My name is Rishy. I work for a big pharmaceutical packaging company. I am incharge to design new cleaning validation program for the facility. we are contract packaging industry for clinical trial studies. We deal with all dosage forms like tablet(coated,uncoated, film coated), capsules, powders, softgels etc. I am trying to pick the worst case dosage form for cleaning studies on coupans. Most of packaging equipment we use here have SS, TEFLON, PLASTIC sort of MOC as a product contact parts.
If anyone can help me to define worst case dosage form for cleaning studies on the coupans would be great help!!
Dear Mr Rishy,
I would like to clarify: you are interested in selecting a “worst-case product”? or “worst-case dosage form”? For selection of “worst-case product” you may use parameters/criteria such as solubility, toxicity, concentration (the more the amount of contaminant more difficult it is to clean), operator’s experience (based on ease of cleaning), visual detection etc. If you are interested in selecting a “worst-case dosage form” then you have to let us know what all dosage forms are processed on the equipment. Assuming that you are processing dosage forms such as tablet (coated, uncoated, film coated), capsules, powders, softgels etc on the same equipment, then the worst-case dosage form should be the one which allows maximum contact of contaminant with the equipment surface e.g., for the dosage forms mentioned above the order in which the contaminant comes in contact with the equipment surface is: Powder (maximum contact of the contaminant with the surface) > Uncoated Tablet > Coated Tablet > Capsules > Softgels (Least contact of contaminant with the surface). Based on this Powder Dosage Form should be the “Worst-case dosage form.”
Thank you very much for your help!
I do have some questions regarding calculating MACO based on various criteria.i will come back to you with questions as you are expert it MACO calculations.