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Peak Biotech - LPLC Systems for Low Pressure Chromatography
Peak Biotech offers LPLC systems engineered for low-pressure chromatography, catering to both pilot and production scales within the biotech and pharmaceutical sectors. These systems are adaptable to continuous or batch processing modes and conform to pertinent industry standards such as CFR Part 11, GAMP5, and S.88. Customization is a core attribute, with a range of configurations available to meet distinct client needs. The systems incorporate features like high-accuracy gradient mixing loops, inline degassing, and comply with sanitary ASME BPE design principles. Standard construction utilizes stainless steel, with explosion-proof models for specific regional compliance, including ATEX and CE marking. Advanced control is provided by the proprietary PeakChrom software, ensuring full process automation, batch control, and comprehensive documentation. Additional options for system enhancement include various instrumentation and automation accessories, ensuring robustness, reliability, and efficient operation.
Peak Biotech LPLC systems are available for low pressure chromatography applications, in pilot to production scale.
The systems are designed for continues or batchprocessing and in compliance with all relevantstandard within the pharmaceutical and biotechindustry.
The systems are custom designed to fit the customer requirements with many different configurations and options.
The systems are controlled by PeakChrom software speciel designed for chromatography process and the software is in compliance with CFR Part 11, GAMP5 and S.88.
Systems are available in linear gradient, step gradient or isocratic version.
High focus on safety and ergonomic design.
Specifications
Flow rate in range 6 - 10000 l/h.
Pressure range up to 10 bar.
Automation / Control system
Fully automated with Peak Control Software, the software is in compliance with all relevant standards like CFR Part 11, GAMP 5 and S.88.
Designed for fully automated batch control. The software is fully documented and tested.
For more details click automation.
Gradient performance
High accuracy gradient mixing loop with feedback from conductivity or other inline instrument.
Inline mixing from 0 - 100% with accuracy below 1% of FS (full scale).
Inline degassing gradient loop.
Systems are avaiable in gradients or isocratic versions.
Materials and construction code
Standard systems are fabricated in Stainless Steel.
All used components are fully documented and tested.
Systems are available in Explosion proof versions that fulfill the requirements for Europe (ATEX) or US (Class One Div xx). Systems for Europe are CE marked.
Designed according to ASME BPE.
Sanitary design
Systems are designed with focus on sanitary design.
Connections are sanitary design with sealings in
PTFE or EPDM.
Flexible
The systems are mobile and can be moved around within the facility.
Easy installation and connection for quick start-up.
Designed for production and 24h running.
Short down time and low maintenance cost.
Reliable and reproducible.
Qualification, validation and services
Peak Biotech offer fully documented qualification pakage (e.g. FAT, SAT, IQ, OQ & PQ) for all equipment.
For more details click qualification.
Standard configuration
Lob rotor or Diaphragm pump 3 heads.
Stainless Steel piping and instruments.
4 Inlets, 2 used for gradient performance.
1 product inlet.
5 fraction outlets.
Conductivity instrument for gradient feedback.
Options
• Extra buffer inlets (4 is standard)
• Extra fraction valve (5 is standard)
• Conductivity after column
• Pressure after column
• Temperature before and after column
• Alternative pump type
• Magnetic flow meter
• Recycle loop
• Filter module, in-line
• Sample loop for small amount of product orcolumn testing
• Nitrogen blowing of product lines
• Heat exchanger
• Load pump
• Valve feedback
• And many others