Sterile Garbage Bag for Clean Room

#1
Hello everybody,

We are currently trying to identify solutions for sterile garbage bags for our clean room (Grade B). For now we try to disinfect the bags before they get into the clean room, however this is not a very reliable method for reducing contamination.

Does anyone have an idea where to locate sterile garbage bags?

Thank you :)
 
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Ronen E

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#3
I wonder why would a sterile garbage bag be necessary in a cleanroom...?

Not everything in a cleanroom needs to be sterile - the humans that go there (assuming that some do) aren’t sterile. Normally the concerns are for gross contamination and particulate matter that has the potential of becoming airborne. Moreover, in a properly designed and operated cleanroom one only needs to be worried about potential “dirt” that is above the physical height where prdocts and their constituents are; garbage containers are typically positioned on the floor and thus pose reduced risk (all other cleanroom assumptions and principles withstanding).
 
#4
One of our "sister" Companies has gotten a non-compliance from the Health authorities for not having sterile bags in their clean rooms. It seems like it should be a non-compliance, because, as you say, the people working in the room are not sterile.

We are exploring all options, because the authorities will be visiting us soon. We have also looked into the possibility of using non-sterile cleanroom bags, and making a risk assessment to satisfy their demands.
 

Ronen E

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#5
It seems like it should be a non-compliance, because, as you say, the people working in the room are not sterile.
This is a misunderstanding. Since the people working in the room are not sterile (they carry and spread around lots of microorganisms, just by hanging around, breathing etc.), there’s usually no point, no requirement and no expectation that objects brought in are sterile. In some specific cases it is required, in some others it’s only required to disinfect, but it’s not the general rule for cleanrooms.

It’s a little difficult to comment further because I know nothing of the specifics of your operations and setup, and I don’t know the details of the authorities’ action. Perhaps there’s something specific and important on that specific occasion. Are we discussing aseptic filling? What class is the cleanroom?

There is no point making a big fuss over a single item (a garbage bag in this case) while cleanroom standards allow a certain amount of particles to float around in the air and each of these particles may carry millions of microorganisms.

We have also looked into the possibility of using non-sterile cleanroom bags, and making a risk assessment to satisfy their demands.
This sounds like a good idea to me.
 
#6
I agree with you completely. I can see that I left out a "does not" in the first qoute - I don't think it should be a non-compliance either.

This seems like a big fuss. Our classification is Grade B, and we produce parenteral products in a LAF-cabinet.

I think we will continue with the risk assessment.

Thank you for your contribution, Ronen.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Our classification is Grade B, and we produce parenteral products in a LAF-cabinet.
So sterile garbage bags would be totally unnecessary in my opinion (I assume they don’t go inside the LAF cabinet). You do need “clean” garbage bags from a reliable source, however.

Does the sister company have a similar cleanroom setup and similar products?
 
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