Active Enzyme in Tergazyme
Q. How long will the enzyme in a 1% solution of Tergazyme remain active?
A. A 1% Tergazyme solution is designed to give good reliable cleaning performance for 8 hours at 120 deg F. This is designed to correspond to an 8 hour work shift.
Cleaning Labware – Narrow Neck Flasks
Q. What is the proper way to clean narrow neck flasks?
A. Narrow neck flasks are best cleaned in labware washers with special attachments that have a spray nozzle that goes up inside the flask. It is very hard to successfully clean narrow neck flasks in a simple home dishwasher or a lab washer that does not have special narrow neck flask racks.
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.