The advantages in development due to scalability and speed of parameter change evaluation are obvious. What's less clear to me is how to avoid possible quality and manufacturing pitfalls. What happens to upstream material that's been introduced if a problem arises? How do you reliably detect and weed out OOS material? Have advances in instrumentation in the industry kept up with the demands of multi-unit processes? (the automobile industry has mind blowing systems that integrate with each other reliably so it's certainly possible). How does downtime for product and equipment changeovers generally compare with batch processing? How have the validation challenges been for you? Thank you for your presentation. I'd love to learn more about the subject.
In my experiences, pharma "continuous" manufacturing is most a gimmick right now. We cannot call continuous a process that takes 16 - 48 hours and them it stops, that's still a batch for me. I like the automation ooportunities and the innovation, but unless we are producing constantly, it shouldn't be called 'continuous", more like automated multi-stage manufacturing system.
The advantages in development due to scalability and speed of parameter change evaluation are obvious. What's less clear to me is how to avoid possible quality and manufacturing pitfalls.
What happens to upstream material that's been introduced if a problem arises? How do you reliably detect and weed out OOS material? Have advances in instrumentation in the industry kept up with the demands of multi-unit processes? (the automobile industry has mind blowing systems that integrate with each other reliably so it's certainly possible). How does downtime for product and equipment changeovers generally compare with batch processing? How have the validation challenges been for you?
Thank you for your presentation. I'd love to learn more about the subject.
Thanks for the very interesting video!!!
In my experiences, pharma "continuous" manufacturing is most a gimmick right now. We cannot call continuous a process that takes 16 - 48 hours and them it stops, that's still a batch for me. I like the automation ooportunities and the innovation, but unless we are producing constantly, it shouldn't be called 'continuous", more like automated multi-stage manufacturing system.