We are a contract manufacturing facility, which utilizes both dedicated and non-dedicated equipment. We calculate MACO’s on a daily bases for all projects using non-dedicated equipment per Destin’s equations. My question is this: Are the same MACO equations that are used to calculate carryover from one product to another used when calculating carryover limits of the same product (same API) but different strengths? Since there will be no concern of cross-contamination is there room to be less stringent with safety factors? This product is utilizing dedicated equipment but planning on making various strengths from 1mg/ml to 16mg/ml. It is our policy to perform validated cleaning procedures following every batch since we do not campaign.
CMO girl