Temperature Monitoring and Prediction in Biopharmaceuticals

In the biopharmaceutical industry, precision is not just a goal; it's a necessity. Every phase of the process must be executed with precision to ensure that the final product meets the high-quality standards required by the sector. A leading British multinational specializing in biopharmaceutical products faced a specific challenge during the lyophilization process: maintaining temperature within the precise limits defined by the Golden Batch. Any deviation could compromise quality and, therefore, fail quality control (QC) approval.

This company needed a solution to monitor the temperature in real-time, predict potential deviations, and provide recommendations to keep production within established quality limits.‍

The Challenge: Keeping Temperature Within Golden Batch Limits

Lyophilization is essential in pharmaceutical production for reducing moisture, requiring extreme precision to maintain temperature within the Golden Batch parameters.

The primary cycle of lyophilization, in particular, posed a significant challenge for the company. At this stage, temperature deviations were more likely. If the temperature strayed from the set limits, the product risked failing QC tests, leading to delays and substantial financial losses.

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The Solution: Predictive Algorithm and Real-Time Monitoring

AG Solution implemented a solution that combines real-time monitoring with advanced algorithm-based predictions to address this challenge.

1. Real-Time Monitoring: Production process data was integrated with the AVEVA PI system, allowing continuous tracking of temperature and other critical process parameters throughout the lyophilization process. This integration ensured that every parameter fluctuation was recorded in real-time, providing adetailed view of the process at all times.
2. Anomaly Prediction: An algorithm was developed to predict possible temperature deviations before they occurred. This algorithm runs continuously with updates every minute, allowing for early detection of any trend toward deviation from the Golden Batch limits. When a deviation trend is detected, the system not only alerts the operators but also offers     recommendations on which production parameters must be adjusted to correct the issue and keep the temperature within the optimal range.
3. Proactive Notifications: If the system detects that the temperature might exceed acceptable limits, it immediately notified the operators. This early warning is crucial for taking corrective actions in time.

Results: Process Optimization and Reduced Deviations

The initial results of this solution are highly encouraging:

• Reduction of Deviations: AI model results indicate that the number of processes deviating from the Golden Batch limits has been reduced by up to 70%. This achievement improves process efficiency and ensures greater consistency in the final product quality.
• Proactive Control: The system's ability to predict deviations and provide real-time recommendations has changed how operators manage lyophilization. They can now act proactively rather than react to problems after they occur, optimizing resource use and minimizing the risk of defective products.

Conclusion: Enhancing Quality in the Biopharmaceutical Industry

Implementing this temperature monitoring and prediction solution has allowed the British multinational to maintain the quality of its products and improve the operational efficiency of its processes. This case demonstrates how advanced technology can significantly impact biopharmaceutical production, ensuring that every batch meets the most stringent industry standards.