Sterility Testing Solutions for Every Project Need
Tessa Patton, Group Leader, BioPharmaceutical Microbiology
Eurofins BioPharma Product Testing is proud to provide clients with various solutions to their Sterility testing needs. Eurofins’ site in Lancaster, Pennsylvania, has on-boarded two new Sterility Isolator systems from Bioquell. The Bioquell Qube is a hard wall isolator that utilizes vaporized hydrogen peroxide (VHP) to decontaminate the workspace and supplies used in Sterility testing. The Sterility test method performed in the Bioquell Qube is compliant with USP <71> as well as the EP and JP chapters for Sterility testing. The method of decontamination is consistent with the technology previously used at Eurofins, however, the new systems allow for a more rapid decontamination time which enables faster processing of samples. The maintenance required on the Bioquell Qube is minimal and takes less than one day to complete. Having two systems in place allows the Lancaster site to offset maintenance tasks for continuous processing of samples. In addition to the two systems in Lancaster, a third Bioquell Qube has been on-boarded at our Eurofins Portage, Michigan, site. Prior to performing Sterility testing in an isolator, Eurofins offers Package Integrity Verification for VHP testing to demonstrate that ingress of VHP into the container or sample packaging does not occur. This testing is highly recommended by Eurofins, as well as the USP, as ingress of VHP can potentially lead to a false negative Sterility result.
Eurofins in Lancaster offers another alternative to Sterility testing, focusing on the support of large volume containers (>1 liter) and medical devices. Eurofins has a business unit focused on the testing of medical devices, which has implemented the use of a clean room to execute Sterility testing in accordance with USP/EP/JP requirements as well as ISO requirements. The clean room provides an option for clients whose samples’ packaging are not compatible with VHP or are large volume containers.
Eurofins has recognized that clients with short shelf life products are in need of a solution to decrease the length of time required to obtain a Sterility result following the compendial chapter. Based on that need, Eurofins has validated a method for a rapid contamination check. The method employs the use of the Biomerieux BACT/ALERT® 3D system. The method has been validated in accordance with USP <1223> and was determined to be non-inferior to the USP <71> Sterility test. While the BacT test was determined to be non-inferior to the USP <71> test, it is not a replacement for the USP <71> test. The service offering provides Certificates of Analysis of an interim read after three days of incubation and the final result after 10 days of incubation. This test is currently offered at our Lancaster site. In order to serve our Midwest clients, a second BACT/ALERT® 3D system has been on-boarded at our Columbia, Missouri, site. Eurofins has designed a streamlined process to allow for rapid turnaround of results. The process begins with Eurofins supplying the client with the required media vessels to be inoculated as a step during the manufacturing process. The inoculated media vessels are then returned Eurofins and placed into incubation on the same day of arrival.
Eurofins offers full scale Sterility testing at multiple sites to support various client needs. Whether you’re dealing with large volume parental, a short shelf life product, or a medical device, Eurofins has the solution to your Sterility testing needs.