Prior Information Notice For Medical Equipments, Pharmaceuticals And Personal Care Products - Market Consultation: Synthesis Modules For Pet Radiofarmaca Production
Prior Information Notice For Medical Equipments, Pharmaceuticals And Personal Care Products - Market Consultation: Synthesis Modules For Pet Radiofarmaca Production
Prior Information Notice For Medical Equipments, Pharmaceuticals And Personal Care Products - Market Consultation: Synthesis Modules For Pet Radiofarmaca Production. Currently, The Department Need With Urgent To Replace The E&Z Synthesis Modules. The 2025 Budget Includes The Replacement Of These Lab Equipment For Both Gmp As R&D. The Current Synthesis Modules From Eckert & Ziegler (E&Z) Were Purchased In 2010 And Are Used For Various More Complex 18F And 11C Radiopharmaceutical Productions For Both Patient Care And Clinical Research. Because The Modules Are Very Outdated, We Want To Replace Them With 3 Trasis Modules. These Must Be Gmp Compliant Cassette Based Modules And Preferred Widely Used In The Field (Field Standard). One Module Must Be Installed At The R&D Lab To Develop New Chemistry And Methods And Its Optimization To Further Be Used In Gmp. The Choice On The Devices In The Gmp And R&D Requires That Both Are Identical (So-Called Mirror System). This Enables Us To Transfer A Method Developed In The R&D Lab To The Gmp Facility More Easily And Quickly. The Other Two Will Be Installed In The Gmp Pet Facility. One Mainly For C-11 Productions Like C-11 Pib, C-11 Ucb-J, And The Other For Complex F18- Radiochemistry. But Also They Can Act As A Back-Up.
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