Stability chamber
A cabinet or walk-in room that holds samples at a controlled temperature and relative humidity for months or years, so that the shelf life of a drug product can be established under ICH storage conditions.
- Pharmaceutical
- Biotech
- Medical devices
- Cosmetics
- Food & nutraceuticals
- Packaging
Stability chamber calibration procedures
Temperature & RH mapping
Places calibrated temperature and humidity loggers throughout the chamber to prove that every usable position stays within the ICH tolerance of the set condition.
Open procedureSensor calibration
Compares the chamber's control and monitoring temperature and RH readings with a calibrated reference instrument placed next to the sensors.
Open procedureAlarm checks
Proves that high and low temperature and RH alarms, door alarms and power-failure alarms trigger at the right limits and reach the right people.
Open procedureInstrument qualification (DQ · IQ · OQ · PQ)
- 01
DQ — Design qualification
Defines the conditions needed (e.g. 25/60, 30/65, 40/75), capacity, uniformity, alarm and backup requirements and a Part 11-compliant monitoring system.
- 02
IQ — Installation qualification
Checks delivery, utilities (power, purified water, drain), sensor certificates, software version and documents.
- 03
OQ — Operational qualification
Tests controller accuracy, empty-chamber mapping at each condition, door-opening recovery, power-failure recovery and alarms.
- 04
PQ — Performance qualification
Loaded-chamber mapping over a defined period (often 24 hours to 7 days) to prove the chamber holds conditions with a typical study load.
Keep every Stability chamber in control: usage logs, calibration and maintenance schedules, and automatic blocking of overdue instruments.