Tuesday, January 30, 2007

Biocompatibility for Medical Device Cleaning Validation

Question:
What types of biocompatibility data does Alconox, Inc. provide for detergents commonly used in medical device cleaning validation?

Answer:
Setting residue acceptance limits as part of your medical device cleaning validation is much easier when appropriate biocompatibility data is available about the critical cleaning detergent you are using. To help assess the biological effects of cleaner residues, Alconox, Inc. conducted extensive evaluations of biocompatibility of its LIQUINOX and CITRANOX detergents. Along with the typical oral toxicity data, Alconox also provides dermal irritation, dermal sensitization, intracutaneous injection, cytotoxicity, and systemic injection toxicity data. These types of relevant data will assist you in setting the most scientific and exposure specific residue acceptance limits. As a result, the derived limits are more practical to achieve, as they are not based on conservative estimates.

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