Settle Plate Change-Outs: Are They Recommended?
Short answer: Yes.
Change-outs should happen and it’s unavoidable. In an ISO 5 zone, it’s important to qualify how you collect viable air – whether that be through continuous active air collection or through passive, settle plates. Your configuration is up to you; however, it needs to be qualified, especially during a contamination or other issue.
How Long are Plates Qualified For?
Plates are typically qualified for 3-4 hours, even if it’s passive air. Most fills go longer than four hours, however some go shorter and at that point, it becomes an aseptic intervention to change out a settle plate.
This data needs to be reported and should be qualified, along with the people who perform these settle plate change outs.
How Should Settle Plate Change-Outs be Handled?
In a settle plate change-out, the plates should be lidded and be cared for with slow deliberate movements. Afterwards, they should be changed out and unlidded. Just like an aseptic intervention, each person performing the change out should understand the physical structure of the settle plate so it’s secure and safe.
Why are Settle Plate Change-Outs Recommended?
The simple answer is data. You have to qualify each intervention and it’s important to have that viable air data, especially during a contamination or if there’s something wrong. You’ll want to do a microbial identification on that contamination so that you know what type of organization it has – whether or not its pathogenic. Knowing what’s going on in the clean room at all times is a vital part of Environmental Monitoring.
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