Services

Services Table

Cyclomedical Applications Group Start-Up Services
 On Site
 SOPVendorOperator TrainingQualification
Equipment Installation/Qualification
InstallationVendor  X
Installation QualificationXX X
Operational QualificationXX X
Performance QualificationXX X
Product Quality Control
Residual Solvents (GC)XXX 
Radiochemical Purity (RTLC) X X X  
Chemical Purity (KTLC) X X X  
Radionuclidic Purity (γ-Spec) X X X  
Bacterial Endotoxins
(Limulus Lysate)		 X X X  
Sterility X X X  
pH X X X  
Half Life X X X  
Manufacturing
FDG ManufactureXXVendorX (3 batches)
Asceptic ProcessingXXX 
Packaging and DistributionXXX 
Raw Materials
Specification BookXXX 
Qualification testsXXX 
Administration
Quality systemXXX 
Facility maintenanceXXX 

Next: Multidose FDG

Previous: Experience