Photostability Chamber Qualification Services
Photostability Chamber Qualification Services
Vashishta Engineering Services specializes in the qualification of photostability chambers used for pharmaceutical stability testing in accordance with global regulatory standards. Our comprehensive validation ensures that your chamber maintains precise environmental conditions required for accurate and reproducible photostability studies.
Key Validation Parameters
We validate and qualify the following critical parameters:
1. Temperature Control & Uniformity
Verification of temperature setpoints and stability
Mapping of temperature distribution throughout the chamber
Assessment of temperature recovery after door opening
2. Humidity Control & Uniformity
Validation of relative humidity setpoints and stability
Humidity distribution mapping
Recovery testing for humidity parameters
3. Light Intensity & Uniformity
Measurement of light intensity at multiple locations
Verification of light uniformity throughout the chamber
Validation of exposure cycles and timing controls
4. Environmental Monitoring
Continuous monitoring during validation studies
Data logging and analysis of all critical parameters
Documentation of chamber performance under load conditions
Our Qualification Approach
Our comprehensive qualification process includes:
Installation Qualification (IQ)
Verification of chamber installation and configuration
Documentation of hardware and software specifications
Validation of safety features and alarms
Operational Qualification (OQ)
Testing of all operational parameters and setpoints
Verification of control system functionality
Validation of alarm systems and safety features
Performance Qualification (PQ)
Empty chamber performance testing
Loaded chamber performance validation
Worst-case scenario testing
Compliance & Standards
Our qualification services ensure compliance with:
ICH Q1B – Photostability Testing of New Drug Substances and Products
WHO TRS 961 – Annex 2: Stability testing of active pharmaceutical ingredients and finished pharmaceutical products
US FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
EU GMP Annex 15 – Qualification and Validation