Continuous CPC Purification
The Continuous CPC platform is a continuous, multiple dual-mode, dual-rotor CPC platform.
The Continuous CPC consists of two interconnected GMP-rCPC devices, a preparative unit, and the control unit. Unlike the standard batch operational mode, it enhances throughput with its continuous injection mode, allowing for more efficient sample processing and multiple increase in production, beside low operational cost. It’s highly scalable, adaptable to various sizes and requirements, and built with robustness in mind, meeting GMP industrial standards for durability. This device is exceptionally versatile, making it adept at handling liquid-liquid chromatography. It incorporates an on-demand solvent handling system that can be tailored to specific industrial standards.
Uninterrupted Excellence
Chromatographic techniques evolved to a point where laboratory and industrial-scale separations are routine work. In centrifugal partition chromatography (CPC) separations, the possibility to work without silica gel and irreversible bondings, and the selection of suitable solvent systems are simplified with the availability of generic sets of solvent combinations described in various publications and books.
In a batch process, the desired product is manufactured in a single production run. Once the batch is completed, a new production cycle can begin.
Continuous processes, however, sustain uninterrupted and ongoing production of the product. This results in a continuous inflow of raw materials and a constant outflow of the product.
Continuous processing is seamless, and offers constant production output for high-demand scenarios, and is highly compatible with other continuous technologies.
Benefits of Continuous Manufacturing
- Smoother transition to higher production volumes: The absence of batch-related constraints allows a disruption-free overall process, making scale-up efforts easier.
- Minimizes both CAPEX and OPEX: No restarting separations, no silica gel or cartridges. No high solvent consumpliton but effective recycling.
- Seamless, nonstop production flow: Eliminate frequent start-ups and shutdowns.
- Automation for efficiency and reduced human errors: Predictive maintenance techniques, can prevent equipment downtime and optimize equipment lifespan.
- Significantly Less Footprint: Continuous manufacturing requires less footprint in your facility, compared to other complicated instruments.
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Continuous CPC Platform
The Continuous CPC is a system with two connected rotors, equipped with four pumps, which allows for continuous or semi-continuous operation in a repeating process. In this setup, a mixture is constantly introduced between the two rotors, and two products are collected one after the other at opposite “ends” of the two-rotor system.
Each cycle consists of two steps, similar to the ascending and descending elution steps in CPC separation modes. These steps differ in the liquid phase used as a mobile phase and its flow direction. In each step, the components we want to separate are dissolved in the mobile phase used at that time.
This setup falls into the same category of separation processes as SMB technology, where we continuously separate a binary mixture into two fractions at very high throughput.
You might come across various names for this setup, like Sequential CPC (sCPC), True Moving Bed (TMB), Trapping MDM, or “intermittent” CCC, but they all refer to the same system.
Threefold Increase In Productivity
Case Study: PA-Remediation of Red Clover
The aim of the separation was to reduce the pyrrolizidine alkaloid (PA) content below 400 ppb. Both methods successfully decreased the content of these alkaloids below the specification, while keeping the isoflavones content of the samples on the same level.
Red Clover (Trifolium pratense) is another commonly used plant in traditional medicine, used to treat diseases such as osteoporosis, heart disease, arthritis, skin disorders like eczema, respiratory problems like asthma, and women’s health issues, such as menstrual and menopausal symptoms.
Application of continuous injection was tested on a red clover aerial parts extract sample containing higher amount of pyrrolizidine alkaloids (PAs).
Due to the wide polarity range of the valuable components (isoflavones) and pyrrolizidine alkaloids, RotaChrom’s CPC method was suitable for continuous injection, and so the remediation was carried out with the Continuous CPC. The platform was operated in the so-called multiple dual-mode (MDM), with periodic changes between ascending and descending mode operations, changing the role of the mobile and stationary phases in every cycle. The successful separation is shown in the table.
The same Class 3 solvents could be used. The original batch method and the implemented continuous separation are compared in the bar graphs in the figure. Like earlier, more than 3-fold increase in productivity was achieved by using continuous mode of injection, while no significant change was in the total solvent consumption.
Chromatogram of the separation of the components.
Comparison in the total solvent consumption and the productivity between batch and multiple-dual modes.
GMP-Compliant Standards
RotaChrom’s Continuous Centrifugal Partition Chromatography (Continuous CPC) platform is a continuous, multiple dual-mode, dual-rotor CPC platform. It consists of two interconnected rCPC devices, a preparative unit, and the control unit. It’s highly scalable, adaptable to various sizes and requirements, and built with robustness in mind, meeting industrial standards for durability.
- The device is exceptionally versatile, making it adept at handling liquid-liquid chromatography
- It incorporates an on-demand solvent handling system that can be tailored to specific industrial standards.
- It enhances throughput with its continuous injection mode, allowing for more efficient sample processing.
RotaChrom ensures that its device complies with cleaning validation and cleaning standards in line with GMP directives:
- The Continuous CPC is explosion-proof, suitable for installation in rooms classified as ATEX/IECEx Zone 2.
- The electrical cabinet comes pre-certified for added safety assurance.
- All wetted components are constructed from high-quality materials like 316L/1.4404 stainless steel or PEEK
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Further compliance data
- Cleaning validation and cleaning methods are customized to your platform, in accordance with cGMP directives. Reference: (FDA: validation of Cleaning Process - Guideline (7/93); FDA Section 211.67 in 21 CFR ; Eudralex Volume 4. Chapter 3.: Premises and Equipment; Eudralex Volume 4. Annex 15. Point 10.)
- The Dual Rotor CPC system is intrinsically safe and can be placed in ATEX/IECEx Zone 2 environments. The electrical cabinet comes pre-certified.
- All stainless steel wetted components are constructed from AISI 316L/1.4404 stainless steel with EN 10204 3.1. certificates or PEEK for maximum durability and reliability.
- All other wetted components come with FDA 21 CFR 177.2600 certificates,which is a must for pharmaceutical production.
- The equipment comes with a software solution with qualification and testing documents available that are designed for FDA 21 CFR part 11, GAMP 5 and EUDRALEX Volume 4., Annex 11. compliance.
- Complete qualification flowchart and process with high quality documentation based on EUDRALEX Volume 4., Annex 15 and Annex 11., and FDA 21 CFR part 11. Requirements (DQ, FAT, IQ, OQ and PV process and documentation) provided.
- Complete traceability for all parts and processes.
RotaChrom brings industrial-scale CPC solutions to businesses, researchers, CROs and CDMOs.
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RotaChrom Technologies developed the world’s first industrial scale centrifugal partition chromatography technology solution. These liquid chromatography machines revolutionized purification by providing innovative, sustainable, and efficient industrial scale LC-CPC chromatography to customers all over the world in various industries, including pharmaceutical, nutraceutical and botanical extracts.
RotaChrom’s proven GMP compliant CPC designs are effective solutions when looking for a high-purity, high-capacity, cost-effective and environmentally conscious solution. RotaChrom, with its in-house research laboratory employing world class PhD chemists, engineers and leading business professionals on multiple continents, is the best partner in purification.
Our portfolio includes several products, which can help you scale your business from research to industry. Select between lab scale, pilot scale or industrial scale purification:
- The rCPC platform for pilot-scale purification tasks within a laboratory environment. It is ideal for all batch sizes, smaller or larger, or campaign type of research work, and continuous-batch production.
- The iCPC platform, which is the largest commercially available centrifugal partition Chromatography instrument in the world. It is designed for industrial-scale purification projects in continuous batch operation mode.
CPC offers many benefits compared to traditional chromatographic solutions.
HPLC, flash, supercritical fluid chromatography and traditional chromatographic are all outperformed by CPC. Without the need for silica gel or cartridges, and the benefit of easy, linear scalability, plus the solvent handling capacity demonstrably make CPC the most cost-efficient chromatography solution long-term.