LimsPulse
General lab & storage

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
Photo of a Stability chamber
Photo: Encik Tekateki, CC BY-SA 4.0 (cropped), via Wikimedia Commons
Follow your site SOP
This is a typical operating sequence for learning. Your instrument model and approved SOP take precedence.
STAGE 1

Before loading samples

  1. 1Check the chamber is qualified, calibrated and within due dates, and that the monitoring system shows it is stable at the set conditions.
  2. 2Confirm the study protocol: condition, number of samples, pull points and storage location.
  3. 3Check the humidifier water reservoir is filled with purified water.
  • Never place samples in a chamber that is in alarm or has an open deviation.
STAGE 2

Loading

  1. 1Label every sample with study number, condition, pull point and date.
  2. 2Place samples only in the qualified (mapped) zone, leaving space between packs and walls for air to flow.
  3. 3Record the location (shelf and position) in the stability log or LIMS.
  4. 4Close the door quickly and check that conditions recover within the time established during qualification.
  • Do not block fans or air inlets. Overloading creates hot and wet spots that were not covered by mapping.
STAGE 3

Routine use and sample pulls

  1. 1Review the monitoring record daily (or as per SOP) and sign it.
  2. 2Pull samples on the scheduled date, within the window allowed by your SOP, and record the pull.
  3. 3Keep door openings short and plan pulls together to limit disturbance.
  • Any excursion must be recorded and assessed, even if conditions recovered quickly.
STAGE 4

Alarm or failure

  1. 1Respond to the alarm, check the cause (door left open, water empty, power, compressor fault).
  2. 2If the fault cannot be fixed quickly, move samples to a qualified backup chamber at the same condition.
  3. 3Raise a deviation and assess the impact of the excursion on every study in the chamber.
In LimsPulse · Calibration Management

Keep every Stability chamber in control: usage logs, calibration and maintenance schedules, and automatic blocking of overdue instruments.

See how