< PreviousPUMPS AND FLUIDS 20 Pharma Business International www.pbiforum.net Handling fluids The correct and efficient handling of fluids is integral to the sector’s continued success, but there are hurdles to get by if it’s going to reach its potential. 20-23.qxp_Layout 1 10/02/2023 14:27 Page 1Pharma Business International 21 www.pbiforum.net PUMPS AND FLUIDS T he fluid handling market in pharma is growing explosively – driven in no small part by increased drug production and a growing adoption of single-use systems. The market is expected to reach over $14bn by 2028, and yet the growth is held back somewhat by the high price of failed clinical trials. Fluid handling is big business in pharma not only in terms of pumping systems used in pharmaceutical manufacturing, but production of fluid-based medicines like syrups, vaccines and injections. It is also being driven in the medical devices market as well, where programmable infusion pumps are seeing increased usage for homecare and preventative treatments. Most medium and large scale manufacturers need to move products around during processing. Pumps are often the most convenient choice as they can be adapted to suit many different types of products (including solids) and do not take up a large amount of valuable floor space in factories. Materials to be pumped tend to fall into two requirements, those which can be pumped and transported via pipes, and those which need to be conveyed with other mechanical systems. Generally speaking, the more viscose the material, the more it will fall into the latter category. However, many types of products can be used in pumps including powders, pastes, liquids, and solid particles suspended in liquids. This means that any pump needs to be specifically designed to produce and process the material in question. In particular, using pumps beyond their intended purpose is likely to damage product. This is especially important in the pharma industry when dealing with cough syrups, liquid medicine, and even 22 Á © stock.adobe.com/SweetBunFactory 20-23.qxp_Layout 1 10/02/2023 14:27 Page 2PUMPS AND FLUIDS 22 Pharma Business International www.pbiforum.net powder particles. This could spell significant financial damage if large batches of product were to be damaged during processing. The main sign that you are using the incorrect pump for your product is change in viscosity, often causing fluids to become runny or separated. Pumps naturally run in the same circles as depositors and fillers, used to fill bottles accurately or to deposit product into capsules and tablets. Understanding the right kind of pump to connect to the right kind of depositor is key for efficient running of a line, but this can become a challenging process when many factories are nowadays trying to improve efficiency by running a single processing line over multiple products on a portfolio. If a line is producing one drug in the morning and another in the afternoon, then there might be subtle differences in the material ingredients that prompt different needs in pumps. The obvious answer is to have two lines, but that is an expensive and inefficient answer and it can take the better half of a decade to get a new factory up and running. Better instead to find a pumping solution that will strike a happy middle-ground between the two. Here, it’s worth consulting specialists as getting it wrong could be expensive not only in terms of replacement parts, but in recalls if any medical product becomes contaminated. In order to assist in the changeover of lines and the efficiency of lines, pumping systems are increasingly making use of IoT solutions and digitalisation to speed up processes. This is not only in terms of measuring and weighing the correct amount of a material to go into a product, as this has been happening for a long time now, but also on changing over lines. By using digital “templates” of a sort to save ingredients of one drug from another, lines can more accurately and speedily be changed over to allow for continued running and reduction in downtime. The pumps and fluid handling industry’s future is bright, but there’s still a lot more work to be done – and there are measured concerns that global and political events around the world have the potential to be a destabilising factor. 20-23.qxp_Layout 1 10/02/2023 14:27 Page 3Pharma Business International 23 www.pbiforum.net PUMPS AND FLUIDS © stock.adobe.com/wacomka 20-23.qxp_Layout 1 10/02/2023 14:27 Page 4SORTING AND WEIGHING 24 Pharma Business International www.pbiforum.net The correct measurements With consumer trust in pharma at an all-time low it’s more important than ever to get everything right and avoid scandal. Perfect measurements come into that. I t’s impossible to argue that trust in pharma hasn’t gone down on average across the world. Whether this is born from conspiracy theories, misinformation, or controversy, the result is that companies are being hit harder than ever by any recall or incident that arises from pharma products. That’s why it’s more important than it ever has been before to get sorting and weighing accurate on the first try, and to make sure no potentially faulty product makes it out into the wider market. Because where a single mistake before might have led to some negative attention and fines, it can now be latched onto by desperate conspiracy theorists who will use it to push an agenda. With how precise medicines are, a slight variation in dosage or measurement of a single ingredient could drastically change the end product, introducing side- effects from the minor to the extreme, seeing high precision instruments turned to that can measure the smallest difference in weight, to allow researchers to make minute alterations to improve effectiveness, and, 26 Á 24-27.qxp_Layout 1 10/02/2023 14:27 Page 1Pharma Business International 25 www.pbiforum.net SORTING AND WEIGHING © stock.adobe.com/vladim_ka 24-27.qxp_Layout 1 10/02/2023 14:27 Page 2SORTING AND WEIGHING 26 Pharma Business International www.pbiforum.net down the line, enable accurate, consistent manufacturing, and the sorting and removal of any products that do not meet expectations. 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 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 24-27.qxp_Layout 1 10/02/2023 14:27 Page 3Pharma Business International 27 www.pbiforum.net SORTING AND WEIGHING can usefully weigh and sort a batch unattended while keeping detailed records. Regulatory authorities across the globe have set rules that influence the design, manufacturing, installation, daily use, hygienic cleaning and preventive maintenance of weighing instruments, and there are several factors that must be considered to make sure weighing processes are effective in pharmaceutical facilities, including firstly selecting the correct weighing scale. Indeed, to establish accurate and effective weighing practices the right tools with suitable weighing ranges must be in place. With a high-quality weighing instrument manufacturers can adhere to stringent standards, mitigate errors, and improve reliability. Choices should be made on the requirements of the industry, environment, and tolerance, in consideration of production factors like line speed, package size, vibrations from plant equipment, and weighing equipment should be designed to prevent contamination of the product and allow for easy cleaning as well as be equipped with features and software that ease regulatory compliance. To keep weighing effective drug makers must also continuously check instrument accuracy, which can be affected by a variety of things including sensitivity, readability, non-linearity, repeatability, eccentricity, and environment of a scale. Scales should therefore be set up, calibrated, and tested properly and regularly according to written procedures and established schedules - which help in detecting and correcting deviations - and weighing processes validated to display conformance with defined specifications. When it comes to testing, this can be labour intensive and see significant downtime, however technology on the market today, such as the aforementioned dynamic check-weigher, can perform In-Process Tests which do not necessitate the shutdown of production lines, reduce error risks in testing procedures, are flexible to adapt to requirements, and automatically generate reports for each test scenario. With high quality drugs a result of reliable production processes, the quality of medicines is dependent on that of weighing instruments. As the development and production process of pharmaceuticals evolves, so does weighing equipment. New equipment is being developed to refine pharmaceuticals manufacturing and efficiency, more reliable weighing instruments are being created for enhanced quality control, alongside those that are more robust to handle demanding hygienic and bacteria cleaning challenges, while the sensors and software associated with these instruments keep improving too. © stock.adobe.com/MIKHAIL 24-27.qxp_Layout 1 10/02/2023 14:27 Page 4HEALTH, SAFETY AND HYGIENE 28 Pharma Business International www.pbiforum.net The final barrier While all labs and manufacturing plants should seek to be incident free, accidents will always happen, and it’s up to the PPE provisions in place to mitigate risk. 28-31.qxp_Layout 1 10/02/2023 14:28 Page 1Pharma Business International 29 www.pbiforum.net HEALTH, SAFETY AND HYGIENE © stock.adobe.com/Gorodenkoff I t can be tough to keep on top of the rapid changes in health and safety regulation, but if one does not the costs can be high. The repercussions can be in the form of a fine, imprisonment or, more seriously, injuries and fatalities. PPE is key in helping prevent workplace injuries and health or safety risks, and employers have a duty to provide it. Its use is particularly important in the pharmaceuticals industry due both to the risk of injury and the importance of hygiene. The COVID-19 pandemic naturally brought hygiene, health and PPE into the spotlight. Even if systems had traditionally been put in place to prevent, for instance, machinery injuries, other less obvious hazards remain, for instance contaminated air resulting in lung harm or corrosive materials or liquids causing skin damage. COVID also alerted people to the hygiene aspect of health and safety, and exposed weaknesses in many systems when it came to employees infecting one another. In light of this, PPE should be seen as more than just a means to lessen physical risk of injury. According to the HSE, PPE is a last 30 Á 28-31.qxp_Layout 1 10/02/2023 14:28 Page 2Next >