Types of Stability Chamber requirements

Stability Chambers are specialized enclosures that create a controlled temperature and humidity environment. Industries as diverse as pharmaceuticals, packaging, environmental testing and controlled storage use immersion or walk-in test chambers for stability testing. These test rooms are designed to find defects or weaknesses in products under different conditions by providing a controlled testing environment. Stability chamber qualification requirements fall under the category of installation, operation, and performance. Stability test chambers are subject to these three qualification tests before being put into operation.

Stability Room Qualification Requirements
To be certified to perform stability testing, an environmental chamber must go through a three-part qualification process. Qualifications must also include calibration records for all instruments used and evidence of their calibration status. 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 that the stability chamber complies with its design specifications. All parts have been counted and checked for proper fit. Appropriate documentation must also be provided, including user manuals and any certifications and standard operating procedures (SOPs).

Requirements: All components must be properly installed and functional for the stability chamber to pass installation qualification. If the chamber has a control panel with a human machine interface (HMI) or other guidance devices such as buttons and selector switches, they must function as designed. All alignment and safety equipment also needs to pass inspection.

Operation Qualification (OQ)
Overview: Run qualification tests to stabilize the room's functions and verify that systems and subsystems operate as expected within the normal operating range—including testing all doors, switches, controls, and alarms.

REQUIREMENTS: The operational qualification test verifies that the temperature and humidity inside the chamber are equalized. To ensure accurate temperature and humidity readings, the operator waits a few minutes for them to stabilize, then runs the test for the specified time.

Conduct Open Doors studies prior to completing operational qualifications. The test consists of opening the door for short periods of time while recording temperature and humidity at short intervals. The door opening test was repeated at least three times to calculate the average recovery time of the chamber.

Performance Qualification (PQ)
Overview: Performance qualification verifies that the stable chamber meets performance specifications at full load. Typically, testing is performed at the operating set point of the chamber, loading a mock product to replicate a typical environment. Measure temperature and relative humidity uniformity using thermocouples and relative humidity (RH) sensors.

Requirements: The stability chamber must operate at full capacity for at least 24 hours to pass performance qualification. After the initial study is complete, the trial will be repeated with an open door study to calculate its mean recovery time.

The stability laboratory qualification and performance process is conducted annually using the same procedures as past testing. After each reaccreditation, the results should be compared to previous years to track the Chamber's overall performance.

XCH Biomedical Stability chambers in pharmaceutical
XCH Biomedical designs and manufactures a wide range of climatic test chambers in compliance with ICH guidelines, including stability chambers, temperature and humidity chamber, walk in environmental chamber,Incubator For Bacterial Culture and vacuum drying oven. You can click to view our full product line.