Bioburden and Product Labels - VD Max studies on all the BOMs

D

Denis

Would appreciate any advice on this subject please - although the product is not a medical device, it is labelled sterile and is sterile filled.

The raw materials (bill of materials issue) is pre irradiated by gamma irradiation , and then assembled and filled (typically a biocide).

I am trying to perform VD Max studies on all the BOM,s to prove that the raw materials prior to entry into a Class 2 clean room ; are sterile (10 -6).

The bioburden on the labels is too high to enable an effective VD Max study.

Has anyone any advice or commentary to assist with me getting labels that will pass the VD Max study?

The labels are stored on a cardboard spool and are typically a laminate type.
 

Marc

Fully vaccinated are you?
Leader
Can anyone help out with this one? It's way out of my field.
 
M

MIREGMGR

I am trying to perform VD Max studies on all the BOM,s to prove that the raw materials prior to entry into a Class 2 clean room ; are sterile (10 -6).

The bioburden on the labels is too high to enable an effective VD Max study.

Has anyone any advice or commentary to assist with me getting labels that will pass the VD Max study?

The labels are stored on a cardboard spool and are typically a laminate type.

As you already are aware, the cardboard spool isn't working in your favor, and suggests that the labels are coming from a maker that doesn't understand your needs and provide a suitable product.

Google searches on "low particulate labels" and "cleanroom labels" come up with several makers of low-particulate, cleanroom-suitable label systems. My guess is that one of these outfits would have a ready-made solution to the particulars of your situation.
 
O

Outsider

Since the raw materials are irradiated prior movement into the class 2 assembly, can you also irradiate the cardboard/ paper spools before transfer?

I have irradiated SBS trays to lower the bioburden in other device applications.
Outsider
 
D

Denis

The labels come in from the supplier wound on the cardboard spools.

I've been in touch with our current label supplier to explain the situation to them.
They have been very helpful , but don't quite grasp the understanding of bioburden, and the potential effect it is having in trying to prove that the labels are sterile (after 25kGy gamma irradiation).

They have sent me some samples wound on a plastic spool that I'll be having a look at soon.
 
M

MIREGMGR

The label manufacturer is an inappropriate choice for a process to be conducted in an environmentally controlled area, if their production isn't itself conducted in an environmentally controlled area.
 
D

Denis

I agree.

I seem to have discovered through this process that the label manufacturer may not be suitable.

Its a pretty widespread problem, most suppliers are unaware of our product requirements (its a historical problem).

But I'm trying to find some resolution to the issue - maybe a change in the label specification is required / maybe a change of supplier.
 
D

Denis

By way of an update - and seeking a bit more advice.

The label supplier sent us some samples for bioburden assessment.

These labels have been tested, but the bioburden is still far too high to enable a successful VD Max testing.

How do others manage to apply labels to products in a sterile environment?
 
B

brandomenon

Have you done testing on the labels to determine the upper limit of what they can handle for irradiation before there are negative effects on the product?

Too much and the colours can fade or they can even lose adhesive abilities. But if the product can handle a large dose, you have the possibility of dosing in multiple events. This allows you to send labels for irradiation, then perform VD Max study and have a second irradiation event to assure sterility of the labels.

This needs controlled conditions from the time the first irradiation happens so that you are not introducing more bioburden.

Another option would be to consider a second sterilizing method like steam or dry heat or ethylene oxide first, then run the VD Max study (and having irradiation as the second sterilization step in routine manufacturing) all depending on how the product holds up.
 
D

Denis

Thanks brandomenon

You've raised some good points, we have in the past "over" irradiated the labels in error, and the artwork is effected - and the material becomes quite brittle which is obviously something that we can't accept.

I hadn't thought of trying using other sterilizing methods, and this is something that I will look into.

The current supplier doesn't have to firm a grasp on what our requirements are, and I will work with them to ensure that they understand - but it may mean a change of supplier.
 
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