From tablet development to full-scale tablet production in only 30 minutes - Scale-up work no longer required!
The Galenic Exchangeable Compression Module (G-ECM) for the MODUL™ P and S is designed specifically for tablet formulation development work and clinical trials production. As only limited product quantities are available in the initial stages of the manufacturing process, every effort has been made to reduce the loss of powder to the very minimum.
Special design features on the Galenic ECM include:
- a purpose-designed powder in-feed system, suitable for product quantities down to 1 kg
- the possibility to use screw-on powder feed containers
- a reduced-volume feeder, minimizing the quantity of powder that remains in the feeder at the end of the compression run
- the possibility to choose the number of punch positions required and to work with blind dies
- the possibility to combine different tooling types on a single turret, for instance 10 D tooling positions and 10 B tooling positions (up to 3 types can be combined)
- the possibility to use screw-on tablet collection containers
- contained tablet sampling
MODUL™ tablet press with Exchangeable Compression Module
The Galenic ECM can easily be switched with a full-production ECM, which means scale-up of production on the same MODUL™ tablet press is only an ECM exchange away!
All relevant parameters related to the compression cycle (pitch diameter, diameter of compression rollers, slope of cam tracks, punch tip velocities and linear die velocity) remain identical when switching from the G-ECM to a production ECM.
As a result, scale-up work is simply eliminated, which reduces the time-to-market for new products and represents a real cost saving. Also, all machine parameters established during the formulation development phase are memorised in the very same control system that will later be used for production.
Adding to the assets of the ECM concept a selection of purpose-designed R & D features, the Galenic ECM presents the following important benefits:
- Different containment levels and cleaning methods: a high-containment and wash-off-line version is available
- Protection of both operator and product
- Prevention of cross-contamination
- Production of very small batches (down to 1kg)
- Preparation of G-ECM off-line for minimal equipment time usage
- Full compression data gathering for analysis
- No need to change compression parameters when scaling-up from formulation development work to clinical batch production, and ultimately to full-scale tablet manufacturing.