Setting Residue Acceptance Criteria
Q. Do you have to set residue acceptance criteria for cleaners?
A. Yes. For pharmaceutical and medical device manufacturing it is required that there be set residue acceptance levels for potential residues such as the active drug, excipients, degradation products, cleaning agents, bioburden and endotoxins.
Effects of Increased Tergazyme Concentration
Q. Currently we allow parts to soak in 1% Tergazyme® enzyme-active powdered detergent overnight. If we were to increase the concentration to 3-4%, do you think it would increase the stability of the solution being active for a longer period of time?
A. You will both increase the rate of auto-digestion due to increased enzyme concentration
Removing Eudragit from Equipment
Eudragit brand coloring agents from Roehm GmbH & Co for coating tablets can be very difficult to clean from tablet coating equipment. Different Eudragits need different types of cleaning agents. Some require acid cleaners with wetting agents and dispersants, and some require alkaline cleaners with wetting agents and dispersants.
Types of Aqueous Cleaners
Q. What are the different types of aqueous cleaners? A. Alconox, Inc. manufactures aqueous cleaners in acid, neutral, mild alkaline and corrosive alkaline for use in various critical cleaning applications.
Pharmaceutical Cleaning Validation for FDA Code
Q. What part of the FDA Code of Federal Regulations applies to cleaning equipment?
A. The FDA Code of Federal Regulations 21 CFR 211.67 applies to equipment cleaning and maintenance. If you are cleaning pharmaceutical equipment with Alconox brand cleaners, our team of experts can assist you in your cleaning validation.
