Problem Solving in Filter and Dispense

Overview

There is no ”one size fits all” approach for biopharmaceutical manufacturing facilities. Every site is different and can come with its own set of constraints. And that can mean that integrating a filtration system into a customer’s site isn’t always straightforward. Let’s look at a recent project for a European biopharmaceutical manufacturer.

The manufacturer had invested in a brand-new facility and were interested in filtration systems for the final step in the downstream process before bottling. But unusually, the design of the suites were such that drug product, buffer and WFI tanks were housed on the floor above where the filtration processes were to be carried out. This layout may have been shaped by the manufacturer’s intention to use hydrostatic pressure to minimize product losses. However, this resulted in a challenge of how to design the systems to accommodate to this height difference to connect to the tank outlets.

The space dedicated to the filtration system on each process line was constrained due to the suite layout and other equipment in the proximity – which limited the space available to a small footprint.

The solution needed to integrate with the process fluid tanks and the customers pre-existing filling system, which further increased the complexity to enable communication with multiple systems. Faced with design implications of a limited footprint and structural considerations, Parker was able to adapt its standard automation offerings to develop a bespoke solution tailored to a customer’s uniquely designed facility.
 

So how did we develop a viable solution? 

• The project was an example of how Parker can interpret a complex and challenging specification into a working solution. 
• The customer’s team visited Parker’s facility in Birtley, UK to discuss their challenges and understand how Parker could support the creation of a bespoke solution. 
• It was determined that hardware from Parker’s SciLog® automated systems range could be used as the basis for a solution for the customer. 

However, this was just the start of the journey. A strong working partnership was developed as Parker’s team worked closely with the customer during the design phase. Regular meetings and reviews of hardware and software designs kept the project on track. 

How does it work? 

• A key component of the system’s success was a compact and bespoke automation skid. 
• The system was fitted with a centralized elevation system, which enabled the upper unit of the system to be raised to the specified height of 2.5m during the filtration step.
• During product filtration and filling, the customer's pre-existing filling line was able to control the pump on the skid. An intermediate bag suspended from a vertical weighing scale in the filling line was utilized as a header bag for filtered product, which then readily provided the product for aliquoting into bottles.
• When the level of product is low, Parker’s software solution enables the filling line to communicate to the pump that it should activate, so that more product will be filtered to fill the header bag again. 
• When the product tank is nearly empty, bubble detectors on the skid are able to monitor the change from liquid to air and send a control signal for the filtration to end. 
• Parker’s software solution enabled the system to link to both buffer and drug product tanks, which in turn provided the pathway to the filling system.
• A custom user interface was also designed in the native language of the customer.
   

PUPSIT

Inclusion of PUPSIT (pre-use post sterilization integrity testing) capabilities was a key factor within the specification of the system based on the EU Annex 1 requirement. Parker was able to provide an automated solution which was integrated into the system as part of the process sequence.
 

Facilitating a successful integration 

• Parker provided both long-term on-site support and remote support to the manufacturer.
• FAT, SAT and IQ/OQ were all performed by Parker to ensure that the system would work effectively to the customer’s specification while also adhering to regulatory requirements. 

Overall, the project demonstrated Parker’s agility and flexibility in creating bespoke solutions for the biopharmaceutical manufacturing sector. We employed our technical expertise and accessibility to develop a synergistic approach to provide a modular solution and overcome the challenges that the customer presented.

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