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.
Is Alconox detergent the same as Liquinox detergent?
Q. Is the Alconox powder equivalent to the Liquinox liquid? If these are the same could you please provide me with some sort of documentation saying that Alconox is the powdered form of Liquinox and that they are interchangeable?
Maximum Wash Temperature for Liquinox
Q. What is the maximum wash temperature for Liquinox? At this maximum temperature is there an accelerated breakdown of detergent?
A. Liquinox is heat stable all the way to boiling at standard temperature and pressure conditions. From a practical standpoint, there are some detergency mechanisms that begin to break down mechanistically as you approach boiling. Emulsions begin to become less stable as you approach within a couple degrees of boiling. If emulsifying is not a critical cleaning mechanism, this may not be relevant to you.
Lowering the pH of Tergazyme
Q. Can you lower the pH of Tergazyme using Citric acid or vinegar?
A. Yes. To adjust the pH of a 1% Tergazyme solution from pH 9.5 to about pH 8.5 add 0.1 grams of 99% anhydrous citric acid for each 5 grams of Tergazyme.