PATROL UPLC Process Analysis System

PATROL UPLC Process Analysis System

Take control of your bottom line with real-time LC

Take control of your bottom line with real-time LC

Process development laboratories are challenged to modernize scientific processes that ensure final product quality and improve process yields. One of the critical components is process analytical technology (PAT), where timely quantitative measurements are taken throughout production to measure Critical Quality Attributes (CQA). 

With Waters, in-process decisions can rely on streaming CQA feedback. The PATROL UPLC Process Analysis System provides access to real-time, chromatographic-quality analysis for in-process samples. This PAT tool gives you streaming CQA feedback, aligning UPLC technology with Quality by Design (QbD) principles in your process development laboratory.

PATROL UPLC Process Analysis System PATROL UPLC Process Analysis System

Specifications

Total system delay volume:

<120 μL with binary configuration, with standard 50 μL mixer or <400 μL, with standard 100 μL mixer with quaternary configuration

Integrated leak management:

Leak sensors as standard and safe leak handling

System synchronization manager:

Injection synchronization between pump and the sample enhances retention time reproducibility

Operating flow rate range:

0.010 to 2.000 mL/min, in 0.001 mL increments

Maximum operating pressure:

15,000 psi up to 1.0 mL/min, 9,000 psi up to 2.0 mL/min

pH range:

pH 2 to 10

Unattended operation:

Leak sensors as standard and safe leak handling, full 96-hour diagnostic data display through console software

Cycle time:

<15 s inject-to-inject with binary configuration, <30 s inject-to-inject with quaternary configuration

Number of solvents:

Up to four, in any combination of two: A1 or A2, and B1 or B2

Solvent conditioning:

Vacuum degassing (six-channels): one channel per solvent, and two channels for the Process Sample Manager (PSM) diluent and sample wash solvents

Gradient formation:

High pressure mixing, binary gradient

Pump seal wash:

Equipped with a programmable active wash system to flush the rear of the high pressure seals and the plungers

Gradient profiles:

11 gradient curves [including linear, step (2), concave (4), and convex (4)]

Primary check valves:

Intelligent Intake Valves (i2 Valve)

Flow accuracy:

±1.0% at 0.500 mL/min, as per Waters AQT/SystemsQT protocol

Flow precision:

0.075 %RSD or ±0.01 min SD, (0.500 to 2.000 mL/min), whichever is greater using premixed solvent

Compressibility compensation:

Automatic, no user intervention required

Priming:

Wet priming runs at a flow rate of 4 mL/min

Pump compositional accuracy:

±0.5% absolute (full scale), from 5% to 95% of flow rates from 0.5 to 2.0 mL/min

Pump compositional precision:

0.15 %RSD or ±0.04 min SD, whichever is greater, based on retention time

Primary wetted materials:

316 stainless-steel, UHMWPE, sapphire, ruby, FEP, PTFE, ETFE, diamond-like coating, PEEK and PEEK alloys, titanium alloys

Number of solvents:

One to four, in any combination as standard

Expanded solvent choices with optional six-port solvent select valve

Solvent conditioning:

Integrated vacuum degassing, four chambers

Two additional for the PSM diluent and sample wash solvents

Gradient formation:

Low-pressure mixing, quaternary gradient

Gradient profiles:

11 gradient curves [including linear, step (2), concave (4), and convex (4)]

Primary check valve:

Intelligent Intake Valve (i2 Valve)

Flow accuracy:

±1.0% at 0.5 to 2.0 mL/min

Flow precision:

0.075 %RSD or ±0.020 min SD, whichever is greater, based on six 

Composition ripple:

<1.0 mAU (<0.1 mAU with optional 250.0 μL mixer) (baseline noise)

Composition accuracy:

±0.5% absolute (full scale) from 5% to 90% from 0.5 to 2.0 mL/min

Composition precision:

<0.15 %RSD or ±0.04 min SD, whichever is greater, based on six replicate

Compressibility compensation:

Automatic, no user intervention required

Priming:

Wet priming can run at flow rates up to 4 mL/min

Pump seal wash:

Equipped with a wash system to flush the rear of the high pressure seal and the plunger

Flow ramping:

Range: 0.01 to 30.00 min to reach 2.0 mL/min

Default:

0.45 min to reach 2.0 mL/min

Primary wetted materials:

316 L stainless-steel (QSM), or Titanium (bioQSM), and/or PPS, fluoropolymer, fluorelastomer, UHMWPE blend, sapphire, ruby, zirconia, Nitronic 60, DLC, PEEK, and PEEK blend

Unattended operation:

Leak sensors, full 96-hour diagnostic display through console software

Maximum sample capacity:

32 available sites for process and control samples

Internal sample capacity:

32 positions for standard 8 mL vials

External sampling:

1 port standard

Number of sample injections:

Up to 60 injections per sample vial

Sample access:

Total random access

Injection mode:

Full-loop injection only

Injection loop volumes:

1 μL, 2 μL, or 5 μL sample loops only

Dilution range:

Up to 1:100

Injection precision (without dilution):

< or =0.5 %RSD for caffeine peak area, full-loop injection

Injection precision with dilution:

< or =1.0 %RSD for caffeine peak area, full-loop injection

Dilution linearity:

1 to 50 dilution factor > or =0.999 coefficient of deviation

Sample carryover:

1 to 50 dilution factor < or =0.01% of the previous injection for caffeine

Needle wash solvent consumption:

Variable (configured by user)

Sample wash solvent consumption:

Variable (configured by user)

Diluent solvent consumption:

Variable (configured by user)

Minimum injection cycle time:

Variable depending injection mode (configured by user)

Minimum on-line sample volume:

Variable based on injection mode, tubing ID and length required (configured by user)

Maximum at-line sample:

100 μL consumed per analysis (vial)

Sample compartment:

4.0 to 40.0 °C programmable in 0.1 °C increments temperature control

Sample compartment:

±0.5 °C from set point measured at the control sensor temperature stability

Sample compartment:

±1.0 °C from set point measured at the control sensor temperature accuracy

Sample compartment:

±3 °C from set point as measured in air, not in a vial temperature distribution

Sample compartment cooling time:

<60 minutes from 30 to 4 °C 

Column capacity:

CM-A: Two columns, as standard (maximum length of 150 mm with filter or guard column) or four columns (maximum length of 50 mm) can be supported with optional tubing kit, up to 4.6 mm internal diameter (I.D.)

CM-Aux: Two columns (maximum length of 150 mm, with filter or guard column); one CM-Aux unit can be configured with one CM-A for support of up to four columns

Switching valves:

Two injector-style, nine-port, eight-position valves (CM-A only); provides programmable, automatic, random access switching, waste and bypass positions for rapid solvent changeover

Column compartment(s):

4.0 to 90.0 °C, settable in 0.1 °C increments temperature range. Two independent heat/cool zones per module, up to four zones in stacked configuration with one CM-A Aux unit (see ACQUITY UPLC® H-Class and H-Class Bio System Specifications Guide for conditions)

Column compartment(s):

±0.5 °C

Temperature accuracy:

(see ACQUITY UPLC H-Class and H-Class Bio System Specifications Guide for conditions)

Column compartment(s):

±0.3 °C

Temperature stability:

(see ACQUITY UPLC H-Class and H-Class Bio System Specifications Guide for conditions)

Solvent conditioning:

Active pre-heating as standard

Column tracking:

eCord™ Technology column information management tracks and archives column usage history

External communications:

Ethernet interfacing via RJ45 connection to host PC

External control:

Empower® Software

User diagnostics:

Available through software on host PC; system control via console software

Connections INSIGHT®:

Provides real-time monitoring, automatic notification of instrument performance, and diagnostic information allowing for quicker problem resolution

PATROL UPLC options:

OPC communications (object linking and embedding (OLE) for process control)

Audible noise:

<65 Dba

Operating temperature range:

4.0 to 35.0 °C (39.2 to 104.0 °F)

Operating humidity range:

20% to 80% non condensing

Power requirement:

100 to 240 VAC

Line frequency:

50 to 60 Hz

Power consumption:

BSM 360 VAC

QSM 360 VAC

PSM 450 VAC

CM-A 400 VAC

Physical dimensions cabinet:

Width: 76.2 cm (30.0 inches)

Height: 182.88 cm (72.0 inches)

Depth: 83.82 cm (33.0 inches)

Overview

  • Ensure final product quality and improve process yields

  • Work with real-time information that provides a great understanding of the efficiency and quality of your processes

  • Achieve best-in-class analyses designed specifically for in-process analysis

  • Rely on results that improve operational efficiency, deliver quantifiable ROI, and increase profits

Recommended Use: Designed for in-process analysis, delivering simultaneous qualitative, and quantitative information. 

Features Header

Features Header

Take control of your process

The PATROL UPLC Process Analysis System is specifically designed for in-process analysis, delivering simultaneous qualitative and quantitative information and allowing you to dynamically adjust and control your process. Gain confidence that your process is under control and within design space with continuous system uptime and remote access from any location.

Improve your bottom line

Rely on results that improve operational efficiency, deliver quantifiable return on investment (ROI), and increase profits with the PATROL UPLC Process Analysis System.

The system will help your lab increase process recoveries and yields, improve brand integrity with quality improvements and faster delivery, boost consumer satisfaction, and improve process understanding. With the PATROL UPLC Process Analysis System, your lab can reduce process cycle times, process and product variability, product rework, and bottlenecks.

Overcome process challenges with UPLC

Spectroscopic technology may provide real-time identity information about processes, but it lacks the ability to simultaneously monitor multiple components at different levels, and does not provide the quantitative analysis, sensitivity, linearity/dynamic range, and resolution that ultra-performance liquid chromatography (UPLC/UHPLC) provides.

The PATROL UPLC Process Analysis System provides a fast and easy-to-use method that generates real-time data, filling the gap where the slower HPLC technique has traditionally come up short as the online and automated analytical tool desired by process chemists.

 

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PATROL UPLC Process Analysis System

The PATROL UPLC Process Analysis System from Waters Corporation stands as a cornerstone in modern process development laboratories, designed to elevate the precision and efficiency of in-process analysis. This system is a pivotal component of process analytical technology (PAT), providing real-time, chromatographic-quality data essential for monitoring Critical Quality Attributes (CQA) and ensuring the alignment of Ultra-Performance Liquid Chromatography (UPLC) technology with Quality by Design (QbD) principles.

The core of the PATROL UPLC system is high-pressure HPLC pumps that deliver precise and consistent flow rates, which are critical for accurate sample separation and analysis. Coupled with an automated autosampler, the system minimizes human error and maximizes throughput by facilitating automated sample injections, enhancing both efficiency and reliability. The chromatographic column within the controlled temperature compartment ensures optimal separation efficiency and reproducibility, leading to consistent analytical results.

Detection capabilities are robust, featuring sensitive detectors such as UV-Vis, fluorescence, or mass spectrometry options that cater to a range of analytical needs. These detectors are integral for achieving high sensitivity and selectivity in quantifying analytes, thereby upholding stringent quality standards.

One of the unique benefits of the PATROL UPLC Process Analysis System is its ability to bridge the gap left by slower traditional HPLC techniques, providing a faster and more reliable method for real-time data generation. This capability is crucial for process chemists who require an online and automated analytical tool that not only speeds up the analysis but also enhances process control.

The inclusion of sophisticated data management software is another key aspect, supporting efficient data acquisition, processing, and interpretation. This software aids in seamless reporting and ensures compliance with regulatory standards, including 21 CFR Part 11 for electronic records and signatures. The system's modular design allows for customization and scalability, making it adaptable to various applications and industry-specific requirements.

By integrating the PATROL UPLC System into their operations, laboratories can significantly improve process yields and final product quality. The system helps reduce process cycle times, variability, and bottlenecks while minimizing product rework. This leads to enhanced operational efficiency, quantifiable return on investment, and increased profits, all while ensuring that processes remain within designed control limits.

Additionally, the system's ability to provide simultaneous qualitative and quantitative information allows for dynamic adjustments in the manufacturing process, ensuring that the production is always aligned with predefined quality parameters. This real-time capability is vital for maintaining brand integrity, boosting consumer satisfaction, and enhancing overall process understanding.

The PATROL UPLC Process Analysis System by Waters offers a comprehensive solution for achieving higher productivity, ensuring product quality, and maintaining regulatory compliance. It is an essential tool for any process development laboratory committed to modernizing and optimizing its scientific processes.

PATROL UPLC Process Analysis System FAQs

What detection capabilities are available with PATROL UPLC?
The PATROL UPLC Process Analysis System supports a range of detection options to meet diverse application needs. It is typically configured with UV/Vis detection but can also be equipped with mass spectrometry (MS) or other detection modules depending on the process requirements. UV detection is ideal for quantifying analytes with chromophores, while MS provides enhanced specificity and sensitivity, which is particularly useful for complex mixtures or trace-level components.

What types of analytes can be monitored using PATROL UPLC?
The PATROL UPLC system is designed to monitor a wide range of analytes in real-time, including small molecules, active pharmaceutical ingredients (APIs), impurities, excipients, degradants, and intermediates. It is particularly well-suited for compounds that require high-resolution separations and rapid analysis in complex process streams.

In pharmaceutical manufacturing, it can be used to track critical quality attributes during synthesis, purification, or formulation steps. The system’s compatibility with various detection technologies and its ability to handle multiple sample types (aqueous, organic, or mixed) make it highly versatile across industries such as pharma, biopharma, chemical, and food processing.

What is the maximum operating pressure supported by the PATROL UPLC system?
The PATROL UPLC Process Analysis System is engineered for high-performance, in-process analysis and supports pressures up to 15,000 psi (1034 bar) when operating at flow rates up to 1.0 mL/min. For higher flow rates—up to 2.0 mL/min—the system operates at a maximum pressure of 9,000 psi (620 bar). These pressure limits allow the use of high-efficiency columns packed with sub-2-µm particles, which are essential for fast, high-resolution separations in demanding process environments.

The system automatically compensates for solvent compressibility to ensure stable and accurate flow, even under varying pressure conditions, helping maintain method integrity and consistent retention times across extended manufacturing cycles.