Supporting 21 CFR Part 11 Regulated Workflows with Next Gen SIFT-MS
This white paper describes how SyftAuditTracer software supports compliance with 21 CFR Part 11 regulations in pharma and CDMO environments. SyftAuditTracer is part of the Syft Tracer Pharm11 bundle solution for high-throughput, compliant workflows.
Syft Contributes Real-Time VOC Data to Aeroparts VOC Ozone Converter Bleed Air Study
This video describes the bleed air study led by AeroParts in Oct 2023 to understand the differences in VOC ozone converter performance. VOC ozone converters have the potential for preventing airplane cabin smoke odor fume events. Learn how SIFT-MS enabled this important study by providing real-time VOC analysis of simulated engine bleed air.
Accelerating residual solvents analysis in 21 CFR Part 11 compliant settings through real-time mass spectrometry
SIFT-MS is a direct, real-time mass spectrometry (MS) technique which offers revolutionary volatile compound analysis capabilities to Pharma and CDMO labs due to its fast time to data, time efficient workflows, analytical flexibility, and ease of use. It expedites analytical workflows, such as residual solvents analysis, by generating faster results than traditional methods. Syft Tracer Pharm11 is a SIFT-MS-based solution that includes SyftAuditTracer software designed for 21 CFR Part 11 compliant environments. This app note describes how volatile impurities can be characterized in real-time including nitrosamines, ethylene oxide, and residual solvents.
Next-Generation Workflows for Environmental Monitoring and Food Safety using SIFT-MS
This talk showcases environmental and food safety applications where SIFT-MS overcomes limitations of traditional chromatographic approaches resulting in faster time to data, significantly higher throughput, and more accurate determination of product and environmental contaminants. Mobile and fenceline environmental use cases from the United Kingdom, New Zealand, China, and Korea are presented.
Quantification of Ethylene Oxide Contamination in the Presence of Acetaldehyde
A rapid analysis method is needed to ensure food safety by high-throughput screening for ethylene oxide contamination. SIFT-MS is a suitable method for rapid quantification of trace amounts of EtO vapors in the headspace of food samples. This study shows experimental data that reveals how the OH− reagent ion is suitable for overcoming product ion overlap and interferences observed with other reagent ions in this analysis.
Volatile Compounds Quantitative Analysis Using Automated SIFT-MS with Multicomponent Gas Standard
This publication reviews best practices for quantitating volatile compounds in a wide range of applications using a multicomponent gas standard. Details of the approach to calculating concentrations from ion−molecule reaction kinetics based on reaction times and instrument calibration functions determined from known concentrations in the gas standard mix are discussed.
VOC Pollution Monitoring in South Korea
This publication reviews VOC pollutant monitoring applications of SIFT-MS in South Korea. SIFT-MS has been applied to emission source characterization, fenceline monitoring, ambient monitoring, pollution mapping, and incident response (including the use of drone-based sampling) for hazardous air pollutants (HAPs), odor nuisance species, and compounds that have high ozone formation potential (OFP) and/or contribute to secondary aerosol (SOA) formation.
SIFT-MS: Real-Time Volatiles Analysis for Continuous Manufacturing of Pharmaceuticals
Watch this on-demand webinar featuring Mark Perkins (Element), Professor Chris Price (CMAC, University of Strathclyde) and Aaron Smith (CMAC, University of Strathclyde) to learn how SIFT-MS provides real-time analysis of volatile impurities when determining solvent drying end points, volatile degradation products, or volatile impurities during hot melt extrusion.
Faster Quantitative Analysis of Volatile Impurities Using MHE-SIFT-MS
In this application note, enhanced MHE workflows are demonstrated using styrene, formaldehyde, and NDMA analyses in polystyrene polymer, Gelucire excipient, and ranitidine drug products, respectively. Reduced calibration frequency in routine analysis enables significant workflow benefits to be realized, including four-fold faster time to first result for quantitative analysis of condensed-phase samples. Over 220 samples per day can be analyzed quantitatively for diverse volatile impurities using the enhanced MHE-SIFT-MS workflow.
High Throughput SIFT-MS Quantitative Analysis: Beer Analysis Using the Method of Standard Additions
Read the application note, "High Throughput SIFT-MS Quantitative Analysis of Beer Using the Method of Standard Additions," to learn how automated headspace-SIFT-MS quantitatively analyzes VOCs in beer with throughput of 12 samples / hr and time to first result that is >2X faster than chromatographic methods.
Rapid Analysis of Residual Solvents and Volatile Impurities for High-Throughput CDMO Workflows
In this webinar, we introduce our new compliant real-time mass spectrometer solution, Syft Tracer Pharm11. A single instrument is capable of running up to 220 samples per day, and multiple methods and analyses can be performed in sequence. The direct headspace-SIFT-MS instrument is chromatography-free, and therefore the need for multiple columns and instrument downtime between methods does not exist. We will highlight several common CDMO tests that have been performed and validated using headspace SIFT-MS, including residual solvents, ethylene oxide, nitrosamines and other extractables & leachables.