Using Continuous Processes and Automation to Remove Contamination Risk

Continuous production has been employed across many industries for some time to improve efficiencies, reproducibility, and quality. For the bio/pharma industry, continuous processes have come a long way, although semi-continuous is still more widely adopted.

“I think, of late, [continuous processing has] come a long way,” asserts Christian Dunne, director of Global Corporate Business Development at ChargePoint Technology. “We're still seeing there aren’t that many full continuous processes out there, but we do see a lot more semi-continuous processing. So that's where you're sort of combining two or maybe three processes together, and that that may be to start with, in terms of stacking them up, allowing the continuous process of material going from one process into another.”

Additionally, with the advent of more robotics, particularly in a cleanroom space, there is scope for companies to remove the operator from certain aspects of the process, which is helping to reduce risk, Dunne confirms. “Placing a robot into the process stream removes the operator, and that's the best thing you can do, from a containment perspective,” he says. “You have less risk for the operator, but you also have a vast improvement on the product quality as well. We do know from a microbiological perspective that generally it's the operator which is the most contaminating source on the process. So, if you can get [the operator] out of there, you've improved both the containment from the operator perspective, and also the product quality as well.”

Automation and reducing potential contamination are common threads throughout the European Union good manufacturing practice (GMP) Annex 1 guidance document, Dunne notes. “It's kind of a theme that's running through the whole of that document, isolating the operators from the process,” he says. “We're seeing lines now that are almost completely autonomous. And I think that [more automation is] going to be something that's going to come in the not-too-distant future.”

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About the speaker

Christian Dunne is director of Global Corporate Business Development at ChargePoint Technology—a pharmaceutical containment and aseptic processing specialist company. Christian has worked in the bio/pharma industry for 20 years covering oral solid dosage manufacturing through to sterile processing and fill/finish manufacturing.