Problem: Client needs to test 1000's of samples quickly
Our customer T2 Biosystems had a unique challenge to validate their product’s accuracy and speed of measurement while following strict FDA processes to ensure repeatability of the process results over many samples in an assay. As background their product was designed to quickly detect critical signs of sepsis for patients by analyzing different biological markers in DNA using their proprietary technology. Because sepsis currently takes multiple days to detect in patient the untimely diagnosis of this disease could ultimately be fatal to the patient. As a result T2 Biosystems designed a product based on university research that required extreme reliability and accuracy in detecting signs of this disease quickly so doctors can treat the symptoms quickly so treatment could begin immediately and prevent the sepsis from spreading.
The challenge that T2 was trying to solve was the need to prove that the technology worked correctly over thousands of assays with repeatable results and so that it could pass FDA certification. To achieve this analysis and prove their technology T2 required an automated solution that would quickly test many samples accurately without measurement errors and to do so while minimizing unnecessary user intervention caused by machine errors.
As a result Origo Automation was tasked to design an automated solution that would guarantee the test process for this product could repeatedly make correct measurement. In addition to solving the technical challenge Origo Automation was tasked to provide an intuitive user interface for operator control, machine error reporting providing a user the correct information to resolve operationerrors, and custom reporting of all calibration and test results.
The technical challenges to achieve the desired accuracy of the product meant the automated solution must deterministically control all process steps and also continually verify the calibration of the instrument. To achieve a test measurement accuracy Origo Automation developed a custom robotic system for performing a strict time controlled process used to test the customers product across a variety of assays. A custom system was designed to house all of the process components and a 4 axis robotic arm was utilized at the system center to handle all sample pick and placement throughout the test process. Origo Automation leveraged the onboard processer for the robotic arm and created software to deterministically move the robot throughout its planned path of motion. On a separate computer Origo Automation designed a multithreaded application that handled all other station operations and control, the software provided access to the embedded robotic motion code, and through a simple and intuitive user interface we allowed non-technical personal to quickly perform tests on assays.
Because accuracy and repeatability of the measurement system were of paramount importance to the customer we Origo Automation developed a sophisticated calibration process with the assistance of the T2 team. All production operation required frequent calibration and accurate calibration results. To achieve the application software traked all calibration information and placed it into a calibration log with date and time stamps used to verify that a calibration process had been performed daily. Prior to starting a production run the latest calibration data was verified with respect to use defined limits and the operator was only enabled to run the product test softwarewhen the calibration results were within the user defined threshold.