Due to the 14-day incubation requirement for compendial sterility, this is often the last data available when testing BioPharmaceutical products for release or stability. So turnaround time pressure has always been an inherent part of sterility testing.

This pressure has become more acute with the emergence of ATMPs, particularly autologous cell therapies which are often given to patients before traditional testing results can be obtained.

Eurofins BioPharma Product Testing has responded to the demand for faster sterility results by streamlining our processes, enhancing our IT solutions, and investing in the most modern equipment.

The system incubates, agitates, and with solid-state reflectometers, continuously monitors the status of each culture bottle for microbial growth.

For autologous cell therapy clients, and others interested in a rapid sterility option, Eurofins BPT has invested in the BacT/Alert system from BioMeriuex. BacT/Alert is a colorimetric based microbial detection system that provides sterility results in 7-10 days. The colorimetric detection system eliminates concerns from turbidity that may result from cellular material or debris. The modular design of this system makes it easily scalable, allowing for increases in capacity by addition of more incubation modules resulting in a consistent level of service. To streamline the sample collection, we would provide sample bottles for filling during the manufacturing process.

For compendial sterility, Eurofins BPT has invested in the Bioquell Qube isolator which provides improved work flow, increased throughput, and shorter cycle time compared to our current soft wall isolators.

This unit features a central vaporized hydrogen peroxide decontamination chamber that allows pass through of supplies into either testing chamber for both membrane filtration or direct inoculation methods. The central chamber can decontaminate supplies in 30 minutes, allowing for continual processing of samples and materials. The unit features a hard wall design and utilizes a catalytic converter that converts hydrogen peroxide into water and oxygen, eliminating the need for expensive venting. Each testing chamber includes a waste chamber allowing for a continual process flow from entry to exit of the test chamber. Our goal with this new technology is for samples to go on test the day of receipt.

At our Lancaster, PA, laboratory, we have 80 microbiologists running a multi-shift operation seven days per week. Your dedicated Project Manager will work with you to set up a sterility program to best meet your needs, including interim reads and/or preliminary results if requested. We offer on-line ordering to pre-log samples into our LIMS to expedite sample receipt, and CoA result with electronic raw data through our innovative 24/7 online portal, LabAccess. All designed to provide you with the fastest, most consistent, and highest quality sterility results in the industry.

Request more information to start working with us today.