Cytiva FineLINE Pilot 35 Preparative Chromatography Column
| Brand | Cytiva |
|---|---|
| Origin | Sweden |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | FineLINE Pilot 35 |
| Price | Upon Request |
Overview
The Cytiva FineLINE Pilot 35 is a high-precision, scalable preparative chromatography column engineered for reproducible, high-efficiency packing of SOURCE™ media—including SOURCE 15 (ion exchange, hydrophobic interaction, and reversed-phase) and SOURCE 30 (ion exchange) resins. Its design leverages hydraulic slurry packing—a validated, pressure-driven method that achieves dense, homogeneous beds in minutes—enabling column efficiencies exceeding 22,000 theoretical plates per meter for SOURCE 15 and >11,000 plates/m for SOURCE 30. The column operates at up to 20 bar maximum system pressure and is constructed for compatibility with standard ÄKTA™ process systems and GMP-aligned workflows. Unlike conventional columns relying on mechanical compression or gravity settling, the FineLINE Pilot 35 employs a single-inlet/single-outlet flow distribution architecture with multi-layer sintered stainless steel frits, ensuring uniform radial flow distribution and minimal backpressure—even at high linear velocities.
Key Features
- Hydraulic packing capability enabling rapid, repeatable bed formation with exceptional density and homogeneity
- Scalable diameter range: configurable from 35 mm to 350 mm (Pilot 35 serves as the foundational platform for method development and small-scale production)
- Electropolished stainless steel column body (316L grade) with precision-machined borosilicate glass end fittings and EPDM elastomer seals
- All polymer components certified USP Class VI for biocompatibility and extractables/leachables compliance
- Integrated SRV-1 bottom isolation valve for secure column sealing during storage or transport
- Standard 25 mm hygienic (DIN 11851 / SMS 1144) flanged inlet/outlet connections with 6 mm ID tubing interface
- Pre-validated flow path geometry with dual-layer sintered metal frits (2 µm default; optional 10 µm available) minimizing channeling and wall effects
Sample Compatibility & Compliance
The FineLINE Pilot 35 is qualified for use with all SOURCE series chromatographic media, including low- to medium-capacity ion exchangers (SOURCE 15 Q/S, SOURCE 30 Q/S), hydrophobic interaction (SOURCE 15 PHE, SOURCE 15 BUT), and reversed-phase (SOURCE 15 RPC) resins. Its materials of construction meet ISO 10993-5 cytotoxicity requirements and USP and biological reactivity standards. The column’s design supports regulatory submissions under ICH Q5, Q7, and FDA 21 CFR Part 11 when used within validated chromatographic processes. Documentation packages include Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) templates aligned with GMP and GLP frameworks.
Software & Data Management
While the FineLINE Pilot 35 is a hardware-only component, it integrates seamlessly with Cytiva’s UNICORN™ software (v7.0+), enabling full traceability of packing parameters—including axial compression pressure, slurry volume, flow rate, and final bed height—via manual entry or direct linkage to ÄKTA™ system logs. UNICORN supports electronic signatures, audit trails, and user-access controls compliant with 21 CFR Part 11. Packing validation reports generated through UNICORN can be exported in PDF/A-1b or XML formats for inclusion in regulatory dossiers. Optional data export modules support CSV-based integration with LIMS or MES platforms.
Applications
- Method development and transfer for purification of monoclonal antibodies, Fc-fusion proteins, and viral vectors
- Small-batch GMP manufacturing of clinical-stage biologics (up to 10–50 g purified product per run)
- Process characterization studies evaluating resin lifetime, binding capacity, and cleaning-in-place (CIP) robustness
- Scale-down modeling for larger-scale FineLINE 70, 100P, 200P, and 350P columns
- Stability-indicating purification of degraded or aggregated species under non-denaturing conditions
FAQ
What is the maximum operating pressure for the FineLINE Pilot 35?
The column is rated for continuous operation at up to 20 bar; however, hydraulic packing is typically performed at ≤10 bar using an external pressure-relief valve (RL4 series, not included).
Is the column compatible with ÄKTA pure and ÄKTA avant systems?
Yes—via standard 25 mm sanitary flanges and 6 mm ID tubing kits; Cytiva provides TC-connector corrugated tubing and M6 adapters for seamless integration.
Are replacement frits and O-rings available as spare parts?
Yes—2 µm and 10 µm sintered stainless steel frits, EPDM O-ring kits (PFR series), and solvent-resistant fluorocarbon alternatives are cataloged and stocked.
Does the column require special tools for assembly?
Standard torque-controlled wrenches are sufficient for non-hazardous environments; ATEX-certified tools are mandatory if used in classified explosive atmospheres.
Can the column be sterilized in place (SIP)?
No—heat sterilization is not recommended due to EPDM seal limitations; steam sanitization is also not supported; chemical sanitization with 0.1–1.0 M NaOH is validated and routinely applied.
