Cleaning Eudragit NE30D and Eudragit E100

Q. We are a oral dosage pharmaceutical and are having some cleaning issues with our coating pans after using 2 different type of Eudragit. Eudragit NE30D is probably the most difficult and our most urgent one to clean, the other is Eudragit E100 (Amino methacrylate copolymer). Do you have any suggestions or recommendations? Also I would be very interested in the validated residual methods that you have on these products.

A. The film residues from EUDRAGIT® NE 30 D polymers are neither soluble in acid nor in alkali. They can, however, be softened and caused to swell by means of an alkaline Solujet or acidic Citrajet wash liquor and then removed with ease using a high-pressure/hot-water cleaning unit or brushes. In difficult cases, the affected parts should be steeped in the detergent overnight. Cloth filters are first soaked in alkaline solution and then washed by machine. I recommend using 3% Solujet at 60-70 deg C to remove EUDRAGIT® NE 30 D. If this is manual cleaning, you need to use insulated buckets to maintain temperature and operators need to have both chemical and heat resistant personal protective equipment.

When processing EUDRAGIT® E 100 for the first time, Citrajet solution is an effective cleaning agent. After repeated use it may be necessary to steep the soiled parts in an organic solvent, such as a 4:6 mixture of isopropyl alcohol and water. For cleaning EUDRAGIT® E 100 I recommend using 2% Citrajet at 60 deg C. Again, if this is manual cleaning, you need to use insulated buckets to maintain temperature and operators need to have both chemical and heat resistant personal protective equipment.

For cleaning validation references, Download our Pharmaceutical Cleaning Validation References PDF.