< PreviousDEPOSITORS AND FILLERS 20 Pharma Business International www.pbiforum.net Accurate filling Accurate measurement, efficient filling and maximum hygiene all add pressure to the depositors and filling sector, and there are plenty of options available to suit any size of operation. Pharma Business International 21 www.pbiforum.net DEPOSITORS AND FILLERS © stock.adobe.com/guteksk7 T hough depositors and filling machines carry out slightly different functions, they are each used for dosing or dispensing an exact amount of a mixture into a product or container. Most depositors are simple machines by design, thanks to their individual function, but it is still possible to customise them to suit any purpose or production line by size and level of output. Semi-automatic filling machines are typically operated by pumps driven by compressed air. Not only can filling be set to repeat, but precise portions can be filled through accurate measuring and dosing equipment incorporated in the weighing or volumetric controls. Needless to say, these machines offer a greater degree of speed and accuracy over manual. Automatic filling machines, on the other hand, boast controls and incline equipment which manages the filling process from material handling, loading, dosing and packaging. Yet whether automatic or not, one of the biggest challenges when it comes to depositors and filling concerns viscosity. Although depositors and fillers are responsible for weighing and portioning a certain amount of product, at their simplest they direct a liquid’s flow to a target – be that depositing medicine into a bottle or a viscous solution into a mixing unit. On the surface this may sound simple enough, yet things become difficult when liquids don’t easily flow – such as gels. In any production circumstance, viscous and semi-viscous liquids are difficult to handle. As one might expect, flow is the biggest issue here. If a substance cannot be made to flow consistently into the machine, then it’s not going to fill or deposit consistently. Managing and controlling that flow is therefore 22 ÁDEPOSITORS AND FILLERS 22 Pharma Business International www.pbiforum.net paramount to ensuring consistent flow and consistent filling. Most filling machines utilise a hopper positioned overhead which uses the power of gravity to maintain flow. When the product is too viscous to flow freely from a hopper, agitation is required to start and maintain product flow. Hoppers can also be fitted with level sensors that trigger automatic replenishment and allow for uninterrupted throughput. Although downward pressure is an ideal means of agitation, it isn’t always necessary, with mixing able to do the job whilst also keeping the contents stirred and in suspension. Yet despite these additions, many products still prove too viscous, making them difficult to flow through the machines. On a production line where downtime needs to be minimised and companies may have to switch a line over to another medical product at a moment’s notice, this isn’t acceptable. Pistons not only provide sufficient force to push product through the depositor or filler head but can offer precise portion control. Simply put, the products to be deposited are drawn in from the hopper by the pistons in the cylinder, the piston Pharma Business International 23 www.pbiforum.net DEPOSITORS AND FILLERS © stock.adobe.com/wacomka then presses the product from the cylinder to the dispensing opening. Another advantage of this approach is that they are incredibly adaptable depending on the requirements. However, there’s more to consider than just the type of depositor or filler. It’s no good investing in high-end machines only to shirk on the transfer pumps. These vital pieces of equipment pump product from one receptacle into another or into a hopper of a depositing machine. As with the fillers themselves, flow is key to bear in mind here as a fully liquid product is going to be much easier to pump than a viscous one. Whether manual or automatic, almost every pharma product line contains some kind of filling or depositing machinery. With that in mind, companies need to ensure that their machinery is up to snuff – delivering not only high throughput, but also preserving product integrity. Although they are almost universal, the needs placed on these machines will differ from company to company, so flow requirements and pumping must be considered. What works for food and drink, for instance, won’t necessarily work for the pharma industry. PROCESS CONTROL AND AUTOMATION 24 Pharma Business International www.pbiforum.net Not a one size fits all approach Not a one size fits all approach Pharma Business International 25 www.pbiforum.net PROCESS CONTROL AND AUTOMATION © stock.adobe.com/Aleksandr Matveev A utomation is not a new term but it’s still a subject that is so often misunderstood by companies as a “do it once and forget about it” scheme. Automation is a constantly evolving phenomenon that needs constant work to stay at the head of the game, but also one which doesn’t always make that obvious. An automated line will continue to work even if it is inefficient, and it will look for all intents and purposes like it’s doing it well. In truth, it probably is doing it better than humans could, but it might not be operating as effectively as it could be. In short, while the move toward automation is obvious, the optimisation of it is anything but. Effective automation requires monitoring and quantification to make sure it’s working at optimal efficiency. The quality production of medications and other pharmaceuticals depends on how well you monitor and control processes. This close eye is what keeps them safe and reliable, as well as consistently effective for the mass market. However, the focus and attention to detail needed for this task, especially on a large scale, inevitably becomes difficult to manage with manual solutions or human labour. To make sure your laboratory procedure, manufacturing practice and beyond meet the exacting standards enforced by the industry, automation is often – if not always – an essential tool for supervising your products in the making every step of the way. To break down the dual concerns for automation, process control incorporates industrial control systems as a means of regulating and economising a continuous production process. Monitoring, on the other hand, can be achieved by computerised systems which adjust The problem with automation is not that it is overly complicated or expensive, but that it requires continued monitoring to make sure the system is running optimally, and it’s possible to have an inefficient automated system and never realise it. 26 ÁPROCESS CONTROL AND AUTOMATION 26 Pharma Business International www.pbiforum.net controls whenever the need arises. Automation also boosts interconnectivity for a smooth yet detailed view of every process contributing to development, manufacture and quality control. Whenever there’s an error or flaw in proceedings, sophisticated warning systems can be applied alongside event reporting systems and status updates, leaving little to no space for mistakes and dangers to go undetected. One of the most important methods by which to optimise automation is to understand that the process is more than just the machinery involved, and much more about the processes that tie it together. In many cases, this refers to software systems. Digital control of processes at every stage of the process allows for rapid monitoring, identification of problems and action to address such. Industry 4.0 (also known as the fourth industrial revolution) has taken too long to be adopted by many, faced in no small part by resistance from labour groups, unions, but also governments not wanting to face the losses of jobs implied by such a change. When it was first introduced, manufacturers saw Industry 4.0 only as a means of raising productivity by the number of products handled or sorted, and with a reduction in labour. What many did not realise, and which some still do not, is that it is an opportunity to invent or reinvent their offerings and strengthen their competitive position. One need only look at China, long considered a manufacturer of cheap knock-off products, rising up through automation to challenge many other economies. There are multiple stages at which pharma manufacturers are required to gather data about quality, performance and overall consistency, and there just as many ways to go about this. In-line control has systems integrated directly into the manufacturing process, and typically within the production line or equipment itself, allowing real-time © stock.adobe.com/ScanrailPharma Business International 27 www.pbiforum.net PROCESS CONTROL AND AUTOMATION monitoring of critical parameters. Examples of this may include sensors for temperature, pressure and flow rates, or automated control systems for adjusting process variables, with any of these enabling immediate adjustments and interventions to maintain stability and quality. On-line systems are closely related; these involve continuous monitoring and control of process parameters through dedicated instrumentation which, while separate from the main production line, is still connected to the process equipment. Data can be collected in real-time here also, but processes are instead analysed remotely or within a centralised control room. Control signals may then be sent from there to the process equipment, to adjust parameters based on the information collected. Off-line systems take a step away from the bustle of the production line, instead monitoring activities from a different location. In these instances, samples or test materials are periodically collected from the manufacturing process and analysed in a separate laboratory or testing facility. This approach allows for detailed analysis and quality control checks, though it does not provide immediate feedback. However, the outside view of processes from this mode of testing can be used either for overall process optimisation, or for identifying long-term improvements. Finally, at-line monitoring for control purposes combines aspects of the in-line and off-line methods, collecting samples or test materials at specified points within the production process and analysing them in a nearby laboratory or testing area. This hybridised approach provides a balance between real-time feedback and detailed analysis, allowing for timely adjustments and quality checks in a manner that may not give instant feedback like fully in-line systems, but allows for thorough investigation into potential improvements to process and control. © stock.adobe.com/GorodenkoffOUTSOURCING 28 Pharma Business International www.pbiforum.net © stock.adobe.com/KadmyPharma Business International 29 www.pbiforum.net OUTSOURCING brands. They’ve had to do this to remain competitive. At the same time, both product maintenance and product development are becoming more complex. Ever- changing regulations across global markets, specific CMC requirements for special product categories, a move toward innovative clinical approaches, and increased digitization of many regulatory processes all require specific expertise that might be unavailable in- house. Outsourcing can also free up in- O ngoing lifecycle maintenance of medium or large portfolios puts a tremendous resource strain on pharmaceutical companies. These activities are crucial to keeping your products on the market but can stretch teams thin, making it harder for companies to focus on new product development, line extensions and further global roll-out activities. Maintaining production has only gotten harder this year as well, with many manufacturers trying to get more out of less and have a single line covering several products and Out of house The strain placed on manufacturers by worsening economic conditions is causing many to look at outsourcing their requirements rather than investing in costly new facilities, and even costlier recruitment processes to fill them. 30 ÁNext >