Are you a researcher, a developer, a commercial producer? Then you need to be able to develop, test and reliably produce specific tracers on a platform that allows you to control and test your cassette design, visualize your process in real time with all key parameters and produce GMP compliant summary or fully detailed reports.
The VIRTUAL SYNTHESIZER® Application (VSA) environment is perfectly in line with the evolution of automated synthesizers using disposable cassette system. Compliant with ISPE GAMP 5 and FDA Title 21 CFR Part 11 guidelines, it provides the means to create an unlimited number of individualized radiotracer synthesis applications.
The VSA consists of a computerized data set that contains all of the pertinent information about the specific radiotracer:
- Radiotracer specific kit test
- Radiotracer specific method with sequence optimisation capability
- Graphical display of radiotracer specific reaction pathway
- Real-time data display in multiple graphs during the synthesis
- Radiotracer specific GMP compliant synthesis report, summary and expanded reports
- Extensive hardware diagnostic tools
- Open sequence development capability for customized synthesis and new radiotracers
- Capability of converting custom developed sequences into standard production methods
- Extended network capability and control
- Time stamped audit trail for traceability requirements
The NEPTIS® Designer application allows the development of customized syntheses and their associated graphical reaction pathways in a stand-alone environment, along with the export of the complete tracer application (Virtual Synthesizer® application) for immediate operation with a synthesizer within the NEPTIS® Control (VSA) module. This tool brings invaluable flexibility in assisting in the development of any type of synthesis on multiple platforms together with its associated environment – graphical definition of the cassette hardware, the associated cassette testing sequence, assistance to build up a pre-validated synthesis sequence, and running and fine tuning them.
The NEPTIS® Trending application is the long-term memory of your operation and performance. It is an advanced tool to review, evaluate and trend your valuable data history. This package allows the exploitation and trend analysis of the accumulated data runs, with additional follow-up functionalities of key parameters (such as calibration, maintenance, etc…).
For organisations that are operating multiple synthesizers, customisation of the package is available as an option.