Contact
Dr. Torsten Knieß
Department Head
Production of Radiopharmaceuticals
t.kniess
hzdr.de
Phone: +49 351 260 2760
Dr. Jörg Zessin
j.zessinhzdr.de
Phone: +49 351 260 4021
+49 351 260 4041
+49 351 260 3351
Quality control
Each single batch of our produced radiopharmaceuticals is daily analyzed by quality control for the following parameters before release for clinical application:
|
• identity |
[HPLC, half-life, γ-spectrometry] |
|
|
• radiochemical purity |
[radio-HPLC, radio-TLC] |
|
|
• chemical purity |
(by-products /starting materials) |
[HPLC, TLC] |
|
(residual solvents) |
[GC/MS] |
|
|
• radionuclidic purity |
[half-life, γ-spectrometry] |
|
|
• pH-value |
[pH-meter] |
|
|
• osmolarity |
[Osmometer] |
|
|
• microbiological purity |
(bacterial endotoxins) |
[LAL test] |
|
(sterility) |
[sterile test for sample A and B] |
|
|
• in process controls during production |
[particle, microbiology, humidity, temperature] | |
|
• hygiene |
[personnel, rooms, equipment] | |
Contact
Dr. Torsten Knieß
Department Head
Production of Radiopharmaceuticals
t.kniesshzdr.de
Phone: +49 351 260 2760
Dr. Jörg Zessin
j.zessinhzdr.de
Phone: +49 351 260 4021
+49 351 260 4041
+49 351 260 3351
