How We Help You to Be cGMP-Compliant
Single Use
Single-use disposables designed to ensure aseptic processing, to avoid cross-contamination and mix-ups of materials. §17.21 §9.35 §9.31
Aseptic Connectors and Disconnectors
An easy and quick solution suitable for use in Grade D environment. No welding is needed! §5.13 §9.44
Safe Sampling
Thanks to the one-way valves integrated on all Cartridge components, reagents and intermediate products sampling is always possible while ensuring aseptic processing. §12.25
Continuous and Remote Monitoring of Key Process Parameters
The expansion process and all the key parameters can be checked remotely in real-time thanks to the dedicated web application. Users can monitor the culture progress from any device (smartphone, laptop, tablet) without accessing the cleanroom. §9.70
Full Process Traceability
The integrated barcode reader allows the identification of Cartridge components and Users actively involved in the manufacturing operations. All critical operations, warnings and alarms are recorded and tracked. §6.39 §17.22
Downloadable Cell Culture Report
The Cell Culture Report is a fully automated recording of all events occurred during the expansion process. The information is provided in a downloadable PDF format that can be easily integrated in any QMS as an auditable document while all the raw data are also available (downloadable LOG file). §6.26 §9.70 §17.22
§* Chapters of the Guidelines on GMP specific to ATMPs – EudraLex Vol.4 /GMP.
