< PreviousPUMPS AND FLUIDS 20 Pharma Business International www.pbiforum.net Optimising pumping Pipes, vats, and vessels, pumps are to a factory what the veins and arteries are to a human body – safely containing and moving around the ingredients often vital to a pharma business. Optimising pumping Pharma Business International 21 www.pbiforum.net PUMPS AND FLUIDS © stock.adobe.com/Aleksandr Matveev F or any pharmaceutical business dedicated to the details of product integrity, quality and effectiveness, controlling and measuring the flow of ingredients should be of utmost concern. After all, optimal performance will define every patient’s wellbeing, and any customer’s trust in each batch of product shipped out. Especially where fluid handling is instrumental to a medication or healthcare product, flow measurement and control are fundamental to its stability and safety. But beyond the essentials of profitability and meeting regulations, in providing valuable insights into fluid dynamics, they also enable efficiency, reduce waste and ultimately contribute to your best possible success. There are many intricacies to the need for accuracy in flow measurement. First and foremost, it ensures that the right amounts of fluids or gases are delivered when and where needed. Whether it’s in the precise dosing of ingredients in pharmaceutical manufacturing, or the controlled distribution of fluids in chemical processes, accurate flow measurement and control enable consistent product quality and performance. Monitoring and controlling your stream of raw materials, such as chemicals and solvents, helps ensure that the right amount is delivered every time. This is critical for maintaining consistent product quality in a field where the right dosage is crucial to public health. If applied to pre-existing quality assurance methods such as batch processing, attention to flow provides detailed levels of control to the collection and handling of ingredients. Raw materials are often subjected to various processing steps, such as mixing, heating and cooling, reaction or purification, and each may be happening simultaneously across multiple batches. Making and controlling measurements allows for keeping track of the multiple liquid or gaseous ingredients that may well be needed for certain pharmaceutical products, throughout these many complex systems of combining and refining. This hazard aversion of effective flow is also vital for regulatory compliance. The pharmaceutical industry may be subject to severe quality standards and guidelines, but they are necessary to ensure the safety and consistency of your products. Accurate flow measurement eases adherence to these regulations by providing the necessary data and documentation to demonstrate process control, precision dosing and your observance of validated manufacturing procedures. This enables your business to meet the requirements set by regulatory bodies, maintain a reputation, and build trust with both customers and stakeholders. The industry’s universal approach to safety somewhat mirrors that of the food and drink industry, which means that the vast majority of pumps will feature stainless-steel exteriors and sanitary function by design. These machines are not just tools to shift liquids, they also safeguard the cleanliness of any contents, ensuring they meet the highest standards of purity at any stage of production. However, the responsibility doesn’t rest solely on machinery. It extends to the human element as well. Personnel should always wear protective gear and give their hands a thorough wash whenever necessary between 22 ÁPUMPS AND FLUIDS 22 Pharma Business International www.pbiforum.net tasks, taking care when moving across the factory floor. When it comes to pumps, the focus must not be on finding the cheapest fabricators who can produce something affordably, but on hygiene specialists who know what they are doing. There are many more fabricators now than ever before but most won’t know a thing about hygiene requirements. Accurately measuring how your liquid ingredients are moving helps identify inefficiencies, optimise machinery operations and adjust flow rates to match the actual demand. This enables savings and reduces operating costs, maximising the overall energy efficiency of systems. No business owner needs reminding how important stripping away energy and material wastage is to an economical process. Here, measuring contributes by ensuring accurate dosing and material handling, avoiding overfilling or underfilling containers. Material spillage can also be better moderated in conveyors, feeders or transfer systems, while monitoring effluents and emissions © stock.adobe.com/Aleksandr Matveev helps control waste outputs. Each of these being managed with care contributes to passing yet more regulations, this time for environmental compliance, identifying areas of waste generation for the application of targeted reduction measures. As an added bonus to offset the constant assessment demands, reducing where you can cares for our planet in the most vital long game, keeping your negative environmental impact to a minimum. Making this observance a part of the daily running of your production line goes hand in hand with a consistent view of every component requiring an even flow. Especially when assisted by machine sensors, real-time monitoring allows your pharma business to identify any deviations promptly for immediate action. This continuous feed of information will help you allocate cost, make the most of your resources, and identify subtle ways to improve your products as well as the operations that help them better serve patients and customers. Pharma Business International 23 www.pbiforum.net PUMPS AND FLUIDS © stock.adobe.com/gumpapaSORTING AND WEIGHING 24 Pharma Business International www.pbiforum.net quality and safety Key forPharma Business International 25 www.pbiforum.net SORTING AND WEIGHING © stock.adobe.com/Kadmy Sorting and weighing are crucial in developing and manufacturing safe and effective pharmaceuticals. E very manufacturer knows that medicine in the wrong quantities becomes a poison, and that’s why effective sorting and weighing equipment is so important on a production line. That is a known factor and there won’t be a manufacturing facility out there without the barebones equipment required, but are there steps that can be taken to make something so critical and already understood more effective? Dynamic check-weighing technology and precision weight sorters in particular are important to the industry, to compliance, process safety, productivity, and process control. With ever-more stringent regulatory requirements concerning product safety and growing cost pressures, dynamic production equipment ensures the optimal running of lines and the production of compliant 26 ÁSORTING AND WEIGHING 26 Pharma Business International www.pbiforum.net medicines. Check-weighers are key as a wider range of pharmaceutical products enter the scene with shorter runs and batch sizes more common, requiring fast and efficient product changeovers and startups that are still able to facilitate the entry of safe products into the supply chain. Check-weighers and precision weight sorters help manufacturers operate in alignment with regulatory frameworks like Good Manufacturing Practices (GMP) and are inspectors on the production line, rapidly honing in on products that would be deemed unsatisfactory, such as incomplete packages and capsules with improper weight that should not reach a patient and instead be rejected from the production process, saving manufacturers from a hit to their brand, preventing disruptive recalls, and maintaining patient safety. The devices can usefully weigh and sort a batch unattended while keeping detailed records. However, just because something is known to be necessary does not mean it’s running at optimal efficiency. A major problem in the pharma industry right now is that of a lack of good manufacturing facilities. This can be down to a lack of space, a lack of investment or a lack of potential staff, but the result is that it’s becoming increasingly common for one factory to produce multiple types of drug. This is fine since many products don’t sell enough to keep a line running 24/7 anyway, so making multiple products on one line is cost-efficient. What it often is not, is time efficient. Changing a line over from one product to another means more than just switching out bulk ingredients. It means a change in recipe, a change in formula and, of course, a change in the weights of each ingredient and the final product. Suddenly, the weighing and sorting calculations that a line has been running on for so long are different. This requires recalibration or coding of every machine on the line, which takes time. Since time is money (and since the line will have to be switched back to the old drug later) this is not a good thing. © stock.adobe.com/Mike MareenPharma Business International 27 www.pbiforum.net SORTING AND WEIGHING © stock.adobe.com/Alexander Limbach Companies have been looking into how automation and possibly even AI- led automation might be used to change over lines in a fraction of the time. Luckily, the pharma industry doesn’t often have to deal with large changes in final product shape or size (like the food and drink industry would), so the process can be a lot quicker. Still, the potential implications for if the process is done wrong and cross-contamination occurs is far greater, which is a factor that is holding many people back from adopting AI too quickly. It may be that “to err is human” but humans have fear and caution that will make them double and triple check something, whereas AI has been known to bull on ahead, make mistakes, then shrug its shoulders. The AI does not have to worry about losing its job due to a critical error. It doesn’t have a family to feed. Still, AI is in its infancy and is adapting quickly. It’s already found use in drug development and automation is – in many ways – less dangerous than that. Using multiple AI, with some slaved to others serving to check or monitor the first, could allow for swift line changes. Since this would be an automated process, health and safety measures would need to be implemented to ensure machinery didn’t hit operators when changing, but this is something that can easily be factored in. We’re likely to see a lot of interesting machines and AI systems at shows and automation events in the coming months, and while the biopharma industry has been famously slow to adapt to new technology in the past, big pharma is snapping up AI startups left and right. This is one advancement the industry is determined not to miss out on. HEALTH, SAFETY AND HYGIENE 28 Pharma Business International www.pbiforum.net © stock.adobe.com/Studio Romantic Processing safety events Processing safety events Pharma Business International 29 www.pbiforum.net HEALTH, SAFETY AND HYGIENE Is health and safety an area that can be delegated to AI? No, but also maybe yes… P utting AI in charge of health and safety on a factory floor sounds like a recipe for disaster, and it may very well be – but there is another area of health and safety that AI might just be perfect for. That is patient safety. Every year, millions of safety events occur from end users, be those adverse symptoms, side-effects, incidents or overdoses. Legally, these are supposed to be recorded and assessed by manufacturers, but the sheer quantity of information makes this task at worst impossible and at best highly delayed. There’s also a lot of fake data to work through, be that lies told by people or misuse of products by older people. The quantity of safety events being recorded means that important ones – be they life- threatening or containing useful insights – often go unseen, buried among hundreds of thousands of other reports. This is an area where pharma 30 ÁNext >