Porous load cycle-Operator error

Hi all, Hope I could find some answers here. If operator by mistake place a large tweezer in addition to existing load in an autoclave ( Porous cycle which is validated), what could go wrong ? How would you risk assess the impact on the autoclave run ? How to ensure successful run ? Thanks in advance

Hi, I will assume that by adding that item (large tweezers) to the existing load, the maximum load that was validated was exceeded and, thus, did not comply with validated parameters/conditions. If this is the case, a process deviation should be issued to investigate root cause, impact to product/process and establish CAPAs.

What could go wrong?
The worst scenario would be that the items from that load were not sterilized effectively

How would you risk assess the impact on the autoclave run?
The best way to objectively assess the risk would be to challenge that load with temperature sensors and biological indicators to demonstrate that with that load, the sterilization cycle is still effective to achieve the required lethality, just as you would do to validate a new load configoration.

How to ensure successful run?
Not sure what you really mean with this question, but to ensure that new load configuration will be successful, that added material (large tweezers) must be place in a way that it promotes air removal from its packaging without obstructing other materials and avoiding condensate accumulation.

I hope this helps.

Thank you so much :slight_smile:

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