Burkert Robolux Units Reduce Diaphragm Valve Requirement By 75%, Eliminate Deadlegs & Cut Cycle Times On Sterile Filling Unit

2nd October 2009
Posted By : ES Admin
Burkert Robolux Units Reduce Diaphragm Valve Requirement By 75%, Eliminate Deadlegs & Cut Cycle Times On Sterile Filling Unit
Burkert’s Robolux valves have eliminated deadlegs and reduced the requirement for diaphragm valves from 8 to 2 on sterile filling units used in the production of Pulmicort, one of the world's leading asthma medicines. The Robolux valves have also greatly simplified the design of the filling units, cutting cycle times and making maintenance and cleaning procedures far easier to carry out.
Pulmicort The asthma medicine is produced by Astra Zeneca, a global pharmaceutical manufacturer, and its production requires ingredients to be mixed together with water to create a final formulation, which is then packaged in plastic ampoules (Blow Fill Seal) as part of a closed cycle process. However, the active ingredient in the medicine is not soluble, so the mixture is a suspension rather than a solution. To avoid sedimentation occurring it is imperative that once compounded and mixed the formulation is kept in continuous motion until filled and sealed. Any deadlegs in the system, where sedimentation might potentially occur, have to be minimised to ensure correct product concentrations are maintained. However, achieving this goal always proved challenging until the global manufacturer needed to increase production capacity and then sought a new solution.

The problem with dead legs, inherent in the original systems, was simply solved by using Burkert Robolux 4-Connection 4-Seat valves. By arranging the required valves and flow paths in single units above and below the holding tank, deadlegs were eliminated. In addition, the Robolux solution greatly simplified the design and installation of the new systems; reducing the number of valves from 8 to 2, as well as reducing the number of T-pieces required and, subsequently, the overall cost of installation and validation. The neater design also made future maintenance and cleaning procedures far easier. After the success of the first installation, two new systems using Robolux valves were quickly added to the facility.

The outstanding success of the initial Robolux applications resulted in follow-up applications of the valves when production was increased further at the pharmaceutical plant. Two new installations were commissioned using the valves; one of these in a clean room - a class 100 000 sterile environment - where stringent monitoring is in place to ensure product quality according to regulatory stipulations.

Commenting on the latest project, a spokesman for the pharmaceutical manufacturer said that: Compared to conventional valves the Robolux valves give us a far better flow path and process function, shortening cycle times and making sure our filling operation runs smoothly

Robolux Valves

Robolux valves are supplied with either manual or pneumatic actuators in sizes from ¼” to 2” (DN4 -50). They are manufactured with a choice of body types: 316-L stainless steel, ultra-pure polypropylene, polypropylene USP V1 and PVDF (polyvinyl-difluoride). The valves also offer the widest range of diaphragm materials to suit all types of media, including EPDM, FKM, PFA/ EPDM, PTFE, Silicone and PFR91.


Robolux valves hold all major certifications: FDA, CE, USP V, USP VI, ATEX, 3.1 and are applicable worldwide. They are used successfully in chromatography, but are also suitable for a wider range of applications including CIP/SIP processes, UF/MF filtration and filling and formulation.

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