Safe utilization of automation technology in the pharmaceutical industry

Intelligent system networking connects the production processes with the building. (Source: Carpus+Partner AG)

Enables more efficient processes in pharmaceutical production: the holistic planning of buildings and production facilities. (Source: Carpus+Partner AG)

Rafael Janik, Project Manager Automation, Carpus+Partner AG (Source: Carpus+Partner AG)

Digitalization is both a great opportunity and a challenge for pharmaceutical companies. Especially in the pharmaceutical industry: Conventional manufacturing processes that require manual interventions are no longer competitive in the long run. Compared to production that fully exploits the possibilities of digitalization, the risk of manipulation or operator errors is too high, and traceability is too limited.

To quickly advance on the path of digitalization and secure a competitive edge, current process systems already offer various features such as audit trail or recipe control, as well as diverse interfaces – including Ethernet or Profibus. When intelligently networked, data can be exchanged and processed automatically between systems without manual intervention. This way, digitalization makes a valuable contribution to Good Manufacturing Practice (GMP), for example through seamless traceability of medicines (track and trace) or paperless production.

Digitalization projects always involve a balancing act between these opportunities and the IT security challenges, which must be comprehensively guaranteed. For the right path toward future-proof and efficient production, expert knowledge in automation technology is required. The specialists at Carpus+Partner guide safely through the maze of digitalization possibilities and ensure seamless planning from building infrastructure to utility systems and complete process automation.

Particularly the automated process chains in pharmaceutical production must meet high requirements for process safety and manufacturing quality. Manufacturers bear responsibility for the health of countless people and rightly adhere to strict pharmaceutical regulations that ensure the quality, efficacy, and safety of medicines. In addition to maintaining consistently high product quality, uninterrupted and economical operation of the systems is another requirement that every pharmaceutical producer must meet today to secure their future viability. Current trends such as personalized medicine and paperless data archiving pose further challenges to the industry.

The days when operators manually entered production data into machines are long gone: For modern quality management and demanding quality assurance, such procedures are too time-consuming and error-prone. Accordingly, all current systems from various manufacturers feature interfaces to integrate them into automated production environments. Besides the advantages and opportunities that digitalization enables – such as step-by-step guided and documented production processes – operators also face challenges: Data interfaces must also be considered from an IT security perspective. Only active and conscious handling of all elements of digitalization can prevent misuse and the theft of valuable data. The solution is an overarching system network across all company areas.

Such cross-system communication ensures efficient cooperation of all individual components: System networking solves the problem of incompatible interfaces between machines and systems from different manufacturers through format-independent data transfer. This guarantees highly reliable communication processes and data integrity in pharmaceutical production.

Traceable production, tamper-proof products

Through seamless networking, production batches can also be made flexible; demand-specific production ensures more efficient and economical processes. System networking also creates additional value for production management: intelligently and requirement-specific planned and implemented, it ensures that relevant production data and resources are always available at the right time and place – essential for smooth and uninterrupted production. It is also always ensured that all process steps are carried out reliably and in the correct sequence. Additionally, seamless documentation and long-term archiving of all data according to GMP, as well as the traceability of all processes, are guaranteed – one of the fundamental requirements for tamper-proof labeling, which has been mandatory across Europe for all prescription medicines since February 2019. Reliable protection against manipulation of data and production processes is provided by an integrated user management system that restricts access securely to authorized personnel.

Since all system data are fully electronically recorded and documented, predictive, usage-specific maintenance of the systems is also possible. Even the smallest deviations in processes are automatically detected; this allows for early, controlled intervention, and production interruptions are effectively prevented. Furthermore, based on the data, the performance of different systems can be compared more easily, and potential improvements can be identified. At the same time, the central control system relieves operators and maintenance personnel, whose tasks are becoming increasingly extensive. Because production data no longer need to be entered manually and the overarching control system precisely specifies process steps, errors are significantly reduced. The operating personnel mainly perform executing and monitoring tasks when operating the systems.

Central coordination and control with government funding

The functioning of a system network with a control system can be illustrated as follows: all components are arranged independently of their physical location in a virtual space and linked into a process line. The control system centrally manages and coordinates all machines involved in production. Like a conductor who creates a harmonious orchestra from a multitude of musicians with different instruments, system networking paves the way for fast, flexible, and at the same time secure and paperless production. Such a system is particularly efficient when all components are optimally coordinated.

This is ensured by experts such as those from the planning and consulting firm Carpus+Partner, which specializes in complex high-tech and pharmaceutical construction projects. "With our highly communicative structures, we provide impulses for new thinking and promote the transfer of knowledge – also from machine to machine," explains Altus Pretorius, project engineer automation at Carpus+Partner. Analogous to the control system, the internationally active company leads the baton in all phases of a construction project – from concept to concrete implementation. Strategic consultants, process engineers, GMP experts, and specialists in system automation jointly determine client requirements and the need for automation components. When working for medium-sized companies, they also ensure the optimal utilization of financial support opportunities for digitalization projects. Because the government has also recognized digitalization as the economic driver in Germany. Therefore, companies are effectively supported with particularly favorable loans for forward-looking projects, depending on their size and investment volume.

"As a holistic planning company, we support projects from complete planning through the realization of technical building equipment (TGA) and process planning to the qualification of design, installation, and operation (DQ, IQ, OQ) of manufacturing systems," explains automation expert Pretorius. "We also assist customers in validating processes and procedures, as well as systems and all computer-controlled systems. This results in a seamless, legally compliant solution that can pass any audit without costly and time-consuming rework."

Fast, flexible, and paperless, intelligent system networking thus guarantees quality and safety in production. When building and production systems come from a single source, the synergy between machines, facilities, qualification, and validation enables particularly efficient processes and makes pharmaceutical companies future-proof in the long term.