Cleaning Validation for Medical Devices, Chemical Contamination

Chemical Contamination

Contamination in medical devices usually comes from components used in manufacturing such as polymers, adhesives, solvents, and metals. The leachability of these impurities into body fluids is of great importance in assessing product safety.

Cleaning Validation, Medical Devices, Chemical Contamination

General Test Methods

Medical devices can be tested for general chemical contamination by several tests that detect a large number of chemicals. These are summarized below:

1. pH, conductivity, and total dissolved solids (TDS) of a water leachate indicate any general inorganic, water soluble contamination

2. Hydrocarbon oil and grease. The device, usually a metal part, is extracted with Freon and the C-H absorption is measure by infrared spectroscopy (IR). This test will detect most organic, lipophillic materials that contain C-H such as petroleum hydrocarbons, oils, platicizers, and soaps.

3. Total Organic Carbon (TOC) of a water leachate. While lipophillic organic compounds can be detected by Freon extraction and IR, water soluble, hydrophillic organic compounds can be detected by TOC on a water leachate. These can include sugars and other carbohydrates, surfactants, alcohols, etc.

None of these tests are very sensitive, and none identify the contamination. One exception may be the IR spectroscopy test. While the test only monitors the C-H absorption, a full scan can be measured on the residue after evaporating the Freon. If the residue is not a complex mixture, it may be possible to identify the material.

More Sensitive and Specific Test Methods

We also suggest using GCMS to screen for organic solvents (volatile organic compounds) and semi-volatile organic compounds (plasticizers, phenols, etc.). Metallic contaminants can be determined using a metals screen by ICPMS. Ion chromatography can determine a variety of common ions, such as chloride, nitrate,

phosphate, and sulfate. HPLC can also be used to detect contamination, however currently we do not offer LCMS for identifying the contamination.

While not all chemical contamination can be detected by these tests, the large majority will be detected by one or more of them.

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