품질검사(Quality Control)
방사성의약품이 생산되면 모든 품질검사가 끝난 다음(Sterility Test 제외)에 약품을 반출하며 품질검사 항목은 다음과 같다.
· Appearance
· Filter Integrity Test (FIT SNUH in House)
· Bacterial Endotoxin Test (PTS)
· Kryptofix2.2.2 Spot Test
· pH (pH Meter or pH Paper)
· Radiochemical Purity (TLC)
· Energy Spectrum (MCA)
· Residual Solvent (GC)
· Half-Life Determination (Dose Calibrator)
· Sterility Test (FTM, TSB)
Quality Control Hot Cell
Quality Control Room 2
Model : HPLC System
제조사 : Gilson, Inc.
도입 : 2011.
Pump : Binary
Detector : 155 UV/VIS, NaI Scintillation(Raytest)
보유 : Prep 3EA, Analytical 3EA
Model : 7820A GC System / Clarus 680 GC
제조사 : Agilent Technologies / Perkin Elmer
도입 : 2011 / 2017
Detector : FID
Model : AR-2000-1
제조사 : Bioscan, Inc.
도입 : 2014.
Detector : P10 Gas-Filled Proportional Counter
보유 : 2EA
Model : Endosafe® PTS KINETIC READER
제조사 : Charles River Laboratories
도입 : 2011.
Sensitivity : 5~0.05 EU/mL
보유 : 2EA
Model : GenieTM 2000 Spectroscopy
제조사 : CANBERRA Industries, Inc.
도입 : 2014.
Detector : High Performance Germanium
Model : BB 15 CO2 Incubator
제조사 : Thermo Scientific Inc.
도입 : 2016.
보유 : 5EA