Critical Cleaning - Alconox, Inc.: Calculating Cleaning Agent Safety Based Limits

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Tuesday, December 11, 2007
Calculating Cleaning Agent Safety Based Limits

Question:
Does Alconox provide information on calculating cleaning agent safety based limits?

Answer:
Alconox, Inc Pharmaceutical Cleaning Validation Method References has an entire section dedicated to cleaning agent safety based limits. Please visit here for more information: http://www.alconox.com/static/section_top/gen_cleanval.asp.

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. If the calculated limit is found to be higher than a less than 10 ppm carryover to the next batch, then the limit can be set to the more stringent 10 ppm carryover level for the safety based limit.

For additional information, the Alconox Technical Team has also written The Aqueous Cleaning Handbook, which in Chapter 10 discusses Measuring Cleanliness. For more information on the Handbook visit http://www.alconox.com/section_customer/book_info.asp.

(Calculating Cleaning Agent Safety Based Limits)