Photostability Chamber Qualification Services

Light and Environmental Controlled Testing Compliance

Pharma Integrity Validations & Services specializes in the qualification of photostability chambers used for drug substance and product stability testing. We verify light energy emission, temperature control, and relative humidity in accordance with ICH Q1B guidelines.

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Key Validation Parameters

1. Lux & UV Light Intensity Uniformity

• Visible light intensity mapping (ensuring $\ge 1.2 \text{ million lux hours}$)
• Near-UV energy mapping (ensuring $\ge 200 \text{ watt hours/m}^2$)
• Spectral distribution and light bank automatic shut-off verification

2. Thermal & Humidity Control

• Chamber temperature mapping during active light exposure
• Relative Humidity (RH) distribution and stability testing

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Regulatory Guidelines Complied With

• ICH Q1B: Photostability Testing of New Drug Substances and Products
• US FDA 21 CFR Part 211: cGMP for Finished Pharmaceuticals
• EU GMP Annex 15: Qualification and Validation