Yolanda74Moon
Involved In Discussions
Hello,
I look after the micobiological monitoring programme in our ISO 7 clean room.
We have had a upwards trend recently and I've been trying to get to the bottom of it, including putting in place extra controls, improving hygiene, cleaning etc...
Some of the samples are taken by QC, and recently, due to staff shortages in the quality dept, some have been taken by the production team.
I have noticed that the samples taken by production tend to be lower.
This could be because of several reasons:
- 1 less person in the room - less movement, less potential contamination.
- quality operator's handling techniques need to be improved, to avoid contamination.
- the production team are a bit more careful, knowing there is real time monitoring
- the corrective actions are starting to take their effect and the contamination is coming under control.
However, I've noticed the agar on the petri dishes looks less "pock marked" - the air samples are taken using a mechanical air aspiration system that sucks 1000L of air in and deposits it directly onto petri dishes. Normally, there are concentric circle "pock marks", but on the recent samples taken by production, I can't see the "pock marks" - I've uploaded a few photos.
There's also one petri-dish where it looks like the air sampler has been partially covered.
The air sampler is calibrated, and within the manufacturer's calibration window, the petri dishes are purchased sterile, with CoA detailing fertility tests, the supplier hasn't changed, the incubation time and conditions haven't changed either.
The air sampler is automatically programmed to sample 1000L, however, I don't have a downloadable proof of the history of the sample times / volumes, and I just have to trust that it's being done correctly.
Does anyone have any experience with this?
Kind regards
I look after the micobiological monitoring programme in our ISO 7 clean room.
We have had a upwards trend recently and I've been trying to get to the bottom of it, including putting in place extra controls, improving hygiene, cleaning etc...
Some of the samples are taken by QC, and recently, due to staff shortages in the quality dept, some have been taken by the production team.
I have noticed that the samples taken by production tend to be lower.
This could be because of several reasons:
- 1 less person in the room - less movement, less potential contamination.
- quality operator's handling techniques need to be improved, to avoid contamination.
- the production team are a bit more careful, knowing there is real time monitoring
- the corrective actions are starting to take their effect and the contamination is coming under control.
However, I've noticed the agar on the petri dishes looks less "pock marked" - the air samples are taken using a mechanical air aspiration system that sucks 1000L of air in and deposits it directly onto petri dishes. Normally, there are concentric circle "pock marks", but on the recent samples taken by production, I can't see the "pock marks" - I've uploaded a few photos.
There's also one petri-dish where it looks like the air sampler has been partially covered.
The air sampler is calibrated, and within the manufacturer's calibration window, the petri dishes are purchased sterile, with CoA detailing fertility tests, the supplier hasn't changed, the incubation time and conditions haven't changed either.
The air sampler is automatically programmed to sample 1000L, however, I don't have a downloadable proof of the history of the sample times / volumes, and I just have to trust that it's being done correctly.
Does anyone have any experience with this?
Kind regards