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First Generation Products :: Second Generation Products :: Kit for Oncological Diagnostic :: Others :: How to Get Technical Support |
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Quality Control
The quality control Department is releasing the radiopharmaceuticals manufactured at Medi-Radiopharma Ltd based on current European Pharmacopoeia and USP monographs. Certificate of Analysis (CA) are issued for all productbatches manufactured. Beside Quality Control methods listed in various pharmacopoeial, monographs additional Q.C. methods (e.g. laser light scattering for colloid size determination, biodistribution in dogs followed by planer/SPECT imaging, are used to prove that quality and demonstrating compliance with the specifications of the product.
Macro-Albumon, Senti-Scint and Cardio-Spect products CA document are presented as on example.
99mTc-Cardio-Spect (MIBI) distribution in animal
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Palltronic Flowstar Integrity Test System |
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Light House SOLAIR 3100+ Laser Counter for clean room testing |
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Dynapro Protein Solution (for Particle size measurement) |
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Shimadzu RF-1501 Spectrofluorophotometer |
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