Alan Baines, director, Testing Solutions at Lonza BioScience explains how automated systems are improving every aspect of endotoxin testing workflows.
Improved Working
Endotoxin testing is an important quality control (QC) measure that is used across the medical and bioscience sectors to ensure the safety of parenteral drugs, medical devices and other raw material products that are used in these markets. A range of methods are employed by QC laboratories to perform endotoxin testing, including the limulus amebocyte lysate (LAL) test and the recombinant factor C (rFC) assay.
Given the large volume of samples that must be processed by QC laboratories, endotoxin testing workflows must be fast and effective to avoid costly delays in the manufacture and release of products. However, with patient safety dependent on the quality of data generated by these routine tests, the need for speed and efficiency must not come at the expense of measurement accuracy. Regardless of the type of assay used for endotoxin testing, these workflows typically involve multiple liquid handling and data transfer steps for a large number of samples, which must be performed reliably, consistently and with the utmost precision.
Despite this, many laboratories still operate manual endotoxin testing workflows, which are often very repetitive and labour intensive, making them vulnerable to human error, leading to the development of repetitive strain injuries (RSI) amongst operators and causing data reproducibility issues across multiple technicians. Fortunately, recent advances in robotics and laboratory automation platforms are helping to streamline and improve performance in the QC laboratory.
Automated platforms for endotoxin testing are enhancing data quality
Manual endotoxin testing workflows present a number of challenges for QC laboratories, including the accuracy and consistency of the data that is obtained. Even when performed by the most skilled personnel, the pipetting steps used in these labour-intensive workflows are inherently vulnerable to human error. Small deviations in the volumes of samples and reagents that are used can have a detrimental impact on the reliability and reproducibility of endotoxin measurements. Manual workflows may also involve multiple manual data recording and processing steps, which may be affected by inconsistencies in the way individual operators perform tasks. Moreover, accidental errors in transcribing data into spreadsheets or databases can have significant consequences for patient safety.
Although many laboratories look to mitigate some of these issues through the application of data validation and verification steps, these additional workflows are tedious and time-consuming, and can take trained team members away from other tasks that add more value to laboratory operations. Furthermore, personnel performing all of these manual steps run a high risk of sustaining RSI, which can have a significant impact on their performance as well as on their personal life, while making businesses liable to claims.
Recent advances in automation technologies designed specifically for endotoxin testing workflows eliminate many of these challenges. The latest automated, plate-based platforms significantly reduce the requirements for manual intervention in endotoxin testing, enhancing measurement reproducibility and improving the consistency of results. These systems can automatically perform all of the necessary steps required to complete workflows, including sample mixing and dilutions for a range of sample types. Through highly precise, robot-controlled liquid handling steps, these systems are delivering extremely accurate measurements, day in and day out.
It’s not just improvements in robotics that are supporting enhanced performance and data quality — some of the latest platforms, such as Lonza’s PyroTec PRO Automated Robotic Solution, integrated with the WinKQCL Endotoxin Detection Software, are also able to improve the relevance and timeliness of key information through improved reporting, integrated trend analysis and flagging of errors or out-of-specification results. As these systems automatically read microplates and save the results directly to a data management solution, like a laboratory information management system (LIMS) or a corrective action and preventive action (CAPA) system, they also eliminate errors associated with the manual transcription of data. By improving the precision of liquid handling and taking human error out of the equation, these sophisticated platforms are helping to boost confidence in the data that’s ultimately used to facilitate the release of products onto the market.
Boosting efficiency in endotoxin testing workflows
Automation platforms are not only enhancing the quality of the data generated by endotoxin testing workflows, they’re also improving laboratory efficiency too. The latest automated systems are capable of processing large volumes of samples with unprecedented speed, enabling the delivery of results and the clearance of products in an accelerated timeframe.
A key advantage of robotic testing platforms is that they are able to operate continuously, with minimal or no manual intervention. Once a run is initiated, these systems automatically execute transfers in and out of the reader at the appropriate times for incubation, extending walkaway times and enabling experienced team members to perform other skilled tasks, such as results analysis. Capable of running 24/7, modern automation systems for endotoxin testing workflows can significantly increase sample throughput and operational efficiency, ultimately reducing the cost of performing each test.
The increased simplicity and convenience offered by modern automation platforms also extends to system set-up, with the latest run-control software applications eliminating the need for complex and time-intensive robot programming steps. Other software features, such as the availability of microplate templates that provide operators with a layout of the robot deck, allow operators to quickly duplicate runs or apply common parameters and reduce the need to repeat tedious tasks. By making these efficient systems intuitive and easy to use, modern automation platforms and run-control applications are helping to deliver highly accurate results faster and more efficiently than ever before.
Conclusion
With precise and efficient endotoxin testing essential for the delivery of safe parenteral medicines and medical devices, growing numbers of laboratories are recognising the benefits of automated testing protocols. Thanks to the latest advances in robotics and run-control software, modern automated endotoxin testing platforms are enhancing the accuracy, speed and efficiency of these important workflows.