A Batch Solution for the Pharmaceutical Industry

A Batch Solution for the Pharmaceutical Industry

Solutions

Results

  • Open platform for easy modifications
  • Flexibility to adapt to future needs
  • Scalability to address wide ranging requirements
  • Pharmaceutical industry-compliant programming

Separation technology company opts for single, scalable, open platform running industry-proven batch solution

Background

Jurag Separation A/S, based in Denmark, was founded in 2001 on the basis of a visionary idea that utilises an electro-membrane separation process to improve the production economy of microbially derived products for the pharmaceutical, biotech, food, beverage and feed ingredient industries.

This subsequently led to the development of Jurag's patented ‘Reverse Electro-Enhanced Dialysis' (REED) technology. The technology uses unique electro-membrane separation technology, which is able to solve complicated separation steps – resulting in significantly increased production yield.

In its efforts to develop a standardised platform, upon which it could base its core technology, Jurag Separation A/S scoured the market and eventually opted for an Allen-Bradley Logix based platform, from Rockwell Automation, which uses library components from the company's industry-leading PlantPAx process automation and control suite.

Challenge

“We tailor every single application to our customers' exact needs,” explains Søren Pedersen, CEO of Jurag Separation A/S. “We visit the customer and work in tandem with its engineers to design and develop bespoke solutions.” Once the customer's needs have been ascertained, Jurag Separation A/S then sub contracts the construction to a third party to build the physical realisation of what the customer requires.

“What is core to the technology,” Pedersen explains, “is getting our process and equipment to work through a programmable automation controller (PAC). In the past we have used controllers from multiple sources, starting almost from scratch every time, but we soon realised that it would be far more effective – in terms of cost, time and engineering effort – if we standardised on one platform for all of our customer solutions.”

What Jurag Separation A/S wanted was an automation supplier that could offer a modular system and programming environment that would satisfy the current and future needs of its customers... no matter how diverse their application requirements, hence the choice of Rockwell Automation. “We now try to make the programming very modular, so we don't have to start with a clean slate every time.” Pedersen explains.

Jurag Separation A/S's REED technology is used in fermentation and similar processes for separation/ isolation of small organic acids. The core of the technology originates from the fermentation of starter cultures, where removal of lactic acid during the fermentation process leads to significant yield increases.

A REED unit is a plate-and-frame stack module where ion-exchange membranes are placed in layers, separated by flow spacers. The flow spacers facilitate the passage of the fermentation broth between each set of membranes. By applying an electric field across the REED stack, fermentation broth can pass the stack, while small charged molecules leave the broth when they migrate across the membranes and enter the dialysis stream. Larger or non-charged components, including proteins, sugars, cells, yeasts, etc. remain in the fermentation broth.

In a manufacturing operation, microorganisms are fed into a tank, which maintains optimal fermentation conditions in terms of temperature and pH. As the organisms grow they produce lactic acid, when these acid levels get too high, the bacteria is no longer able to reproduce and the tank contents reach the limit of what can be produced within a certain fermentation capacity/tank volume.

“What our REED Technology does is continuously remove the excess lactic acid, which results in a very significant increase in productivity,” Pedersen elaborates. “In the production of Probiotics we can often see a tenfold yield increase.

“We also needed to incorporate proven batch capabilities into the solution,” Pedersen explains, “because we tap into batch processes in order for our technology to integrate into existing equipment and production runs.”

It is normal practice for fermentation steps to operate independently of subsequent processes; the batch is prepared and then the whole volume is handed onto the next step in the production procedure. However, with this new technology, coupled to an advanced batch solution, Jurag Separation A/S will also be able to offer the potential of a continuous process that is tied into the rest of the production run.

Solution

Jurag Separation A/S was also looking to generate a bigger presence in the pharmaceutical industry. “We wanted a solution that can be used in a pharmaceutical production line; one of primary reasons for adopting PlantPAx from Rockwell Automation. With PlantPAx we can provide the cGMP documentation needed for the industry. We also wanted a one-solution answer; we did not want limitations, it also had to be scalable, as we often develop pilot-scale devices that then need to be transitioned into full production machines. With a great many companies already using the PlantPAx suite, we knew we were headed in the right direction.

“Once Rockwell Automation was in possession of our ‘wish list' we also asked it to recommend a good local programmer,” Pedersen elaborates, “which it did, in the form of a local Danish System Integrator (SI) called Vengcon.”

Vengcon undertook all the programming – with Jurag Separation A/S using this step as a learning process, so it would be able to do subsequent system modifications at its customers without relying on the SI. “We like the freedom that this approach allows us,” explains Pedersen. “With other suppliers we were often tied to closed systems that required significant external input. A lot of the processes we are designing systems for are new or involve new technologies, so there will be a lot of modifications needed after the customers starts using the equipment – we need the ability to do minor changes, without relying on third parties.”

Jurag Separation A/S wanted to make use of as much of the standard code elements (plug and play) from the PlantPAx library as it could; for pH probes, process measurement devices, etc. “We didn't want someone to programme a unit if library code already existed,” Pedersen explains, “so we based as much of our solution as possible around devices that already had code within the PlantPAx library. There were two primary reasons for this: one, to save time and, two, to make the system as open and flexible as possible for other people to be able to use it, using a standard, easier-to-use programming environment. PlantPAx and its library also foster easier integration into existing systems (such S88) from a programming point of view.”

Results

“The system that we have built,” Pedersen explains, “is very different from those we have built using other software and hardware suppliers. Where we are seeing greatest advantage is in the flexibility with what we can do ourselves. It is much easier for us to make changes in the new system than it was with the older, more closed solutions. The software is also more user friendly for a ‘non-programmer'. In terms of real-life performance... it is still a little early to gauge – we are still training.

“We have a very good relationship with Rockwell Automation and the SI,” Pedersen enthuses. “What really appeals to me is the follow up from the commercial side of things. If you ask questions you get a fast response. Rockwell Automation's customer service is really impressive; especially when you take into account the size of customer that we are. We are a small customer getting a very big level of service.”

Rockwell Automation also recognised this project was an opportunity to expand its existing presence in the pharmaceutical industry. “We got so much support, and Rockwell Automation demonstrated a very different approach to that from other suppliers,” Pedersen concludes. “We got a great deal of engagement from them. Other suppliers said: ‘Here's the equipment... you work it out'. Rockwell Automation showed a long-term investment; its competitors had a very short-term, quicksale view.”

Rockwell Automation's overall offering was capped off with significant input from one of its Global Process Technical Consultants (GPTCs) who offered a lot of in-depth support, particularly on the batch and documentation system, while fostering the relationship between Jurag Separation A/S and the SI.

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