How a Top 5 Pharma Company Protects Production and Increases Productivity Using BACT/ALERT® 3D

A top 5 pharmaceutical company incorporated automated, rapid sterlity testing using BACT/ALERT® 3D.  Their approach was designed to detect any microbial contamination at the earliest possible opportunity and has been key in maintaining control over their production processes.

By incorporating a rapid detection system, BACT/ALERT, for in-process control, the company has achieved remarkable reductions in the time required for sterility results. Traditionally, sterility testing could take anywhere from 14 to 21 days. However, with the implementation of BACT/ALERT, results are now obtained within a much shorter timeframe—7 to 10 days. This expedited process not only ensures timely detection of any contamination but also enables prompt remedial actions, thereby preserving production efficiency.

The company relies on the cutting-edge BACT/ALERT® 3D system to conduct in-process testing, particularly for samples from the upstream stages of their production process. The innovative technology empowers them to detect and address any deviations from specifications at an early stage, facilitating swift corrective measures. In instances requiring investigation, the system streamlines the process, enabling comprehensive analysis within a week. Moreover, the company utilizes BACT/ALERT® 3D for the sterility testing of select vaccines, further reinforcing their quality assurance measures.

The adoption of the BACT/ALERT® 3D system has not only enhanced the company's quality control capabilities but has also driven notable improvements in productivity and cost-efficiency. By automating the monitoring of cell culture processes, the company has achieved significant resource savings in the laboratory. The system's user-friendly interface eliminates the need for extensive technical expertise, simplifying sample setup and operation. As a result, the company reported substantial cost savings amounting to €150,000 per year, along with a remarkable reduction in cycle time by 50% to 75%. Despite the complexities inherent in their production matrices, the implementation of BACT/ALERT® 3D has led to a significant enhancement in product quality, underscoring its efficacy in optimizing production processes.

BACT/ALERT® 3D is a state-of-the-art solution for industrial sterility testing, offering a myriad of benefits ranging from its space-saving modular design to its intuitive interface and flexible data management capabilities. As a reliable and objective alternative to traditional microbial detection methods, it empowers laboratories of any scale to uphold uncompromising standards of product safety and quality.

The successful integration of a rapid in-process testing regimen, facilitated by the adoption of BACT/ALERT® 3D technology, has positioned the pharmaceutical company at the forefront of quality assurance and productivity in the industry. By leveraging BACT/ALERT® to fortify their production processes, they continue to set new benchmarks for excellence while ensuring the safety and efficacy of their products for consumers worldwide.