Waters Empower 3 Software Manual – This technical review of chromatography data systems (CDS) examines how CDS were developed, how they can be used most effectively, and what changes we can expect in the future.
This collection is the final part of a series of four articles on high-performance liquid chromatography (HPLC) modules, coverage pumps, autosamplers, ultraviolet (UV) detectors, and chromatography data systems (CDS). It provides a technical overview of CDS design, historical perspectives, current marketing landscape, instrument management, data processing techniques and future trends.
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Chromatographic analysis, including high-performance liquid chromatography (HPLC), gas chromatography (GC), ion chromatography (IC), supercritical fluid chromatography (SFC) and capillary electrophoresis (CE), is a major part of the tests performed in analytical laboratories. . All of these devices have one thing in common: they all require the use of a Chromatography Data System (CDS), which plays an important role in instrument control, data processing, reporting, and data archiving.
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In laboratories performing controlled tests for quality control, pharmaceutical development or manufacturing, CDS is a client-server network designed to ensure data security and integrity. Our observations show that laboratory scientists in controlled laboratories spend more time processing data than before the chromatographic system. Therefore, a comprehensive understanding of the role of CDS in instrument control and data processing is necessary to better understand improved analytical methods.
A modern CDS is an advanced software system used in the rapidly changing fields of analytical science to manage instruments, collect and process data, and generate reports. A literature search revealed surprisingly few reviews of CDS and related topics in textbooks (1-2), book chapters (3-6), and journal articles (7-8). However, detailed information is available from manufacturers on specific CDS and can be found on websites, brochures, and manuals (9–12).
In this section, we aim to provide an overview of CDS and its key role in analytics workflow, focusing on client-server networks. We review the historical development of CDS and the principles of instrument management and data processing (data acquisition, peak integration and identification, calibration and reporting) as well as the current marketing landscape and contemporary trends. We explain.
Table I summarizes the requirements and desirable characteristics of a modern CDS network for regulated laboratories. These requirements and principles of operation are discussed in detail in the following sections. Our goal is to increase the laboratory scientist’s understanding of the fundamentals of CDS, thereby making laboratory practices more efficient.
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Let’s begin with a brief historical overview of the evolution of CDS. Figure 1 shows four devices for processing chromatography data from the 1970s.
A line chart recorder records analog signals (in volts or millivolts) from chromatography detectors and produces chromatograms against the detector response on a long roll of moving chart paper. Chart recorders were the primary data processing devices for early chromatographs in the 1960s and 1970s. Quantification was assessed by manual measurement of peak heights or peak areas, using a “cut-and-drag” peak area or triangulation calculation method (peak-width half-peak height). These records are rarely used today except in preparative chromatography (3).
The electronic integrator for chromatography (with the Hewlett-Packard HP-3380A in the mid-1970s and the Shimadzu C-R1A in the early 1980s) heralded the “electronic revolution” era in the electronic integrator. These are thermal paper printers and capable recorders with built-in A/D converters, LCD displays, internal storage memory and software for automated high integration, calibration, quantification and reporting. Some have provided calculations for System Compatibility Test (SST) parameters and basic programming for tuning. These were relatively inexpensive devices and were light years ahead of the typical chart recorders of the time.
Their use was short-lived as they were quickly replaced by the arrival of the personal computer (PC) in the 1980s, which offered greater flexibility and limitless capabilities in managing data and controlling devices. However, due to their low cost and performance suitable for small laboratories, some models such as the Shimadzu C-R8A Chromatopak data processor survive today.
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In the 1980s, manufacturers of analytical instruments began to use microprocessor technology in the design of all analytical instruments, which soon led to the use of the personal computer workstation as the preferred controller and data processing device.
One of the most successful computer-based workstations for chromatography was pioneered by Nelson Analytical in Cupertino, California in the early 1980s, followed by the highly successful CDS network TurboChrome. An important part of TurboChrom’s success was the early adoption of the Windows operating system. Nelson Analytical was acquired by PerkinElmer in 1989, and Turbochrome continued to dominate the early client-server-based CDS market for several years until stronger competitors emerged in the mid-1990s (6, 13).
The first commercial chromatography network CDS was probably the HP-3300 data acquisition system launched by Hewlett-Packard in the late 1970s and installed in many large chemical and pharmaceutical laboratories. It is a minicomputer-based system that can acquire data from up to 60 chromatographs via A/D converters (4).
In the 1990s, Windows-based PC workstations and client-server CDS networks dominated small and large laboratories due to their versatility, ease of use, and ability to ensure compliance with 21 standards.
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In the client-server model, adding a computer to the network as a client increases the processing power of the entire system (4, 7). A client typically provides a graphical user interface, tool management, temporary data storage, and part of the data processing in a distributed computing system. Server manages databases and performs data transactions with clients. An important responsibility of the server is to provide central control of the applications, as well as to ensure the integrity and security of the data. The client/server model has many important advantages, such as highly scalable system design (global multithreaded setup for small labs), reduced system maintenance problems, easy sharing of data and methods by all users, and the ability to support – support. Remote access using web browsers on computers or mobile devices (tablets and smartphones) (4, 7)
The current market size of HPLC is approximately US$5 billion, with four major manufacturers, Waters, Agilent, Thermo Fisher Scientific and Shimadzu, consistently holding 80% of the global HPLC market in recent years (15-16). According to a top-down analytics survey, the market size for CDS is approximately US$700 million (17), US$425 million for HPLC, and US$275 million for GC. The top three providers are Waters, Thermo Fisher Scientific and Agilent.
Waters has been at the forefront of CDS since 1992 when it first introduced Millennium software on an Intel-486 microprocessor computer with an Oracle database. With the continued development of the current Empower CDS (current version 3), Waters has established a very strong position in the pharmaceutical industry and has gained wide recognition from regulatory authorities.
Thermo Fisher Scientific has become one of the leading CDS providers with its Chromeleon software platform (launched in 1996), which now offers comprehensive compliance coverage and global networking capabilities for control, data acquisition and control for high-precision MS instruments. Contains work. and data processing. Known for multi-vendor instrument control, Thermo Scientific ChromLean provides control for CDS chromatography and single-quadrupole MS, triple-quadrupole MS and HRMS instruments, popular in routine and development laboratories.
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Agilent’s HPLC instruments are popular in research laboratories and scientists have embraced ChemStation CDS with its easy-to-use instrument control interface. The latest updated version (version 2.4) of Agilent’s OpenLab CDS includes advanced data processing and regulatory compliance capabilities, making it more competitive among QC labs. Agilent still offers an edition of OpenLab ChemStation for specialized applications such as 2D-LC.
Shimadzu HPLC and GC instruments have a strong presence in the food, environmental, pharmaceutical quality control and industrial markets, and the company’s network offers CDS LabSolutions for GC, HPLC and secondary ion MS systems.
The rest of the CDS market belongs to manufacturers who offer their own brands of small equipment or controllers and data equipment for chromatography or purification instruments. Examples include Clarity (DataApex), ChromePerfect (Justice Lab Systems), CompassCDS (Scion Instruments), PeakSimple (SRI Instruments), ChromeNavi 2.0 (Jasco), and Chrome/TotalChrome (PerkinElmer).
CDS has improved efficiency, reliability and ease of use over the last three decades due to advances in software, computers and network implementation. The current features and desired features of a modern network CDS are listed in Table 1. Due to the rapidly evolving technologies and diversity of product features to suit different market segments and devices, it is difficult to provide clear general statements or descriptions of CDS. The reader is therefore referred to manufacturers’ websites and brochures for additional technical details on specific systems.
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Next, we focus on the role of CDS in the analytical workflow and review the principles of instrument control, data acquisition, peak integration, and data processing with specific CDS illustrations for UV and MS instruments.
Today, performing regulatory HPLC release testing of a pharmaceutical sample requires significant laboratory resources to be devoted to regulatory compliance. Testing equipment, training personnel, and testing methods take a lot of time and energy. The laboratory must also adhere to internal quality systems and processes and standard operating procedures
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