Fatih Kaya and Gerald Buerkle, Vetter Pharma01.25.19
Progressive technological advancements will impact the pharmaceutical industry. Within the scope of digitalization, industrial productions are linked with modern information and communication technology that enable a primarily self-organized production process, and help gain valuable, useable data. A special sector of Industry 4.0 is the so-called Pharma 4.0 sector which aims at adapting promising and feasible approaches from Industry 4.0 into the highly-regulated pharma world environment. This approach may result in high barriers to change but also in regulations to promote a digital roadmap.
The challenges in our industry are diverse. Pharma and biotech companies must prepare themselves for the future in a focused manner, including the technological advancements of digitalization. Their partners such as contract development and manufacturing organizations (CDMOs) have to follow these developments in the same way. By doing so early in the process, they have the opportunity to get involved in their customer’s processes at ground level and be a valued partner. But how can digitalization be implemented successfully in a company?
Quality first, especially in the era of Pharma 4.0
In the field of high-value injectable products, quality, in particular, is the first and foremost requirement. This should come as a surprise to no one, since patients are actually being injected with the very drugs that a CDMO manufactures for its pharma and biotech customers. Therefore, overall, every outcome resulting from 4.0 initiatives that has a positive impact on establishing a stable high product quality will be seen as a benefit. As a consequence, suitable process performance is achieved, a set of controls are established and the body of knowledge is continually expanded. Because one of the main benefits of pharma 4.0 technologies is to increase the quality of business processes and to make them both safer and more efficient, one approach to getting there is to view numerous single pharmaceutical production steps as a whole, with a focus on the complete value chain and potentially the whole supply chain up to the application.
However, digitalization can hardly be implemented in one step—it needs to be understood as a comprehensive program. Several subprojects lead to an increasing connection of the process steps within an organization. Particularly within the pharmaceutical industry, this poses special challenges for a company. Processes are well-established and recognized by the regulatory authorities and even small changes must be newly validated. However, when these steps are implemented successfully, it presents significant potential for ever-higher quality and additional efficiency.
Digitalization within a CDMO based on the example of Visual Inspection
The processes must conform to extensive regulations and documentation requirements. After the production process, every single filled unit ordered by the customer is subjected to a final visual inspection. The quality check of the aseptically prefilled syringes, vials and cartridges is a separate production step following compounding and filling, and prior to secondary packaging steps. Each and every day, several hundred staff members at Vetter are preoccupied with this inspection.
For many years, the inspection results and their evaluation have been recorded in a paper-based manner in combination with an SAP system. Approximately 60,000 manufacturing specifications were printed from SAP each year and made available to the Visual Inspection staff members to document their inspections. Afterwards, the shift coordinator manually entered the results in the batch analysis and the SAP system.
Smarter and more efficient processes
In a feasibility study, an internal Vetter project team evaluated whether the current paper-intensive processes could be replaced by an app, thus increasing efficiency in terms of quality and costs. The study yielded a clear result—the procedure can be digitalized. As a consequence, every Visual Inspection workstation was equipped with a tablet computer and staff members now enter their inspection findings directly into the ERP system via an SAPUI5 app, making current and future processes even more efficient, safer and digitally traceable. With the support of an IT service provider, the company created a digital environment in which all processes related to data recording and batch analysis are integrated. The apps were developed in a follow-up project.
Today, approximately thirty different applications are available for several process versions of visual inspection including manual and semi-automatic visual inspection. The Visual Inspection staff log onto the tablet computer with their SAP account, initiate the relevant app and document the data. Thus, the manufacturing specifications for data recording and batch analysis are automatically created in SAP and attached to the process-order documents. At a glance, the new procedure offers easy recording, automated transmission and consolidation, as well as the ability to analyze immediately.
Practical example for digitalization
Digitalization activities in the pharmaceutical industry are a special challenge because the effects of new technologies on pharmaceutical processes, in particular, must be analyzed comprehensively. For example, tablet computers used in Visual Inspection were checked for any reflections that might cause impairment of the display in viewing the test samples, or if continuous disinfection could have an effect on tablet function. In training courses, staff members were instructed in the use of the new devices, including their processes and handling. The apps were also permanently advanced and expanded by additional applications. In conclusion, the outlined project is a demonstrative example for benefit-providing digitalization in the pharmaceutical industry.
How to efficiently be prepared for a 4.0 future
How can companies prepare for the challenges of digitalization on a superordinate level? Thinking ‘outside the box’ and being open-minded for diverse promising approaches for today and the future is essential. This preparation ranges from the creation of innovation platforms, to close cooperation with educational institutions, associations, and research institutes. In addition, future-oriented companies should be seeking close relations with players from different industries who experience similar challenges, thus encouraging a mutual exchange of information. And, one must never forget a core activity—maintaining the continuous engagement and dialogue with customers and other valuable parties throughout the pharmaceutical supply chain.
As illustrated, Pharma 4.0 is a topic which affects an entire company. Thus, it is critical to include all employees in this journey from the very start. By doing so, any market player can actively support the process of helping to lead the pharma and biotech industry into a prosperous era while keeping in mind the benefit for patients worldwide.
Gerald Buerkle is vice president for production at Vetter Pharma-Fertigung GmbH & Co. KG in Ravensburg. He began his career at Vetter in 2002 as head of production and was initially in charge of five manufacturing lines for customer fillings. In 2005, he was named director pharmaceutical production/site manager at the site Ravensburg Vetter South. Gerald has over 20 years’ experience in the pharmaceutical industry.
Fatih Kaya is team leader for IT business applications – quality and documents at Vetter Pharma-Fertigung GmbH & Ko. KG in Ravensburg. Since assuming this position in 2016, his primary function is the operations and further development of quality application systems. Fatih began his career at Vetter in 2013 as a project manager in the process optimization division, leading projects with a focus on IT supplied process optimization.
The challenges in our industry are diverse. Pharma and biotech companies must prepare themselves for the future in a focused manner, including the technological advancements of digitalization. Their partners such as contract development and manufacturing organizations (CDMOs) have to follow these developments in the same way. By doing so early in the process, they have the opportunity to get involved in their customer’s processes at ground level and be a valued partner. But how can digitalization be implemented successfully in a company?
Quality first, especially in the era of Pharma 4.0
In the field of high-value injectable products, quality, in particular, is the first and foremost requirement. This should come as a surprise to no one, since patients are actually being injected with the very drugs that a CDMO manufactures for its pharma and biotech customers. Therefore, overall, every outcome resulting from 4.0 initiatives that has a positive impact on establishing a stable high product quality will be seen as a benefit. As a consequence, suitable process performance is achieved, a set of controls are established and the body of knowledge is continually expanded. Because one of the main benefits of pharma 4.0 technologies is to increase the quality of business processes and to make them both safer and more efficient, one approach to getting there is to view numerous single pharmaceutical production steps as a whole, with a focus on the complete value chain and potentially the whole supply chain up to the application.
However, digitalization can hardly be implemented in one step—it needs to be understood as a comprehensive program. Several subprojects lead to an increasing connection of the process steps within an organization. Particularly within the pharmaceutical industry, this poses special challenges for a company. Processes are well-established and recognized by the regulatory authorities and even small changes must be newly validated. However, when these steps are implemented successfully, it presents significant potential for ever-higher quality and additional efficiency.
Digitalization within a CDMO based on the example of Visual Inspection
The processes must conform to extensive regulations and documentation requirements. After the production process, every single filled unit ordered by the customer is subjected to a final visual inspection. The quality check of the aseptically prefilled syringes, vials and cartridges is a separate production step following compounding and filling, and prior to secondary packaging steps. Each and every day, several hundred staff members at Vetter are preoccupied with this inspection.
For many years, the inspection results and their evaluation have been recorded in a paper-based manner in combination with an SAP system. Approximately 60,000 manufacturing specifications were printed from SAP each year and made available to the Visual Inspection staff members to document their inspections. Afterwards, the shift coordinator manually entered the results in the batch analysis and the SAP system.
Smarter and more efficient processes
In a feasibility study, an internal Vetter project team evaluated whether the current paper-intensive processes could be replaced by an app, thus increasing efficiency in terms of quality and costs. The study yielded a clear result—the procedure can be digitalized. As a consequence, every Visual Inspection workstation was equipped with a tablet computer and staff members now enter their inspection findings directly into the ERP system via an SAPUI5 app, making current and future processes even more efficient, safer and digitally traceable. With the support of an IT service provider, the company created a digital environment in which all processes related to data recording and batch analysis are integrated. The apps were developed in a follow-up project.
Today, approximately thirty different applications are available for several process versions of visual inspection including manual and semi-automatic visual inspection. The Visual Inspection staff log onto the tablet computer with their SAP account, initiate the relevant app and document the data. Thus, the manufacturing specifications for data recording and batch analysis are automatically created in SAP and attached to the process-order documents. At a glance, the new procedure offers easy recording, automated transmission and consolidation, as well as the ability to analyze immediately.
Practical example for digitalization
Digitalization activities in the pharmaceutical industry are a special challenge because the effects of new technologies on pharmaceutical processes, in particular, must be analyzed comprehensively. For example, tablet computers used in Visual Inspection were checked for any reflections that might cause impairment of the display in viewing the test samples, or if continuous disinfection could have an effect on tablet function. In training courses, staff members were instructed in the use of the new devices, including their processes and handling. The apps were also permanently advanced and expanded by additional applications. In conclusion, the outlined project is a demonstrative example for benefit-providing digitalization in the pharmaceutical industry.
How to efficiently be prepared for a 4.0 future
How can companies prepare for the challenges of digitalization on a superordinate level? Thinking ‘outside the box’ and being open-minded for diverse promising approaches for today and the future is essential. This preparation ranges from the creation of innovation platforms, to close cooperation with educational institutions, associations, and research institutes. In addition, future-oriented companies should be seeking close relations with players from different industries who experience similar challenges, thus encouraging a mutual exchange of information. And, one must never forget a core activity—maintaining the continuous engagement and dialogue with customers and other valuable parties throughout the pharmaceutical supply chain.
As illustrated, Pharma 4.0 is a topic which affects an entire company. Thus, it is critical to include all employees in this journey from the very start. By doing so, any market player can actively support the process of helping to lead the pharma and biotech industry into a prosperous era while keeping in mind the benefit for patients worldwide.
Gerald Buerkle is vice president for production at Vetter Pharma-Fertigung GmbH & Co. KG in Ravensburg. He began his career at Vetter in 2002 as head of production and was initially in charge of five manufacturing lines for customer fillings. In 2005, he was named director pharmaceutical production/site manager at the site Ravensburg Vetter South. Gerald has over 20 years’ experience in the pharmaceutical industry.
Fatih Kaya is team leader for IT business applications – quality and documents at Vetter Pharma-Fertigung GmbH & Ko. KG in Ravensburg. Since assuming this position in 2016, his primary function is the operations and further development of quality application systems. Fatih began his career at Vetter in 2013 as a project manager in the process optimization division, leading projects with a focus on IT supplied process optimization.
