Contichrom® PILOT
The Contichrom® PILOT 300X is a preparative HPLC system engineered for pilot-scale manufacturing of pharmaceuticals in a GMP environment. It combines twin-column continuous chromatography (MCSGP with AutoPeak®) with the robustness required for pilot-scale production. Designed to handle both aqueous and organic solvents, the system is fully compliant with hazardous location requirements (ATEX Zone 2, Class I Div 2), making it ideal for the purification of peptides, oligonucleotides, and other synthetic molecules. With a maximum operating pressure of 100 bar, a flow rate of up to 300 mL/min, and columns up to 10 cm ID, methods developed on the Contichrom CUBE transfer directly to the PILOT 300X using established scale-up protocols.
Overview
GMP-Ready Preparative HPLC for Pilot-Scale Manufacturing
The Contichrom® PILOT 300X is a preparative HPLC system engineered for pilot-scale pharmaceutical manufacturing in GMP environments.
- Twin-column continuous chromatography (MCSGP with AutoPeak®)
- ATEX Zone 2 / Class I, Div 2 certified for organic solvents
- 100-bar pressure, up to 300 mL/min flow rate
- Purpose-built for peptides, oligonucleotides, and synthetic molecules
- ChromIQ® X software with 21 CFR Part 11 compliance
One System, Multiple Processes
A single GMP-ready platform — no hardware changes between modes:
| Mode | Technology |
|---|---|
| Batch | Single-column batch purification |
| 2D Integrated Batch | Two orthogonal steps, one automated process |
| Continuous polishing | MCSGP with AutoPeak® |
| Impurity enrichment | N-Rich® with AutoPeak® |
- Every process benefits from AutoPeak® dynamic control
- Enables unattended 24/7 operation
ATEX-Compliant for Organic Solvents
Fully certified for hazardous location operation:
| Specification | Value |
|---|---|
| European | ATEX Zone 2 |
| North American | Class I, Division 2 |
| Enclosure | IP23 |
- Intrinsically safe components throughout the fluid path
- Electrical cabinet with nitrogen air purge
- ATEX-compliant keyboard via electronic safety barrier
- ESD-protected low-pressure tubing
- Ideal for reversed-phase purification with flammable organic solvents
High-Pressure, High-Performance Design
Built for demanding pilot-scale applications:
| Specification | Value |
|---|---|
| Maximum Operating Pressure | 100 bar (10 MPa / 1450 psi) |
| Flow Rate | Up to 300 mL/min per pump |
| Column ID Range | 2.7–10 cm |
| Flow Path Materials | SS 316L or Hastelloy |
- Supports modern high-performance resins for RP and IEX chromatography
- 20 automated buffer/sample inlets eliminate manual switching
- Choose between SS 316L or Hastelloy flow paths
ChromIQ® X Software Suite
GMP-ready control software with 21 CFR Part 11 compliance:
- Method Editor — Batch, integrated, and continuous process design
- AutoPeak® — Dynamic process control for MCSGP and N-Rich®
- Data Integrity — Secure PostgreSQL database with full audit trail
- User Management — Multi-level access with Active Directory support
- Connectivity — OPC UA client/server for plant integration
- Workflow — Methods transfer from CUBE’s ChromIQ® 9 wizards to ChromIQ® X for pilot-scale execution
Comprehensive Application Range
| Application | MCSGP | Integrated Batch | N-Rich |
|---|---|---|---|
| Peptides | ✓ | ✓ | |
| Oligonucleotides | ✓ | ✓ | |
| Nutraceuticals | ✓ | ✓ | |
| Impurity Isolation | ✓ |
- All processes run on the same hardware
- AutoPeak® dynamic control across every mode
MCSGP: Continuous Polishing at Pilot Scale
MCSGP with AutoPeak® resolves the purity-yield trade-off that limits batch chromatography:
- Impure side-fractions automatically recycled to the second column with in-line dilution
- Near-complete recovery of target molecule at target purity
- Eliminates re-chromatography and reduces QC burden
- Significantly lower eluent consumption and improved Process Mass Intensity (PMI)
- Enables downscaling of upstream synthesis batches through higher yields
- AutoPeak® ensures consistent quality via unattended 24/7 operation
Dynamic Process Control
AutoPeak® adjusts collection windows in MCSGP and N-Rich® using real-time UV triggers:
- Compensates for feed variability, column aging, and retention shifts
- Delivers consistent purity and yield without operator intervention
- Minimizes scope for user error
- Enables robust, unattended 24/7 operation
- Makes the process more economical and reliable at pilot scale
Scalable from Lab to Production
Part of the Contichrom® platform with established transfer protocols:
| System | Flow Rate | Application |
|---|---|---|
| Contichrom® CUBE | 0.1–100 mL/min | Method development |
| Contichrom® PILOT 300X | Up to 300 mL/min | Pilot / clinical manufacturing |
| Contichrom® TWIN HPLC | 0.5–36 L/min | Commercial GMP production |
- Develop on the CUBE, scale on the PILOT 300X, produce on the TWIN
- Consistent AutoPeak® control principles across all systems
- YMC ChromaCon provides expert assistance for every scale-up step
Designed for GMP Compliance
Built to meet stringent pharmaceutical manufacturing requirements:
- Developed under the GAMP 5 framework
- 21 CFR Part 11 compliant software (ChromIQ® X)
- Comprehensive Turnover Package (TOP) conforming to ASME BPE standards
- Full material traceability with certificates (FDA 21 CFR 177, USP ⟨88⟩ Class VI, EMA 410/01)
- Surface roughness of wetted metallic parts: < 0.8 µm
TOP includes: P&IDs, material certificates, calibration certificates, component lists, performance reports.
Precision Hardware You Can Count On
A stand-alone, GMP-ready system on clean-room compliant wheels:
- 4× Pumps — Binary gradient + 2 isocratic, active seal wash
- 2× UV Detectors — 4-channel, multi-wavelength (200–600 nm)
- 2× Conductivity sensors — 0–250 mS/cm
- 8× Pressure sensors — Post-pump, pre-column, post-column
- 2× Temperature sensors — On column outlets
- 1× Air sensor — Ultrasonic on feed line
- Pneumatic valve network — 20 inlets, HP switching, 4+4 fractionation outlets
- 24″ HMI — ATEX-compliant touchscreen on rotatable arm
- Optional: pH sensors, eluent heat exchangers, fraction collector interface
How it works
Robust Hardware Engineered for GMP Pilot-Scale Chromatography
The PILOT 300X is designed as a stand-alone unit for GMP environments:
- Clean-room compliant wheels with IP23-rated enclosure
- Entire fluid path outside the main chassis for accessibility and serviceability
- Two column positions for independent and interconnected operation
- Cold room compatible (4–30 °C)
- Every component engineered for automated high-pressure switching (MCSGP, N-Rich®)
Four High-Precision Piston Pumps
Four dual-head piston pumps deliver up to 300 mL/min each at 100 bar:
| Pump | Role |
|---|---|
| P1A + P1B | Binary gradient — polishing |
| P2 | Isocratic — dilution, regeneration |
| P3 | Feed — sample loading with air sensor |
- Flow Rate Accuracy: ±2% (above 2.0 mL/min)
- Precision: ±0.5% RSD
- Gradient Accuracy: ±2% (above 10 mL/min for 10–90 %B)
- Active seal wash — 2 loops: 1 for feed pump, 1 shared
- Low pulsation for stable baselines
20-Inlet Buffer & Sample Selection
Four dedicated valve assemblies provide 20 addressable inlets:
| Pump Group | Inlets | Function |
|---|---|---|
| Gradient (P1A/P1B) | 8 (2× 4-port valves) | Elution solvents |
| Isocratic (P2 + P3) | 12 (2× 6-port valves) | Feed, buffers, wash |
- Fully automated buffer and sample selection
- Supports complex multi-step methods without manual intervention
Pneumatic Valve Network
Fast-acting, pneumatically actuated on/off valves form the fluidic control core:
- LP Inlet Valves (×4) — 20 total inlets for automated buffer/sample selection
- YMC Fast-Switching HP Valves (×7+) — Flow direction control (forward, reverse), column bypass, and inter-column connections for continuous processes
- Fractionation Valves (×2) — 4 product outlets + 4 waste outlets
- Optional: Interface for external fraction collector (ATEX compliance: user responsibility)
Dual UV Detectors
| Parameter | Specification |
|---|---|
| Type | Multi-wavelength, 4-channel Diode Array (DAD) |
| Range | 200–600 nm |
| Path length | 0.5 mm (exchangable for 0.1, 0.3, & 1 mm options) |
| Light source | Long-life deuterium lamps via fiber-optic guides |
- Unique post-column placement essential for monitoring between interconnected columns
- Provides the real-time UV signals that enable AutoPeak® dynamic process control
In-Line Process Sensors
Comprehensive real-time monitoring across the entire system:
| Sensor | Quantity | Placement |
|---|---|---|
| Conductivity | 2 | Column outlets |
| Pressure | 8 | Post-pump, pre/post-column |
| Temperature | 2 | Column outlets |
| Air (ultrasonic) | 1+ | Feed line (+ optional) |
- Conductivity sensors (0–250 mS/cm) track gradients and buffer transitions
- Pressure sensors enable precise system and differential pressure monitoring
- Air sensor protects columns from dry running and allows complete feed consumption
Static Mixers
Three high-pressure static mixers ensure homogeneous fluid composition:
- Gradient mixer — After P1A/P1B for reproducible mobile phase composition in RP and mixed-mode applications
- Recycle line mixers (×2) — In-line dilution during MCSGP side-fraction recycling, ensuring optimal binding conditions at the second column
- Material: All SS 316L
Column Management
Flexible column configurations for varied applications:
- 2 column positions with dedicated inlet, outlet, and bypass valves
- 100 bar maximum column pressure
- Column ID range: 2.7–10 cm (depending on linear flow rate)
- External mounting for easy access and temperature control
- Bypass valves allow single-column operation while the second position is serviced
ATEX Safety Systems
Multi-layered safety design for organic solvent operation:
- Intrinsically safe components throughout the fluid path
- Electrical cabinet protected by continuous nitrogen air purge (requires 8–10 bar N₂)
- ATEX-compliant keyboard connected via electronic safety barrier
- ESD-protected low-pressure tubing
- IP23-rated enclosure
- Certified: ATEX Zone 2 (Europe) / Class I, Division 2 (North America)
Human-Machine Interface (HMI)
System control via integrated industrial PC running ChromIQ® X:
| Component | Specification |
|---|---|
| Touchscreen | 24″ Siemens, Full HD, ATEX-compliant |
| Keyboard | ATEX-compliant, integrated touchpad |
| Mounting | Rotatable arm (front or side position) |
- Safe and efficient operation within GMP environments
- Flexible positioning within your facility
GMP-Grade Flow Path
Every wetted surface selected for chemical resistance and biocompatibility:
| Component | Materials |
|---|---|
| Pumps | SS 316L/Hastelloy, PEEK, ETFE, ceramic, PTFE |
| Valves | SS 316L/Hastelloy, PCTFE, FFKM, PTFE |
| HP Tubing | SS 316L or Hastelloy — 1/8″ OD, 1.78 mm ID |
| LP Tubing | FEP (ESD-protected) — 1/4″ OD, 4.8 mm ID |
| UV Detectors | PEEK, Quartz, FEP |
| Conductivity | PEEK, Titanium |
- Choose between SS 316L or Hastelloy for the complete flow path
- Full traceability with certificates (FDA 21 CFR 177, USP ⟨88⟩ Class VI, EMA 410/01)
- Surface roughness < 0.8 µm on wetted metallic parts
Optional Hardware
Extend system capability with optional modules:
| Option | Specification |
|---|---|
| pH Sensors (×2) | pH 1–14, glass/PEEK wetted parts, 16 bar max |
| Eluent Tempering (×3) | RT–60 °C eluent pre-heating (pre-column, x2), RT cooling at outlet (x1) |
| Fraction Collector | External interface (ATEX compliance: user responsibility) |
| Air Sensors | Additional ultrasonic sensors for buffer lines |
- pH probes install on product and waste outlet lines
- Eluent tempering requires external water source for heating/cooling
- Fraction collector supports large-volume collection
Process Capabilities
Beyond Batch: Continuous Chromatography at Pilot Scale
The PILOT 300X is engineered for twin-column continuous processes that fundamentally improve purification economics:
- MCSGP with AutoPeak® — Continuous polishing
- N-Rich® with AutoPeak® — Impurity enrichment
- 2D Integrated Batch — Multi-step automated purification
- Batch — Single-column gradient and isocratic operation
- All accessible from a single GMP-ready platform
- Move beyond the limitations of sequential batch chromatography
MCSGP with AutoPeak® — Continuous Polishing
Twin-column continuous polishing that eliminates the purity-yield trade-off:
- Impure side-fractions automatically identified and recycled to the second column
- In-line dilution ensures optimal binding conditions
- Near-complete recovery at target purity — no re-chromatography
- AutoPeak® dynamically adjusts collection windows via real-time UV
- Compensates for drift, column aging, and feed variability
Target: Gradient polishing separations Molecules: Peptides, oligonucleotides, small molecules, nutraceuticals
MCSGP — Performance Gains
| Metric | Result |
|---|---|
| Yield | Near-complete recovery at target purity |
| Re-chromatography | Eliminated |
| Column size | Smaller — parallel processing removes idle time |
| Eluent consumption | Significantly reduced |
| Synthesis batch size | Downscaling possible due to higher yields |
| PMI | Significantly improved |
| Process control | AutoPeak® enables unattended 24/7 operation |
One column elutes while the other loads — continuous output, zero downtime, consistent quality.
2D Integrated Batch — Multi-Step Automation
Couple two orthogonal chromatography steps in a single automated process:
- Product from column 1 transfers directly to column 2 with in-line dilution
- No intermediate hold tanks or manual handling
- Example: RP polishing (Dim 1) → AIEX polishing (Dim 2)
- Reduces process time, QC burden, and facility footprint
Target Molecules: Peptides, oligonucleotides, small molecules, nutraceuticals
N-Rich® with AutoPeak® — Impurity Enrichment
Automated twin-column cyclic process for isolating low-abundance compounds:
- Fresh feed added each cycle while depleting unwanted products
- Target compounds continuously recycled and accumulated on-column
- Up to 80× faster than traditional pooled HPLC approaches
- AutoPeak® compensates for retention shifts across many cycles
- Drastically reduces manual handling and project time
Target Molecules: Low-abundance compounds
N-Rich® — Performance Gains
| Metric | Result |
|---|---|
| Processing speed | Up to 80× faster than pooled HPLC |
| Manual handling | Drastically reduced |
| Purity | Significantly higher than semi-prep batch |
| Project time | Dramatically shortened |
| Process control | AutoPeak® ensures consistency across all cycles |
Four stages: Design → Enrichment → Depletion → Elution.
Batch Chromatography
Single-column batch purification with full gradient and isocratic capability:
| Mode | Applications |
|---|---|
| Isocratic | Affinity capture, SEC, desalting |
| Gradient | IEX, RP, mixed-mode polishing |
- 100-bar design supports modern high-performance resins
- Full UV/conductivity/pressure/temperature monitoring included
- Reversed-phase and ion exchange chromatography
Regulatory Compliance & Documentation
Certifications
- CE and ATEX Zone 2 (Europe)
- UL and Class I Division 2 (North America)
- Developed under GAMP 5 framework
- Complies with FDA 21 CFR Part 11 regulations
Standards & Directives
- 21 CFR Part 211 (Subparts C & D)
- EudraLex Vol. 4, Part II, Chapter 5 / ICH Q7
- EC Machine Directive, Low Voltage Directive, EMC Directive
- RoHS / REACH
- NFPA 70/79 (US version)
Materials & Documentation
- All wetted materials selected for biocompatibility and chemical resistance
- Full traceability with certificates (FDA 21 CFR 177, USP ⟨88⟩ Class VI, EMA 410/01)
- Surface roughness of wetted metallic parts: < 0.8 µm
- Turnover Package (TOP) conforming to ASME BPE standards
TOP includes: P&IDs, material certificates, component lists, calibration certificates, performance reports.
Specifications
General Specifications
| Maximum Pressure | 100 bar (10 MPa / 1450 psi) |
| Flow Rate | Up to 300 mL/min per pump |
| Column ID Range | 2.7–10 cm |
| Operating Temperature | +4 °C to +30 °C |
| Hazardous Rating | ATEX Zone 2 / Class I, Division 2 |
| Enclosure Rating | IP23 |
| Flow Path Materials | SS 316L or Hastelloy options |
| Control System | ChromIQ® X on integrated industrial PC |
| Processes | Batch, 2D Integrated Batch, MCSGP, N-Rich® |
Physical Specifications
| Footprint (W × H × D) | 180 × 197 × 85 cm (transport config.) |
| With HMI Extended | Up to 242 cm width or 150 cm depth |
| Weight | 650 kg |
| Mobility | Lockable, clean-room compliant wheels |
| Power Supply | 100–240 VAC, 50–60 Hz, 2000 W |
| Required Utilities | Nitrogen 8–10 bar for ATEX purge |
Pumps
| Configuration | 4× dual-head piston pumps (1× gradient, 2× isocratic) |
| Flow Rate (Isocratic) | 2–300 mL/min per pump |
| Flow Rate (Gradient) | 10–300 mL/min (Sum A+B), 10–90 %B |
| Flow Rate Accuracy | ±2% (above 2.0 mL/min) |
| Flow Rate Precision | ±0.5% RSD |
| Gradient Accuracy | ±2% (above 10 mL/min for 10–90 %B) |
| Active Seal Wash | 2 loops: 1 for feed pump, 1 shared |
Detectors & Sensors
| UV Detectors (×2) | 4-channel, multi-wavelength DAD, 200–600 nm, 0.5 mm path (exchangeable for 0.1, 0.3, or 1 mm) |
| Conductivity (×2) | 0–250 mS/cm, SS 316L/Hastelloy wetted |
| Pressure (×8) | Post-pump, pre-column, post-column |
| Temperature (×2) | 0–80 °C, on column outlets |
| Air Sensor (×1) | Ultrasonic sensor on feed line (additional air sensors optional) |
| pH (×2, optional) | pH 1–14, 16 bar max |
Valves & Flow Path
| Valve Actuation | Pneumatically actuated on/off valves |
| Buffer/Sample Inlets | Gradient: 8 (2× 4-port) · Isocratic: 12 (2× 6-port) |
| Column Connections | 2 positions with inlet, outlet, bypass (100 bar) |
| Outlets | 4 product + 4 waste |
| HP Tubing | SS 316L/Hastelloy, 1/8″ OD, 1.78 mm ID |
| LP Tubing | FEP (ESD-protected), 1/4″ OD, 4.8 mm ID |
| Mixers | Static (1× gradient + 2× recycle line) |
Software
| Software | ChromIQ® X Software Suite |
| Method Design | Editor for batch, integrated, and continuous processes |
| Dynamic Control | AutoPeak® (MCSGP & N-Rich®) |
| Data Integrity | 21 CFR Part 11, full audit trail, secure database |
| User Management | Multi-level, Active Directory support |
| Connectivity | OPC UA client/server |
User Interface
| HMI | ATEX-compliant Siemens, 24″, Full HD |
| Keyboard | ATEX-compliant, integrated touchpad |
Optional Modules
| Eluent Tempering | RT–60 °C pre-heating · RT cooling at outlet · External water required |
| Fraction Collector | Interface for external collector (ATEX: user responsibility) |
Resources
- All Media Types
- Brochures & Datasheets
Contichrom PILOT 300X Brochure
Overview of the technical specifications and functionalities offered by the Contichrom PILOT 300X
