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Pharmaceutical R&D Technology: Granulation, Blending, Drying, Milling & Pelletizing

PharmaConnect™ R&D Processing

At the heart of GEA's small-scale and R&D approach is PharmaConnect™, which allows a number of diverse process modules to be docked to a single control unit.

Contained R&D Processing

GEA's complete contained Granulation line for research and development, takes the process from dispensed raw materials to finished tablet. The system on show clearly demonstrates the flexibility that can be achieved throughout the process – including high shear granulation, pelletization and blending, drying & milling – in a totally contained environment. It illustrates how GEA's inspired technology can be selected to form a total solution tailored to suit each user’s specific requirements, whether through integration or split valve or disposable containment technology.

PharmaConnect™ Technologies

Based on GEA's market-leading granulation technologies and designed for laboratory through to pilot plant scale, the PharmaConnect™ can process batches from 200 g to 25 kg or more, all from a single control unit.

The PharmaConnect™ is not just limited to granulation; its unique design allows any number of process technologies to be operated from the single operator interface, including

  • PMA™ - bottom-driven high shear granulation
  • Gral™ - top-driven high shear granulation
  • NICA™ - extrusion and spheronization
  • BUCK™ – IBC blending systems and containment
  • TRV – high shear inhalation blending.

Through-the-Wall or Mobile Control Unit

Two versions of the control unit are available: a through-the-wall option and a mobile module. The unit also features a touchscreen user interface, a module drive motor and GEA’s Module Recognition System (MRS), which automatically detects the type and capacity of the connected module, seamlessly displaying an image of the process on-screen and both enabling and defining the correct operational set points and parameters. 

PharmaConnect™ is true PAT-compatible, cGMP-compliant, plug-and-play solution for the busy formulation scientist.

PMA Working Volumes and Batch Sizes

Development
Equipment SizeTypical Minimum Batch @ 0.6sgTypical Maximum Batch @ 0.6sg
1240 g450 g
3720 g1.35 g
51.2 kg2.25 kg
Intermediate
Equipment SizeTypical Minimum Batch @ 0.6sgTypical Maximum Batch @ 0.6sg
102.4 kg4.5 kg
153.6 kg6.75 kg
Pilot
Equipment SizeTypical Minimum Batch @ 0.6sgTypical Maximum Batch @ 0.6sg
204.8 kg9 kg
307.2 kg13.5 kg
6014.4 kg27 kg

High Speed Blender Module featuring a single, bottom driven impeller, the TRV is a high speed blending unit that is particularly suitable for the rapid batch blending of small quantities of active pharmaceutical ingredients with base excipients, typical of inhalable products.

Inhaler Lady

By combining the high surface area of the main impeller blade with the directional effects of the feeder blade, rapid, homogenous and stable blends can be produced in a reproducible manner.

TRV High Shear Blending

For more than 40 years, Turbo Rapid machines have delivered high intensity blending solutions for dry powders. The unique, high speed TRV impeller blades provide the homogeneity and stability that are key factors in the production of inhalable drugs. 

Available with working capacities from 150 g up to 30 kg, the TRV is available as a standalone or PharmaConnect™ options.

Key Features & Benefits

  • the PharmaConnect™ offers interchangeable bowls that are geometrically scaled to assist with the scale-up of the process; to swap between the process bowls takes less than 2 minutes
  • the TRV system is dedicated to the production of DPI products 
  • the impeller surface area is much greater than a conventional high shear granulator, increasing the energy input to the mixing process; the impeller also runs up to a tip speed of 20m/s — twice as fast as a conventional high shear granulator (HSG)
  • the increased energy input leads to a very homogenous product, with Relative Standard Deviations of typically less than 2% and often less than 1% (compared with around 4% for a conventional HSG and 8% for a low shear blender)
  • the increased energy input encourages the active ingredient to adhere to the lactose carrier; this adherence ensures that the formulated product maintains its composition during storage and throughout the filling operation; if the active ingredient does not adhere to the lactose, then there is a risk of segregation during storage and filling, leading to blisters that are out of specification
  • the inhaler device is designed to provide sufficient shear to detach the active ingredient from the lactose carrier, so the micronized active ingredient travel down into the deep lung, whereas the lactose remains in the upper areas
  • the energy imparted by the blades helps to break the cohesion of the lactose to ensure that it is free-flowing and therefore allow the active ingredient to mix thoroughly.

PharmaConnect™ primary granulation processes are based around GEA's established PMA™ granulator technology, providing the user with the ability to process batches from 100 g up to 25 kg and over.

Технология локализации компании Pharma Penn

Available as a through-the-wall or mobile unit.

Granulation Module

A range of standard bowl sizes are available to handle batch quantities of
1-3 L for development scale (the optimal choice for recipe and process development using very small quantities of active material); 5, 10 and 15 L (an intermediate scale for continued product development; and 30 and 60 L for pilot-scale production. However, the modular format of PharmaConnect™ allows special modules to be used for customer-specific needs, such as non-standard capacities, different shapes or even different materials such as glass.

PMA™ Bottom-Driven High Shear Granulation

Offering a wide range of processing capacities, standard module sizes for the bottom-driven PMA™ are set at 1, 3, 5, 10, 15, 20, 30 and 60 L, with each unit being geometrically scalable. Critically, each of these modules features its own impeller drive motor, maintaining a consistent energy input per unit volume and enabling true scale-up data to be generated, even at the 1 L level, for commercial expansion.

Gral™ Top Driven High Shear Granulation

The state-of-the-art Gral™ top driven granulation system is renowned worldwide for its high quality, robust design and scalability. The UltimaGral™ comes with a 10 L bowl and can be scaled-up to provide 25 and 75 L capacities, facilitating the move to production-scale equipment. Furthermore, integration with the PharmaConnectTM control unit provides complete process flexibility.

Extrusion and Spheronization: Pharmaceutical pellets offer many additional features compared with conventional tablets.

PharmaConnect NICA

GEA is able to offer all the typically used pelletization processes and assist with the selection of the process that best suits your needs.

NICA™ IPS5

PharmaConnect NICA full

Designed specifically as a pelletization system for the pharmaceutical industry and able to pelletize small batches (50 g) using the operating principles of larger pilot-scale and production machines, the NICA™ IPS-5 extruder and spheronizer is the perfect development partner for the PharmaConnect™.

The NICA™ IPS5 operates exclusively as a process module on the GEA PharmaConnect™ platform, combining the NICA™ E100 basket extruder with the NICA™ S250 spheronizer.

Blender Module for Development and Pilot-Scale Applications

PharmaConnect IBC Blender

GEA's extensive process knowledge and continuous research delivers the most efficient mixers and blenders. We offer a wide range of technical solutions and process options to ensure efficient mixing and blending of pharmaceutical powders and granules.

IBC Blending Systems

Featuring the unique, removable Blending Prism™ and designed to handle a complete range of laboratory sized IBCs (3–75 L) using a single process module, NIR technology can also be applied to provide online blend homogeneity detection. The Prism™ adds low shear mixing to the rotating IBC, adding to the turbulence of the tumbling product and reducing the blend time.

Связанные продукты

Contained Powder Sampling

Contained Powder Sampling

GEA offers a range of contained sampling devices for the pharmaceutical industry. These devices are build around the Buck® valve technologies.

FlexStream™ Fluid Bed Processor

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.

Fluid Bed R&D Processing of Pharmaceuticals

Fluid Bed R&D Processing of Pharmaceuticals

A complete range of technologies for R&D designed for specific applications, our small-scale range covers every aspect of pharma oral solid dosage production, from high shear mixers, fluid bed dryers and single pot systems to extruders and spheronizers, blenders and containment solutions, right through to tablet compression.

Gral™ High Shear Granulators

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.

Hicoflex® Disposable Containment System

Hicoflex® Disposable Containment System

A disposable high containment Interface for the safe & dust-free transfer of solid dosage material to fully protect your operator, your product and the environment.

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™ P Tablet Press

MODUL™ P Tablet Press

The MODUL™ P, the smallest tablet press in the ECM-based MODUL™ series, is particularly suited for formulation development and small-scale production. The extremely short changeover time offered by the MODUL™ P results in a tremendous increase in productivity, especially when the production schedule involves a succession of many small batches.

PharmaConnect™ PLUS

PharmaConnect™ PLUS

Designed for small-scale granulation and research and development applications, particularly with potent actives, the PharmaConnect™ PLUS — based on the established combination of a single control unit with a diverse range of process modules — further benefits from both physical and control integration with GEA’s fluidized bed processors: the FlexStream™ 500 and the FlexStream™ 1000.

PMA™ High Shear Processor

PMA™ High Shear Processor

PMA™ High Shear and PMA-Advanced™ Mixer and Granulator is a multipurpose processor that's equally suitable for the high speed dispersion of dry powders, aqueous or solvent granulations, effervescent production and melt pelletization for Pharma applications.

UltimaPro™ Single Pot Processors

UltimaPro™ Single Pot Processors

UltimaPro™ Single Pot Processors (One-Pot Processor) offer a choice of mixing, granulation and drying options integrated into one processing vessel. With our help, choose the most appropriate technique for the product.

Service products

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