ACQUITY UPLC Process Sample ManagerHigh content information in real-time for your online and atline in-process analyses

With the ACQUITY UPLC® Process Sample Manager, you’ll get:■■ Both online and atline

functionality for streamlined

process development and

production workflow

■■ Sample dilution capabilities

for reduced manual steps

and errors

■■ Barcode-driven operational

automation capabilities

■■ Complete and automatic

tracking and traceability

of results

■■ Programmed recording of

sample information and

results to DCS/LIMS

COMP REHENSIV E P ROC ESS UNDERSTANDING – QUANT ITAT IV E RESULT S

Process Analytical Technology (PAT) is a mechanism to design, analyze, and control

manufacturing processes through the measurement of parameters which affect product

quality. PAT is a critical component of Quality by Design (QbD), an approach to

development and manufacturing based on the principles of maximizing and incorporating

scientific understanding. QbD-designed processes can leverage that understanding

for maximum profit and quality assurance through flexible process deployment and

incorporation of appropriate analytical control strategies.

With access to this high content tool, process development groups can quickly gain

knowledge of the process, take steps to optimize it, establish the operational space for scale

up and effect speedier commercialization. The knowledge gained from this data during

process development can also be leveraged for continuous improvements strategies, as well

as reference for future development. The PATROL UPLC® Process Analysis System is the

only automated solution available that can provide high content information in real-time for

both online and atline analyses. The system addresses the need for in-process analysis of

pharmaceutical, bio-pharmaceutical, food, and chemical products.

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Minutes0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0 22.5 25.0Long HPLC runtimes are no longer a hindrance to the decision-making process. Here, a 25-minute HPLC analysis was run in 2.5 minutes using UltraPerformance LC® (UPLC®).

ACQUITY UPLC Process Sample Mananger.

FULL ANALYT ICAL AUTOMATION AND CONFIDENC E WIT H REAL-T IME LC ANALYSES

The ACQUITY UPLC PSM can draw and analyze samples directly

from batch reactors, flow reactors, bioreactors, or even purification

columns. This enables unattended, real-time, quantitative

multipoint reaction monitoring or purification fraction analysis.

This functionality fully automates an ACQUITY UPLC,

ACQUITY UPLC H-Class, ACQUITY UPLC H-Class Bio, or

PATROL UPLC Process Analysis System, enabling unattended

operation for continuous reaction sampling, analysis, and

reporting of results. The kinetics of a reaction can be accurately

tracked at specified time points, 24 hours a day, 7 days a

week – with no need for manual intervention. This reduces

the need for repeat experiments, as well as reduces the risk of

making incorrect assumptions about optimal conditions for the

reaction that can result in unnecessary process time, wasted

materials, reduced yield, and increased impurities. Results can be

communicated back to a LIMS or Distributed Control System for

feedback/feed-forward process control as well as data archiving.

ENHANC ED AUTOMATION FOR AT LINE WORKFLOWS

Samples, standards, and controls required for analysis can be

placed in a 4 – 40 °C 32-position carousel tray of the ACQUITY

UPLC PSM through an access-restricted door. A barcode reader

further automates the workflow by tracking samples throughout

the entire process in the compliant-ready Empower® CDS. The

unique barcode for each sample vial is like a dossier; it contains

all the vital injection, dilution, analysis, data interpretation, and

reporting instructions for the sample set. In addition to saving

time, this automation further minimizes the risk of errors arising

from manual operator intervention.

SAV E T IME AND REDUC E VARIABILIT Y

At the heart of the PATROL UPLC Process Analysis System is the

ACQUITY UPLC Process Sample Mananger (PSM). Waters created

the ACQUITY UPLC PSM to give process development engineers

a better understanding of the process steps. The ACQUITY

UPLC PSM automates both atline and online sample analyses

with minimum intervention. With the placement of the system

alongside the reactor, process engineers have the real-time LC

information they need to quickly make process adjustments.

The automation brought to process sample analysis by the

ACQUITY UPLC PSM streamlines workflow and assures analytical

consistency, thereby reducing the number of tedious and error-

prone steps in the analysis. It is the core of the PATROL UPLC

Process Analysis System, and can be easily added to any installed

ACQUITY UPLC, ACQUITY UPLC H-Class, or ACQUITY UPLC

H-Class Bio Systems.

Atline sample analysis is made easy with a simple software user interface for vial introduction.

The ACQUITY UPLC PSM, shown as part of the

PATROL UPLC Process Analysis System.

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9 steps

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Complete traceability of your sample■■ Multiple injections can be made from any vial

■■ All information about a sample is tracked from the time

it is introduced to the ACQUITY UPLC PSM and analyzed

to its authorized removal

■■ Traceability of and access to precious or controlled substance

samples can be restricted to authorized users through Empower CDS

BUILT- IN QUALIT Y ASSURANC E WIT H P ROGRAMMABLE DILUT IONS

The ACQUITY UPLC PSM’s advanced fluidics, with unique static

dynamic mixing, produce accurate and precise dilutions. Samples

can be automatically diluted to ensure the dynamic range of

the detector is not exceeded throughout the process – aliquots

of samples (online or atline) can be diluted in increments of

0.1 at any ratio, up to 1:100, prior to analysis. This automation

capability eliminates the variability and time delay typically

associated with manual sample dilution.

Automatically generated calibration curves reduce analyst-to-analyst inconsistency

Quantitative results are only as accurate as the analyst’s standard

preparation and calibration curve creation. With programmable

dilutions of a single standard stock vial, the ACQUITY UPLC PSM’s

automated fluidics eliminate additional standard preparation

steps and reduce the overall variability in the generation of

calibration curves in Empower Software.

The barcode reading capability of the ACQUITY UPLC PSM allows users to ensure that the appropriate analysis parameters are loaded every time.

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R2 = 0.9998

0.000 0.028 0.056 0.084 0.112 0.140 0.168 0.196 0.224 0.252

Calibration curve created from a single vial. Calibration curves can be created for reagents, intermediates,

impurities, and final products, generating quantitative results.

A typical offline sample analysis sequence can be reduced from nine distinct steps to four through the automated sample logging, dilution, analysis, and reporting functions embedded within the ACQUITY UPLC PSM and Empower CDS.

Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com

Waters, The Science of What’s Possible, ACQUITY UPLC, UltraPerformance LC, UPLC, Empower, NuGenesis, and PATROL UPLC are registered trademarks of Waters Corporation. Paradigm is a trademark of Waters Corporation. All other trademarks are the property of their respective owners.

©2014 Waters Corporation. Printed in the U.S.A. May 2014 720005052EN LM-SIG

EMPOW ER SOF T WARE MET HODS, REPORT ING, AND COMMUNICAT IONS

The ACQUITY UPLC PSM is compatible with PATROL UPLC

and ACQUITY UPLC systems controlled by Waters Empower

Chromatography Data Software. Easy-to-view dashboards collect

and display critical performance data for system monitoring.

Empower Software ensures and manages data integrity with

advanced security features and audit trails with enhanced

21 CFR Part 11 compliance capabilities. For process information

management, the system can be interfaced to NuGenesis® Scientific

Data Management Software, Paradigm™ Software, Laboratory

Information Management Systems, and Distributed Control Systems.

Online UPLC analysis of different time points of a chemical reaction. The quantitative data from the chromatograms can be exported and displayed in a reaction map to visually track the formation of the API and the consumption of the starting material as the reaction progresses.

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Injection #API Starting MaterialProcess Impurity 1 Process Impurity 2 Process Impurity 3 Process Impurity 4

Simultaneous monitoring of low-level impurities.