Life Sciences Firm Develops Stem Cell Facility

Life Sciences Firm Develops Stem Cell Facility

Solutions

Results

  • Highly sensitive and valuable product and processes are well protected
  • Highly efficient and cost effective plant
  • Optimization of CAPEX and OPEX
  • System supports S88 and CFR 21 part 11 compliance
  • Fully validated system DQ, IQ, OQ, PQ

Leading pharmaceutical facilities company leverages control, integration and scalability features of Logix controllers to create state-of-the-art control solution

Background

Biopharmax is an engineering company established 40 years ago that focuses on the pharmaceutical industry. It has designed and constructed over 100 facilities in 14 countries around the globe and is actively present in Europe, China, India and the Middle East.

The company's mission is to design build and validate pharmaceutical facilities of the highest level and has a proven track record of handling and addressing the most advanced biotechnology processes and products.

Biopharmax integrates Rockwell Automation products in several of the customer facilities it designs and constructs, including a recent project for Pluristem in the field of Stem Cell growth and final therapy dose production. The Pluristem's requirement is for Biopharmax to set up a state-of-the-art facility – the first of its kind in the world – that can produce final Stem Cell therapy products on a commercial scale.

According to Solomon Gahtan, Business Development Manager at Biopharmax: “We have a unique model where we will design a factory from the start, construct it in its entirety and then validate it to make sure it is prepared for regulatory approval such as USFDA. We hand over at the approval stage and then take responsibility remedying any issues.

Not all companies work this way; some will use a designer and then various sub contractors. In this instance you often get a dispersed control system for each of the individual elements of the factory. In our case, we take the plant as one, including the HVAC, plant utilities, critical systems, such as Purified Water (PuW) Water For Injection (WFI) and Pure Steam (PS), and other production elements.

“In doing so, we can better protect sensitive product batches from any variance in the plant conditions as room temperature, humidity and cleanliness,” he continues. “We can better monitor the various parameters and, when required, enhance the necessary remedial action activated by the control system itself. This may turn out critical for protection of the product batches during the production stage. We can also achieve better optimisation of energy consumption by the HVAC system and reduce unnecessary OPEX. The ControlLogix PLC-based solution helps towards the reliability and flexibility needed to achieve these goals, and we find the Rockwell Automation system of to be a light system and of the appropriate size that allows us to provide these advantages even for a small or medium plant.”

Challenge

Stem Cell products are extremely difficult to grow and produce. Pluristem holds many patents for processes and devices that would address the growth process as well as final dose production and filling. Such facilities have to adhere to stringent regulatory standards such as USFDA and EMEA.

The new facility is designed and constructed from scratch within an existing building. The project scope includes HVAC and clean rooms of the highest A and B classes, plant utilities, critical utilities, such as PuW, WFI and PS, as well as Buffer and Media production.

Pluristem is a start-up company and with this project takes a leap from the R&D stage to commercial-scale production. Being so, CAPEX as well as the OPEX optimisation are a major challenge for the designer, and it is extremely important to provide the client with these advantages. Furthermore, future expansion plans have to be addressed and the solution must facilitate a seamless future expansion.

Stem cells are currently the pinnacle of the biotechnology industry and, being a relatively new field, require special care as process and product are highly sensitive. The growth process is relatively long and may last a few weeks, which increases the risk and financial impact of batch loss due to any failure in the plant conditions.

Solution

The system is based around an Allen-Bradley ControlLogix PLC solution. Running over EtherNet/IP and a combination of remote I/O and serial link communication gives Biopharmax the ability to meet these challenges successfully. All service areas are of grade C clean rooms, while production is in grade A and B with a minimum foot print. This significantly reduces energy consumption as well as CAPEX. Another very important design feature is the full separation between production suites to avoid risk of cross contamination.

EtherNet/IP between the PLC and the Variable Speed Drive control, as well as serial link communication with the FFUs, allow the system to analyse the highly detailed data received from these components and activate corrective measures where required. This significantly increases the system performance in response to changing conditions as well as helping to optimise energy consumption. Furthermore, SMS alerts have been introduced to provide the staff with the ability to react instantly to any undesired variances.

Remote I/O has been chosen not only for ease of implementation, improved speed and higher reliability, but also to help towards easy integration of future expansion while negating unnecessary handling of infrastructure that may disturb smooth plant operation and cleanliness.

“We have managed to design a plant with separate production suites to avoid cross contamination,” he explains. “Nevertheless, we could minimize the footprint and the high energy consuming grade A and B clean rooms. We have therefore given the customer an overall very cost-effective solution.

“When we design a plant,” he continues, “we always look at the possibility of expansion while still using a control system that will control the entire plant including the future expansion and we have well catered for this future possibility.

“We have a very close relationship with Rockwell Automation,” he concludes. “We can always communicate on specific problem solving and have great help when it comes to finding and building solutions for our customers. We prefer using Rockwell Automation when given a choice and can also rely on it in terms of supply and logistics.”

Results

Gahtan proudly explains: “As far as we know, this project has led to the creation of the most efficient and cost effective facility in the world for cell therapy. “Using the Rockwell Automation solution,” he continues, “we have been able to develop a fully integrated control system for Pluristem that takes into consideration the different elements of the plant. This solution is able to react very quickly to any undesirable variables and provide the correct alarms and remedial action, helping to protect an extremely valuable process and product.

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