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.
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.
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.
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.
ConsiGma™ offers
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.
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.
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.
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.
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.
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
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.
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.
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.
This standalone module allows you to start developing your PAT models for the continuous manufacturing process offline during the early stages of R&D.
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.
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.
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.
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.
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™ 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.
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 haber bültenine abone olarak GEA yeniliklerinden ve hikayelerinden haberdar olun.
KaydolunSize yardımcı olmak için buradayız! Sadece bir kaç detay ile sorgulamanıza yanıt verebileceğiz.
Bizimle irtibat kurun