Continuous Flow Technology (CFT)
Application of continuous flow technology (CFT) to drug substance manufacturing compared to use of traditional stirred batch type reactions is an example of the innovative approaches taken to process design that you can expect from Siegfried.
As one of the most promising future process technologies CFT offers advantages for:
- Improving the degree of purity achieved and/or higher process yield
- Avoiding ultra-low temperature process steps
- Simplifying process scale-up
- Achieving a higher process stability
- Enabling safe operation of chemistries otherwise not possible in batch mode
These advantages led Siegfried to institute a laboratory program with the goal of implementing this technology at manufacturing scale in a cGMP pharmaceutical context. With the right process, CFT can provide the improved level of process control desired by Quality by Design (QbD) approaches, combined with improved process economics as compared to batch operations.
Siegfried has successfully applied CFT at both lab and pilot levels for a variety of processes. We have several published case studies which illustrate the types of desired process improvements that can be achieved:
Our equipment inventory for CFT includes glass and metal equipment (nickel, hastelloy C22, & steel apparatus), as well as measurement and control equipment required for mass flow, pressure, temperature and volume (on-line Raman probe used).
Also, CFT is well suited for evaluating a reaction's parameter space using statistical experimental design. In this area we apply Stavex®, a tool for software-supported experimental design.
If you need a fresh alternative look at how your process could be developed, Siegfried would be delighted to evaluate with you the benefits continuous flow can offer. The prospects for improving standard batch processes can be much greater than you first expect.