Rapid transfer of fluid from one clean room to another and minimised risk of contamination

The customer's main purpose was to quickly transfer liquid from one area to another while minimising the risk of contamination. In addition, the customer sought to maximise efficiency and reduce operator errors.

The customer investigated several solutions as potential options for aseptic fluid transfer.

The first solution that was investigated was the use of ​mobile single use bags, as they already used 3D bags in several places in the process.

Another solution they investigated was a diaphragm valve, which they used in other applications.

The third solution evaluated was an 8” AdvantaPass portal and single use system designed for the different wall thicknesses between each of the clean rooms in the system. The single use system is designed to meet operating pressures, flow rates and product compatibility.

While the use of ​3D bags for transferring liquids between the clean rooms could be easily implemented, the risk of breakage of the bags and product loss during the transfer was assessed to be too great and considered not acceptable.

Similarly, the diaphragm valve was rejected as a solution because it did not create sufficient barrier separation between the two quality spaces, as the diaphragm valve does not create a uniform seal around the outer diameter of the pipe. There were also concerns regarding the cleaning validation due to the containment areas created by several moving parts.

Conversely, the AdvantaPass system met the requirements for barrier repair between clean rooms with its patented silicone gasket design. By having multiple fluid transfer lines in the single use collection, the customer was able to maximise efficiency and reduce operator errors.

The AdvantaPass system proved to be the ideal solution for the plant design and for the challenges that this major medicinal product manufacturer faces in its processes. The system's flexibility combined with AdvantaPure's commitment to understanding their bio-treatment needs led the customer to choose the AdvantaPass system for all its fluid transfer processes between clean rooms.