A special FAT has been successfully completed at Tema Sinergie and we would like to say thank you to Charles Ross and Andrew Cumming!
Why is this FAT so special? Because the Aseptic Processing Isolator System – V model, which underwent in-house validation, has been specifically designed for the Translational Research Institute (TRI) in Brisbane, Australia: the equipment will shortly be installed in the newly setup TRI Clinical Manufacturing facility and hands-on competency based Training Hub, the result of a joint project between TRI and Vaxxas, a startup specializing in next generation vaccine technology.
As Charles Ross, Head of Clinical Operations and Supply at Vaxxas, has explained:
“What we have now is this super flexible, super accessible facility… where people can come in and manufacture their early stage clinical trial product. Staff will be trained up at the facility…. then these people can be a pool of staff for commercial entities to use to manufacture their product.” (quote from https://www.tri.edu.au/news/mtpconnect-podcast-tri-vaxxas)
We at Tema Sinergie are truly honored to contribute in such an innovative and truly unique project, by putting our cutting-edge technology at the service of healthcare and scientific progress.
Tema Sinergie has been selected as a partner among many other manufacturers thanks to our technical skills, outstanding technological proposal, continuous support and understanding of specific customer needs.
The isolator perfectly meets the required flexibility, allowing it to be used both by start-ups and researchers in the small-scale manufacture of early stages clinical trials products (including new generation vaccines, cell and gene therapies). Moreover, the equipment will be used as a training tool for staff and students in pharmaceutical aseptic manufacturing.
Being it a fully GMP compliant equipment, it will be very useful for training on several aspects, such as:
- Unidirectional airflow and HEPA filtration.
- Filters DOP testing.
- Monitoring of internal physical parameters: air velocity, pressure, temperature and relative humidity.
- Particle (non-viable) and microbiological (viable) monitoring systems.
- Bio-decontamination processes thanks to the integrated VPHP generator and H2O2 sensors.
- Introduction/Extraction of material using Rapid Transfer Ports.
- Glove integrity testing using our Automatic Glove Leak Testing System (AGLTS).
- GMP compliant data acquisition, storing and reporting through Tema Sinergie’s software application DataWall.