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CHEMICALS & P


S & PHARMACEUT


UTIICAL S Bridging the islands of autom atio n


The ideal holiday arrangement for the world’s althy elite and a distant fan asy for the rest of s d liv r u tim te iso


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isla o in


for those stuck in rush ica io


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autom tion supplier EU Automation, discusses the potential of continuous manufacturing compared to its isolated,, batch manufacturing alternative


The i eal hol day arrangement for the w rld’ wealthy elite and a distant fantasy for the rest of us, private islands deliver ultimate isolatiion in our modern world. While this may seem like paradise for those stuck in rush hour traffic, in the real world, communication is key. Here, Robert Holloway, head of order fulfilment at industrial automation supplier EU Automation, discusses the pot nt al of cont uous manufactur g compared t its iso


y head of order ful b tch


sing traditional batch manufacturing methods, pharmaceutical companies often operate through so-called islands of automation - a series of disconnected, single unit processes. With production taking place in separate environments, or on separate manufacturing lines, this traditional operating model is notorious for slowing assembly and high levels of downtime. Last year however, the Food and Drug Administration (FDA) called for manufacturers to abandon this outdated model and instead, make the switch to continuous manufacturing (CM). Renowned as a way to shorten the supply chain, increase agility and improve the flexibility o f development and manufacturing, this continuous method has clear advantages over its stop-start, batch counterpart. The FDA endorsement may have recently shone a light on the benefits, but continuous manufacturing is by no means a new process. In fact, for the majority of other manufa industries, including auto


U


Robert Holloway, head of order fulfilment at industrial automation supplier EU Automation


Robert Holloway, head of


industrial automation order fulfilment at


supplier EU Automation


motive, oil and cturing


gas and electrical components, this PAT SAVES TI method of production is a well-


established standard. So, why has the pharmaceutical industry been slow to adopt the practice?


SEAMLESS OPERATION SEAMLESS OPERATION


Despite its benefits, migrating to continuous manufacturing is not necessarily the remedy to cure all difficulties faced by the pharmaceutical industry. Changing processes often requires a changing of systems, more often considered a threat than an opportunity. This dramatic shift from batch to continuous manufacturing can cause reluctance from stakeholders and staff and the journey to introducing this method depends highly on conviction. In additional to the cultural challenges, integration is a notable problem for the industry. Many original equipment manufacturers are only capable of supplying one piece of the puzzle. For continuous manufacturing to truly succeed, all of the pieces must fit together seamlessly. For example, an equipment manufacturer may provide a


PAT SAVES TIME IN CONTI UOUS DRY TABLET PRODUCTION The paradigmshift towards continuousmanufacturing currently taking place in


pharmaceuticalmanufacturing has gathered further pace, helped by a recently published whitepaper by Prof. Ravendra Singh of Rutgers University. The paper entitled ‘New scopes of PAT for real time advanced control of continuous pharmaceutical manufacturing process’, outlines how continuousmanufacture of tablets can be


achieved via automatic feed-forward/feed-back control of the process based on real time product quality attributes, paving the way for further uptake of the technology Process Analytical Technology


gy by the global pharmaceuticalmajors. gy (PAT) allows pharmaceutical products to be produced continuously on a


production line, enabled by the use ofmultivariatemodels that predict product quality attributes during manufacture. This information allows the process to be controlled to optimise product quality, whilst also shortening production times. Prof. Singh selected Optimal Industrial Automation’s synTQ proprietary PAT data management tool in constructing a continuous tablet production pilot plant at Rutgers University. This allowed his teamto ‘obtain a precise pre-defined end-product quality of a pharmaceutical product, asmandated by regulatory authorities’. Real timemonitoring of powder bulk density, drug concentration and blend uniformity were successfully carried out to enable the optimisation of the finished tablet product.With the con demonstrating proof that PAT can provide such results, uptake of PATmonitoring software is expec


ted to rise. cept


Optimal Industrial Automation 3ltd.co T: 01454 333222T: 01454 333222 10 10 DECEMBER/JANUAR 201 ANUARY 2017 | AU AUTOMA MAT ATION www.o .optim imal-ltd.co.uk factu in


solution for continuous coating or tablet packaging, but the same machinery may not be designed to integrate with the equipment that precedes or follows it. Without the expenditure of a costly equipment overhaul, the machinery will continue to be reliant on a human machine interface (HMI) to operate and control each separate single-unit cell. To truly bridge these processes into one seamless operation, there are several requirements for the


manufacturing facility. Unlike other industries, continuous manufacturing equipment for the pharmaceutical industry is relatively small. Therefore, floor space should be small and th e equipment easy to reach, allowing for quick changeovers for multi-product manufacturing. For manufacturers of more than one product, or highly complex prescription products, this small, modular and transferrable equipment is essential to enable formulation flexibility .


NAT NA URAL PROGRESSION ATURAL PROGRESSION


CONTINUOUS DRY TABLET PRODUCTION advancements have meant continuous manufacturing has become a natural progression for the industry. The move towards continuous manufacturing is, without doubt, a huge step for


Batch manufacturing has existed for centuries, but today, technological


manufacturers. Companies planning to make the migration should arm


themselves with a long-term strategy and work with an expert partner for the implementation. Despite the challenges of the transition as industria l


,


automation technology develops, the take up of continuous manufacturing holds a lot of potential for the pharmaceutical industry.


EU Automation www


ww. T: 0845 521 3088T: 0845 521 3088 www.euautomation.com ma /AUTOMATION AT /AUTOMATION


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