Tag Archive | "ADE"

Detecting Residue in Cleaning Validation

When beginning cleaning validation, a company must identify the residues to be tested and then select the best detection method. Alconox Inc. is here to help. We provide validation service support

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Calculating Cleaning Agent Safety Based Limits

Q. Does Alconox provide information on calculating cleaning agent safety based limits?
A. Cleaning agent safety based limits are typically calculated from a safety factor of an acceptable daily intake (ADI), a (1/1000 or more) reduction of an LD50 preferably by the same route of administration, or reproductive hazard levels. Alconox, Inc Pharmaceutical Cleaning Validation References PDF has an entire section dedicated to cleaning agent safety based limits.

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