Quick transfer of fluid from one cleanroom to another and minimised risk of contamination

The customer's main objective was to quickly transfer fluid from one area to another while minimising the risk of contamination. In addition, the customer was looking to maximise efficiency and reduce operator error.

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

The first solution explored was the use of mobile single use bags, as they were already using 3D bags at several points 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 gantry and single use system designed for the different wall thicknesses between each of the cleanrooms in the plant. The single use system is designed to accommodate operating pressures, flow rates and product compatibility.

While the use of 3D bags to transfer liquids between cleanrooms could be easily implemented, the risk of bag breakage and product loss during transfer was deemed too high and considered unacceptable.

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 multiple moving parts.

Conversely, the AdvantaPass system met the requirements for barrier separation between cleanrooms with its patented silicone gasket design. By having multiple fluid transfer lines in the single use assembly, the customer was able to maximise efficiency and reduce operator error.

The AdvantaPass system proved to be the ideal solution for the plant design and the challenges this large pharmaceutical manufacturer faced in their processes. The flexibility of the system, combined with AdvantaPure's commitment to understanding their bioprocessing needs, led the customer to choose the AdvantaPass system for all their liquid transfer processes between cleanrooms.