Interestingly, one of the first operation units to use single-use technology in bioprocessing is the one that has been among the last to benefit from single-use automation. The step in question is the bulk filtration of product prior to shipping. Parker Bioscience Filtration has developed a fully automated, single-use solution for controlled freeze-and-thaw and final filling: Scipure FD.

‘This system focuses on automating the single-use part of bulkfilling’

“Our system tackles a variety of challenges – not just the typical problems concerning the contact points between stainless steel and single use”, says Michael Matthijssen, sales manager Benelux at Parker Bioscience. “The Scipure FD removes manual processes, for instance, and uses standard operating procedures, automated monitoring and control.”

The system eliminates open processing in order to avoid contamination. It provides for automated traceability, as part of complete logging of Good Manufacturing Practice (GMP) procedures. It also uses client-specific ‘recipes’ for continuity and repeatability.

Validation

“This system focuses on automating the single-use part of bulkfilling”, summarises Matthijssen, “but it doesn’t end there. It also ensures for freeze-and-thaw cycles that maintain product integrity, even at temperatures down to minus 90 degrees for longer transports. And it includes the tools for complete validation, as well as the software needed to control the entire procedure.” The Scipure FD can work either on its own, or be integrated into the client’s system: “There’s all kinds of options for customisation.”

Last but not least, Parker Bioscience offers its clients on-site assessments and testing, and as well complete annual service. “What’s unique about the whole package is its comprehensiveness: it combines all hardware, software, testing, training and service”, says Matthijssen. “In addition, there’s several unique elements. One is our patented close seal that has been validated to minus 85 degrees. Another is a J-tube system that diverts the liquid flow to the side of the bottle, which reduces foaming and allows for more controlled filling.”

Upgrades

Parker Bioscience will continue to develop upgrades. “The first generation only accommodated bottle and container systems”, says Mattijssen. “The second generation is also suitable for bags. It is a multifunctional system that can be fully customised.”

The company is currently developing solutions for downscaling to smaller volumes, for instance for RNA techniques and to allow for smaller volumes for risk mitigation purposes. “Naturally, these smaller-volume processes have to be GMP-compliant as well”, says Matthijssen. “We’ve come a long way, but making this system plug-and-play is still a challenge. For now, we’re focusing on the scalability of single use and automation.”