ConsiGma®
ConsiGma® Dosing and Blending (DB) Modules
Designed to achieve optimal blending results, the ConsiGma® DB modules facilitate the testing of dosing and blending operations and can be integrated with any continuous up- or downstream process.
Depending on its configuration and the formulation, the system can achieve throughputs of 1 to 400 kg/h.
The Conductor software ensures seamless control of the entire process and full reporting. Tracking of OOS and material genealogy can be integrated into the controls. Handshaking with up- or downstream equipment can also be offered.
ConsiGma® DB modules can be implemented in a wide variety of situations, including the following:
- Dosing and blending of external phase additions (lubricant) together with a pre-blend
- Dosing and blending of multiple (up to four components) of flowable powder materials
- Asan R&D module to investigate the dosing and blending process for NCE, orphan drugs or low-dose APIs
- As a dosing and blending unit combined with other continuous up- or downstream processes for both low dose and high throughput products, depending on the configuration
The modules are suitable for ethical, CDMO, generic, nutraceutical or CMO operations.
Standard Configuration
- 2 to 7 loss-in-weight feeders
- Linear or ribbon blender
Available Options
- Choice of feeder (GEA or qualified third-party supplier)
- Continuous flow or mini-batch blending capability
- Blend uniformity measurement with Lighthouse Probe®
- Customer selected tablet press (GEA or other – control interface to be clarified)
- OOS rejection
- Material genealogy
Main Benefits
- Use with existing equipment (roller compaction, compression, etc.)
- Continuous or mini-batch flow capability
- Replace only a single step in the process with minimal impact as per SUPAC guidelines; plant scheduling and testing remain the same as current process.
- Higher blend homogeneity – all powder particles go through the same mixing event
- Higher material yield
- High flexibility from very low to very high API content
- In-process blend uniformity control – second-by-second
- Compatible with variable throughput capacities
Read more about how GEA and its partners are implementing this technology to lead the way toward smaller, more flexible, continuous processing technologies that are transforming the future of pharmaceutical development and manufacturing.
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Produtos relacionados
ConsiGma® Direct Compression with Linear Blending (DC-LB) Lines
A highly integrated solution for continuous linear blending and direct compression, the ConsiGma® DC-LB lines offer all the advantages of continuous manufacturing: supply chain agility, small footprint, controlled blending and compression and improved quality.
ConsiGma® Granulation and Compression (GC) Lines
Highly integrated solutions for continuous wet granulation, drying and tablet compression, the ConsiGma® GC lines offer all the advantages of continuous manufacturing: supply chain agility, small footprint, controlled granulation and improved quality.
ConsiGma® Gentle Coater
The ConsiGma® Gentle Coater is based on the GEA high-performance tablet coating technology that gently and accurately deposits controlled amounts of coating materials onto tablet cores — even if they are hygroscopic or friable.
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The Lighthouse Probe® can be used for real-time monitoring of chemical and pharmaceutical processes and provides in-process window cleaning at any time, recalibration during the process, full CIP (cleaning) of wash housing and seal, and a clear view inside – even in difficult conditions.
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