ConsiGma™ Continuous Processing Continuous Processing for Pharma R&D

In early research and formulation development, the availability of the active ingredient is often very limited and there is a need for process equipment that is capable of producing only a couple of hundred grams to develop new drug formulas. In response to this need, GEA developed lab-scale versions of the ConsiGma™ concept.

Development

Whatever your ultimate goal for production is, the first step will always be the development of either a new formulation or a new process.

An ideal development process can test the whole design space in a minimum amount of time, with a minimum amount of product and would not require scale-up to a larger machine when transferring to production.

Continuous processing offers you the solution to these needs. Our Consigma™-1 R&D concept is designed to allow you to test and develop the individual process steps with a minimal amount of product, on a small-scale equipment, but using the same parameters as you will need to use on the smallest size of the production equipment, ConsiGma™-25, as the technology used is identical.

 

DoE (Design of Experiments)

In development, people want to investigate the capability of their processes and develop strategies to avoid or manage the effects variability from various sources.

DOE (Design of Experiment) studies are a good tool to discover the real capability of a process, but unfortunately running such studies on conventional batch plants has been too expensive in terms of both materials and time. However the process intensification of ConsiGma™ gives an opportunity to explore a wider range of process parameters with less product and less time. The result is much better process understanding in a shorter time and with lower costs. 

ConsiGma™ 1

Inspired laboratory scale continuous processing for fast and easy R&D. Revolutionise the way you develop and produce tablets.

Description

ConsiGma™ 1 consists of the same patented continuous high shear granulator as the ConsiGma™ 25 system, equipped with all necessary auxiliaries to allow the development of the granulation process. A small dryer equal to one drying segment of the ConsiGma™ production dryer and capable of handling 0.5 to 1.5kg of granules, can be added to the lab machine, creating a unique combination with integrated controls for the development of continuous processes. This allows you to develop your products on the same scale with product quantities starting from a few 100 grams up to a few kg. The results are directly transferrable to ConsiGma™ 25.

Key Features

  • Mobile laboratory continuous granulator with optional fluid bed dryer segment for early phase R&D work
  • Flexible batch size
  • Process Parameters Directly Transferrable to Production Unit
  • Minimized losses
  • Fast change-over
  • Advanced user-friendly controls
  • “Out of the box, ready to use”

 

ConsiGma™ 25

ConsiGma tableting line
ConsiGma Tableting Line

Although the ConsiGma™ 25 wet granulation and drying line is intended to be a production line, it is equally suited for R&D work. It enables you to quickly confirm the results obtained on the individual development modules, but now combined in a single line/equipment. Furthermore, by running the line for a longer time, it can easily produce your clinical batches as well as your production runs, thereby effectively eliminating the need for scale-up.

ConsiGma™ Tablet Coater

Innovative tablet coating technology for continuous pharmaceutical production.

Concept

The ConsiGma™ coater is a revolutionary, new, high performance tablet coating technology that accurately deposits controlled amounts of coating materials on tablets – even if they are hygroscopic or friable. Designed specifically to be an integral part of the ConsiGma™ continuous high shear granulation, tableting and drying system, this groundbreaking machine is able to coat small quantities of tablets at very high rates, offering improved heat and mass transfer and using much less coating material than traditional technologies. 

Presenting a paradigm shift in tablet coating, this new type of coater subjects tablets to a cascading tablet movement that enables greater fluid application rates (higher coating build rates) than traditional coating pans. In addition, it is PAT compatible, efficient – warm up and drying times are faster than conventional coaters – and reliable, delivering a consistent, homogenous and even tablet weight gain and coating distribution. And, because the coater operates at higher speeds and temperatures than other products on the market, higher spray rates and improved tablet mixing can be achieved, expanding its application potential to polymer coatings and beyond what is currently possible. It can even be used to dedust tablet cores prior to coating. 

With more tablet movement within the coating barrel, the revolutionary design and the application of enhanced process conditions, the small-volume ConsiGma™ coater concentrates the tablet coating process, enabling faster throughput, time and cost savings, increased efficiency and a higher quality finished product, all of which are fundamental aspects of the drive towards continuous processing. 

 

Key Features

For R&D purposes, the coater offers 

  • a single wheel design to enable development of the coating process
  • a 7 minute total batch time for aesthetic coats (5.5 minutes of coating)
  • integrated dispensing hoppers with optional volume control
  • exchangeable coating wheels offering two nominal batch sizes of 1.5 and 3.0 kg
  • integrated liquid feed systems with peristaltic pumps and mass flow meters
  • an air-knife system to create the tablet cascade
  • a wide range of tablet shape and weight capabilities
  • inline coating thickness monitoring with the Kaiser Raman probe.