New B. Braun plant to feature advanced process technologies

Melsungen, Germany – Pharmaceutical and medicals supplier B. Braun Melsungen AG’s new Euro164-million LIFE Nutrition plant will feature advanced fluid handling and process control technologies when it comes fully on-stream later this year.

The LIFE facility, at the company’s Melsungen HQ in northern Germany, will manufacture and package solutions for clinical nutrition, such as amino acid solutions, carbohydrate solutions and fat emulsions on two production lines

The new unit had to be housed in a building that was spatially identical to that of B. Braun’s older LIFE plant. This meant that the company required space-saving solutions for the complex valve interfaces to be used in the production processes.

B. Braun’s engineering consultancy Chemgineering selected Burkert’s Robolux multi-port process valves and process fittings. The patented Robolux design allows two independent process switching functions to be achieved with one membrane.

This reduces installation requirements, eliminates T-adaptors and minimises the overall number of valves and membranes required, explains Alexander Equit, Burkert’s national key account manager for pharma, biotech and fine chemistry.

“The multi-port membrane valves were designed for high-purity installations and make it possible to design complex systems that are considerably more compact,” said Equit. “Even a 10-port valve interface requires very little installation space, has a minimal internal volume and practically no dead flow zone.”

The lower inner volume, he added, improves flow and evacuation properties, and make cleaning and changeover of the interfaces for the manufacture of other products is easier and faster.

A new fluidics scheme was developed on the basis of the Burkert valve interface, with modern multi-port Robolux systems included in the provisional plans for the new LIFE plant.

“The compact design, as well as the possibility to connect Robolux with standard systems, has resulted in valve interfaces that meet the technical and practical needs of the LIFE plant - such as maintenance and cleaning, as well as flexibility in different operational modes,” said S. Reinhardt, a spokesman for C Dostal – the organisation that operates both B.Braun’s original LIFE Infusion and new LIFE Nutrition plants. 

The Robolux interfaces can be cleaned effectively due to directional flow, which systematically prevents the typical disadvantages of ring systems that have large inner volumes and undefined flow, factors that complicate cleaning. In steam sterilisation, Burkert says its valve interface reaches the required sterilisation temperature in about half the time required with alternative systems.

Prior to selection, Burkert had to demonstrate that the complex Robolux valve interfaces could be delivered with a surface quality, as defined by the Basler Standard BN94. To meet this requirement, Burkert company, BBS-Systems AG of Wil, Switzerland developed a process for relectro-polishing the Robolux systems, which involved removing 30µm of metal from the media contact surface with a special electrolyte, under DC current.

Subsequent to the development of the electro-polishing system, audits were carried out to validate not only the electro- polishing process itself, but also the black- white separation in Burkert’s production plants of products that are intended for the biotech sector.

This separation means that all components manufactured from stainless steel may come into contact only with stainless steel, to avoid contamination and rust film. This is also true for the bodies of fittings used in conjunction with the Robolux valves. These are produced on special production lines, where only stainless steel is used.

Production of the Robolux units for B Braun was also checked regularly in unannounced factory acceptance tests. For these, Burkert has conducted riboflavin tests on the most complex of the valve interfaces, using its own proprietary test rig, where the inside of the valve interfaces is soaked with a test solution containing riboflavin that fluoresces when exposed to UV light.

Separately, B. Braun has selected Honeywell to provide process control systems for a new factory that will produce clinical nutrition and infusion therapy solutions.

Honeywell’s Experion Process Knowledge System (PKS) will be used at the LIFE Nutrition site to control production processes, optimise production output and maintain quality control standards. The project follows the vendor’s involvement in the development of B. Braun’s LIFE1 factory, four years ago.

“Honeywell’s proven technology and experience with LIFE1 made it the obvious choice for the LIFE Nutrition project, which represents an important and significant expansion of our business,” said Thomas Gaebler, vice president Global Process Engineering for B. Braun.

“The pharmaceutical and batch features within Experion PKS combined with Honeywell’s ability to execute specific applications fit our requirements perfectly. We have also had strong service in the past from Honeywell,” added Gaebler.

B. Braun will use Experion to streamline production at the new factory by allowing plants to unify process, production and business management. The system links critical plant subsystems, including process units and safety systems, and delivers relevant information directly to operators in the control room.

In tandem with the Experion system, Honeywell’s Qualification and Version Control System will allow B. Braun’s plant operators to electronically manage and maintain the control modules. Meanwhile, Experion Batch Manager’s embedded batch functionality will allow B. Braun to execute batches at the control level rather than using a separate server.

The package also includes Honeywell’s Uniformance PHD for the collection, storage and analysis of process data. The PHD architecture allows data to be gathered from disparate control systems into a unified database for long-term storage.