Cleaning Machined PTFE Parts
Q. I just received your chapter on cleaning SOPs and I look forward to reading it. In parallel, I was hoping to get your thoughts or a bit of advice on how to create and implement cleanliness specifications/processes for machined (PTFE) plastic parts. Cutting fluid for the machining center is basically a water soluble vegetable oil-based fluid. The use of this plastic manifold and cover is within an electro-mechanical-fluidic subsystem (“Delivery Module”). This delivery module accumulates a quantity of 59wt% Hydrogen Peroxide that has been … Click to Read The Full Question and Answer.
Sporicidal Properties in Alconox Cleaners
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.
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 . . .
Cleaning Aluminum with Alconox
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.
Meeting 21 CFR-Part 211.67 Standards
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.