Q. Do you have a product/detergent that has a sporicidal properties?
A. Alconox detergents remove pathogens, they do not kill them. None of the detergents from Alconox, Inc. have sporicidal properties.
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 . . .
Q. Which Alconox cleaners can be used on Aluminum?
A. The Alconox brand cleaners recommended for cleaning aluminum are Alconox, Liquinox, Tergazyme, Alcojet, Alcotabs, Detojet, Citranox, Luminox, Citrajet, Solujet and Tergajet. Detergent 8 is not recommended for cleaning aluminum. Aluminum forms a natural passive layer in air that allows it to be successfully cleaned without adverse reactions with cleaner. A passive layer forms in under an hour, provided there is no oily film present. Once the passive layer is formed, the recommended Alconox brand cleaners can be used to clean the aluminum at concentrations of less than 5% at 90 deg C or less for up to one hour.
Q. What is 21 CFR- Part 211.67? How can Alconox, Inc help pharmaceutical manufacturers meet these requirements?
A. The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published by the Government Printing Office (GPO) in the Federal Register (FR) by the Executive departments and agencies of the Federal Government. The FDA regulatory guidelines specifically for Title 21 CFR-Part 211.67 details the FDA clean standards on Equipment Cleaning and Maintenance.
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