< PreviousHEALTH, SAFETY & HYGIENE 20 Pharma Business International www.pbiforum.net 20-23.qxp_Layout 1 14/02/2022 08:49 Page 1Pharma Business International 21 www.pbiforum.net HEALTH, SAFETY & HYGIENE Health, safety and hygiene are the three main and fundamental conditions within the pharmaceutical industry; any issue that impacts these conditions could have serious consequences on the productivity of a company and quality of a product, but also on the health of the employees, on their productivity, motivation and, hence, result in a loss of capital and resources. Maintaining good safety and hygienic standards can be complicated for pharmaceutical companies; not only do they need to follow basic health and safety measures but, because of the nature of the industry, they also need to comply to strict guidelines and rules to ensure high standards of hygiene and the complete safety of their products and of their workers. There are a range of rules and regulations that involve practices, etiquette and use of equipment that need to be followed throughout the whole processing and manufacturing of a product and that are not only meant to ensure good quality standards, but also guarantee the safety of personnel, and it is fundamental that these regulations are followed. The amount of work companies needs to carry out to ensure a safe and healthy work environment is substantial and constant, and also costly; there are rules and regulations to follow, assessments and check-ups that are implemented every day and equipment needed to be kept updated and functioning in order to keep everyone safe. However, despite the daily workload and the money and resources companies need to invest in order to provide the safest equipment and conditions for the staff, all the requirements are necessary to avoid any potential accident and injury that could cost a company big lawsuits and loss of profit. All these procedures are extremely costly due to their maintenance and due to the resources and material needed on a daily basis, which requires large Health and safety regulations are never easy to follow for any manufacturing company, but because of the nature of the products, it is more complicated for the pharmaceutical industry. Balancing good manufacturing standards and safety requirements can be challenging, but making sure everyone is safe at all times always has to be a priority. Keep it safe 22 Á 20-23.qxp_Layout 1 14/02/2022 08:49 Page 2HEALTH, SAFETY & HYGIENE 22 Pharma Business International www.pbiforum.net investments. Companies need large quantities of single-use PPE and single- use equipment, when possible, to keep the environment sterile, and they also need updated machinery and constant maintenance; moreover, they need specific cleaning procedures and sanitising practices and products that keep people safe from the chemicals. All these elements require investments in equipment and specialised personnel that can cost companies large quantities of money and resources that cannot be available for everyone. Implementing and maintaining good health and safety standards is also very costly and it can have a serious impact on a company’s life and productivity. Companies constantly need to make sure personnel is healthy and appropriately equipped with PPE at all times, they need to make sure all equipment and machinery is safe to use and updated, and they also need to provide workers with a safe environment free of any potential hazard or threat. Additionally, due to the delicate and potentially dangerous nature of the products and ingredients and the complexity of the equipment and machinery, health and risk assessments of staff and equipment and environments are constantly needed. Health and safety regulations include a series of procedures that range from simple activities like washing hands regularly, cleaning up spills and maintaining work areas tidy and clear, making sure equipment is not damaged and correctly labelled at all times, to more complicated cleaning and sterilising procedures like the use of specific chemicals or the use of more sophisticated equipment and PPE. Equipment and machinery need to be classified as suitable for use beforehand and assessed regularly to make sure they are safe to use at all times and replaced in case of damage or breakage to avoid any safety risk for employees. Similarly, like machines and environments are required to be assessed and go through risk assessments to be considered suitable for work, so do workers. Due to the potential dangers, they could face throughout the supply chain, employees need to go through assessments themselves to make sure they are fit to work in determined conditions and are 20-23.qxp_Layout 1 14/02/2022 08:49 Page 3Pharma Business International 23 www.pbiforum.net HEALTH, SAFETY & HYGIENE safe to use hazardous equipment and chemicals. Another key element of health and safety within the pharmaceutical industry is training. Companies need to make sure all employees know how to safely use all equipment and keep themselves and other safe from any potential hazard, along with knowing what to do in case of danger. Training is a big investment that costs companies large quantities of money and time, but it is fundamental and will in the long run provide a return over investment through widening the range of services a company offers. There is no doubt the COVID-19 pandemic has represented a big challenge for the pharmaceutical industry. Despite having a slight advantage when it came to safety procedures and equipment, pharmaceutical companies have found themselves trying to maintain all operations efficient and productive, while still having to balance all the new regulations, like social distancing or the limited number of staff available, with the growing demand for products and development of new medicines like the vaccines. New procedures and new regulations have in a way slowed down the pharmaceutical industry which was still required to be productive and functioning during very delicate and dangerous times, and all the new guidelines have probably changed how the industry works and will influence health and safety procedure forever. Nonetheless, the industry has proved to be able to balance the high demands with keeping everyone safe through a series of investments like new machinery, PPE and the hire of external companies. It is not an easy task for pharmaceutical companies to keep everyone safe at all times. The COVID-19 pandemic has been particularly tough on the pharmaceutical industry, as it disrupted and slowed its operations with all the new safety regulations, while increasing the demand for new products. But if the pandemic has taught the industry anything it is how resilient it can be and how anything can be accomplished if people work together, especially when it comes to keeping each other safe. © st ock. adobe .com/ Iv an Tr aimak 20-23.qxp_Layout 1 14/02/2022 08:49 Page 4LABORATORIES 24 Pharma Business International www.pbiforum.net Digital transformation: the lab of the future 24-27.qxp_Layout 1 14/02/2022 08:50 Page 1Pharma Business International 25 www.pbiforum.net LABORATORIES © st ock. adobe .com/ Gor odenk of f With digitalisation, intelligent systems and heightened automation becoming the new norm for labs, facilities need to be transformed to beat competitors. The digitalisation of labs has been expedited over the past two years as they were tasked with rapidly analysing a new virus (COVID-19), and developing and delivering treatments and vaccines, all while keeping staff safe and dealing with disruption. Concurrently, increased demand for pharmaceutical products, the need to bring products to market faster, and for labs to evolve as innovation in pharma accelerates is influencing a reassessment of labs. Much like in other areas of the pharmaceutical industry, investment has consequently been poured into laboratory digital transformation. While this trend was growing more cautiously pre-pandemic, digital transformation plans spreading across years have been implemented within months, seeing significant changes in operations. It has become a requirement for labs to be digitally enabled and globally connected to support the future of the pharmaceutical industry and allow for innovation, and there is a plethora of different technologies (hardware and software) being utilised to transform labs, particularly Internet of Things (IoT) technology, artificial intelligence (AI)/AI- powered analytics, automation, and robotics. These connected, digitalised, ‘smart’ labs come with a wealth of 26 Á 24-27.qxp_Layout 1 14/02/2022 08:50 Page 2LABORATORIES 26 Pharma Business International www.pbiforum.net benefits, from simplifying data management and processes, increasing efficiency, and boosting quality control to enhancing the skills and capabilities of professionals. Depending on your laboratory requirements, digital transformation will have different scopes. Digitalisation is set to have a major impact on the R&D lab of the future, as highlighted by Deloitte who envision an interconnected ecosystem of data, platforms, instruments, and advanced analytical tools supporting scientists across teams and geographies to quickly discover breakthrough therapies. This lab is able to optimise and advance value- stream processes from target identification to preclinical development via digital innovation. To achieve this, labs need to implement a number of tools. Machine intelligence for instance is set to empower researchers, changing human-led scientific methods, and when inserted into research processes facilitates faster analysis of molecular structures and identification of promising compounds. AI in the future lab can be applied to knowledge graphs to automate target identification and validation, cutting down time spent screening molecular libraries to uncover lead molecules. AI algorithms and machine learning, which continuously learn and adapt, can guide researchers as they identify, process, and test molecules and therapies. Furthermore, AI-based computational chemistry toolkits allow scientists to delve into novel spaces and expand the pool of potential structures to consider as drug candidates, growing development pipeline size, and AI is a critical tool for efficiently and accurately reviewing data, discovering patterns, and improving analysis. The automation of lab processes is also important to smart labs - especially labs with repetitive and high-throughput processes - through physical and digital robots, taking on sample and buffer prep, pipetting, and standard analytical testing for example, with high precision, reliability, and repeatability, minimising manual work, saving time and reducing potential for human error, particularly in steps at higher risk of variability, as well as freeing up scientists to focus on activities such as result interpretation, decision making and creative discussions. Of course automation is present already, primarily partial automation, with just the most routine processes fully automated - those that bring the best return on investment. Looking at a fully automated lab, liquid handling systems and robotic arms can perform the assays and transfer containers between different devices, and other labs go even further, requiring no human interaction, with robotic arms taking samples from storage, transferring them to an analytical device, and the scientist checking data. Meanwhile to enhance the work of staff, digital assistants with augmented reality (AR), virtual reality (VR), natural language processing (NLP), and computer vision can enable hands-free work, presenting a lab procedure’s steps, notes from prior experiments, and record video and audio observations. 24-27.qxp_Layout 1 14/02/2022 08:50 Page 3Pharma Business International 27 www.pbiforum.net LABORATORIES Digital transformation in labs also means an improvement in how we interact with enormous amounts of data and control experiments. Embracing IoT (a system of internet connected objects with sensors, processing ability, software, and other technologies that exchange data over a wireless network), for instance, research platforms and smart instruments can clean, store and upload real-time data to cloud platforms automatically, and this data can be used to gain AI-driven insights that help companies discover and develop new medicines while reducing costs as well as harness information from instruments, process sensors et al. for workflow optimisation and process management. IoT allows connectivity and effortless access to, and sharing of, data and insights as needed, across organisations and geographies, strengthening collaborative work with cloud tech connecting global teams. Moreover, the use of IoT sees it help remote teams monitor and control experiments and equipment. This can be done around the clock, enabling more flexibility and creating agile teams. With digitalisation - the use of intelligent, connected systems - becoming the new normal for labs, those that do not upgrade their facilities will lose out to competitors who are able to get therapies to market quicker with reliability and strong quality control. © st ock. adobe .com/ Gor odenk of f 24-27.qxp_Layout 1 14/02/2022 08:50 Page 4SORTING AND WEIGHING 28 Pharma Business International www.pbiforum.net To develop lifesaving medicines, weighing and sorting instruments are a necessity. They play a vital role in a number of stages of pharmaceutical production, in bolstering productivity, and with manufacturers held to strict standards, both by regulators and the public, are essential in quality control and ensuring safety. In the first instance weighing equipment facilitates the innovative research behind new products. High precision scales support researchers to establish the right recipes, then state of the art weighing instruments integrated in production control software enable fast, safe and reliable production, prevent substances in medicines being supplied dangerously in the wrong quantity, and hold a critical place in quality control of pharmaceutical packages and verification of contents. Quite simply, without today’s weighing equipment, we would not be able to produce drugs with the same level of quality at the current quantity. In order to be effective and efficient, medicines must contain exact quantities of ingredients (a slight change in amount of a substance could affect intended effects and side effects), 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, 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. Key for quality and safety Sorting and weighing are crucial in developing and manufacturing safe and effective pharmaceuticals. 30 Á 28-31.qxp_Layout 1 14/02/2022 08:50 Page 1Pharma Business International 29 www.pbiforum.net SORTING AND WEIGHING 28-31.qxp_Layout 1 14/02/2022 08:50 Page 2Next >