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ConsiGma™

ConsiGma™ Continuous Tableting Line

Taking a blue sky powder-to-tablet approach to pharmaceutical manufacturing, ConsiGma™ offers continuous oral solid dosage granulation, drying and tablet compression in a single production line.

Continuous Line

The ConsiGma™ continuous tableting line (CTL) is a multipurpose platform that has been designed to transfer powder into coated tablets in development, pilot, clinical and production volumes in a single integrated unit.

Revolutionise Tablet Development and Production

The ConsiGma™ system is designed for plug flow, first-in first-out production (avoiding back mixing), providing consistent quality and allowing for the inline control of critical quality attributes.

The system can be configured to perform dosing and mixing of raw materials, wet or melt granulation (using the same co-rotating twin screw granulation unit), drying (cooling for melt granulation), tableting, coating and quality control, all in one line. 

By producing granules continuously, batch sizes are determined by how long you run the machine or by how much inbound material is supplied; and, because of ConsiGma™’s innovative design, the amount of waste produced during start-up and shut down is significantly reduced compared with conventional methods. Quality is measured throughout the process and, as such, drastically reduces the cost per tablet. Critical quality attributes are measured second-by-second and any deviation from the norm is immediately reported to the operator.  

ConsiGma™ was developed in compliance with the FDA’s QbD initiative. It satisfies the industry’s need for reduced risk and higher quality while avoiding lengthy and costly validation and scale-up to bring products to market faster and cheaper. The inherent flexibility enables manufacturers to meet demand, keep expensive cleanroom space to a minimum and reduce inventory costs.

Optionally integrated advanced process control and PAT tools enable monitoring during production, so quality can be designed into products from the start. ConsiGma™ provides maximum output in an energy efficient way, has been tested using more than 120 different formulations and is already being used by several large pharmaceutical companies, and both ethical and generic research and manufacturing centres worldwide. 

Key features

ConsiGma Tabletting line - dryer section

ConsiGma™ offers

  • maximal end-product safety using online quality control
  • contained processing 
  • 10 times faster testing in R&D and no product transfer scale-up
  • 40% reduction in labour costs  
  • 60%reduction in manufacturing space   compared with current industry standards
  • 50% energy savings based on reduced power requirement and heat recovery

To enhance flexibility even further, the ConsiGma™ can also be configured for dry and melt granulation. The system can also be connected to the GEA MODUL™ tablet presses with an Exchangeable Compression Module (ECM) and a double drum ConsiGma™ coater to form a truly continuous tableting line.

GEA believes that continuous processing improves the quality of pharmaceutical end products: by focusing on whole product lifecycle quality and by understanding the capability of your processes, managing sources of variability and decreasing any associated risks.

連続打錠 web

The ConsiGma™ continuous high shear granulation and drying system is a multipurpose platform that consists of several modular blocks, which can be combined to form the continuous production line.

The Basic Modules

In the granulation module, up to four dry ingredients, or a premixed powder, are individually dosed and delivered to the continuous high shear granulator. The granulation liquid is also accurately dosed  and thoroughly mixed with the dry components, resulting in a continuous flow of wet granules — of constant quality and  density —  that is subsequently transferred to the dryer. There are no over-sized agglomerates so a wet mill is not required. 

The dryer module, based on the classic fluid bed drying principle, splits the continuous flow of granules into sections of the dryer. The sections are emptied and the product transferred to the evaluation module. The drying curve of each sample is monitored. 

In the evaluation module, dried granules are received for dry milling. Here, critical quality attributes such as particle size distribution, humidity and content uniformity can be measured inline. 

All captured data can be analyzed by the control system and parameters can be adjusted to keep the process within a narrow band of defined quality parameters. 

The ConsiGma™ can process capacities from 500g up to tonnes, with time being the only variable. Batch size is determined simply by how long you run the machine.

With its light weight, ultra small size and modular construction, ConsiGma™ fits perfectly into every R&D department or existing tablet production room. No need to change the building, just wheel it in, connect the power and an air supply and off you go. Installation time and costs are reduced to a fraction of the current benchmark. 

Optional Modules

Feeding & blending module: If more than four components need to be mixed continuously, the ConsiGma™ line can be extended with a module to incorporate more ingredients. Dosing is achieved using loss-in-weight feeders that supply a low shear inline blender, which, in turn, feeds the high shear granulator.

Tablet compression module: The MODUL™ P rotary tablet press can be connected to the system to immediately convert the produced granules into tablets. The MODUL™ P offers equal final compression forces for all tablets and adjustable dwell times at pre- and final compression.

Tablet relaxation & coating module: If the final dosage form is a coated tablet, a continuous coater can also be integrated. As some tablets require "relaxation" time before coating to ensure optimal quality, a suitable system can be included.

関連製品

ConsiGma™ Continuous Direct Compression

ConsiGma™ Continuous Direct Compression

The ConsiGma™-DC for direct compression is the latest expansion of GEA's continuous portfolio for cost effective, compact, high yield manufacturing systems. It offers a robust and flexible manufacturing method for a wide range of products.

ConsiGma™ Continuous Tablet Coater

ConsiGma™ Continuous Tablet Coater

After compression, many tablet formulations need a coating to achieve the final product characteristics desired. To complete the ConsiGma™ tableting lines, GEA has developed a coater in line with its continuous manufacturing concept.

Lighthouse Probe™ - online measurement

Lighthouse Probe™ - online measurement

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.

MODUL™ Tablet Press Technology

MODUL™ Tablet Press Technology

All MODUL™ tablet presses are based on the Courtoy™ Exchangeable Compression Module (ECM) concept. The ECM is completely isolated from the remainder of the machine, contains all product contact parts and can easily be removed from the press in a contained way. This means that the press itself remains powder-free and requires no cleaning.

Wash-Off-Line for Pharmaceutical Plants

Wash-Off-Line for Pharmaceutical Plants

In addition to providing complete containment services, GEA also offers multifunctional wash skids that can be moved from one location to another and used to clean different parts of the process. Every plant delivered by GEA has a tailor made CIP, WIP or Wash-Off-Line (WOL) system to suit your application.

医薬品製造プロセスプラント向けの CIP

医薬品製造プロセスプラント向けの CIP

プロセスの最適化は効率的で効果的な洗浄にかかっています。 CIP (Clean-in-Place: 定置洗浄) システムは、流動床乾燥機、高せん断力造粒機、液体投与製剤システムなど、GEA 製の製薬業界向け全装置に組み入れることができます。 洗浄プロセスの自動化によって再現性が確保され、検証が可能になり、ダウンタイムが最小限になります。

医薬研究開発用連続処理

医薬研究開発用連続処理

初期の研究と製剤開発では多くの場合、有効成分の利用性が非常に限定されていることから、新規薬物の構造式を開発するために、わずか数百グラムの薬物を製造可能な処理装置の必要性があります。この必要性に対応して、GEA は ConsiGma™ コンセプトに基づく実験室規模の装置 ConsiGma™ 1 を開発しました。

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