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As part of a cleaning validation, acceptable residue limits for the cleaner being used needs to be determined. This determination is made by calculating a safety based limit and comparing it to a 10 ppm carryover limit. The lower of these two limits calculated is the limit to adopt. In order to calculate the safety based acceptable residue limit, the acceptable daily intake (ADI) of the cleaner needs to be calculated. This requires several pieces of information including identification of the Alconox, Inc cleaner that is intended to be used as well as the typical weight of patients that will be exposed to the pharmaceuticals manufactured on the respective equipment being validated. An appropriate safety factor needs to be selected, usually the default is 1,000 unless it is a particularly hazardous material (1). The resulting ADI can then be used to calculate a safety based acceptance limit for cleaner residue by knowing the batch sizes to be manufactured, the surface area of the shared equipment being cleaned and largest daily patient dose of drug being manufactured. The result is the safety based limit. Next in order to calculate the 10 ppm carryover limit, you use the same batch size and equipment size used in the safety based limit to calculate the 10 ppm limit. The calculator automatically determines and displays the lower of the two limits calculated, either the safety based limit or the 10 ppm carryover limit. This is the residue acceptance criteria limit. The limit of quantitation for the analytical detection method you choose has to be below this limit so that the method is sensitive enough to detect at the residue acceptance limit. If you have additional questions or concerns or you need to purchase trial samples of cleaner, you can do so:
(1) PDA Journal of Pharmaceutical Science & Technology Technology Vol 52 No 6 Nov-Dec 1998 Supplement Report No 29 Points to Consider for Cleaning Validation p 18
This information is presented to help communicate our understanding of how validation has been carried out in pharmaceutical and medical device processing. The information given here is made without any representation or warrantee, as it is presented for your own investigation and verification.