CPhI 2018

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.

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.

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.

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.

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.

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.

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.

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.

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

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.