Paul Daniel

Jul 28, 2021
Hi Bhavna -

Technically, the answer is “Yes”. But it takes more work than just adding a “no loading zone” sign. And it may create more problems than it solves.

First, doing this will absolutely get the attention of an auditor. So, you want to make sure you do it right. Don’t rely on a sign, because people don’t pay attention to signs. You need to put a physical cage in place that prevents people from using the space, but is of a design that will not block airflow.

But how big do you make this cage? Since you only have one location that was out of spec, you really don’t know how big the “no loading zone” should be. The only safe way to define this space it to extend it all the way to the sensors that were within specification. This will take up about a third of the available space in your chamber, if you mapped with 9 sensors. If you want the “no loading zone" cage to be smaller, you will need to do some additional mapping to prove the remaining available storage space is viable and is in specification.

This spot that is out of specification could be a sign that the unit needs repair or is too old. It may be a better pathway to do some maintenance on the chamber and tuning of the control system, and try to improve the performance of the chamber. You might even want to consider replacing the unit if you can’t improve the performance, especially if it is a critical piece of equipment, such as a stability chamber.

I would even support placing sensors in a temperature buffering material before I would support taking a section of it out of service as a “no loading zone”. This can be a workable solution if your have known product volumes stored in the chamber, such that you can simulate smaller volumes with a buffered sensor. While I would rather not attract the attention of an auditor, I would rather defend a temperature buffering approach, than try and explain my rationale for the borders of a “no loading zone”.

In summary, yes you can mark an area as “do not use” or “no loading zone”, but you must be able to force people not to use it (e.g. by using a cage, not just a sign), and you will have to justify the boundaries of your cage with some additional mapping. While it may solve your mapping problem, it brings bigger problems because of the loss of storage area, the increased mapping effort, and the increased audit attention.

I hope this helps!