ORA Neptis® Module
CMR offers ORA (Optimized Radiochemical Applications) modules from our partners to our clients. These synthesis modules are designed for the automated production of radiopharmaceuticals, including Fluorine-18, Carbon-11, as well as therapeutic and diagnostic radionuclides. Each module is installed and serviced by experienced engineers and can be certified upon request.
Applications - list of molecules used: [18F]F-Acetate, [18F]F-Choline, [18F]FDG (1 synthesis), [18F]FDG (2 syntheses), [18F]FMISO, [18F]NaF, [18F]PSMA-1007, [18F]FDGal, [18F]FES, [18F]FET, [18F]FDOPA, [18F]FLT.
GMP compliance: ORA modules ensure seamless integration into your Quality Assurance Program. ORA has been ISO13485 certified since 2014. All NEPTIS documentation complies with stringent GMP standards, while NEPTIS software meets 21 CFR Part 11 requirements. All NEPTIS automatic modules adhere to GAMP5 standards.
Advantages: reliable automation of synthesis processes, support for a wide range of radionuclides, compliance with international quality and safety standards.
- Partner
- ORA (oraneptis.com)
- Certification
- ISO13485 (since 2014), 21 CFR Part 11 software compliance, GAMP5
- Molecules supported
- F-Acetate, F-Choline, FDG, FMISO, NaF, PSMA-1007, FDGal, FES, FET, FDOPA, FLT (all 18F)