Photo-stability chambers qualification

The temperature and humidity tolerances within the chamber should be challenged as part of the photo-stability chamber qualification just as they are for a tempera-ture/humidity chamber. 

Abstract An important aspect of all stability studies is the stability chambers themselves. This chapter is intended to provide a description of the different sizes and types of chambers that are available, the chamber tolerances required, and to provide some practical information for qualification, calibration, maintenance and monitoring of the chambers. Temperature, humidity and photo-stability chambers are included. Also included are guidelines on how to handle chamber excursions. 

As with temperature and humidity chambers, the DQ/IQ/OQ/PQ stages may be handled separately or combined to some degree. There may be very little difference between the qualification of a temperature/humidity chamber and a photo-stability chamber. The following describes what might be added to the qualification guidelines, previously provided in Tables 14.1 (IQ), 14.2 (OQ), and 14.3 (PQ), that make photo-stability unique. 

Photo-stability chambers may be incorporated into the back-up system used for the temperature and humidity chambers although back-up systems are not necessarily as critical for photo-stability as these types of studies can be fairly easily repeated if necessary. Any back-up system in place should be described and tested during qualification. 

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See also in sourсe #XX -- [ ]

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