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Continuous Processing Solutions for Oral Solid Dosage Forms 2 · CONTINUOUS PROCESSING CONTINUOUS PROCESSING · 3

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Continuous Processing Solutions for Oral Solid Dosage Forms 2 · CONTINUOUS PROCESSING CONTINUOUS PROCESSING · 3 Continuous Processing Solutions for Oral Solid Dosage Forms 2 · CONTINUOUS PROCESSING CONTINUOUS PROCESSING · 3 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 methods for generic by producing tablets continuously, batch drugs or extending the lifecycle of existing oral sizes are simply determined by how long solid dosage (OSD) forms, issues such as you run the machine. It is also helping the reducing the cost-per-tablet, increasing patient pharmaceutical industry to produce higher safety and optimizing the price/performance quality products, enhance drug safety, reduce balance are common daily concerns. its industrial footprint and decrease waste (particularly during start-up and shutdown), Many pharmaceutical companies still rely on which provides significant advantages to traditional batch manufacturing processes to governments, companies and patients alike. produce drugs. Now, however, with changing perspectives from the regulatory bodies, Continuous processing is clearly the future such as FDA and EMA, the pharmaceutical of pharmaceutical manufacturing. In fact, industry, slightly less risk averse and willing a majority of the top ten pharmaceutical to improve both supply chain efficiency and companies have now confirmed that product throughput, has recognized that their strategy is to develop both new continuous manufacturing (CM) solutions chemical entities (NCEs) and, when can accelerate product development, reduce economically and technically viable, also costs, improve production economics and manufacture legacy ethical and generic increase manufacturing flexibility. products using continuous technologies. 4 · CONTINUOUS PROCESSING 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 manufacturing and including equipment, process, control strategy, Also, its experience in pharmaceutical OSD formulation and regulatory support. production technologies and continuous processing experience in other industries, such as chemicals GEA has taken the lead in providing the pharmaceutical and food, gives GEA an edge in supporting the industry with new technologies based on the most pharmaceutical industry in this game-changing innovative way of granulating, drying and making switch from batch to continuous. tablets using potent APIs. The company has pioneered continuous manufacturing in drug production and At the heart of GEA’s fully integrated, powder- was the first supplier to provide and install a complete to-tablet CM solution is ConsiGma®, a complete powder-to-tablet line for customer use. portfolio of technologies designed to transfer powder into finished dosage forms in development, Using a QbD approach, drug manufacturing cycle pilot, clinical and production volumes. ConsiGma® times — from API to product release — can now includes systems for dosing and mixing raw be measured in hours rather than weeks. The clear materials, wet or dry granulation, drying, tableting, benefits demonstrated by the use of ConsiGma® coating and quality control, which can be integrated technology are facilitating the switch to continuous in one compact production line. manufacturing and helping pharmaceutical companies to minimize risk as they transition from With a range of solutions developed according batch systems. By reducing development timelines to Lean and Six Sigma process guidelines, GEA and API use, and eliminating scale-up and product is an established expert and a single-source transfer, ConsiGma® is not only compact and cost- solution provider of equipment, technology and effective, it also offers greater operational efficiencies know-how for this evolutionary powder-to-tablet and more environmentally friendly manufacturing. CONTINUOUS PROCESSING · 5 6 · CONTINUOUS PROCESSING CONTINUOUS PROCESSING · 7 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, parametric release, reduced quality cost • time-to-market: fast deployment, full flexibility with modular ConsiGma® is a Six Sigma-inspired manufacturing platform, construction, POD-based installations possible. incorporating different technologies to produce oral solid dosage forms in a continuous, cost-efficient way: The ConsiGma® Principle • by collecting more information during R&D with less product The ConsiGma® platform allows users to make exactly the • by excluding risky, time- and product- number of tablets required to meet immediate demand — with consuming scale-up exercises the quantity limited only by the running time of the machine • by introducing online measurement and closed or by how much inbound material is supplied; and, because of loop control targeting real-time release (Six ConsiGma®’s innovative design, the amount of waste produced Sigma production), reducing waste to zero during start-up and shut down is significantly reduced compared • by incorporating flexible batch size (JIT with conventional methods. production), reducing inventory • by decreasing the energy cost per tablet, Using continuous production and a “risk-based approach” reducing environmental impact. to GMP, the ConsiGma® system delivers much higher and consistent quality. Parametric release is achieved ConsiGma® was developed in compliance with the FDA’s QbD through inline testing. initiative. It satisfies the industry’s need for reduced risk and higher quality while avoiding lengthy and costly validation Quality is measured throughout the process and, as and scale-up to bring products to market much faster. This such, drastically reduces the cost per tablet. Critical flexibility enables the production of products to meet demand, quality attributes are measured second-by-second keeps expensive cleanroom space to a minimum and reduces and any deviation from the specification is inventory costs. Integrated advanced process control and PAT immediately reported to the operator. tools allow monitoring during production, so quality can be Optionally integrated advanced process designed into products from the start. control and PAT tools enable monitoring during production, so quality can be ConsiGma® continuous oral solid dosage tableting lines designed into products from the start. (granulation, drying, tablet compression) are designed for plug- flow, first-in first-out (FIFO) production, avoiding back-mixing, providing a consistent quality and allowing for the inline control of critical quality attributes. ConsiGma® ticks all the pharmaceutical industry’s boxes: 8 · CONTINUOUS PROCESSING 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, that operate on the gravimetric, loss-in-weight principle. even when height is a limiting factor, we can select and provide the most appropriate blender for your project. They will be included in all GEA continuous manufacturing lines and are technically superior to commercially available feeders. Granulation As most fine pharmaceutical compounds need their flowability and processing properties to be improved for downstream Dry Blending processes, granulation, which allows primary powder particles Blending is one of the most demanding unit operation to adhere and form granules, is the most important unit in today’s processing industries and a critical step in operation in drug manufacturing, with wet granulation the production of high quality end products. Affecting accounting for up to 80% of the tablet formulations. both cycle times and total cost of ownership, selecting the most
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