ISO Class 8 particle count (annual certification vs monitoring)

#1
Hi everyone,

I'm new to this field and I have a question about particle count: annual certification vs monitoring between annual certifications. We have a firm that comes annually to perform particle count certification of our class 8 rooms (ISO 13485). My questions is, do we need to monitor the particle count levels on a hourly/daily/monthly basis? The certification firm said no, but I need to see this in black and white (some kind of official literature) to back me up in case a client or auditor asks us for monitoring data. I want to make sure the certification firm isn't wrong.

Please don't be shy to ask me questions if I'm missing some stuff since I'm new to this.

Thanks in advance,

Jocelyn
 
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AgnieszkaSz

Involved In Discussions
#2
If the room is classified, it is important that you are able to prove that the air particle count is kept within limits between annual certifications, too. We do monthly checks and also check airborne particle count after HVAC breakdowns or intentional switching off (introduction of machines), breakdown of overpressure cascade and other disturbing incidents.
Please turn to ISO 14644-2 "Cleanrooms and associated environments - Part 2 - Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.
 

Ajit Basrur

Staff member
Admin
#3
Annual is the industry standard. Additional monitoring of critical and non-critical areas should be determined based on a documented risk assessment; typically the critical areas would get a greater attention.
 

Philip B

Involved In Discussions
#4
A year is a long time to go without any testing. We do quarterly particulate monitoring (risk assessed down from monthly initially). We also do two-weekly microbiological monitoring which could give an indication of a particulate problem via settle plate results. We also have the filters serviced every six months. Also, you can do it yourself (we do), you just need to buy a particle counter. You definitely don't need hourly / daily testing in a Class 8 devices cleanroom, that's more for pharmaceutical cleanrooms.
 

levatorsuperioris

Involved In Discussions
#5
If you are making medical devices you need at least quarterly monitoring. The smoke studies and OQ studies should be used to justify where you take the samples from. Everything Philip B has said is very much applicable. You will struggle to pass a Sterilization audit without this activity and the remediation will be very expensive.
 
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