ISSN: 1546-962X
CODEN: JAIOAD
Published Online: 18 January 2006
Page Count: 9

Cleanliness Testing and Identification of Residues on Polymer Medical Devices

Zurbrügg, D
Chemist, Niutec Inc., Winterthur,

(Received 23 May 2005; accepted 28 September 2005)

Abstract

Machining and cleaning are key processes in the manufacturing of metal, ceramic, and polymer medical devices. During these processes, the components and final devices are exposed to processing aids, handling equipment, cleaning agents, and packaging materials. Methods for the cleanliness testing of such potential residues are discussed in this paper. To assess the effectiveness of the total organic carbon (TOC) analysis for cleanliness testing, the recovery of organic residues was studied. Spiking tests showed that nonpolar hydrocarbons are not well extracted, neither by 1 h ultrasonication nor by 24 h refluxing in boiling water. This results in a very poor TOC recovery for mineral oil-like residues. Good recovery and a high sensitivity for such residues are obtained by solvent extraction following Fourier transform infrared spectroscopy (FTIR) analysis. Furthermore, extracted organic residues from machined polymer devices were identified by gas chromatography mass spectrometry (GC-MS). The results indicate that nonpolar polymers like ultra-high molecular weight polyethylene (UHMWPE) absorb hydrocarbons from mineral oil-based processing aids during machining.

Keywords:
cleanliness, medical devices, polymers, TOC, FTIR, GC-MS

Paper ID: JAI13391
DOI: 10.1520/JAI13391
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