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.
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.