PharmaConnect™ R&D Processing

概述
TRV Blender
Granulator
Nica™ Pelletizers
IBC Blenders

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 Size	Typical Minimum Batch @ 0.6sg	Typical Maximum Batch @ 0.6sg
1	240 g	450 g
3	720 g	1.35 g
5	1.2 kg	2.25 kg

Intermediate
Equipment Size	Typical Minimum Batch @ 0.6sg	Typical Maximum Batch @ 0.6sg
10	2.4 kg	4.5 kg
15	3.6 kg	6.75 kg

Pilot
Equipment Size	Typical Minimum Batch @ 0.6sg	Typical Maximum Batch @ 0.6sg
20	4.8 kg	9 kg
30	7.2 kg	13.5 kg
60	14.4 kg	27 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.

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.

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 PharmaConnect^TM control unit provides complete process flexibility.

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

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

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

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.

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

PharmaConnect™ R&D Processing