Testing of Rigid containers

[Michelle Klett]

When your facility purchases new rigid containers and the instrumentation is in place, do you run biologicals on them before the container is put into circulation and if so, how do you do it? I have read to place 5 bios in the basket with the instruments - 1 in each corner and one in the middle. Also, do you run maintenance bios on your containers and if so, how often? THANK YOU in advance for any feedback.

[jrc]

I have never run any tests to see if my containers worked. Looking through AAMI ST33, which deals with rigid containers, I only saw something about prepurchase testing. Evidently, there is no regulation regarding initial qualification of containers, a la the initial qualification of sterilizers.

[Tracy Humphreys]

I cannot locate any standards for this however, everytime I receive a new rigid container I test three times with a BI and class five integrator in all four corners and every level of a container. Also when new instrumentation is added to trays I perform quality assurance tests with BI in them as well. This ensures that the sterilant indeed did penetrate all areas of the tray.

[Ray Taurasi]

You may want to check with the manufacturer of your specific container for verification testing instructions. The manufacturer should also provide you with the documentation relative to their validations which will specify limitations, bundaries and instructions for use of their device. Generally verification would be done as you indicated - by placing 5 biologicals inside of instrument tray one in each corner and one in the center for proper verification the test should be conducted 3 x each producing satisfactory results.

[Carol Forrest]

AAMI Standard ST79 10.9 and 10.10 addresses some of this. This comes from 2006 standards.;)