Types of Stability Chamber Qualification Requirements
Stability test chambers are specialized enclosures that create a controlled temperature and humidity environment. Various industries such as pharmaceuticals, packaging, environmental testing, and controlled storage utilize reach-in or walk-in chambers for stability tests. The chambers are designed to find defects or weaknesses in products under varying conditions by providing a controlled testing environment. Stability chamber qualification requirements fall under installation, operation, and performance categories. Stability chambers undergo these three qualification tests before being placed in operation.
Stability Chamber Qualification Requirements
For an environmental chamber to receive a certification to conduct stability tests, it must undergo a three-part qualification process. The qualifications must also include calibration records of all instrumentation used and evidence of their calibrated state. The three qualification types are
- Installation Qualification (IQ)
- Operation Qualification (OQ)
- Performance Qualification (PQ)
Together, these three stability chamber qualification requirements and tests support and document proper operation.
Installation Qualification (IQ)
Overview: The first qualification verifies whether or not the stability chamber meets its design specifications. All parts are accounted for and checked that they are correctly installed. Proper documentation must also be present, including the user manual and any certifications and standard operating procedures (SOPs).
Requirements: All components must be properly installed and functional for a stability chamber to pass installation qualification. If the chamber has a control panel with a human-machine interface (HMI) or other pilot devices such as pushbuttons and selector switches, they must work as designed. All calibration and safety equipment also need to pass inspection.
Operation Qualification (OQ)
Overview: The operation qualification tests the individual functions of the stability chamber and verifies that the systems and subsystems perform as intended under normal operating ranges—including testing all doors, switches, controls, and alarms.
Requirements: The operation qualification test verifies that temperature and humidity have equalized inside the chamber. To ensure accurate temperature and humidity readings, the operator waits a few minutes until they stabilize, then runs the test for the specified time.
A door opening study is performed before completing the operation qualification. This test involves opening the door for a short period while recording temperature and humidity in short intervals. The door open trial has been repeated a minimum of three times to calculate the chamber’s average recovery time.
Performance Qualification (PQ)
Overview: The performance qualification verifies that the stability chamber meets performance specifications under a full load. Usually, the test is performed at the chamber’s operating setpoint with a simulated product loaded to replicate a typical environment. Temperature and relative humidity uniformities are measured using thermocouple and relative humidity (RH) sensors.
Requirements: The stability chamber must perform under full load for at least 24 hours to pass performance qualification. After the initial study is complete, the trial gets repeated with a door-opened study to calculate its average recovery time.
The stability chamber qualification requirements and performance process is done annually using the same procedures as past tests. After each requalification, the results should be compared with previous years to track the chamber’s overall performance.
Lunaire Stability Chambers
Lunaire Environmental designs and manufactures a variety of chambers for climate testing that meet ICH guidelines, including stability chambers, humidity stability chambers, steady-state chambers, shelf-life testing chambers, and walk-in rooms. You can view our full product line here.