GMP-Compliant CPC Platform
Research & Production CPC Platform with GMP-compliant Design.
The GMP rCPC is RotaChrom’s liquid-liquid centrifugal partition chromatography (CPC) platform, designed to adhere to Pharma-GMP regulations.
Pharma-GMP regulations are strict. This is how you can achieve compliance.
Producing API-grade and pharmaceutical compounds requires adhering to strict and meticulous regulations. Several companies aiming to enter the market struggle to comply to these regulations. This is why we'd like to introduce the GMP-compliant rCPC platform to you.
The GMP rCPC is RotaChrom’s liquid-liquid centrifugal partition chromatography (CPC) platform, designed to adhere to GMP regulations.
The rCPC platform can be used for API-grade compound production and pilot-scale purification and research tasks in a pharmaceutical environment.
Reach GMP-compliant compound purification with RotaChrom.
- The device you receive will be fully compliant to FDA 21 CFR part 11 requirements.
- All wetted stainless-steel components conform to AISI 316L SS with EN 10204 3.1. material certificates.
- All other wetted components come with FDA 21 CFR 177.2600 certificates, which is a must for pharmaceutical production.
- The rCPC 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.
More than just a device.
RotaChrom offers more than just a centrifugal partition chromatography platform.
What you will receive if you decide to work with us:
- GMP-Compliant Pilot-scale Research & Production Centrifugal Partition Chromatography Platform.- Bespoke GMP-Compliant Design for Your Goals, Requirements, and Facility.
- Material Certificate and Traceability for All Parts of the Equipment.
- Software Designed for Security and Traceability of Operation.
- Cleaning Validation and Cleaning Method Tailored to Your rCPC and Solvent System.
Bespoke Design for Your Goals, Requirements, and Facility.
No two Partners are the same. Chromatographic challenges and goals, and facilities are all individual and unique, and cannot be handled by generic “cookie cutter” solutions.
RotaChrom’s team can help its partners benefit from bespoke and custom-made purification solutions. Our team will ensure that the device the Partner receives is optimized so they can achieve maximum extraction.
Read more about LLC's advantages in the white paper.
Download your free GMP compliance guide here.
To help you learn more about GMP compliance and how the rCPC can help you in your API production journey, we would like to offer you a free guide, which contains all the relevant data and knowledge to get you started.
Please complete the form below to download your free guide.
rCPC Datasheet
The table below shows the performance and data of the rCPC, highlighting its maximum capacities.
Centrifugal Partition Chromatography
Centrifugal partition chromatography (CPC) is a liquid-liquid chromatographic technique, in which separation occurs between two immiscible liquid phases. Both the mobile and stationary phases are liquids, and the liquid stationary phase is immobilized by a strong centrifugal force. The solute’s retention depends simply on the liquid-liquid partition coefficient (Kd).
RotaChrom engineers designed 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.
RotaChrom brings industrial-scale CPC solutions to businesses, researchers, CROs and CDMOs
What you have seen so far is just the tip of the iceberg.
If you'd like to dive deeper, please fill in the form above, and grab your free copy of RotaChrom's 'Advanced Chromatography' white paper. The paper covers 4 in-depth chapters about CPC and LLC.
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.
