The Stability Chamber is a specialized enclosure that creates a controlled temperature and humidity environment. Industries as diverse as pharmaceuticals, product packaging, environmental testing and managed storage use immersion or mobile inspection chambers for stability testing. These inspection areas are created to resolve commodity issues or defects under various issues by providing a managed testing environment. Stability holding chamber certification requirements apply to the process of installation, operation and fulfillment. These three certification tests are easily accepted by the Stability Laboratory before being put into operation.

Stability Chamber Certification Requirements

To be licensed to conduct stability testing, environmental chambers must undergo a 3-part certification process. Skills must also contain calibration documentation for all tools used and evidence of their calibration status. The three authentication types are

Installation Qualification (IQ)

Functional Qualification (OQ)

Energy Efficiency Certification (PQ)

These three Stability Chamber certification requirements and tests support each other and document the appropriate functionality.

Installation Qualification (IQ)

Overview: The first certification verifies that the Stability Chamber conforms to its design and style characteristics. All parts are inventoried and checked for fit. Appropriate paperwork such as end user guidance must also be provided, followed by any certification and normal operating procedures (SOPs).

Requirements: All factors need to be properly placed in the Stability Chamber and functioning for mobile setup authentication. If the containment room has a user interface with a stand-alone unit user interface (HMI) or some other auxiliary equipment such as switches and selector switches, they must function as created. All alignment and base security products are also required to successfully pass the assessment.

Functional Qualification (OQ)

Overview: Administer certification testing to control room functionality and verify that technology and subsystems operate as expected across the full range of typical functions – including testing of all doors, switches, managers and security alarms.

REQUIREMENTS: The Functional Qualification Check verifies that the temperature and humidity in the holding chamber are balanced. To determine precise temperature and humidity data, operators wait a few minutes so they can take control, then run checks to a specific time.

Perform Open Doorways research prior to completing functional skills. The exam consists of starting entry for a short period while recording temperature and humidity for a short period of time. The doorway activation check frequency is no less than 3 times to calculate the normal time to restore the containment room.

Energy Efficiency Certification (PQ)

Overview: Efficiency certification verifies that the safety holding chamber matches the efficiency characteristics when fully loaded. Typically, testing is performed at the functional set point of the holding chamber, with mock commodities activated to replicate a typical environment. Determine temperature and comparable humidity uniformity using thermocouples and comparable humidity (RH) detectors.

Requirements: The Stability Chamber must run at full capacity for about 24 hours before it can be certified for efficiency. After the original test is complete, the demo will often open the door test to calculate its indicated recovery time.

The stability chambers in pharmaceutical certification and fulfillment process is conducted annually using the same process as the previous test. After each recertification, the results should be compared to previous years to track the efficiency of the chamber.

XCH Biomedical Walk-in stability chamber in Prescription Drugs

XCH Biomedical has designed and produced a series of weathering test chambers in compliance with ICH recommendations, such as incubators, constant temperature and humidity chambers, mobile environmental incubators, microbial incubators and vacuum drying chambers. Click to view our complete product range.