Continuous Processing Solutions for Oral Solid Dosage Forms

14 Years of Inspiration No other company has as much experience and done more to pioneer continuous manufacturing for the pharmaceutical industry Pharmaceutical manufacturers face CM is more efficient, agile and flexible many challenges when developing technology, offering more consistent and products and getting them to market in reliable tablet production with the reduced a timely, safe and cost-effective way. use and loss of resources such as precious APIs and raw materials, less stoppage time From formulating new molecular entities to and minimal manual intervention. Plus, improving the production...

14 Years of Continuous Learning With a continuous line running at a customer’s site manufacturing concept. Thanks to our collaboration since 2007, GEA has, from the very beginning, led with complementary partners (universities, research the field with flexible development options that institutes and industrial partners, such as RCPE, facilitate the commercial manufacturing process and Siemens, UGent, etc.) we can offer a 360° approach enable greater process understanding to be achieved to continuous manufacturing, taking you from with smaller quantities of material. early development to commercial...

CONTINUOUS PROCESSING ·

Going Continuous The shift from batch to continuous production could represent one of the largest paradigm shifts in pharma processing since validation and qualification systems were introduced By focusing on quality during the whole product lifecycle — not • broad opportunity, ethical and generic, worldwide just “tested in” quality — and by understanding the capability • R&D: flexible batch size, no scale-up, fast DOE of your processes, sources of variability can be managed and any • reduced investment and running costs: easy to install, reduced associated risk can be eliminated. use of utilities,...

Process Chain Powder Dosing Based on extensive process knowledge and continuous The accurate dosing of powdered excipients is a key and research, GEA offers a wide range of technical solutions critical technology for the continuous production of oral solid and process options to ensure the efficient mixing and dosage forms. As an enabler of its CM philosophy, and to meet blending of pharmaceutical powders and granules. market requirements, GEA, in an alliance with a supplier of extremely accurate load cells, offers a range of compact feeders Depending on the process, product and system set-up,...

enhanced dual process control make them ideal For drying the wet granules, the dryer module – based on components of a continuous line allowing the tablet fluid-bed drying principles – splits the continuous flow of press to react to any variation in production rate, granules into packages, drying each of them in a separate without affecting the tablet quality. segment of the dryer and thereby guaranteeing plug-flow. When each segment is dry, it is emptied and transferred Tablet Coating to the evaluation module – where critical quality attributes Designed specifically to be an integral part of...

MAKING CONTI REAL In collaboration with Pfizer and G-Con, GEA developed the PCMM (Portable, Continuous, Miniature and Modular manufacturing) platform, now operational at Pfizer’s facility in Groton, Connecticut, USA. Conceived, designed and built through a future-facing initiative between the three partners, the PCMM technology has at its center GEA’s state-of-the-art miniaturized and mobile ConsiGma® continuous oral solid dosage (OSD) pharmaceutical processing technology. Configurable for either direct blending and the compression of powder streams into tablets, or for wet granulation, drying,...

Continuous Production Solutions Without the issues of start-up and/or shutdown waste, ConsiGma® provides maximum output in an energy efficient the ConsiGma® manufacturing platform is capable of way, has been tested using a wide variety of formulations and is continuously producing pharmaceutical products. This concept already being used by several large pharmaceutical companies, enables the use of the same system for both development and both ethical and generic research and manufacturing and production work without the need for scale-up; the centers worldwide. determining factor for the amount...

ACCELERATING DRUG DEVELOPMENT To investigate continuous manufacturing (CM) and streamline, The process starts by blending the API with the excipients, Vertex Pharmaceuticals, Inc. partnered with GEA to enhance dispensed using loss-in-weight feeders into a continuous inline their existing technology and implement primary and backup blender. After initial blending, the machine can be configured CM processes. The company invested in a multi-product so that the blend flows into a twin-screw wet granulator (wet development and launch rig (DLR) to manufacture multiple granulation), a roller compactor...

ConsiGma® Continuous Granulation and Compression (GC) Line Production-scale continuous high-shear granulation, drying and tableting The ConsiGma® GC is an innovative solid dosage production Standard Scope of Supply platform designed to achieve operational excellence in the • One loss-in-weight (LIW) feeder for preblended materials pharmaceutical manufacturing Industry. Raw materials are • Twin-screw granulator converted into final dosage forms in development, pilot, • Post-granulation sampling system clinical and production volumes using wet granulation in one • Liquid addition via peristaltic...

Main Benefits • Horizontal or vertical layout • No scale-up or tech transfer risk • Post hoist for IBC feeding to LIW feeder • Reduced operational risk compared with batch • Preblending station with up to six • Minimal operators required feeders and two linear blenders • Lower risk of OOS product • One additional LIW feeder to add individual • Less operational cost (less space, no work raw materials into the granulator in progress, higher efficiency, etc.) • Diverter system to remove OOS material before • Less personal protective equipment (PPE) required and after granule conditioning unit •...