Flexibility in Continuous Manufacturing-ConsiGma? Technology:from API to Coated Tablet

来源 :2014国际过程分析与控制中国区论坛 | 被引量 : 0次 | 上传用户:jooey
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  The ConsiGma is a Continuous multipurpose platform that has been designed to transfer powders into coated tablets in development,pilot,clinical and production volumes in a single compact unit.The system can perform dosing and mixing of raw materials followed by either d irect compression or granulation and tableting.Different granulation technologies can be applied: wet,dry and melt granulation are possible.T ableting,coating and quality control can all be done in line.As the system can handle or produce granules continuously,there is no waste during start-up and shutdown and the batch size is simply determined by running time.Quality is measured throughout the process and,as such,drastically reduces the cost per tablet.Continuous processing has gained a lot of interest from the pharmaceutical industry in the last years for many reasons.One of them is the possibility to continuously monitor the critical quality attributes of the product during the process,enabling real-time release.An indispensable prerequisite for continuous process monitoring and real-time r elease i s however the p resence o f reliable inline PAT sensors.Together with a number of pharmaceutical companies,GEA Pharma Systems has been conducting studies to build a strong understanding of capabilities and constraints of ConsiGma technology and process.The case studies aim at proving the business value of the new technology in 4 areas: time,quality,cost,and agility.ConsiGma is a 6 sigma-inspired manufacturing platform,incorporating different technologies to produce oral solid dosage forms in a continuous and cost-efficient way by collecting more information during R&D phase,in a short time with le ss p roduct,excluding r isky,time-and product consuming scale-up exercises and i ntroducing online measurement and closed loop control targeting real-time release(6 sigma production).The technology was developed in compliance with the FDAs QbD initiative.It satisfies the industrys need for reduced risk and higher quality while avoiding lengthy and costly validation and scale-up to bring products to market faster and cheaper.The inherent flexibility enables manufacturers to meet demand,keep expensive cleanroom space to a minimum and reduce inventory costs.
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