Caron 6545 - Manual (Page 60)

6540 Series Operations Manual Rev_I.docx 4/7/2014 60
APPENDIX A – VALIDATION (REFERENCE ONLY)
What is Validation/Qualification?
Validation/Qualification is the act of providing documented evidence that the installed equipment or systems
perform as specified during the design phase and meets the specifications of the manufacturer, the owner,
and applicable regulations. Typically, one would Qualify equipment but Validate a process. Steps include
Installation, Operation, and Performance Qualification. Validation/Qualification is more elaborate than
Equipment Manufacturer’s Installation in that it involves several additional steps farther performing system
calibration, worst case and functionality testing. Calibration of individual components is recommended prior
to validation.
Recommended Equipment for Validation/Qualification
Data acquisition system
Calibrated radiometer/photometer with calibrated UVA and VIS detectors
10 calibrated temperature sensors
2 calibrated humidity probes (if humidity control only)
Recommended validation steps to include
 Controller functionality testing
 System calibration of light controller (UVA and VIS light)
 Light uniformity mapping
 Chamber temperature mapping
 Chamber humidity mapping (reference only)
 Comprehensive final report
Light Detector Calibration
The UVA and VIS light detectors integrated into the chamber are high quality instruments specifically suited
for the application. These features include:
 Detectors are calibrated to NIST traceable standards
 Detectors are planar, cosine-corrected and have a Teflon hemisphere
 UVA light detector calibrated to exact lamp’s spectral power distribution
 VIS light detector spectral response closely follows CIE photopic action spectra & wide band width
For testing to a minimum exposure/dose level (such as ICH Q1B confirmatory testing), it may be useful to
calibrate the light detector to correspond with the minimum intense shelf location (see calibration).
Temperature and Humidity Calibration
To isolate the disturbance of lamp radiation, temperature and humidity sensors are mounted out of direct
lighting and measure air conditions entering the chamber. With the lights fully on, the chamber displayed
temperature (and humidity) may be different than a sensor on the shelf because of the light radiation. Any
temperature sensor in direct lighting should be wrapped in aluminum foil or similar material to measure air
temperature. A calibration offset can be applied to equate to conditions anywhere within the chamber (see
calibration).