If someone could help. I would like to know what approach to should I use when undertaking a cleaning validation study on a train of equipment that manufacture different products with the same active ingredient. eg one product Aspirin 300 mg tablets another product (different exipents) Aspirin 100mg.
Do I calculate MACO
Equipment Blender, sifter, compression.
Jay
Hi !
In this case, you may need to establish your cleaning procedure when you process the product (having same active but different strengths) from higher strength to lower strength. Lower to higher no need since there will not be any impact… Also no need to calculate any MACO values as the active drug is common in my openion…
Thanks.
However both the products have the same percentage of active ie 60%.
Jay
Dear Jay,
usually this case is regarded as dedicated equipment, assuming that if the equipment is visibly clean the carryover is small enough and will not change the potency of active in the next batch. However, there are exceptions to be considered: Because the cleaning process needs to remove every contaminant, not only the actives, but also excipients, should be considered as target for the cleaning validation. In most cases, the excipients are ruled out during the risk analysis used to define your worst case, but, for example, in the case of colorants, the excipients need to be included in the cleaning validation because colorant contamination causes complaints although with little risk for the patient.
Regards
Alfred