Photostability Chamber Qualification
Current ICH guideline Q1B requires pharmaceutical products to demonstrate that exposure to light will not cause degradation of the drug product or packaging. In addition to temperature and humidity, the photostability chambers used for this testing may have up to two other parameters qualified: Ultraviolet (UV-A) radiation and illuminance, or visible light intensity (cool white light, i.e. K lux). These parameters are measured individually at various locations on each shelf below a light bank within a grid of usable area. Values recorded for these parameters across the shelf area can vary, so the mapping is necessary to determine the optimum placement of the product under test.
As temperature has a significant impact on both light intensity and irradiation, the UV-A and illuminance of each shelf must be mapped for each temperature set point at which product will be tested at. It is recommended that the equipment end user determines the operating conditions at which product will be tested before performing the qualification, rather than mapping the UV-A and illuminance of each shelf for each temperature set point at which the chamber is qualified to operate.
Masy BioServices can perform installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of your photostability chambers, validating the critical conditions required for accurate photostability testing. Masy offers both experienced validation personnel and the necessary equipment to complete your photostability chamber qualification.
Contact Masy BioServices today for your photostability chamber qualification needs.