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Surviving the storm: how to stay afloat in troubled financial waters. Plus the latest on Lean, and the challenges of setting up international clinical trials.

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25 May 2011

Combined competence to serve the pharmaceutical and biotechnology industry

Buerkert Fluid Control Systems | www.buerkert.com


Bürkert Fluid Control Systems and BBS Systems combine to make one of the most comprehensive partnerships in the hygienic processing segment.

“Bürkert and BBS can deliver whole customized control cabinets or just a single control device”
-Mike Rodd

“Understanding the business of our customers and the end-users of our products in very great detail is decisive for both Bürkert and BBS. We teamed up to improve our analysis of the market and customer needs, with the aim of improving client profitability,” says Mike Rodd, Segment Manager – Hygienic Processing (HP) at Bürkert Fluid Control Systems and Director of BBS Systems.

Mike gives an insight into how the alliance is driving forward together to offer customers, especially those on the pharmaceutical and biotechnology segment, increased flexibility, optimum safety and access to a wealth of engineering expertise and experience that will enhance their business performance whilst enjoying a partnership on a global level.

The new alliance delivers fluid control systems and components for an industry which depends more crucially on time and space factors than many other segments. “The major players in the pharmaceutical business calculate with an ROI of months sometimes when building a new plant,” explains Mike Rodd.

The pharmaceutical industry is driven by
  •  product yield
  •  flexibility of the process lines
  •  efficient maintenance
  •  process efficiency
  •  optimised process performance
  •  fast and flawless cleaning cycles

Bürkert and BBS see themselves as vital partners for this industry, offering a complete range of services, from consulting and engineering to installation, testing and after sales service. “When we develop new products, our first goal is always to improve the business parameters of the end-user,” says Mike Rodd.

“If, for instance, a customer presents a particular challenge for a complex valve configuration, we work on a solution on the basis of the customer’s process schematics, create a simulation with all critical values and flows, and finally present a solution which optimizes the fluid paths and overall space as well keeping instrumentation to a minimum. Wherever possible, we eliminate dead legs,” he adds. “We can thus ease approvals and the certification and validation process for the end-user – aspects which are all of utmost importance in hygienic processing.” As well as a comprehensive range of standard valve components to work with, the alliance is also fortunate to have the unique Robolux valve within the range; this unique diaphragm valve utilises a single diaphragm together with a body that has two weirs; “the trick is in the actuator” explains Mike Rodd, “we have a single actuator housing with two independent air operated chambers that stroke separate compressors on the single diaphragm; it is the answer to many of our customers needs and the ultimate solution for complex arrangements.”

Hygienic Processing
The alliance is continuously involved in elaborating the latest specifications and requirements and works in special interest groups – e.g. as a member of ASME BPE – to push the hygienic processing industry towards higher standards and greater value for their customers.

In the world of hygiene, where compactness, smart communications, plant footprints, cleaning and sterilization, dead legs, cross-contamination and validation are everyday concerns, Bürkert and BBS provide process efficiency and higher yields by offering unlimited process modularity. End-users profit from the combined experience of both companies. And in addition to convincing functionality and cleanability, all instruments and components are not only good- looking, they are also flexible and can be used in many different processes – for even easier operation, internal processing and preventative maintenance.

From the control room, the upstream and the downstream processing area, through to the plants utilities services the scope of systems and components from Bürkert and BBS cover all the different application environments in hygienic processing – effective and efficient in each application whilst working harmoniously together to provide a reliable total plant solution.

It’s all about control
In hygienic processing industries, measuring and controlling the flow of liquids and gases demands superior instrument performance and networkability. Standard connectivity with modular, decentralized monitoring, intelligence and diagnostics are the platform for flow control networks which provide reliable productivity data from the plant level flow network. Control can be deployed when and where it is needed: whether centralized in a control cabinet with communication via profi-bus, device net or field-bus or locally in the plant. Bürkert’s process control centres, valve mounted PID controllers or valve tops for remote control are flexible regarding to I/Os and communication protocols.

Water Treatment
“Water quality and consistency are essential to the success of the final product, and thus to the overall success of the company.” Controlling the water, especially the water-for-injection loop (WFI) in a pharmaceutical plant, is critical and demands superior instrument performance, networkability and process component interface. Bürkert and BBS are involved in the complete water supply chain from groundwater treatment and incoming water supply processing, satisfying stringent requirements, inline sampling and verifications, and finally decontamination, treatment and/or neutralisation. An otherwise unattainable synergy of rugged valves, process actuation, sensors and networked communications make sure that pH, conductivity, flow, pressure and level are under control. “Water is one of the most valuable ingredients and we focus a lot of attention on this important resource,” Mike mentions. “Joe Vandehey is Bürkert’s global segment manager for water treatment and we work closely together with our customers needs firmly in mind; having global segment managers is vital to our customers´ continued benefit.”

Steam is essential
Steam as a heat transfer medium, cleaning agent and as a crucial sterilizer or an ingredient can be regulated precisely with Bürkert and BBS systems and solutions. Mike Rodd: “Heat and/or steam transfer concerns accurate temperature control, for WFI (the distillation process of pure steam), it means absolute quality of process measurement and control.” Whether you need temperature transmitters, pressure transmitters, valves with integrated PID process controllers, solutions as highly accurate globe valves, rugged angle pattern piston type process valves (for utilities side) or hygienic diaphragm valves (for the process side), ball valves, check valves, flow indicators or any combination of these components – Bürkert and BBS provide cutting edge solutions for any heat transfer application in the pharmaceutical and biotechnology segment.

Clean-In-Place
Hygienic processing applications have to be highly reliable and flexible; this demands excellent cleaning properties and/or sterilisation using clean in place (CIP) or sterilise in place (SIP). “The chosen cleaning process and cycles are a significant and crucial part of the whole plant performance; we understand the process deeply and all our products are designed to for efficiency and most importantly safety” says Mike Rodd. Absolute safety when hot steam and chemicals are involved is paramount; every stage of the cleaning regime has to be controlled and safely documented. Our products are designed for harsh shifts from acid to basic, resistant to wash down and performance oriented; our mechanical components such as quick connects, unions and flanges and sight glasses withstand the conditions and maintain a secure process. Devices like inductive conductivity transmitters, sanitary divert valves or local process control centres, ensure reliability and safety when switching from water to clean steam, and from chemical to surfactant, and safeguard the complete control of the whole process.

Fermentation
“Our customers have invested significant time and money in preparing the ingredients for the fermentation process,” Mike Rodd continues; “this gives us the chance to highlight some very special products which continue to make sure we are supporting our customers´ business drivers; on the reactor, our sterile flanges, ingolds and access ports are of the highest quality materials engineering and precision machined. The result is completely reliable environment control for the culture creation; we combine that with exceptional components for fermenter gas control, pH and pressure monitoring and field bus solutions, which are used to join up separate reactors within coordinated processing lines.”

Downstream Processing
Filtration, separation and chromatography require precise and flexible systems; “we help our customers get as much product yield as possible in the right place with the least amount of waste; this is really the area where the combined engineering competence and process-application understanding is fully utilised to deliver fast flow shifts, minimum dead space and reduced footprint” explains Mike Rodd. It is a critical area for valves and instrumentation and combing all the opportunities that the alliance offers gives rise to some unique and exciting solutions. “Downstream is the home of the Robolux solution” says Mike Rodd; “extending the principle of a highest possible return on investment is generated from this area of the plant and it is natural for us – we like it best when our customers see and realise the advantages we have engineered for them through choosing our solutions”.

Batching, Mixing and Filling
Bürkert and BBS deliver fully tested and approved components and sub systems to batch, mix and finally fill different compounds, such as primary active drug ingredients worth thousands of euros per gram. “But filling a bottle or a pack does not only mean simply opening a valve.” The velocity of product, quantity, product type, and consistency of process, reliability, accuracy, and repeatability as well as other specific demands all need to be considered.

Connectivity
Bürkert’s experience lies in linking all parts of the production process via electrical signals. BBS links all the parts mechanically: sterile weld unions or quick connectors, flanges, fittings, hoses, and pipes are the world of the Swiss manufacturer. And where Bürkert stands for process design, flow, and instrumentation, BBS completes the offer with a huge number of special valves like check valves or point-of-use valves, sampling systems, flow indicators for process visualisation, and heat exchangers – to name just a few of the wide range of components. Mike Rodd explains: “BBS delivers all the mechanical parts which perfectly complement our product range. Moreover, the cooperation with BBS gives us more flexibility when using exotic materials like hastelloy for example. We can also supply hoses, approved for sterile use, as flexible connections between the various processing devices. The BBS hose is of exceptional quality; it is platinum cured silicone with optional types of reinforcement and has the advantage of working with the BBS re-usable unions which means the modularity and flexibility is transferred to our customers bringing major benefit and cost efficiency when exchanging them.”

Together, the Bürkert and BBS alliance offers all the mechanical and instrumentation components needed in a HP plant as well as complete process control solutions and systems. With more than 40 locations worldwide, the alliance is now even closer to its customers everywhere in the world, and boasts even more manufacturing capacity to satisfy the increasing demand and to share techniques and best practice ideas. “The combined product range of BBS and Bürkert is like a very large Lego kit – everything fits perfectly. This is unique, and makes us stand out from our competitors,” as Mike Rodd points out.

Bürkert Fluid Control Systems
Founded in 1946 Bürkert Fluid Control Systems is a leading manufacturer of control and measuring systems for fluids and gases. Present in more than 35 countries around the world with over 2000 employees globally looking after four research & development centres, five production locations, and five system houses to deliver the very best in technology and services.

Bürkert Fluid Control Systems
Christian-Bürkert-Straße 13-17 D-74653 Ingelfingen
T: +49 (0) 7940 10 91 111
F:+49 (0) 7940 10 91 448
Et: mike.rodd@burkert.com
www.burkert.com

BBS Systems AG
Founded in 1993, BBS today is one of the worlds most important and significant manufacturers of piping components and solutions dedicated to the HP segment. Located in Wil (ZH), Switzerland, the company employs more than 30 people locally and with their alliance partner reaches globally with hundreds of knowledgeable employees.

BBS Systems AG
Im Landbüel
CH-8196 Wil (ZH)
T: +41 44 864 8484
F: +41 44 864 8490
E: Heinz.bolli@bbs-systems.com
www.bbs-systems.com