Article Figures & Data
Figures
- FIGURE 1.
Temperature difference before and after calibration at 98°C. Reaction vials containing 5.0 mL of water were heated in AccuBlock D1200 dry bath. Before calibration, measured temperature was 3.5°C below set point of 98°C; after calibration, measured temperature reflected set temperature. Dotted line is parameter of selected working condition: 98°C set point and heating for 8 min.
- FIGURE 2.
Temperature curves for selection of dry bath set points. Temperatures were measured in reaction vials containing 5.0 mL of water. Box denotes manufacturer-recommended range of temperatures for labeling in reaction solution (90°C–98°C). Principal investigator recommended heating time of 7–10 min at 95°C–98°C set point. Temperature at intersection of box and 2 dotted lines will be best range for labeling. For 105°C set point, temperature will easily reach at least 98°C at 8 min. Both 98°C and 100°C set points fit well within range of 8–10 min. At 7 min and 98°C set point, temperature will be below 90°C. For 95°C set point, temperature can reach only 90°C at 10 min.
- FIGURE 3.
68Ge content in generator eluates. Generators were eluted weekly; specification was <0.00100%. Generator 1 was eluted about 480 times in 375 d, and 68Ge breakthrough was <0.00031% throughout. Generator 2 was eluted about 720 times in 339 d; 68Ge breakthrough increased to up to 0.00060% after 590 elutions (280 d) but was still within 0.00100% limit.
- FIGURE 4.
Comparison of iron and zinc content of eluates. Weekly eluates were obtained from 2 generators (specification was <0.01 μg/MBq). Data showed that both iron and zinc content were well below specifications.
- FIGURE 5.
RP with multiple lots of NETSPOT kits. Production failures attributable to human error are not shown. Arrows indicate when new lot or cartridge condition was introduced into production. First 476 runs used dry silica gel cartridges to remove 68Ge breakthrough; average RPs were 97.2% and had more failures, but only 1 lot (PG 1917017) exhibited very high RP and few failures. Remaining run data showed no differences in RPs between conditioned cartridges and no cartridge; both methods were reliable, and average RPs exceeded 99.4%.
Tables
- TABLE 1
Comparison of Iron and Zinc Content in 0.1 M HCl after Contact with Potential Sources of Contamination
Contamination source Iron (ng/mL) Zinc (ng/mL) Becton Dickinson needle 84.33 ± 68.97 4.03 ± 0.68 B. Braun needle 2.27 ± 2.09 4.56 ± 2.26 Contact septa 66.23 ± 12.07 2887.13 ± 278.07 Gallium eluent without needle 6.00 ± 1.41 4.83 ± 1.92 Condition Total runs (n) Failure rate Success rate (n) Mean RP Total (n) Due to operator error (n) No conditioning 476 33 4 443 (93.07%) 97.18% (SD, 5.42) 0.1 M HCl, 2.0 mL 33 0 0 33 (100.00%) 99.58% (SD, 0.27) Sterile water, 2.0 mL 271 6 4 265 (97.79%) 99.08% (SD, 2.58) No cartridge 224 2 0 222 (99.11%) 99.37% (SD, 1.45) Total 1,004 41 8 963 (95.92%) 98.25% (SD, 4.19)
