FUZKK Pharma Utilities Portal
A catalogue of pharmacopoeial utilities for Quality Control: calculations, CSV input checks, JSON outputs and software validation preparation.
Summary
CSV / LIMS / ELN / MES
The portal consolidates utility packages for pharmacopoeial quality control, radiopharma, medical gases, liquids, API monographs and specialist product groups.
Audit readiness
Audit readiness (IQ/OQ). Each utility is supplied with URS and FS templates. This significantly accelerates software validation for FDA/EMA/Roszdravnadzor inspections.
Packages
AllRPH: combined radiopharmaceutical QC package
107RPH combines PetRad, PetRad2 and PetRad3 into one umbrella package for PET/SPECT, therapeutic radionuclides, generators, labelled compounds, decay calculations, sterility, endotoxins and radiochemical/radionuclidic purity.
Rph Hyperpolarized Xenon Lifecycle QC Suite
2929 utilities for the hyperpolarized xenon lifecycle: isotope composition and gas purity, SEOP and polarization, T1/storage/transport, safe blending and delivery, MRI/SPECT QC, dosimetry, scavenging, recovery and recycling.
RPH Tc-99m Renal Radiopharmaceutical and Imaging QC Suite
1616 utilities covering the Tc-99m renal workflow: generator eluate and Mo-99 breakthrough, Sn(II), labeling stoichiometry and pH, radiochemical purity and stability of MAG3, DTPA, DMSA(III) and glucoheptonate, gamma-camera uniformity, renal uptake and plasma clearance, bladder voiding efficiency, patient dosimetry and decay-in-storage waste management.
Radiopharmaceutical Diagnostics and Therapy QC Suite
3636 utilities for clinically oriented radiopharmaceutical and workflow quality control: PET/SPECT tracers, the Tc-99m renal workflow, PRRT, PSMA therapy, targeted alpha therapy, radioembolization, bone-pain palliation, immuno-PET and generator-based radionuclide control.
PET Scanner State QC Suite
1414 utilities for PET/PET-CT scanner state control: Ge-68/Ga-68 source activity, blank sinogram, detector efficiency, normalization acquisition and factor distribution, normalization-file assignment, trending, energy window, TOF, attenuation-correction map, PET/CT cross-calibration and the daily operational decision.
LabEx QC Suite
60LabEx package for laboratory QC methods: chromatography, spectroscopy, microbiology, sterility, endotoxins, particles, dissolution, water, cleanrooms and sample preparation.