Test Capabilities for Continuous Processing

Test Capabilities for Continuous Processing

An overview of the test capabilities for continuous processing at our test center in Wommelgem, Belgium

Test Capabilities for Continuous Processing

The ConsiGma® concept enables small amounts of product to be processed and developed quickly and efficiently. And, once a formulation has been optimized, it can be reliably reproduced in pilot, clinical or production batches, simply by running the machine for longer, avoiding scale-up problems and the lengthy validation processes that hinder bringing new products to market faster.

ConsiGma® is a Six Sigma-inspired manufacturing platform, incorporating different technologies to produce oral solid dosage forms in a continuous, cost-efficient way:• • by collecting more information during R&D in a short time with less product

• by excluding risky, time- and product- consuming scale-up exercises

• by introducing online measurement and closed loop control for real-time release (Six Sigma production)

• by incorporating flexible batch sizes (JIT production) and reducing inventory

• by decreasing the energy cost per tablet, reducing the environmental impact.

The Test Center in Wommelgem enables you to investigate the possibilities that continuous manufacturing can offer for your production. Following technologies are available for testing: • ConsiGma® 1 for initial continuous wet granulation trials, feasibility and first DoE tests.

• Continuous Tableting Line CTL 25: a continuous wet granulation and drying production line, able to operate at a nominal throughput of 25 kg/h. Tablet compression and tablet coating can immediately be linked to the granulation and drying process, to evaluate the full continuous process.

• Offline Compact Feeder (CF): to investigate the right set-up of the feeder for your ingredients before moving to the full production line.

• ConsiGma® CDC50 for continuous direct compression • ConsiGma® Coater Continuous Coating of tablets produced by the CTL25 or CDC50.

At GEA, we believe that continuous processing improves the quality of pharmaceutical end products by focusing on quality during the whole product lifecycle not just “tested in” quality — and by understanding the capability of your processes, managing sources of variability and decreasing any associated risks.

CONTINUOUS PROCESSING CAPABILITIES.

ConsiGma® 1 for R&D scale continuous granulation.

7 The GEA Pharma Solids Test Centers in Belgium.


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