ACQUITY UPLC Process Sample Manager High 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 COMPREHENSIVE PROCESS UNDERSTANDING – QUANTITATIVE RESULTS 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. AU 0.00 0.70 1.40 2.10 2.80 Minutes 0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0 22.5 25.0 Long 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.
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ACQUITY UPLC Process Sample Manager · preparation and calibration curve creation. With programmable dilutions of a single standard stock vial, the ACQUITY UPLC PSM’s automated
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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.
AU
0.00
0.70
1.40
2.10
2.80
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.
4 stepsQUP
LCPS
MAC
QUIT
Y
9 steps
TYPI
CAL
PROC
ESS
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
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.
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