Description
The next generation K-Prime 40 chromatography systems enable the user to separate and purify a broad range of proteins, vaccines, Mab's and other bio-engineered products at the methods development, pilot separations and large manufacturing scales.
Each system is designed to provide a full range of features and capabilities which meet the most stringent and demanding purification requirements. Each system may be fitted with a wide variety of options to configure the system to meet your specific needs. The units are sanitary in design, with pipework configured to ensure optimal fluid management, near-zero un swepted volume with no cross-port contamination from deadlegs or trapped fluids. This results in superior chromatographic separations with improved purity and increased product yields.
Industry-standard instruments, sensors and "off the shelf" components are used ensuring high system reliability, quick availability of spare parts and minimized process down time. Each unit is supplied with a comprehensive Users Manual and Validation Guide and is subjected to a full Product Acceptance Test (PAT) prior to shipment thus ensuring proper operation at the customers site. All wetted materials are FDA conforming or are subjected to USP VI testing to ensure suitability for BioPharm applications.
Scalability
Four sizes of K-Prime 40 systems are available, specifically designed to suit your processing needs from process development to full scale production. Recipes developed on smaller scale systems can be transferred to larger systems quickly and easily, enabling rapid scale up of new products where "time to market" is critical. Validation efforts are significant reduced due to commonality of design and automation platform.
Common Control Platform
Each chromatography unit includes the CCP control system which is based upon the widely-accepted Intellution iFix SCADA program. CCP provides the user with the necessary tools to develop and run repetitive and consistent separation routines. System operation, programming and protocol development is done through an intuitive, user-friendly, graphical interface which shows systems status, allows manual control and initiation of automated recipes. The embedded PC downloads recipes to the systems on board PLC for later execution and connects to a plant network via a high speed ethernet communications link.
Data Handling and Security
Full monitoring and recording of process parameters is provided for compliance with cGMP procedures. All original data is recorded and stored in unalterable format which may later be viewed in several file formats.
To ensure regulatory compliance CCP meets 21 CFR Part 11 requirements for electronic signature and batch records.
Validation
Process validation tools are included to simplify documentation of system operation and the development of purification protocols during process development. Recipe development tools eases rapid scale up to the production suite. System operations are protected during execution with user-definable alarms to ensure process integrity and operational safety.
| 40-I | 40-II | 40-III | 40-IV |
| Flow Rate Range, L/min | 0.02 - 0.5 | 0.1 - 3 | 1 - 10 | 5 - 30 |
| Tubing Size, mm | 3 | 6 | 10 | 25 |
| Pressure Rating, bar | 7 | 7 | 7 | 5 |
| Buffer Inlets | 4 | 4 | 4 | 6 or 8 |
| Bubble Auto Vent & Alarm | • | • | • | • |
| Pipework | Plastic | Plastic | Plastic | 316L SST |
| Magnetic Flow Meter | • | • | • | • |
| Fraction Valves | 3, 5, 10 | 3, 5, 10 | 3, 5, 10 | 3, 5, 10 |
| Post-column UV, pH & Conductivity | • | • | • | • |
Options
• Precolumn instrumentation
• Automated clean in place
• Mass flowmeter
• Combination filter/bubble trap
• Ethernet enabled printer
• Desktop PC. Enables remote monitor or system control and recipe development
• Valve operation indicator & position switch
• Dual wavelength detector with simultaneous peak detection
• UV detector auto zero
Customer Specified Units K-Prime 400 BioChromatography Systems
In addition to our range of pre-engineered solutions Millipore has the capability to design innovative separation system solutions which meet unique processing and site requirements.
With hundreds of chromatography systems installed at validated facilities we offer a comprehensive library of proven solutions to rapidly meet any chromatography application, from small scale to the purification suite. The K-Prime 400 Chromatography systems may be configured to meet unique applications.
Examples are:
• System configurations to meet unique processing or cleaning requirements, i.e. class 10000 and/or cold room environments
• Pipework requirements enabling multi-column operations
• Unique flowrates applications, from 50 mL/min to over 100 L/min
• Special requirements for specific components, valve, instruments
• Explosion proof to relevant standards to address use of hazardous and flammable solvents
• Unique design to address regulatory needs, UL, EN, ASME, CE, etc..
• Additional functionality which enable comprehensive investigative applications
• Customer specific automation requirements
• Corrosion resistant materials, i.e. plastic, Hastelloy-C
• Connectivity requirements to other unit operations, (.i.e. TFF systems), where precise process optimization is a necessity
Millipore engineers work closely with customers to ensure custom engineered systems are designed and assembled to exacting specifications, quickly and cost effectively.
After assembly each unit undergoes comprehensive qualification testing prior to shipment to ensure proper operation. Like our pre-engineered systems each unit comes complete with a comprehensive documentation package.
Ordering Information
For further information contact your local Millipore representative.
