Fluid Bed Processing for Pharma Applications
FlexStream Fluid Bed Processor
FlexStream is a new multi-purpose processor that addresses the current shortfalls of traditional fluid bed processing, including linear scale-up, fully contained loading and unloading for Pharmaceutical applications.
Traditional Fluid Bed Technology
Fluid bed operations such as drying, granulation or particle coating are often major process steps in the production of solid dosage forms. And, even though the technology has been in use by pharmaceutical companies, globally, for more than 50 years, it has still a lot of shortfalls. Each unit operation needs dedicated machinery or process containers to achieve optimal performance. Another area of concern is scale-up, a task that is often complicated by different bed heights and inconsistencies between fluid bed processors. From a performance standpoint, granules produced by fluid bed granulation often show an excellent compression behaviour but can be weak and flow poorly (compared with high shear granulation). Some formulations can’t be granulated in a fluid bed at all, and coating applications based on conventional Wurster columns are subject to a number of drawbacks, such as scale-up issues, loss of coating material and agglomeration loses.
FlexStream Technology
Using proven GEA fluid bed technology to achieve fluid bed granulation, drying and pellet coating (or tablet coating) in a single module, FlexStream is a new multipurpose processor that addresses the current shortfalls of traditional fluid bed processing, including linear scale-up, fully contained loading and unloading, and superior product homogeneity for both LOD and PSD. Offering only one product container for all unit operations, the FlexStream reduces your build envelope (both height and footprint) and provides PAT-compatible in-line particle growth measurement.
The FlexStream Concept
The FlexStream concept has the additional advantage that no mechanical adjustment is necessary to switch between using the equipment as a dryer, a granulator or a coater. And, impressive test data prove that, in addition to these commercial benefits, FlexStream gives superior product quality when compared with conventional top-spray granulation or Wurster coating.
Key Features
- WIP and CIP: Process optimisation depends on efficient, effective cleaning. Automation of the cleaning process ensures repeatability, allows validation and minimizes downtime.
- Rapid discharge using lean phase conveying system: enhanced by the Non-Sifting Gill Plate airflow from both above and below the air distributor is used to discharge the dry granules in a very efficient manner, avoiding the need to place the receiving container under negative pressure.
- Through-the-wall installation: ensures that all auxiliary equipment is housed outside the process room. This greatly simplifies GMP compliance.
- Solvent emission control: A range of open- and closed-cycle systems to remove or recover organic solvents is available.
- Spraying systems: Nozzles, pumps and liquid preparation units are supplied according to process needs.
関連製品
医薬品の流動床プロセス
GEA は、流動床処理装置 (米国での呼称は流動床 Multi-Processor™) を製薬業界のブレンド、造粒、乾燥、ペレット化、コーティング向けに提供しています。
医薬品の流動床研究開発プロセス
特定用途向けの研究開発のために幅広い技術を提供する当社の小規模装置シリーズは、経口固体製剤生産のあらゆる側面を網羅しており、高剪断力混合機、流動床乾燥機およびシングルポットシステムから押し出し機およびスフェロナイザ、ブレンダおよび封じ込めソリューション、錠剤圧縮に至るまで、幅広い装置を対象にします。
PMA High Shear Processor
PMA Bottom-drive High Shear Granulators suitable for the high speed dispersion of dry powders, aqueous or solvent granulations, effervescent production and melt pelletization for Pharmaceutical applications.
Gral High Shear Granulators
Whether the customer’s requirement is for high shear mixing or granulation, GEA has a solution for every processing challenge and can help select the technology that is most suitable for your Pharma application.
