6 Continuous validation of HPLC performance in regulated laboratories
Testa Analytical announces the successful completion of extensive testing for its flowmeter software driver designed for chromatography data systems (CDS) in a regulated pharmaceutical laboratory environment.
Robust testing of new software packages and drivers is a crucial aspect of any product release, particularly when the software is intended to seamlessly interface with chromatography software packages from various HPLC and GPC/SEC manufacturers.
Jeanette Ziemba, Technical Manager at Testa Analytical, stated: “Our new flowmeter software driver, after comprehensive in-house testing, underwent extensive evaluation in a leading European pharmaceutical lab. Managing a diverse range of HPLC instruments with different chromatography data systems in a tightly regulated client-server environment, the lab was pleased with how the software driver facilitated easy acquisition and traceable logging of flow data from all its liquid chromatographs. The software’s capability to support multiple Flowmeters connected to different HPLC systems in both analytical and semi-prep applications significantly streamlines tasks.”
She further explained: “The ability to save real-time flow rate data with each chromatogram is a valuable tool for comprehensive quality assessment of any HPLC, UHPLC, LC/MS, or GPC/SEC system. The software driver, built on
rc.NET technology, ensures cross-platform connectivity of all Testa Analytical flowmeters to Chromatography Data System software packages, including OpenLab (Agilent Corp), Clarity Chromatography Software (DataApex), Empower (Waters Corp), LabSolutions (Shimadzu Corp), and WinGPC Software (Agilent).”
Ms Ziemba concluded: “The capability to collect and store real-time flow rate data, along with chromatography detector signals, not only enhances quality assessment but also provides continuous validation of compliance with the planned chromatographic separation method. In essence, this affordable flowmeter software driver complements and extends the capabilities of any modern liquid chromatography software package.”
More information online:
ilmt.co/PL/EVbj 62239pr@reply-direct.com
Positive pressure manifold enhances sample preparation
Porvair Sciences introduce the new UltraPPM LITE positive pressure manifold for sample preparation. A simple, reliable and reproducible instrument for increasing throughput of multiwell processing plates.
The Porvair UltraPPM features an interchangeable head design that allows for a simple user switch between 96, 48, 24 and 384 well filter plates. This makes it the most versatile pressure manifold available and ideal for laboratories with changing projects.
Additionally, the UltraPPM LITE has been manufactured with a gas flow path free from fluorinated polymers, making it suitable for PFAS analysis. Sample dry-down is an essential step in a number of EPA methods for the analysis of PFAS, and it is therefore prudent to reduce any potential contamination introduced by the measuring system.
Many sample preparation process’ require solvent to pass through a filter held within a multiwell plate. The filter itself might be a simple particulate filter, or a more complex chemically active system to extract target analytes from a sample. In any application the filter acts to resist the flow of the sample and solvents, which can lead to delays and long processing times. For many years Porvair Sciences has manufactured a vacuum manifold the increases the pressure difference across this filter thereby decreasing the time needed to process a plate. The alternative is to apply a positive pressure to the head of the plate forcing the solvent through rather than pulling it.
Positive pressure has a number of advantages over vacuum. Vacuum may not be strong enough when analysing viscous samples, the gas source used can be controlled unlike using lab atmosphere, it is easier to operate since there is no vacuum release required, which needs to be carried out in a controlled slow way to prevent disturbing the collected eluants and potentially cross contamination.
More information online:
ilmt.co/PL/0MX9 62049pr@reply-direct.com
Automated chromatographic modelling and optimisation software
S-Matrix is a world technology leader in Automated Quality-by-Design (QbD) Software to support Chromatographic Analytical Method Development, Validation, and Transfer. S-Matrix’s Fusion QbD® Software is a comprehensive integration of chromatography modelling and advanced statistical tools supporting all stages of Analytical Procedure Lifecycle Management (APLM). Flexible Design of Experiments (DoE) technology, automated UV and MS spectra based peak tracking, and hyper-precise chromatographic modelling of any integrated peak results enable Fusion QbD to support all chromatographic separation modes and all stages of method development from identifying initial method conditions through chemistry system screening (method scouting) to final robust method optimisation, including full forced degradation study automation and integrated robustness simulation for all included critical System Suitability performance characteristics throughout the entire experimental region – the correct basis for accurately establishing the robust Method Operable Design Region (MODR). Fusion QbD also supports Sample Preparation method optimisation and Replication Strategy optimisation with full integration of USP <1210> Interval metrics. Additionally, Fusion QbD contains a full automated experimentation suite for method validation and transfer. Fusion QbD is 100% aligned with all current regulatory guidances and contains the core QbD methodologies and tools presented in ICH Q2(R2), ICH Q14, and USP <1220>. Fusion QbD’s strategic regulatory compliance and data integrity support features include full CDS automation with ChemStation, Chromeleon, and Empower with complete bi-directional audit trail, full Part 11 compliance support, and a built-in Project Management System.
More information online:
ilmt.co/PL/zzYD and
ilmt.co/PL/pK6y 62086pr@reply-direct.com New IC system elevates lab capabilities
Thermo Fisher Scientific Inc has unveiled the Thermo Scientific™ Dionex™ Inuvion™ Ion Chromatography (IC) system, a cutting-edge instrument designed to simplify and enhance ion analysis for laboratories of all sizes. With a focus on reliability, efficiency, and adaptability, this new IC system caters to the diverse analytical needs of researchers working with ionic and small polar compounds.
In response to the increasing emphasis on environmental safety, particularly concerning food and water supplies, Thermo Fisher aims to provide versatile and sensitive instruments for comprehensive testing and analysis. The Dionex Inuvion IC system is aligned with the company’s mission to contribute to a healthier, cleaner, and safer world. It equips environmental, industrial, municipal water, and food and beverage labs with the essential tools to detect ionic contaminants in water and identify corrosive substances in oil and gas. Additionally, the system ensures quality assurance and control of small ionic compounds in food, beverages, and pharmaceuticals.
The Dionex Inuvion IC system is engineered to streamline lab operations by offering easily configurable workflows and a compact footprint. Its flexibility allows customisation to meet current analytical requirements while enabling the extension of IC capabilities to adapt to changing sample types and workflow needs in the future, ensuring a cost-effective and efficient solution.
Lidija Raicevic, Vice President and General Manager of Ion Chromatography and Sample Preparation at Thermo Fisher Scientific, stated: “As the originator of ion chromatography, we continue to lead innovation in all areas of instrumentation and column chemistry to meet our customers’ growing needs for better resolution, faster results, and intuitive lab experience. The Dionex Inuvion system is built on years of expertise and will provide enhanced capabilities to labs of all sizes while helping streamline our IC portfolio.”
Key features of the Dionex Inuvion IC system include advanced pump technology that enhances speed, quality, and reproducibility; operator-friendly engineering to improve the user experience; and user-installable accessories to extend capabilities and achieve the highest quality results.
More information online:
ilmt.co/PL/pKVy 62117pr@reply-direct.com
INTERNATIONAL LABMATE - APRIL 2024
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