Laminar Flow qualification

Hello everyone:

What are the regulatory requirements for how we should qualify the laminar air on the unloading side of a sterilizing autoclave? Is it even possible to meet Class A laminar when pulling a hot load out of an autoclave?

To my knowledge, in our bulk manufacturing facility we are currently classifying this space as Class A when the autoclave is static/at rest and Class C at dynamic.

Thanks for your help,

DM

A set-up which I have seen, is that on the outlet of an autoclave there is 100% ceiling HEPA coverage. This 100% HEPA coverage area can also be isolated from the rest of the room with a plastic soft shell area and plastic curtains. This will help with the laminar airflow in that area. The 100% HEPA coverage will ensure the area is Grade A at rest.

I do have a few questions for you for the next stages of material flow: What will you do with the parts after you unload them? What areas/classifications will you pass them through? You don’t want to unload the items in a laminar Grade B area, only to then pass them through a Grade C area, and then back into a Grade A/B area again (unless of course you take additional precautions (there are a few ways to do this)…

Unload the material in mobile LAF and transfer in grade A area