CoMetro CP100-LDI Dual-Piston High-Pressure Preparative HPLC Pump for Protein Purification

Overview

The CoMetro CP100-LDI is a dual-piston, high-pressure isocratic preparative liquid chromatography pump engineered specifically for robust and reproducible protein purification and biopharmaceutical process development. Operating on the principle of positive displacement via synchronized dual piston heads, it delivers continuous, pulse-free solvent delivery essential for maintaining column integrity and resolution during large-volume sample loading—critical in downstream processing of monoclonal antibodies, recombinant proteins, and viral vectors. Its architecture supports sustained operation at up to 6000 psi (standard) with optional 10,000 psi configurations, enabling compatibility with both conventional preparative columns (e.g., 21.2 mm × 250 mm) and high-efficiency media such as POROS or Capto resins. Unlike analytical-scale pumps, the CP100-LDI prioritizes long-term flow stability over ultra-low flow capability, making it suitable for gradient-elution–compatible systems when paired with external solvent selection valves and fraction collectors.

Key Features

• Dual parallel piston heads ensure uninterrupted flow delivery, eliminating pressure pulsation and minimizing baseline drift during extended runs (>24 h).
• Adjustable flow rate range of 0.1–100 mL/min with ≤0.1% RSD precision and ±1% absolute accuracy across the full span—validated per ISO 9001 calibration protocols.
• Wetted path constructed from chemically resistant materials including electropolished SS316L and PEEK, supporting compatibility with aggressive mobile phases (e.g., high-concentration ammonium acetate, guanidine HCl, low-pH citrate buffers).
• Integrated auto-cleaning cycle for pump heads—programmable via front-panel interface—to flush residual salts from seal surfaces and extend service life of plunger seals and check valves.
• Modular design allows field-swappable pump heads and easy access to maintenance points without disassembling the main drive assembly.
• RS-232 and optional Ethernet connectivity support remote monitoring and integration into centralized lab automation platforms.

Sample Compatibility & Compliance

The CP100-LDI is routinely deployed in cGMP-adjacent environments for purification of therapeutic proteins under controlled conditions. Its mechanical design and material selection comply with ISO 13485 requirements for medical device component manufacturing support. While not an FDA-listed device itself, the pump meets critical elements of FDA 21 CFR Part 11 when operated with compliant software (e.g., third-party chromatography data systems with audit trail functionality). It supports buffer exchange and desalting steps aligned with ICH Q5A(R2) guidelines for viral clearance validation studies. All wetted components are non-leaching and extractables-tested per USP , ensuring no interference with UV detection at 280 nm or downstream mass spectrometry analysis.

Software & Data Management

The CP100-LDI operates independently via its embedded microcontroller interface or synchronously through external command protocols (ASCII-based SCPI commands). When integrated into validated chromatography systems, it logs timestamped operational parameters—including actual pressure, delivered flow, runtime, and cleaning cycles—into secure CSV or XML files. These records support retrospective review during regulatory inspections and satisfy ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate). Optional firmware upgrades enable enhanced event logging, password-protected parameter locking, and configurable alarm thresholds for overpressure or flow deviation events.

Applications

• Preparative-scale ion exchange and size exclusion chromatography of IgG and Fc-fusion proteins.
• Buffer exchange and diafiltration in process intermediate hold steps prior to ultrafiltration/diafiltration (UF/DF).
• Continuous-flow affinity capture using immobilized Protein A columns under scalable flow conditions.
• Method transfer from analytical to pilot-scale purification workflows requiring precise volumetric control.
• Integration into automated flow chemistry platforms for multi-step bioconjugation or enzymatic modification reactions.

FAQ

What is the standard warranty period for the CP100-LDI pump?

CoMetro provides a 24-month limited warranty covering parts and labor for defects in materials and workmanship under normal laboratory use.
Can the CP100-LDI be used with organic solvents such as acetonitrile or methanol?

Yes—when equipped with SS316L pump heads and compatible seals, it supports common HPLC-grade organic modifiers; however, prolonged exposure to >70% TFA or halogenated solvents requires custom seal material consultation.
Is the pump compliant with electronic record requirements under 21 CFR Part 11?

The hardware itself does not constitute a Part 11 system; compliance depends on integration with qualified software that implements audit trails, electronic signatures, and role-based access controls.
How often should the pump head seals be replaced under typical protein purification usage?

With routine auto-cleaning and proper buffer filtration (0.22 µm), seal replacement intervals typically exceed 6 months at 5000 psi and 50 mL/min continuous operation.
Does CoMetro offer IQ/OQ documentation packages for this model?

Yes—qualified users may request vendor-supplied Installation Qualification (IQ) and Operational Qualification (OQ) templates aligned with ASTM E2500 and ISPE GAMP5 standards.