAkkS, UKAS or SWEDAC.
Calibration status and measurement uncertainty feed directly into the qualification evidence.
Where possible, we calibrate permanently installed sensors without removing them.
Approach
Agree on instruments, ranges and tolerances.
Plan calibration on site and keep downtime to a minimum.
Comparison against traceable reference instruments.
Hand over calibration certificates, report deviations.
Questions
Temperature, humidity, differential pressure and air velocity. Other quantities on request. We agree the ranges based on your instrument list.
Insights
Qualification
Why warehouses, cold rooms and climatic chambers are mapped, how measuring points, duration and load are defined, and what EU GDP, EU GMP and WHO say.
· 8 min read
Qualification
DQ, IQ, OQ and PQ explained: objectives, test points and evidence for each qualification stage, with practical examples from cleanrooms, HVAC and compressed air.
· 9 min read
Audit
Audit preparation for technical GMP projects: document map, URS to qualification, CAPA, calibration, maintenance and walkthrough, with a checklist.
· 7 min read
Contact
You will get a personal reply with a first assessment of scope and approach.