Wireless Dissolution Calibration Reporting for Data Integrity
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Solution Overview
Problem
Existing dissolution instruments require frequent calibration to ensure reliable data, but current calibration methods are cumbersome and do not easily produce high-integrity results.
Innovation Solution
A Bluetooth-enabled calibration system comprising a vessel module, instrument module, and data conversion module, along with a tri-axial accelerometer and wireless transceiver, to measure and convert calibration data into un-editable visual reports, ensuring compliance with regulatory standards.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional calibration methods are used for dissolution instruments, then calibration can be performed, but the process is cumbersome and time-consuming
Solution Approach 1:
The patent replaces manual mechanical calibration procedures with an automated system using sensors, wireless transceivers, and computer processors. The vessel module with various sensors automatically measures calibration parameters (shaft wobble, basket wobble, verticality, centering) and transmits data wirelessly to a computer, eliminating the need for manual measurement and data recording.
Solution Approach 2:
The calibration system performs self-calibration by automatically measuring its own parameters through integrated sensors. The system independently collects data from multiple sensors, processes the information, generates calibration reports, and determines whether calibration is needed based on measured values, reducing reliance on operator intervention.
2Reliability
If traditional calibration methods are used, then calibration data can be obtained, but the integrity and compliance of the data is compromised
Solution Approach 1:
The patent replaces manual data collection and processing with an automated electronic system. Sensors automatically measure calibration parameters and transmit data wirelessly to a computer processor that automatically processes the data, generates reports, and determines calibration status, eliminating manual errors and ensuring data integrity.
Solution Approach 2:
The system incorporates feedback mechanisms where the computer processor automatically analyzes measured values against calibration criteria, generates calibration reports with pass/fail determinations, and provides visual or audible notifications when calibration is needed. This automated feedback ensures consistent and reliable calibration decisions.
3Productivity
If manual calibration procedures are used, then the process can be completed, but productivity and efficiency are reduced
Solution Approach 1:
The patent combines multiple calibration measurement functions into a single integrated vessel module. The module integrates sensors for measuring shaft wobble, basket wobble, shaft verticality, vessel verticality, centering, and other parameters, along with a wireless transceiver and processing capabilities, allowing all calibration measurements to be performed simultaneously through one device.
Solution Approach 2:
The vessel module serves multiple calibration functions simultaneously - measuring various geometric parameters, transmitting data wirelessly, processing information, and generating calibration reports. The system can calibrate different types of dissolution instruments using the same module, making it a universal calibration solution.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Facilitates easy, convenient, and high-integrity calibration of dissolution instruments by generating un-editable reports that adhere to regulatory standards, enhancing data reliability and efficiency.
Implementation Method 1
the instrument module including a tri-axial accelerometer to measure the vessel plate vibration in an X-axis, a Y-axis, and a Z-axis
Data Source
AI summary
A wireless-enabled dissolution instrument calibration system including a vessel module measuring a first set of data related to the calibration of dissolution instrument, an instrument module measuring a second set of data related to the calibration of the dissolution instrument, a data conversion module configured to receive the first and second set of data and convert the data into visual data on a report, and a wireless transceiver coupled to the vessel module, the instrument module, and the data conversion module. The wireless transceiver transmits the first and second set of data to the data conversion module automatically as the first and second set of data is measured. The data conversion module organizes the visual data on the report into spreadsheets and/or tables by the particular measurement and renders the visual data un-editable to safeguard compliance.