Menü

ConsiGma™

ConsiGma™ Devamlı Tabletleme Hattı

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.

Devamlı Hat

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 Tabletleme hattı - kurutucu bölümü

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.

Devamlı Tabletleme 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.

İlgili Ürünler

ConsiGma® Compact Feeder (CF) Test Rig

ConsiGma® Compact Feeder (CF) Test Rig

The ConsiGma® CF20 test rig is a standalone module that allows you to characterize the feeding behavior of your products during the early stages of R&D.

ConsiGma® Conductor 4.0

ConsiGma® Conductor 4.0

An indispensable part of the ConsiGma 4.0 portfolio, the Conductor 4.0 control system architecture ensures smooth operation and communication between the different elements of the continuous manufacturing line

ConsiGma® Direct Compression with Ribbon Blending (DC-RB) Lines

ConsiGma® Direct Compression with Ribbon Blending (DC-RB) Lines

A cost-effective solution for continuous dry blending and tablet compression using ribbon blending, ConsiGma® DC-RB lines make the advantages of continuous manufacturing (supply chain agility, small footprint and improved quality) available for all.

ConsiGma® Dosing and Blending (DB) Modules

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.

ConsiGma® Granulation and Drying (GD) Modules

ConsiGma® Granulation and Drying (GD) Modules

Based on proven continuous twin-screw granulation technology, the ConsiGma® GD modules enable the production of higher quality granules under better control, even in a bin-2-bin set-up.

ConsiGma® PAT Test Rig

ConsiGma® PAT Test Rig

This standalone module allows you to start developing your PAT models for the continuous manufacturing process offline during the early stages of R&D.

ConsiGma™ Devamlı Doğrudan Sıkıştırma

ConsiGma™ Devamlı Doğrudan Sıkıştırma

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™ Devamlı Tablet Kaplayıcı

ConsiGma™ Devamlı Tablet Kaplayıcı

Sıkıştırma sonrasında bir çok tablet formülasyonunun, istenilen son ürün özelliklerini elde etmek için kaplanması gerekmektedir. ConsiGma™ tablet hatlarını tamamlamak için GEA, devamlı üretim konseptine uygun bir kaplayıcı geliştirmiştir.

İlaç AR&GE çalışmaları için Sürekli İşleme

İlaç AR&GE çalışmaları için Sürekli İşleme

Araştırma ve formül geliştirmenin ilk safhalarında, etken maddenin bulunabilirliği genellikle sınırlı olduğundan, yeni ilaç formüllerini geliştirmek için sadece bir kaç yüz gramlık üretim yapabilen proses ekipmanlarına ihtiyaç duyulmuştur. Bu ihtiyaca yönelik olarak GEA, ConsiGma™ konseptinin laboratuvar ölçekli versiyonu olan ConsiGma™ 1'i geliştirmiştir.

İlaç tesisleri için Yıkama Hattı

İlaç tesisleri için Yıkama Hattı

İzole edilmiş sistemlerinin sağlanmasının yanı sıra GEA ayrıca bir yerden başka yere taşınabilen ve prosesin farklı bölümlerinin temizlenmesi için kullanılan çok-fonksiyonlu yıkama skid'leri de sunmaktadır. GEA tarafından teslim edilen her tesisin, uygulamanızla uyumlu özelleştirilmiş bir CIP, WIP veya Yıkama-Hattı (WOL) vardır.

İlaç Üretim Tesisleri için CIP

İlaç Üretim Tesisleri için CIP

Proses optimizasyonu etkili ve etkin temizliğe bağlıdır. CIP sistemleri, kurutucular, yüksek-parçalayıcı granülatörler ve sıvı dozaj formülasyon sistemleri de dahil olmak üzere GEA tarafından ilaç endüstrisi için üretilen tüm ekipmana takılabilmektedir. Yıkama prosesinin otomasyonu, tekrarlanabilirliği sağlar, doğrulama imkanı verir ve hizmet dışı kalma süresini minimuma indirir.

Lighthouse Probe™ - çevrim içi ölçüm

Lighthouse Probe™ - çevrim içi ölçüm

Lighthouse Probe™ kimyasal ve farmasötik proseslerinin gerçek zamanlı izlenmesi için kullanılabilir ve herhangi bir zamanda proses-içi pencere temizliği, proses esnasında yeniden kalibrasyon, yıkama yuvası ve sızdırmazlık için tam CIP (temizlik) ve -çok zorlu koşullarda bile- net bir iç görüş sağlar.

MODUL™ Tablet Presi Teknolojisi

MODUL™ Tablet Presi Teknolojisi

Bütün MODUL™ tablet presleri, Courtoy™ Değiştirilebilir Sıkıştırma Modülü (ECM) konseptine dayanmaktadır. ECM, makinenin geri kalanından tamamen izole edilmiştir, ürünle temas parçalarını muhafaza eder ve presten muhafazalı bir şekilde kolayca çıkartılabilir. Bu da presin kendisinin tozsuz kaldığı ve temizlik gerekmediği anlamına gelmektedir.

GEA Insights

GEA haber bültenine abone olarak GEA yeniliklerinden ve hikayelerinden haberdar olun.

Kaydolun

Size yardımcı olmak için buradayız! Sadece bir kaç detay ile sorgulamanıza yanıt verebileceğiz.

Bizimle irtibat kurun