Moisture levels in medical device packages influence a variety of crucial device properties, e.g. mechanical properties, corrosion and leach rates, drug potency, and ultimately shelf life. This is especially true for drug releasing and biodegradable device materials. It is therefore important to establish a high degree of control and accuracy of the humidity levels at all relevant stages in the production process as well as in the final package. In the current study we demonstrate a newly developed method for accurate headspace moisture trace level analysis in medical device packages using extractive gas phase Fourier transform infrared (FTIR) spectroscopy. Volumetric aliquots were extracted, using a specially designed extraction assembly, from the headspace of medical device relevant packages. The headspace water concentration was analyzed using a validated gas phase FTIR system1. Water bands in the spectral region 1 were chosen for the quantitative analysis. Sample spectra were compared, with a least square fit procedure, to water reference spectra at known concentration. Accurate quantification was demonstrated for headspace water vapor concentrations less than . This is considerably lower than feasible with conventional package headspace moisture analysis techniques. The results of this study demonstrate the benefits of using extractive gas phase FTIR for low level moisture analysis of small headspace volumes.
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Design Of Medical Devices Conference Abstracts
Headspace Moisture Analysis in Medical Device Packages
Bruce Lindner,
Bruce Lindner
Pace Analytical Life Sciences
, Oakdale, USA
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Michael Curtis,
Michael Curtis
Pace Analytical Life Sciences
, Oakdale, USA
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Jonas Weissenrieder,
Jonas Weissenrieder
Pace Analytical Life Sciences
, Oakdale, USA
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Mark Schwab
Mark Schwab
Pace Analytical Life Sciences
, Oakdale, USA
Search for other works by this author on:
Bruce Lindner
Pace Analytical Life Sciences
, Oakdale, USA
Michael Curtis
Pace Analytical Life Sciences
, Oakdale, USA
Jonas Weissenrieder
Pace Analytical Life Sciences
, Oakdale, USA
Mark Schwab
Pace Analytical Life Sciences
, Oakdale, USAJ. Med. Devices. Jun 2008, 2(2): 027504 (1 pages)
Published Online: June 11, 2008
Article history
Published:
June 11, 2008
Citation
Lindner, B., Curtis, M., Weissenrieder, J., and Schwab, M. (June 11, 2008). "Headspace Moisture Analysis in Medical Device Packages." ASME. J. Med. Devices. June 2008; 2(2): 027504. https://doi.org/10.1115/1.2927393
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