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SYSTAG scale-up solutions
As a specialist in automation and laboratory scale chemistry, SYSTAG can provide precisely tailored chemical laboratory automation solutions that meet the specific challenges of pharmaceutical process scale-up in chemistry.
The aim of scale up is to be able to transfer the reaction process developed in the laboratory at milliliter or gram scale to a full production process run on full-sized industrial reactors at multi-litre or kilograms scale.
Process scale up challenges
For all applications, chemical process scale up needs to be done as efficiently and reproducibly as possible and in pharmaceutical applications, there are also the additional challenges of ensuring reproducibility and consistency, as mapped by a validable data audit trail to satisfy the demands of regulators and quality assurance and control (QA/QC).Furthermore, there is the increasing need to integrate the scale up process in the pharmaceutical industry in particular among what may be a highly diverse network of individual development laboratories and industrial production facilities, possibly organized on global lines. What is required is a flexible and universal system that can integrate control, automation and data recording of reactors from the smallest chemistry laboratory scale up to the kilo-batch on a single shared platform: FlexyConcept from SYSTAG.
FlexyConcept process scale up and design
SYSTAG’s FlexyConcept integrates the management and outputs of different control and automation systems into a single architecture and operating environment. It unites a family of application control platforms that between them cover the entire scale-up process, from laboratory to industrial production.
- FlexyCUBE for lab scale screening and development: a parallel process optimization system that allows up to six steel or jacketed glass reactors to be independently controlled from a single PC, using parallel design of experiment (DoE) or individual operation. Ability to use progressively larger scale up reactor sizes from 70ml up to 400ml means FlexyCUBE can be used as a multifunctional instrument for process research (route scouting) as well as for process development. Simple operation and robust components allow use almost from the start of development cycle, while the fully automated control system can return important insights from small tests for the next scale-up step, with high reproducibility and full data capture enabling more meaningful results from the experiments.
- FlexyPAT for process flow optimization: this individual reactor lab automation solution allows several jacketed scale up reactor vessels to be operated from a single PC as customized turn-key systems, facilitating integration of existing legacy hardware to reduce cost, speed up the automation process and increase user acceptance. The FlexyPAT concept allows simple and inexpensive system extension with user-friendly system configuration through integrated sensor identification to encompass a very wide range of possible expansion or tailoring options. FlexyPAT can import the experimental parameters set on FlexyCUBE and scale-up by 20 times to explore physical aspects during the work-up process, including phase separation optimization of crystallization. Combined with online analysis tools such as FTIR or particle size analyzers, FlexyPAT can provide an in-depth and comprehensive insights into the process flow, greatly reducing process time and resources.
- FlexyPlant for customized automation of kilo lab scale plants: handling reactor sizes up to 250 liters, FlexyPlant uses total turn-key solutions for plants, sensors and fittings in collaboration with proven partners. FlexyPlant also enables automation of special apparatus, such as rectification units, hydrogenation laboratory autoclaves, polymerization plants, etc., and delivers valuable benefits, including a consistent operating concept shared with laboratory and pilot plant scale up applications, automated data capture and reporting, cGMP qualification and conformance with CFR 21 Part 11 data requirements.
The key to consistent ‘Look and Feel’ across all control systems, ranging from FlexyCUBE through FlexyPAT to FlexyPlant is the use of FlexySys application software and user interface throughout. This minimized the need for operator training, maximizes acceptance and allow all systems to be remotely monitored and operated from a PC with increased safety and maximum operating comfort. Seamless data recording of the different reaction variables can be compared easily and quickly and automation steps or complete recipes exchanged between individual reactors using intuitive drag & drop.
Thanks to this unique combination of process research, process development and scale-up, the process engineer can realize the complete synthesis and scale-up of the entire process on the same plant, allowing more efficient space utilization and the highest possible throughput of the individual processing steps.
Click on Parallel Process Development and Scale up by Factor of 300 for pharmaceutical industry case study.
Click on SYSTAG FlexyPlant specific laboratory automation solutions to download product bulletin.
SYSTAG’s FlexyConcept architecture covers the entire spectrum of process development and scale up