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
LEARN & PRACTICE

Test your Stability chamber knowledge

Multiple-choice questions

Pick an answer to see whether you are right and why.

  1. Q1. What is the ICH Q1A(R2) accelerated storage condition?

    basic

  2. Q2. What are the typical tolerances for temperature and RH in an ICH stability chamber?

    basic

  3. Q3. Why is temperature and RH mapping needed if the chamber already has a calibrated control sensor?

    intermediate

  4. Q4. During mapping at 40 °C / 75% RH, the lowest RH logger reads 72.1% and the highest 78.3%. What is the conclusion against ±5% RH?

    intermediate

  5. Q5. The chamber RH keeps falling below set point. What is the most likely cause?

    intermediate

  6. Q6. Which long-term condition is usually chosen for products to be marketed in hot and very humid climatic zone IVb?

    advanced

Viva questions

Think of your answer first, then open it to compare.

  1. 1. What would you do if a stability chamber went into a temperature alarm overnight?

    Find and fix the cause if possible; if not, move samples to a qualified backup chamber at the same condition. Record the excursion's size and duration from the monitoring system, raise a deviation and assess the impact on every study in the chamber using stability data.

  2. 2. Name the three calibration checks done on a stability chamber and why each is needed.

    Sensor calibration proves the control and monitoring sensors read correctly; temperature and RH mapping proves the whole storage zone is within tolerance; alarm checks prove excursions will be detected and reported to the right people.

  3. 3. Why do you map both empty and loaded chambers?

    An empty chamber shows the equipment's own performance. A loaded chamber shows how real sample loads affect airflow, recovery and uniformity. Both are needed to define the qualified storage zone and the maximum load.

In LimsPulse · Calibration Management

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

See how