AR Batch Record Automation for Chromatographic Data Capture
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Solution Overview
Problem
The challenges of maintaining quality and uniformity in decentralized pharmaceutical manufacturing, particularly for radiopharmaceuticals with short half-lives, are exacerbated by the need for rapid documentation and complex, subjective interpretation of chromatographic and spectroscopic data, which is often manual and time-consuming, and the integration of diverse and often outdated equipment into a network for electronic record management is costly and impractical.
Innovation Solution
A computer apparatus and process using an augmented reality (AR) headset to automate the population of batch records by extracting and interpreting chromatographic and spectroscopic data, providing real-time feedback and quality control, and supporting operators with equipment setup verification, reducing the need for network and software integration of existing equipment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If manual interpretation of chromatographic and spectroscopic data is used, then operator expertise can be applied to complex data analysis, but the process becomes time-consuming and error-prone
Solution Approach 1:
The patent replaces manual mechanical interpretation of chromatographic and spectroscopic data with automated image processing and machine learning algorithms. The system captures instrument displays, processes the visual data through automated algorithms, and generates batch record entries without manual intervention, thereby reducing documentation time while maintaining accuracy through consistent automated analysis.
Solution Approach 2:
The system enables self-service by allowing the batch record generation process to automatically extract and interpret data from instrument displays without requiring operator intervention. The automated image processing and data extraction capabilities allow the system to serve itself by capturing, analyzing, and documenting results autonomously.
2Adaptability or versatility
If diverse and outdated equipment is integrated into a network for electronic record management, then centralized data management is achieved, but the cost and complexity of integration becomes prohibitive
Solution Approach 1:
The patent introduces an intermediary layer consisting of image capture devices (such as cameras or smartphones) that photograph instrument displays, and image processing software that extracts data from these images. This intermediary approach allows diverse and outdated equipment to be accessed without direct network integration, as the system processes visual representations of the data rather than requiring electronic connectivity to the instruments themselves.
Solution Approach 2:
The system creates visual copies (photographs) of instrument displays and processes these copies to extract the required data. By working with image copies rather than requiring direct electronic access to the instruments, the system enables data extraction from diverse and outdated equipment without the need for complex network integration or software interfaces.
3Ease of operation
If hands-free access to batch records is provided in cleanroom environments, then operator convenience and contamination prevention are improved, but the complexity of the interface and interaction increases
Solution Approach 1:
The patent replaces manual mechanical interaction with batch records (typing, clicking, scrolling) with voice-based interaction and automated data population. Operators can speak commands to navigate and complete batch records, while the system automatically populates fields by extracting data from instrument displays, thereby maintaining hands-free operation while reducing interface complexity through automation.
Solution Approach 2:
The system performs self-service by automatically extracting data from instrument displays and populating batch record fields without requiring operator input. This reduces the interaction complexity as the system handles data entry autonomously, requiring minimal operator intervention beyond voice commands or simple confirmations.
Data Source
AI summary
A computer apparatus and computer-implemented process for generating a batch record (BR) from a master batch record (MBR) during manufacture of a batch of pharmaceutical product. In the control software, a graphical analysis interface is provided for processing graphs of spectroscopic or chromatographic analysis. A group of fields in the MBR is assigned to the analysis. The operator wears an augmented reality headset and uses this to capture an image of a graph from an instrument display. The graph image is then processed to extract the graph and its metadata, and then further processed to find peaks and assign attribute labels to the peaks, and thus populate the analysis fields. Overlay images are then transmitted to AR headset to present to the operator the populated analysis fields. The operator then accepts or rejects the populated analysis fields by issuing user interface commands.