Screening Analysis of Phthalate Esters and Qualitative Analysis of Other Additives in Medical Supplies Using the Py-GC/MS Screening System

Importance of the Topic

Phthalate esters are widely used plasticizers in medical devices but are associated with reproductive toxicity and regulatory restrictions. Monitoring their presence and potential leaching into fluids is essential to ensure patient safety and compliance with international standards.

Study Objectives and Overview

This application note demonstrates a rapid, solvent-free screening method for phthalate esters and simultaneous qualitative profiling of other additives in medical supplies. The approach utilizes pyrolysis-gas chromatography/mass spectrometry (Py-GC/MS) aligned with IEC 62321-8 requirements.

Methodology

A selection of seven medical items—including blood transfusion bags, tubing and syringes—was analyzed using Shimadzu’s Py-Screener system. Samples underwent direct pyrolysis without organic solvents. A combined Scan/SIM acquisition enabled highly sensitive quantification of target phthalates and total ion current capture for unknown components. Calibration curves were prepared with a 1000 mg/kg phthalate standard mixture.

Used Instrumentation

• Shimadzu Py-Screener pyrolysis module
• Gas chromatograph–mass spectrometer configured per application conditions
• NIST Mass Spectral Library (2014) for spectral matching

Main Results and Discussion

High concentrations of DEHP (~8%) were detected in blood transfusion bags and tubing; DBP was quantified at ~150 mg/kg in one tubing sample. No detectable phthalates were found in syringes. SIM mode provided quantification with relative standard deviations below 10%. Scan mode identified additional additives:

• Bis(2-ethylhexyl) adipate
• Tri(2-ethylhexyl) trimellitate (TOTM)
• Tris(2,4-di-tert-butylphenyl) phosphate
• Lubricants: palmitic acid, palmitic acid methyl ester, stearic acid butyl ester

Benefits and Practical Applications

The Py-GC/MS approach eliminates lengthy solvent extractions, reduces analysis time, and meets international screening standards. It supports quality control, enables comprehensive additive profiling, and aids regulatory compliance in medical device manufacturing.

Future Trends and Applications

Future developments may expand the target list to other regulated plasticizers, incorporate automated spectral matching workflows, and integrate complementary detectors for broader screening. High-throughput and on-site testing solutions could enable real-time monitoring of leachable compounds.

Conclusion

Shimadzu’s Py-Screener with combined Scan/SIM analysis offers a robust, efficient method for screening phthalate esters and identifying non-target additives in medical supplies, enhancing safety evaluation and regulatory adherence.