Self Contained Biological Indicators as internal PCD

B

BeccaLo

#1
Good afternoon all,

We are looking at performing PQ on a new steriliser chamber. An operational decision has been made that we use self contained BIs (Biological Indicators). However, these seem to be too large to fit into the lumen of our considered 'worst case' product. How do we approach this?

Thank you
 
Elsmar Forum Sponsor

Qara123

Involved In Discussions
#2
A possible method is to place BI strips in the lumen and place another SCBI on the outside (of your packaging?). Perform a few sterilization cycles so that you can show the SCBI is "harder" to inactivate than the BI strips in the lumen and that the SCBI is your worst-case.

SCBIs have various resistance based on their packaging so you need to pick the appropriate one. Note that this is based on what I know about EtO sterilization.
 

planB

Trusted Information Resource
#3
BeccaLo,

two options you may want to consider

1) Would it be possible to modify your device in a way that you attach a Line Pickerill helix to your lumen? This is described in EN 1422:2014, and you can find the original paper here.

2) Try to find another (simulated) worst-case product representing your actual product with the tiny lumen, as Qara123 suggested. You would have to demonstrate the new worst-case by running sub-lethal cycles in which you would aim at achieving the folloiwn result:
- sterility of your actual product
- survivors on your new (simluated) worst case product.

HTH,

Gerhard
 
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