Maintenance of Class 9/8 clean room in a medical devices factory

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Gert Sorensen

#11
Re: Maintenance of Class 9/8 clean room

The allergies resulting from using the disinfectants too much? that could be a point but for now we have not discovered anything like this. perhaps it would be a good idea to use various and exchange them... In this case risk of allergies should be reduced.
I know China does not have the strictest of environmental laws :notme: , but I feel that we have a responsibility to help the workers to decent HSE conditions.
On a slightly different note, we have experienced that some cleaning products have reduced efficiency after a period of time. So, we use interchangeable products for cleaning.

The filters and over-pressure seams to be OK. The clean-room has been constructed just recently so I trust all should be fine here.
Is your over-pressure sufficient?

Overkill? Hm... is it a problem?
Overkill is always a problem. It is expensive and time consuming, and it reduces the respect for QA....
 
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Wes Bucey

Quite Involved in Discussions
#12
Re: Maintenance of Class 9/8 clean room

I subscribe to Clean Room magazine as an aid when I consult with clients encountering clean room opportunities for improvement. It is available for free to American subscribers in the trade. The electronic version may also be available for free to Europeans. The publisher's home page is http://www.qmags.com/ scroll down until you find the icon for Clean Room to view a sample issue.

I've found the suppliers of various products to be an excellent source of information for exploiting opportunities for improvement.
 
G

gereard_kgb

#13
Re: Maintenance of Class 9/8 clean room

Thanks Wes. I'll try it.

"I've found the suppliers of various products to be an excellent source of information for exploiting opportunities for improvement." - sure they are :) :)


I'll check the data on over-pressure and let know.

How do you measure over-kill? is there any pieces of information on it?
 
J

jeffrey_Chang

#14
Re: Maintenance of Class 9/8 clean room

Hi,
Although, we are not in the medical devices business but we are doing wafer where we need a class 100 clean room. Basically, the class is determined by the no. of particles count in the clean room.
  1. Do you measure the particles count regularly to ensure the clean room class is maintained to what it is supposed to be?
For a class 100 clean room, all personnel are to wear jumpsuit with gloves and face mask. Before entry to the clean room, we are to wash our hands with plain water and air blow dry. We have the hand washer and air blower at the entrance.
Absolutely NO cosmetics (makeups), no perfume etc are allowed in the clean room; i.e. you cannot put on makeups when you are in the Class 100 clean room. The clean room is with HEPA filters and laminar flow.
That's all I can think for the time being.
thks.
jeffrey.
 
G

gereard_kgb

#15
Re: Maintenance of Class 9/8 clean room

Thanks.
In our factory we are running ISO class 8, GMP class D. I am not sure how does it count for the particles count...

In our CR people need to do the same - wash and air blow dry them. Also hands disinfection is required every time people enter the premises and than every 2 hours (what was found an exaggeration by Gert :notme: )
Full suits are obligatory for everyone - gown, cap, feet covers and face covers.
We let people use no cosmetics, chew no gums in the clean room.
It is also necessary to re-wash hands any time they touch their face or blow their nose.

We are buying the particles counter now... :notme:

Right now I am in the position to say that we have found the place of contamination. Generally most of the premises were OK except for one place. Most probably the contamination was brought with some packing materials being cut in the CR and during introducing the products though the windows... I trust this needs some more attention.

Any way all the information gathered in the thread will be very useful (at least for me :) )


:thanks: :thanx: :thanks:
 
J

jeffrey_Chang

#16
Re: Maintenance of Class 9/8 clean room

Thanks.
Most probably the contamination was brought with some packing materials being cut in the CR and during introducing the products though the windows... I trust this needs some more attention.
Hi Gereard,
One more additional point, when you are bringing in any equipments, machinery or instruments etc into the clean room. Wipe downmust be performed in the staging area; i.e. the equipments, machinery etc must be clean with DI water before getting it into the clean room.
No detrashing of boxes in the clean room area since boxes could have fibers. We are also using lint free paper in the clean room. We use room ionization as well but it is very costly to install and maintain room ionization.
thks.
jeffrey. :)
 
G

gereard_kgb

#17
Re: Maintenance of Class 9/8 clean room

Yes, you are right at this point of course.
The procedures for introducing the products are prepared and followed.
We tend to use double packing so that the outer one is left outside the cleanroom and the internal one unwipped in the airlock window or unpacking area of the clean room (depending on the product and its manufacturer).

:)
 

Ajit Basrur

Staff member
Admin
#19
Since you mentioned that there is a particular spot which has contributed to high counts, some more thoughts -

1. You can use smoke test to check the flow of air pattern. This can detect any improper flow and thereby show you deadspots. These areas have high concentration of particles. This will also detect if Return air filters are effectively functioning.

2. Check if the floors and walls are free from crevices

3. You could increase the pressure differential between the decartoning room and the cleanroom.
 
G

gereard_kgb

#20
1. You can use smoke test to check the flow of air pattern. This can detect any improper flow and thereby show you deadspots. These areas have high concentration of particles. This will also detect if Return air filters are effectively functioning.
Qualityalways, thank you very much for your comments.
Smoke test - what smoke can be used so that no contamination is introduced? are there any ready made products? how is it done?
are there any standards... ;)

:thanks:
 
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