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Even a small error during machine set-up can bring the entire production process to a standstill. Such situations often have dramatic consequences in pharmaceutical production, and with sensitive drugs, strict regulatory requirements and the potential impact on patient care leave little room for error.
Optima offers 14 digital products in its IPAS portfolio (Intelligence Production Assistant Services) to maximize safety in pharmaceutical fill-and-finish processes. The digital solutions from Optima’s IPAS portfolio are specifically geared toward the challenges faced by machine operators and designed with maximum safety in mind. They provide a complete overview of processes and systems as well as direct support where needed.
Our expert, Waldemar Mayer, Group Leader Development Robotics & Digitalization at Optima Pharma, is familiar with the various challenges of format changes in pharmaceutical systems and explains how machine operators can use Change Over Assist to make set-up faster and safer.
Anyone working in pharmaceutical production knows the risks. During machine set-up, an incorrectly selected or ill-fitted format part can have serious consequences. One example: If a 2-ml format part is accidentally fitted instead of a 10-ml format part, there is a risk of machine damage. Production interruptions are even more serious if a format part is missing after a decontamination cycle. While in a best-case scenario, it is possible to insert the missing part subsequently via a port, in many cases this means restarting the entire decontamination process – resulting in considerable time loss.
Such errors can have serious consequences. Sensitive drugs requiring lyophilization within a narrow timeframe are at an acute risk due to delays, resulting in financial losses and potential bottlenecks in patient care. In addition, regulatory requirements such as Annex 1 stipulate that product-contact parts must be installed under specific conditions to ensure sterile production processes.
For these reasons, Waldemar Mayer and his team at Optima Pharma asked themselves how to better support operators during format changeovers and machine setups.
The Change Over Assist is a digital system that guides operators through the format changeover process, systematically eliminating sources of error. At the heart of the Change Over Assist is an interactive step-by-step guide that clearly structures the entire process - from the removal of the old format parts to the correct installation of the new ones. This is supplemented by digital documents and videos that visually detail each step. Pharmaceutical companies can customize the system, adding company-specific SOPs or other content to perfectly integrate it into their workflow.
Another system advantage: Each format part is equipped with a data matrix code. Before the part is installed, the operator scans the code. The system automatically checks to ensure it is the correct part in the precise installation sequence. The installation must then be confirmed by the operator, ensuring maximum safety. This makes certain that all required parts are fitted correctly before the decontamination process begins.
Change Over Assist also allows two operators to work on the system simultaneously. The system monitors progress and ensures that all work steps are carried out correctly. It also tracks who performed each step and when. Optionally, time stamps can be stored to further increase efficiency.
To provide the operator with optimum support, Change Over Assist offers various display options from classic HMIs and tablets to ‘Hololens’ smart glasses or OLED displays. These media guide the operator directly to the relevant points on the machine and present the next steps in a display adapted to the respective medium. A simple top view of the machine on the HMI simplifies things by quickly guiding the operator to the right place.
Change Over Assist is an example of how digital assistance systems and AI-powered technologies are making pharmaceutical production safer and more efficient. Optima relies on intelligent systems to support operators and minimize errors. This development is part of an innovation process in which digitalization is playing an important role.
Author
Waldemar Mayer
Group Leader Development Robotics & Digitalization at Optima Pharma
