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Charles E. Taylor, Robyn A. Rourick and John P. Walsh
Kalypsys, Inc. Pharmaceutical Sciences Department 10420 Wateridge Circle, San Diego, CA 92121
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2 Chemical Stability Block
the exhaust hose connection
• Opaque 96 well plate with foil sealing
3 Chemical Stability Chamber Partition
to the fume vent. • Actinometric monitoring a dry standard (Compliance with FDA Q1B Section IV)
4 Photo Stability Block
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5 Robotic Arm Grip
6 Lamp Fixture Future Developments
7 Inlet/Outlet Fans
Chemical Stability Chamber
8 Extruded Aluminum Frame
9 Ventilation Exhaust Pipe • Implement corrosion proof 96 well vessel
Figure 4a: CAD rendering of device; viewing angle for Figure 4
10 Exhaust Vent for Chemical Stability
→Plate with glass inserts
11 Extruded Aluminum Frame
12 Chemical Stability Chamber Access
Figure 6: CAD rendering of the device with arrows corresponding in color to →Stainless steel
13 Chemical Stability Sample Block
the sub‐figure boxes containing photographs of the assembled device. • Sealing the wells/vials to minimize the evaporation
Figure 1: CAD representation of Figure 2: Photo of constructed The black panels contain the chemical stability chamber, and the white
14 Photo Stability Sample Block Figure 6b: Front‐view of the chemical
stability chamber with top chamber integrated to the liquid panels correspond to the photo stability chamber. →Pierceable PTFE sealing mat
15 Robotic Arm Grips for Door stability chamber. The sample vial
invisible to highlight the two handler deck; chemical portion is Photo Stability Chamber
16 Photo Stability Chamber Door block is shown, with the white round
inner chambers: chemical black and the photo chamber is 17 Inlet Cooling Fan for Light Ballast exhaust vent in the background. • Implement fiber optic delivery of light to 96 well plate
(leftside) and photo paneled in white. 18 Ventilation Exhaust Pipe
(rightside). →No heat transfer
Table 1: Corresponding descriptions
Results: The photo stability chamber provides for appropriate sample photo for Figures 4 and 5. →Controlled exposure of wells
Figure 5a: CAD rendering of device; viewing angle for Figure 5
degradation in 72 hours with only 40 mg of sample consumed. With the • Employ non‐actinometric methods of monitoring the light energy
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chemical stability chamber’s elevated sample temperature and highly →Spectrometer/lux meter
caustic conditions, appropriate degradation occurs within 4 hours. Each
chamber is still undergoing thorough performance characterization, but Figure 10: Example chromatograms illustrating the Acknowledgements
Figure 6d: Front‐view of the photo stability
trials thus far have shown consistent hardware performance and repro‐ effectiveness of a 4 hour time course in the The authors would like to thank the following parties for their guidance and
chamber, with the access door open. The
ducible sample results. chemical stability chamber. Bisacodyl was service in the production of this device: Mike Fanolla of FandL Solutions
Peltier device is visible protruding
degraded in 3% hydrogen peroxide for 4 hours at
Conclusions: The chamber constructed meets the performance expectations through the deck, the gold colored clean (distributor of the 8020 materials used to build the device), Torrey Pines Scientific
Figure 7: Picture sequence of 60o C. The control sample is considered to be a 6 Figure 9: Picture sequence of
and functionality to provide for automated accelerated sample degrada‐ air vents shown on the left and the lamp for their efforts in supplying the Peltier devices, and McMaster‐Carr for their
chemical s t a b i l i t y minute time point, as this is the amount of time photo stability automated
tion on a platform that allows for rapid LC/MS sample analysis. that it takes from sampling to end of analysis.
housing is slightly visible on the right. great customer service.
Figure 5: Front‐view annotated illustration of the device design features and parts. automated sample removal. sample removal.