6 ways to increase productivity and quality in pharmaceutical manufacturing

1. Protect Data integrity and compliance 

Pharmaceutical companies are subject to strict regulations and standards and must also carefully protect the integrity of their data. Finding an efficient, reliable way to do so can help these companies to boost their productivity and product quality.

Switching to electronic data recording, for instance, can increase efficiency and reliability in quality control. Initial results become available during the production process, and reports and compliance documentation are ready as soon as a batch is finished. With paper-based data recording, this information takes much longer to process.

Electronic, automatic data recording also reduces the likelihood of errors when recording production data. If a recorded value is outside of the expected range, quality management will receive an automatic alert. Also, when data is stored on a cloud-based system, all employees have access to the most up-to-date data, regardless of which internet-connected device they’re using.

With zenon, you can also alter your processes without revalidation, which saves you significant amounts of time and money. zenon also provides full, out-of-the-box compliance as standard. Equipment, processes or operations do not need to be altered in spite of the conversion. zenon’s solutions meet regulations such as FDA 21 CFR Part 11 and Annex 11 of the EU GMP guidelines. The platform also meets the requirements of Good Automated Manufacturing Practice (GAMP) 5 Software Category 4. These features enable you to meet compliance requirements more easily and efficiently.

2. Reduce paper and simplify operation workflows

Few industries have quality requirements as strict as those of the pharmaceutical industry. Every part of the process, from making the products themselves to package labeling to sanitizing the equipment used, must be tightly controlled.

In the pharmaceutical industry, the batch process, in which products are made in batches rather than continuously, is common. While this comes with benefits, it also means that one small mistake can ruin a whole batch. A bad batch means a significant amount of wasted money, time and raw materials.

If the manufacturer doesn’t catch the bad batch, the damage can be even worse, leading to serious bodily injuries, resulting in fines and lawsuits, as well as a huge damage to the reputation.

To avoid these and other negative scenarios, effective batch control is essential. zenon's Batch Control feature, for example, enables you to easily control the process and optimize production with user-friendly interfaces, hardware-agnostic implementation and seamless integration.

The data that pharmaceutical manufacturers collect about their processes is crucial to ensuring product quality. Many companies, however, still rely on paper documentation, which leaves data collection and management prone to errors.

Using automation with mobile devices can help reduce the likelihood of these errors and make data collection more efficient. zenon’s Paper on Glass application allows you to digitize and automate your data-related processes. The process itself doesn’t change, however, so it’s also efficient for validation. With Paper on Glass, the user gets detailed instructions for each task, such as safety instructions or prescribed user actions, which help to prevent errors.

zenon collects data from many different sources, standardizes it and analyzes it. It produces easy-to-read reports, which help with quality assurance, available immediately after a batch is completed. With paper-based data collection, completing these reports is often a much longer and more expensive process.

3. Maximize efficiency and flexibility

Efficiency refers to how much input, including time, money and materials, it takes a business to produce a given amount of output. So, efficiency is closely linked to productivity.

Using zenon, for instance, lets you collect information from across your entire facility, enabling you to get a clear picture of your operations' efficiency. You can use the data and reports you obtain to uncover areas where you can improve your processes and facility.

zenon also enables you to automate various parts of your processes. Automation can allow you to get the same amount of work done with less manual input, time and resources. For example, with automated alarms, operators receive immediate notification of problems and can correct them quickly.

Validation is a crucial part of the pharmaceutical manufacturing process because of the regulations and standards the industry must adhere to. zenon can help increase efficiency in this area, as well. It offers full compliance as standard and allows you to change or improve your processes without revalidation, which can save you a significant amount of time and resources.

zenon also helps you to streamline the packaging portion of your production process. Like during the batch production process, during packaging, zenon can control, monitor and visualize your process, making it easier for you to identify ways to improve it. You can also access data remotely, so you can monitor and work on your process from anywhere. This mobility, along with user administration and access rights, also help you ensure each employee gets precisely the information they need, which can help to speed up the process.

One influential factor in these areas is the convergence of information technology (IT) and operational technology (OT), which prompts manufacturers to take advantage of Industrial Internet of Things (IIoT) technology.

Efficient IT/OT communication means the efficient sharing of data between the production and business levels. For example, it lets you use the data collected from your manufacturing process to inform business decisions that can improve efficiency. zenon helps to create seamless communication between these two levels by providing a common structure for information flow.

4. Improve the life of production assets

Another way that companies in the pharmaceutical manufacturing business can increase their efficiency is by improving the life and uptime of their machinery.

When equipment breaks down and needs replacement, companies lose money, both to purchasing or repairing their equipment and to lost production time. If equipment underperforms, a company may not be able unleash its full potential because of the slow or defective machines. Faulty equipment could also cause damage to batches of products, which means wasted time and resources.

Investing in high-quality equipment can help companies avoid these equipment issues. Having an effective maintenance program in place is also essential.

One way to improve your maintenance program is to switch from a fixed maintenance schedule or reactive maintenance program to a predictive maintenance program. This kind of program involves forecasting when machines need maintenance work so that you can determine the optimal frequencies and times to conduct maintenance. This helps you to avoid doing unnecessary maintenance work, which can increase costs, as well as missing signs of future failures, which can result in downtime and high repair costs.

To inform your predictions, you can use data from sensors affixed to your equipment. If your system detects abnormalities in how your system runs, you will receive an alert that maintenance work is needed. Using zenon and other external applications, you can create maintenance schedules easily and efficiently due to the automation these systems provide.

By investing in quality equipment and creating an efficient maintenance program, pharmaceutical businesses can avoid downtime and errors in production, thereby increasing productivity.

5. Integrate all technology 

Pharmaceutical manufacturing processes are complex, and the facilities contain a wide range of equipment and systems. The production process on its own is complex, but you also have to consider the auxiliary equipment and the building systems. The production process for pharmaceuticals requires a tightly controlled environment, so even heating and cooling systems must be kept in mind.

Integrating these systems can make it easier to control the production process and environment and ensure it’s optimized to increase productivity.

A comprehensive platform like zenon can be helpful in this area, as you can use it to monitor, control and optimize production equipment as well as other systems. It allows you to keep track of your entire system and see how the different parts interact. This enhanced visibility can help you find ways to improve efficiency and productivity.

The native drivers and industry protocols within zenon help to make integration easy, even if you have many different kinds of equipment from different manufacturers and generations. zenon Historian, for example, can use native drivers to connect to any system, whether that’s an enterprise resource planning (ERP) system, manufacturing execution system (MES) or another type of system, without any changes to the third-party system.

You can also integrate all areas, including clean rooms, into a single monitoring system. zenon includes chronological event lists, alarms, test logs, archiving and more, all in one platform. This provides you with improved analysis and data presentation, which helps you to gain better insights into your systems and how to improve them.

6. Improve industrial security

Cyberattacks and other security threats can bring production to a halt. These threats can also cause pharmaceutical companies to hesitate to adopt new technologies that could boost their productivity. New technologies, such as IIoT devices, can provide many benefits but can also introduce potential new threats that must be protected against.

Because these technologies can provide productivity improvements and many companies hesitate to adopt them, finding a way to implement them while protecting against security threats can offer a substantial competitive advantage.

All pharmaceutical companies need to have a robust cybersecurity system in place. These systems play a crucial role in enabling companies to adopt innovative, new technologies. Companies also need to choose to use technologies that have excellent cybersecurity features built into them.

Looking for providers that have earned certifications can help with this. COPA-DATA has received a certificate of conformity to the ISA/IEC 62443-4-1:2018 security standard from TÜV SÜD, which is part of the German Association for Technical Inspection. This certificate demonstrates that our processes meet the requirements of current industrial IT security guidelines.

zenon includes security features such as encryption, authentication, file signature, secure interfaces and secure user administration, which protect against data loss and other threats. These features make it easy to integrate zenon into your existing security strategy.