Medical devices play a crucial role in the treatment, diagnosis, and care of patients, and medical device manufacturers must rigorously test the chemical structure and physical property materials to ensure both the devices and their packaging meet regulatory standards and performance criteria, guaranteeing their suitability for intended use.
Waters and TA Instruments combined instruments, software, consumables, and support enables robust workflows to streamline analytical testing and materials measurements – whether your lab is focused on chemical and materials property testing, extractables and leachables (E&L) studies, or durability assessment. Leveraging cutting-edge technological advancements and strategic partnerships with Waters, you can accelerate innovation and commercialization processes, simultaneously minimizing risks, cutting costs, and ensuring utmost patient safety.
Waters and TA Instruments LC, GC-MS/MS, and measurement systems offer superior performance in separation and sensitivity for medical device materials characterization, identification, and quantitation.
Obtain high quality heat flow data for up to three samples simultaneously with the Discovery X3 Differential Scanning Calorimeter that features a multi-sample cell to increase productivity on every level of your E&L material research.
Obtain the most accurate rheological data over a wide range of conditions with the ARES-G2, routinely used in R&D labs and manufacturing sites to gain detailed insights into a material’s micro-structure and relate it to the end-use properties.
Take high pressure TGA to a new level with the Discovery HP-TGA that offers a high balance resolution of better than 0.1 µg in an easy-to-use benchtop design for routine analysis.
Minimize metal-sensitive analyte loss and improve recovery with the ACQUITY Premier System for a step change in chromatographic performance, lab efficiency, and risk control.
Replicate and improve the performance of your existing LC methods without compromising data quality with the Arc HPLC System that eliminates the burdens of older, less efficient LC systems.
Address your complex E&L separation challenges while delivering the reliability, robustness, sensitivity, and increased throughput of convergence chromatography techniques with the ACQUITY UPC2 System.
Whether you need to reach ultra-trace levels in complex samples for E&L, the Waters APGC source provides atmospheric pressure ionization for increased selectivity, sensitivity, and confidence in analyte identification – so your lab can overcome many of the typical limitations of vacuum-based systems. Waters APGC brings advanced MS technologies previously unavailable to GC users.
Reach lower limits of quantitation even for challenging negative ionizing compounds with the Xevo TQ Absolute, an incredibly compact tandem quadrupole mass spectrometer that delivers absolute performance.
Maximize sample information for your analytes from detailed characterization to accurate quantitation with the Xevo G3 QTof, which enables complete confidence in your results.
Reduce the risk of unexpected coelutions or constituent presence by routinely verifying trace chemicals with absolute certainty using the ACQUITY QDa II Mass Detector and increase the analytical value of every sample tested.
Report examples for analysis information and target summary.
Cosmetic cream matrix-matched calibration curve for hydroquinone 0.01 to 5% w/w.
Identified extractables in a low density polypropylene bottle (LDPE) hexane extract using ACQUITY UPC2.
Peak identification and quantification.
