Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E))

#1
Hi all,
I'm vietnamese. So, my english is so bad. Sorry about this.
I'm in an urgent situation that our CE Notify Body need us provide IQ and OQ of clean room. The problem is that we only have a control room (with some control such as air shower door, hygiene, temperature...). But, we don't have clean room. For detail, we have measured particle concentration which is reach class 8 (according to ISO 14644-1). In addition, we also control microorganisms by some procedure like hygiene, measuring microorganism in worker hand, surface, equipment...
My question is if class Is need a exactly cleanroom?
Please help me this problem.
Thank you so much.
 
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indubioush

Quite Involved in Discussions
#2
You explain that you have a controlled space where you measure the particles and microorganisms. This is a clean room. Why do you say it is not a clean room?
 
#3
You explain that you have a controlled space where you measure the particles and microorganisms. This is a clean room. Why do you say it is not a clean room?
We don't have pressure gage to control routine differential pressure. We don't control airflow also. In addition, the construction of our room isn't clean room. But, we have procedure to control contamination such as: prevent contamination equipment, procedures for transport of material between areas, good hygiene practices, clothing (gowning, gloves, hair covers, facial hair covers, sanitizing soap, finger cots), behavior in work area, periodic cleaning and maintenance of air vents, periodic particle concentration measurement, periodic microorganism measurement in worker hand/ equipment and table surface.
 

chris1price

Trusted Information Resource
#4
It sounds like your room is "controlled - not classified", ie you have controls but do not state you meet an ISO14644 classification. I would firstly avoid calling it a "cleanroom" as it does not meet the standard.

There is nothing wrong with this provided there is no regulatory expectation to have one, and there is no contamination or microbiological specification for the product you are making. If such a product specification, then you should have a classified room.
 
#5
It sounds like your room is "controlled - not classified", ie you have controls but do not state you meet an ISO14644 classification. I would firstly avoid calling it a "cleanroom" as it does not meet the standard.

There is nothing wrong with this provided there is no regulatory expectation to have one, and there is no contamination or microbiological specification for the product you are making. If such a product specification, then you should have a classified room.
Many thanks. Yes, we don't have clean room. In detail, our product is surgical gown (made by smmms fabric) and surgical drape (with material is smmms, nonwoven absorbent fabric, some plastic PE film and PU incise film). We have ETO sterilization system also. However, the CE auditor ask us a clean room. They request according to clause 6.4.1 and 6.4.2 of ISO 13485:2016. Could I debate them about this NC?
 

chris1price

Trusted Information Resource
#6
If you are sterilising the product, you need strict controls over the cleanliness of the manufacturing area. The auditor is correct in raising the non-conformance, your room needs to meet ISO14644, including pressure monitoring and airflow, I would suggest at least Class 7 or higher when in use. Without these you can not control the flow of dirty air, or what control is happening in the room between the times when you monitor particulate.
 
#7
Many thanks. I understand the risk of contamination. Although we don't have pressure differential control and air flow control, we have do some control such as air shower door, hygiene, temperature, pest control, protect cloth, shoe, mask.... The problem is this Notify Body certificated ISO 13485:2016 to us, but they raise this NC's for CE marking assessment (which is still reviewing 10 months after ISO 13485:2016 certificated cause of some NC's). This auditor didn't ask about clean room request since inside audit. In that time, we cannot construct a clean room in one or two months to close NC. In detail, we still apply MDD not MDR.
 

indubioush

Quite Involved in Discussions
#8
I agree with Chris. You need to attain compliance to ISO 14644 and ISO 14698. This means you will have to construct the clean room and do regular monitoring. This includes doing bioburden testing. You probably will not get CE Mark until this is done.
 

chris1price

Trusted Information Resource
#10
Sorry, but the answer is yes you need a cleanroom. In order to sterilise a product, you need a controlled level of bioburden. If the background environment is not consistently clean, you can't provide that control.
 
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