The Polish subsidiary of a major international generics and specialty pharmaceutical manufacturer has chosen a Bioquell Qube M-11 system to provide the ideal environment for carrying out its product sterility testing.
Previously, the quality department had been performing sterility testing utilising a laminar flow system and cleanroom for product protection. The critical nature of such testing and the potential risks to the results from human intervention has led the company to change to the latest in isolator technology. This will allow testing to be carried out within a guaranteed ISO 5/EU Grade A environment and provide an added level of protection from contaminations that can cause false positive results.
The Bioquell Qube M-11 system (one gassing unit, one processing extension and one passout chamber) has proven to be Bioquell’s most popular sterility test configuration. The main Qube hydrogen peroxide vapour module (QHPV) doubles up to not only provide the means of decontaminating the whole system but also forms a rapid decontamination port for material loads prior to them being passed into the Qube extension module (QEXT) for carrying out the sterility test. The Qube material transfer device (QMTD) exit hatch completes the system configuration ultimately allowing for materials to be passed out without compromising the controlled environment.
There are now a number of Qube systems with integrated sterility pumps offering a complete sterility test solution within the Polish market.