In the pharmaceutical industry, ensuring compliance and data integrity in bacterial endotoxin testing (BET) is critical. Traditionally, many organizations have relied on the gel-clot assay due to its simplicity and cost-effectiveness. However, as regulatory standards evolve and the focus on data integrity grows, the limitations of this manual, error-prone method have become apparent. A global healthcare company specializing in lifesaving medicines and technologies recently transitioned from the gel-clot method to Charles River’s Endosafe LAL cartridge technology, achieving significant improvements in compliance, efficiency, and lab productivity.
The decision to switch was driven by a routine quality risk management assessment, which highlighted the gel-clot method as a potential compliance risk. The company sought a solution that was rapid, automated, and aligned with modern data integrity guidelines. After evaluating various options, they adopted the nexgen-MCSTM multi-cartridge system and Endosafe③EndoScan-VTM software. This transition addressed key challenges, including reducing human error, simplifying training requirements, and improving traceability through a fully searchable audit trail.
The benefits of the cartridge technology were immediate. Test times were reduced from 60 minutes to just 15 minutes, allowing technicians to test more samples in less time. The simplicity of the system also enabled faster training of new technicians, expanding the pool of qualified staff. Additionally, the automation eliminated subjective analysis, ensuring accurate and reliable results while freeing up staff to focus on other critical lab tasks. As Dr. Ganesh, the company’s Microbiology Head Laboratory Manager, noted, “The simplicity of the cartridge technology greatly reduces the potential for mistakes, which pleases both us and auditors.”
Vendor support played a crucial role in the successful implementation. Charles River Laboratories provided technical assistance during installation, qualification, and product validation, ensuring a smooth transition. Management approved the business case after recognizing the risks of maintaining the status quo and the advantages of adopting cartridge technology. The implementation not only met but exceeded expectations, delivering unforeseen benefits such as cost savings and improved lab efficiency.
In conclusion, the shift from the gel-clot method to Endosafe LAL cartridge technology has positioned the organization to meet current regulatory demands while enhancing operational efficiency. Dr. Ganesh expressed satisfaction with the process, stating, “We are very happy with the way things have gone.” This case study underscores the value of embracing innovative solutions to address compliance challenges and improve overall laboratory performance.
Reference: https://www.criver.com/resources/transitioning-gel-clot-endosafer-lal-cartridge-technology
