Medical Device Cleaning Validation Method References For Alconox

Source: Alconox, Inc.
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Medical Device Cleaning Validation Method References For Alconox,

Identifying residue—in a medical device environment involves: the process fluids, polishing compounds, mold releases, bioburden, endotoxins, cleaning agents and any degredation or interaction products. This document is intended to help with the cleaner residue identification.

Selecting a residue detection method—for cleaners, may involve choosing a specific method or a non-specific method. Specific methods test for a specific ingredient and include: high-performance liquid chromatography (HPLC), ion selective electrodes, flame photometry, derivative UV spectroscopy, enzymatic detection and titration. Non-specific methods test for, the presence of a blend of ingredients, such as: total organic carbon, pH, and conductivity. The FDA prefers specific methods, but will accept nonspecific methods with adequate rationale for their use. For investigating failures or action levels, a specific method is usually preferable. (A later section of this chapter lists references to several methods for each cleaner brand.)

SOURCE: Alconox, Inc.

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Medical Device Cleaning Validation Method References For Alconox,