- AI
- NVIDIA
- Microsoft
- Case story
Discover how to revolutionize your pharmaceutical manufacturing processes and achieve a significant 50% reduction in line clearance time.
This case study explores how we seamlessly integrated advanced AI technologies into the existing OT environment, ensuring compliance with industry regulations while driving operational efficiency.
By leveraging AI and AR, we were able to optimize line clearance procedures, minimize downtime, and enhance overall productivity. This transformative solution demonstrates the power of technology in modernizing pharmaceutical manufacturing.
Business Goal
Line clearance is a standardized procedure ensuring that equipment and work areas are free from remnants of a previous process. It is integral for preventing cross-contamination or mislabeling in pharmaceutical manufacturing. However, the existing process at a leading global pharma company required three personnel and took around 60 minutes daily for each line clearance procedure. The goal was to significantly reduce the time and manpower devoted to this necessary task.
Line Clearance procedure and reconciliation in GMP
In accordance with US FDA CFR 211 and international GMPs, our procedures ensure the use of correct labels, labeling, and packaging materials in drug production. Emphasizing prevention of mix-ups and cross-contamination, we employ measures such as physical separation from other drug product operations.
International GMPs underscore minimizing the risk of cross-contamination, mix-ups, or substitution during packaging operations.
Our line clearance procedure includes steps like cleaning the area and machines, removing previous products and waste, reconciling printed materials, and thorough documentation, aligning with stringent regulatory standards for pharmaceutical production.
Solution
We proposed an innovative solution involving Augmented Reality (AR) glasses equipped with a Computer Vision AI system to the second person responsible for verifying the cleanliness of the room and readiness for the next product. These AR glasses could detect irregularities invisible to the naked eye, therefore enhancing the efficiency and effectiveness of the inspection process. The AR glasses were programmed to recognize the quality of cleanliness and any foreign objects that should not be present during the line clearance procedure.
Beyond just aiding detection, the AI system also immediately generated the necessary report about the quality of line clearance performed, saving additional time. Our solution aimed to reduce line clearance processing time from 60 minutes to 30 minutes, ensuring better quality control and the ability to recognize new objects in the area. To minimize disruptions, our AR solution seamlessly integrated with the existing line clearance procedure without the need for any major modifications or pause in the manufacturing process.
Result
The AR-based Intelligent Line Clearance solution significantly optimized the pharmaceutical plant's operations. By automating report generation and enhancing detection capabilities, we achieved:
- A remarkable 50% reduction in line clearance time, allowing the procedure to be completed in 30 minutes as opposed to the previous 60-minute duration.
- This increase in efficiency led to a more streamlined production line, where resources were allocated more effectively, resulting in notable cost savings.
- The improvement in quality control also significantly reduced the possibility of cross-contamination or mislabeling of products, thus minimizing potential losses and further saving costs.
- In addition, the accelerated line clearance process enabled the plant to increase its overall production output, offering an additional avenue of cost-effectiveness and business growth.
Thus, our solution offered tangible, measurable benefits not just in terms of operational efficiency, but also in terms of financial performance.
Challenges
Adapting AR technology for complex environmental conditions
Pharmaceutical plants present a challenging environment for the implementation of AR technology due to their complex layouts and strict cleanliness requirements. Our team worked on customizing the AR system to be responsive and effective in such demanding conditions.
Ensuring accurate recognition of new objects
The AI system was required to be trained to recognize and alert operators about new objects (never seen before) that must not be present during the line clearance process. Ensuring the accuracy of this recognition was a challenge that required extensive data collection and continually improving the AI model. Maintaining a clean environment and adhering to strict line clearance regulations were imperative for the plant's successful operation. Therefore, our AI system had to reliably identify any items that deviated from the norm and were not part of the approved items for a specific process.
Balancing speed and thoroughness
A faster line clearance process should not compromise on accurancy. It was crucial to ensure that the AR and AI system was efficient in identifying any irregularities while maintaining a faster clearance process.
According to Worldmetrics more than 50% of pharmaceutical companies are using AI for process optimization.
