2 In the fast movIng and tIghtly controlled pharmaceutIcal Industry, the drIve Is always on to brIng more new products to the market and brIng them quIcker. an InnovatIve pIece of engIneerIng technology could play a key role In makIng thIs happen.
harmaceutical manufacturing is complex, tightly controlled and highly regulated. and it has to be because, with people’s health at stake, there can be no margin for error. like many other manufacturing industries, drug companies are under increasing pressure to make more faster, while reducing costs and maintaining high quality standards. according to the us food and drug administration’s process analytical technology (pat) guidelines for 2004, pharmaceutical manufacturers could achieve all these goals by shifting to continuous processing. currently, ingredients for medicines tend to be produced in batches. batch processes are very often inefficient and cannot manage the variability of the incoming material characteristics in a proper way. therefore, batch processes often result in reduced reliability and poor yields. a statistically disputable sampling step, after every batch, decides whether the product of that batch can be released to the next production step. Making medicines batch processing has been a feature of making medicines since the very early days. drugs were made as and when required, first by extracting the active ingredients from plants by soaking them in water or alcohol to create a potion for the patient to drink. later, medicinal plants were dried and ground into powders. but the problem was how to make sure patients received an accurate dose of medication. the invention of tablets provided the solution. before industrialization in the 19th century, tablets were handmade by pharmacists. with the introduction of the pill machine – a brass plate with grooves – greater accuracy was assured. PIll gaIns ConsiGma is a small unit that can easily be installed in existing production rooms, avoiding the need for expensive building alterations. It has environmental advantages, too. Running the machines continuously uses energy more efficiently over a longer period. fast-forward to the 21st century and the difference in tablet-making couldn’t be more marked. drug manufacture is carried out on a massive scale, using sophisticated processes. a typical tablet press can produce from 250,000 to more than one million tablets an hour. nevertheless, as wim van der goten, sales director of gea collette, points out: “the production methods for solid dosage forms are rather conservative compared to other industries, like food and chemicals, where continuous processing has been the standard for many years now. but continuous processing can only be successful with the development of better production techniques to provide consistent quality and measurement tools that allow for full control of production quality, at every instant”. Quality innovation with this in mind, a team at gea collette developed an innovative way of manufacturing granules for tablet production – consigma. this is a continuous high shear granulation and drying system which embraces the six sigma manufacturing quality standard*. it incorporates quality control at every instant inside the process and ensures that the outcome is 100 per cent within specification. it offers major advantages says van der goten: “for example, a 300 kg batch process can only be controlled once, on end quality, while, with consigma, the batch is controlled 6,000 times in-line.” the project won the gea innovation award 2008, presented at the company’s global management meeting in beijing. an appropriate location given that the chinese capital has been the focus of record-breaking excellence with the olympic games. in this case, ultimately, the pharmaceutical industry and patients could turn out to be the real winners. one machine can operate successfully on any quantity from small 500g r&d batches to full-scale production. there is no process scale-up, which drastically cuts development time and cost so that new medicines can be made available to patients much faster. the granules produced can be compressed better which makes the tablet presses run more efficiently. since consigma was launched in april 2008, several companies have invested in the technology, including two of the top ten pharmaceutical manufacturers, one of which is using it for production of a blockbuster drug. the development of consigma began three years ago and pharmaceutical companies were involved from the outset as they helped determine the specifications for the new system. a multi-disciplinary team of process engineers, technologists, software and service engineers from gea collette worked on the project, assisted by r&d staff from gea pharma systems. and the continuous processing revolution doesn’t stop there. gea pharma systems has developed a continuous blender, while gea courtoy has developed an advanced on-line pat for its tablet presses. * six sigma is a disciplined, data-driven process and methodology for developing products. it focuses on improving processes and eliminating defects. GENERATE MAGAZINE ISSUE 07 3
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