Reprocessing Single Use Medical Devices
Single use medical devices cannot be re-used without FDA compliant reprocessing procedures. Essentially reprocessing a single use device constitutes manufacturing it which requires compliance with FDA medical device manufacturing regulations. Appropriate cleaners must be chosen and cleaning validations done.
Alconox, Inc. cleaners can be used for medical device reprocessing cleaning. Alconox provides technical bulletins, books, and support for the use and validation of their cleaners, such as this Medical Device Whitepaper and Guidebook and our Medical Device Cleaning Validation References PDF.
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.
Plastic Soak Containers for Cleaning
Q. What kind of plastic container can I use to hold a detergent soak solution?
You can use any container that is robust enough to hold typical aqueous solutions of chemicals. A polypropylene or other chemical resistant plastic container such as HDPE will work just fine for cleaning.
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
Max Concentration for Tergazyme
Q: When using Tergazyme® enzyme-active powdered detergent, the recommended concentration is 1%. Are there occasions when a greater concentration is used? If so, is there some kind of saturation point where a high concentration will be ineffective?
A: Tergazyme detergent has a solubility limit around 10% (w/w) in water depending on temperature.
