Making Science Work - GEA at CPhI

Making Science Work

Under the umbrella theme of “Making Science Work,” GEA will be highlighting its innovative technology and equipment for the pharmaceutical, biopharmaceutical and biotechnology industries at CPhI Worldwide, the world's leading pharmaceutical platform.

High Performance Tablet Coating Technology

ConsiGma® coater is a high performance tablet coating technology that accurately deposits controlled amounts of coating materials on tablets, speeding up production and ensuring a high-quality end product. The Coater can be an integral part of a batch or continuous line.

MOBILE MINOR™ spray dryer with highly efficient powder separation

At CPhI, we met with Soren Madsen and talked about the MOBILE MINOR™ spray dryer. Offering an improved design but maintaining the same compact footprint, the MM-100 spray dryer from GEA, equipped with the new and highly efficient cyclone CEE (Cyclone Extra Efficiency), and is the newest addition to the MOBILE MINOR™ range. In the MOBILE MINOR™, solutions, suspensions or emulsions can be dried into representative powder samples, facilitating the retrieval of the process data required for scaling-up to industrial production. It is a flexible and easy-to-handle spray dryer which has become standard equipment in the R&D departments of many leading manufacturers, independent research institutes and universities worldwide. By nature, spray drying is a continuous process and is designed to offer both high productivity and uniform product quality during sustained periods.

Integrated Pelletization System

Sean Gray, Sales Manager - Batch Granulation, explains the NICA™ Pelletizing System. The NICA™ is a turnkey pellet production plant that combines a mixer/granulator, extruder and spheronizer in a single, integrated process. Wet powders continuously pass through a low-shear radial extruder; the extrusions are fragmented and formed into pellets in the spheronizer.

Fast track R&D Tablet Compression

Always looking to improve the research, development and scale-up process for oral solid dosage forms, we’re currently working on a compaction data acquisition and analysis system (CDAAS). Comprising mechanical components (feeders, hoppers and tooling), electrical elements and a software package, the CDAAS makes it possible to do formulation development work on a production-scale tablet press using minute amounts of product. 

GEA discusses the challenges of DPI Blending

At CPhI Madrid 2018, Mark Rowland discusses the process of DPI (Dry Powder Inhalable) production and the key attributes necessary for the process. Utilizing GEA’s High Speed TRV™ Blending system, API and Lactose are mixed to form a product with the key attributes of a high level of homogeneity and formulation stability. TRV™ is available as standalone equipment of as part of the innovative PharmaConnect system with a batch capacity range from 200g to over 50kg.

On display during the event

  • the ConsiGma® Coater gently and accurately deposits controlled amounts of coating materials on tablet cores (can be used in a batch or continuous process line)
  • the IPS25 pelletizing system fuses NICA™ extrusion and spheronization technologies to create a range of compact, continuous solutions for the production of spherical pellets
  • the MOBILE MINOR™ MM-100 spray dryer (with atomizer), equipped with the new CEE cyclone for highly efficient powder separation
  • the BUCK® UMC Valve is a modular containment solution that can be equipped to fit most secondary pharma applications
  • the BUCK® MCV and MC Lite Actuator for improved operational flexibility
  • the Hicoflex® system ensures fully contained powder transfer during charging and discharging

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Feria de Madrid - Climatización
28042 Madrid Spain
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GEA HAS DEVELOPED A DEDICATED SERIES OF PHARMACEUTICAL SPRAY DRYERS

Spray drying is a technique preferred by a growing number of pharmaceutical companies to produce better drugs. This ultrafast and gentle drying technology offers unique ways to define particle characteristics.

GEA offers a range of spray dryers designed specifically for R&D, product development and small volume production.

A pioneer in all aspects of spray drying with more than 10,000 contracted and installed plants worldwide, we can help you to choose the most suitable equipment, assessing each project on its individual needs and tailor the process and the spray dryer to match your specific requirements.

GEA has developed a dedicated series of pharmaceutical spray dryers. The PHARMASD™ (PSD) dryers have been designed using standard modules that incorporate all the features required for cGMP production in the drug manufacturing environment. Available in a range of sizes (1–7), PSD dryers offer capacity ranges from 80 to 4000 kg/h of drying process gas.

By nature, spray drying is a continuous process and is designed to offer both high productivity and uniform product quality during sustained periods. 

Spray drying can also help to better commercializeyour discoveries by providing

  • modified release and taste masking
  • increased bioavailability
  • aseptic production
  • products for inhalation
  • direct compressibility

MOBILE MINOR™ SPRAY DRYER WITH HIGHLY EFFICIENT POWDER SEPARATION

Offering an improved design but maintaining the same compact footprint, the MM-100 spray dryer from GEA, equipped with the new and highly efficient cyclone CEE (Cyclone Extra Efficiency), is the newest addition to the MOBILE MINOR™ range.

The newly developed cyclone CEE offers a higher separation efficiency, which increases the yield and reduces emissions. Installed in almost 2400 plants worldwide, the cross-application MOBILE MINOR™ spray dryer is robust, reliable and versatile. Ideal for process scale-up applications, it is also easy to use, clean and move.

Further special features of the MOBILE MINOR™ include

  • process gas flow up to 100 kg/h at 200 °C for increased capacity
  • accurate gas dispersal to minimize powder deposits
  • optional high capacity HEPA filters for baby food or hazardous chemical applications
  • powder collection glasses in sizes from 250–3500 mL can be supplied as standard
  • powerful supply blower with flow indication
  • easy to remove and clean laser-cut gas guides (patent pending)

The universal gas disperser for the rotary atomizer as well as the two-fluid nozzle can easily be exchanged with an optional low velocity gas disperser — which has a similar flow pattern to the DPH gas dispersers used in larger PHARMASD™ spray dryers — for nozzle atomization.

SSP MOBILE MINOR 1200x675

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MAKING TABLETS - R&D, PILOT- AND FULL-SCALE PRODUCTION

Offering manual and fully automatic rotary tablet presses, our innovations include a unique dual control, PAT-compatible technology that monitors and controls tablet weight, hardness and density with an accuracy that cannot be achieved any other way.

Other unique features ensure a constant flow and equal distribution of powder that are without equal, as well as integrated data collection and analysis, and advanced process control.

Our MODUL™ tablet presses provide the fastest product changeover in the market, and our PERFORMA™ tablet presses provide the highest outputs. Plus, with the introduction of the ECM-based (Exchangeable Compression Module) MODUL™ rotary tablet press, GEA revolutionized the pharmaceutical industry.

FAST TRACK YOUR R&D

Always looking to improve the research, development and scale-up process for oral solid dosage forms, we’re currently working on a compaction data acquisition and analysis system (CDAAS). Comprising mechanical components (feeders, hoppers and tooling), electrical elements and a software package, the CDAAS makes it possible to do formulation development work on a production-scale tablet press using minute amounts of product.

With this new kit, less than a kilogram of product is more than enough to proceed with the fundamental characterization of the compression process on a commercial-scale rotary tablet press. Test sequences can be generated with multiple runs to optimize the press parameters. 

Loaded into the GEA MC5 control system as a single recipe, the machine will modify the variable parameters for each run according to the recipe-defined values and produce a specific number of tablets.

So, with very little product, several tests can be done before producing a clinical batch with a well-defined set of parameters. Plus, as the clinical or pilot batch is produced on the same machine under equivalent conditions, there are no scale-up issues.

TABLET_COMPACTION_DATA_ACQUISITION_AND_ANALYSIS_SYSTEM

TABLET COATING

The ConsiGma® coater from GEA is a high-performance tablet coating technology that gently and accurately deposits controlled amounts of coating materials on tablet cores — even if they are extremely hygroscopic or friable.

Ideal for both batch-based and continuous applications, the ConsiGma® coater is able to process small quantities of tablets at very high rates, offering improved heat and mass transfer.

PAT-compatible, the ConsiGma® coater is easy to clean and offers significant cost savings compared with conventional systems in terms of time, materials, downtime, process revalidation, stability testing, etc.

With a smaller technical space requirement than established technologies, less cleaning and a reduced plant area is needed. And, being a continuous production technology, no scale-up is required and the maximum batch size is almost infinite.

ConsiGma coater

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14 YEARS OF CONTINUOUS LEARNING

Continuous processing is clearly the future of pharmaceutical manufacturing. In fact, a majority of the top ten pharmaceutical companies have now confirmed that their strategy is to develop both new chemical entities (NCEs) and, when economically and technically viable, also manufacture legacy ethical and generic products using continuous technologies.

With 14 years of continuous learning, GEA has firmly established its longevity in the CM market. And having completed more than 70 projects involving a variety of filed and authorized products, including the first ever FDA-approved breakthrough therapy developed and manufactured using the ConsiGma® platform, no other company has as much experience and done more to pioneer continuous manufacturing (CM) for the pharmaceutical industry.

CONSIGMA® COATER

The ConsiGma® coater from GEA is a high-performance tablet coating technology that gently and accurately deposits controlled amounts of coating materials on tablet cores — even if they are extremely hygroscopic or friable.

Ideal for both batch-based and continuous applications, the ConsiGma® coater is able to process small quantities of tablets at very high rates, offering improved heat and mass transfer.

PAT-compatible, the ConsiGma® coater is easy to clean and offers significant cost savings compared with conventional systems in terms of time, materials, downtime, process revalidation, stability testing, etc.

With a smaller technical space requirement than established technologies, less cleaning and a reduced plant area is needed. And, being a continuous production technology, no scale-up is required and the maximum batch size is almost infinite.

CONSIMA® _COATER

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POWDER HANDLING TO GRANULATING, TABLET COMPRESSION AND COATING

Experts in every aspect of batch-based processing, GEA offers a complete range of technologies for the production of solid dosage forms: from powder handling to granulating, drying, tablet compression and coating, including the first ever continuous high shear granulation, drying and Experts in every aspect of batch-based processing, GEA offers a complete range of technologies for the production of solid dosage forms: from powder handling to granulating, drying, tablet compression and coating, including the first ever continuous high shear granulation, drying and tableting system.

NICA™ IPS25 PELLETIZING SYSTEM

The IPS25 combines the NICA™ Extruder with Spheronizer to deliver a market-leading solution for pilot-scale pellet production. Fitted with an actuated dosing valve, the system can automatically transfer consistent batches from the extruder to spheronizer and deliver a continuous production capacity of around 25 kg/h. Operating in manual mode, the IPS25 is equally suitable for lab-scale operations with batch sizes as little as 400 g.

NICA™_IPS25_PELLETIZING_SYSTEM

CONSIGMA® COATER

The ConsiGma® coater from GEA is a high-performance tablet coating technology that gently and accurately deposits controlled amounts of coating materials on tablet cores. Ideal for both batch-based applications, the ConsiGma® coater is able to process small quantities of tablets at very high rates, offering improved heat and mass transfer.

PAT-compatible, the ConsiGma® coater is easy to clean and offers significant cost savings compared with conventional systems in terms of time, materials, downtime, process revalidation, stability testing, etc. And, with a smaller technical space requirement than established technologies, less cleaning and a reduced plant area is needed.

ConsiGma coater

CONTAINED MATERIALS HANDLING

Benefiting from a long history of containment expertise, GEA supplies materials handling equipment and integrated solutions to the global pharmaceutical and healthcare industries.

Taking an individual approach to each customer’s needs, and applying our extensive experience and know-how, we combine performance excellence with technological innovation to deliver long-term competitive advantages.

BUCK® CONTAINMENT VALVES

Fundamentally different to all other containment valves, the MC Valve moves away from the old passive and active set-up now utilizing identical half valves on both container and process equipment to provide containment in the range 1.0-10.0 ug/m³ STTWA. This step change in split butterfly valve design is supported with the MC Lite Actuator ring.

The MC Lite Actuator Ring, weighing less than 4 kg, can be moved around a facility and used to manually dock, lock and open any two BUCK® MC Half Valves, which improves operational flexibility while reducing initial equipment outlay and ongoing equipment maintenance costs.

Providing the highest levels of containment and built on the successful BUCK® MC Valve platform, the BUCK® UMC Valve utilizes a vacuum extraction system to provide containment levels down to 0.1–1.0 mcg/m³ based on STTWA. The UMC Valve offers a modular containment solution that can be equipped to fit most secondary pharma applications.

BUCK®_VALVE

HICOFLEX® DISPOSABLE CONTAINMENT SYSTEM

With the Hicoflex® system, GEA ensures fully contained powder transfer during the charging and discharging of hazardous material. The Hicoflex® is attached to both a disposable containment bag, for material transport, and to a disposable containment adapter that fits onto the inlet or outlet chute to allow product transfer.

Hicoflex® Spray Bag

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INVESTING IN THE FUTURE OF PHARMA

The GEA Pharma Solids Center (GPSC) represents our continued commitment to and our ongoing support for the current and future pharmaceutical industry. With a total footprint of 1100 m2, including 200 m2 of technical space, the GPSC epitomizes the state-of-the-art in oral solid dosage (OSD) form testing, development and optimization, and offers a full range of batch and continuous manufacturing technologies.

From cost assurance and process enhancement to real-life simulations and test and loan machines, we provide a unique range of services that are designed to improve production and expedite time to market.

The GPSC offers

  • customer demonstrations and trials on our batch and continuous equipment
  • training sessions and classes
  • hands-on laboratory experience
  • pharmaceutical product development assistance
  • CQA evaluation support
  • testing of new concepts (equipment and advanced controls)
  • scale-up from laboratory to production (1:10)
  • process development/refinement to increase the understanding and capability of GEA equipment
  • risk/OEL-based API testing in a GMP-like environment
ConsiGma-1

GMP SPRAY DRYING FACILITY

The GEA pharmaceutical GMP spray drying facility — one of the world’s most advanced centers of excellence — is available for the production of samples for process development, stability/toxicology studies and clinical trials material and, when required, spray drying intermediates for human medical products for commercial use.

The GEA pharmaceutical spray drying facility is fully equipped and cGMP-compliant. We offer spray drying process development as well as the contract manufacturing of spray dried intermediate drug products.

The facility includes two GEA PharmaSD™ spray dryers: a PSD-1 spray dryer with a feed rate of up to 10 kg/h for initial cGMP testing and small-scale production; and a full-scale PSD-4 unit.

This means that 1:1 trials can be performed — enabling direct technology transfer from testing to commercial production. Initial tests can be done under flexible conditions at our non-GMP test center prior to cGMP-condition testing.

Our expertise includes processing APIs and excipients using spray drying, encapsulation and spray congealing, as well as spray drying final drug formulations.

GMP_SPRAY_DRYING_FACILITY

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Making Science Work - GEA at CPhI

Making Science Work

Under the umbrella theme of “Making Science Work,” GEA will be highlighting its innovative technology and equipment for the pharmaceutical, biopharmaceutical and biotechnology industries at CPhI Worldwide, the world's leading pharmaceutical platform.

High Performance Tablet Coating Technology

ConsiGma® coater is a high performance tablet coating technology that accurately deposits controlled amounts of coating materials on tablets, speeding up production and ensuring a high-quality end product. The Coater can be an integral part of a batch or continuous line.

MOBILE MINOR™ spray dryer with highly efficient powder separation

At CPhI, we met with Soren Madsen and talked about the MOBILE MINOR™ spray dryer. Offering an improved design but maintaining the same compact footprint, the MM-100 spray dryer from GEA, equipped with the new and highly efficient cyclone CEE (Cyclone Extra Efficiency), and is the newest addition to the MOBILE MINOR™ range. In the MOBILE MINOR™, solutions, suspensions or emulsions can be dried into representative powder samples, facilitating the retrieval of the process data required for scaling-up to industrial production. It is a flexible and easy-to-handle spray dryer which has become standard equipment in the R&D departments of many leading manufacturers, independent research institutes and universities worldwide. By nature, spray drying is a continuous process and is designed to offer both high productivity and uniform product quality during sustained periods.

Integrated Pelletization System

Sean Gray, Sales Manager - Batch Granulation, explains the NICA™ Pelletizing System. The NICA™ is a turnkey pellet production plant that combines a mixer/granulator, extruder and spheronizer in a single, integrated process. Wet powders continuously pass through a low-shear radial extruder; the extrusions are fragmented and formed into pellets in the spheronizer.

Fast track R&D Tablet Compression

Always looking to improve the research, development and scale-up process for oral solid dosage forms, we’re currently working on a compaction data acquisition and analysis system (CDAAS). Comprising mechanical components (feeders, hoppers and tooling), electrical elements and a software package, the CDAAS makes it possible to do formulation development work on a production-scale tablet press using minute amounts of product. 

GEA discusses the challenges of DPI Blending

At CPhI Madrid 2018, Mark Rowland discusses the process of DPI (Dry Powder Inhalable) production and the key attributes necessary for the process. Utilizing GEA’s High Speed TRV™ Blending system, API and Lactose are mixed to form a product with the key attributes of a high level of homogeneity and formulation stability. TRV™ is available as standalone equipment of as part of the innovative PharmaConnect system with a batch capacity range from 200g to over 50kg.

On display during the event

  • the ConsiGma® Coater gently and accurately deposits controlled amounts of coating materials on tablet cores (can be used in a batch or continuous process line)
  • the IPS25 pelletizing system fuses NICA™ extrusion and spheronization technologies to create a range of compact, continuous solutions for the production of spherical pellets
  • the MOBILE MINOR™ MM-100 spray dryer (with atomizer), equipped with the new CEE cyclone for highly efficient powder separation
  • the BUCK® UMC Valve is a modular containment solution that can be equipped to fit most secondary pharma applications
  • the BUCK® MCV and MC Lite Actuator for improved operational flexibility
  • the Hicoflex® system ensures fully contained powder transfer during charging and discharging

Want to know more?

Contact Us