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

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gereard_kgb

#1
Hi Everyone,

Just recently we have launched our medical devices factory and we are in our learning period now.
We are running class 9/8 clean room and I am afraid we are having some problems with the level of cleanness in the clean room.
Could you share your experience regarding the maintenance of the clean room? What disinfectants and other cleaning products to you use to clean the premises?
How about cleaning the hands of the personnel? How often do they do it and what disinfectants are used for this purpose?
do they work in gloves or with bear hands?

Do you use UV laps in the whole clean room to enhance the bacteria killing?


All hints are welcome.

:thanx:
 
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CarolX

Super Moderator
Super Moderator
#2
Re: Maintenance of Class 9/8 clean room

Sorry I can't help you but I moved your thread to the medical device board - may get some response here.
 
G

Gert Sorensen

#4
Re: Maintenance of Class 9/8 clean room

Hi Everyone,
Just recently we have launched our medical devices factory and we are in our learning period now.
And what a learning period you are in for :D

We are running class 9/8 clean room and I am afraid we are having some problems with the level of cleanness in the clean room.
Sounds about right :D

Could you share your experience regarding the maintenance of the clean room? What disinfectants and other cleaning products to you use to clean the premises?
Cleaning done on a daily basis. Operators clean the specific premises before production starts and an external company comes in at night to clean the entire room. Don't know what specific products are used, but try Google for "clean room cleaning products", you may get lucky.

How about cleaning the hands of the personnel? How often do they do it and what disinfectants are used for this purpose?
do they work in gloves or with bear hands?
Operators are required to wash hands everytime they have been out of the clean room. No gloves used.

Do you use UV laps in the whole clean room to enhance the bacteria killing?
No. We sterilize our products :lmao:
 

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C

cochranemurray

#5
Re: Maintenance of Class 9/8 clean room

Have you established and validated a cleaning method with associated frequencies? Most freely available cleanroom disinfectants will do a job for you if you have validated your method. Have the cleanroom staff been instructed in the necessary hygiene rules? As well as a bacterial soap, we have hand sanitizer stations where staff can "top up".
When you say you have problems with cleanliness, have you established the possible source of the contamination (is it human or is it raw materials.
I presume when you started up the cleanroom, it was tested at rest and active. After a few monitoring sessions you will have set limits for levels of contamination and corrective action? Don't get too hung up on these limits as they will inevitably come under pressure as you build up staff numbers and increase production levels.
If you monitor the staff (usually the main source of contamination) and establish suitable cleaning frequencies, things should settle down, but the improvement may not be immediate.
What products are you making?
 
G

gereard_kgb

#6
Re: Maintenance of Class 9/8 clean room

Cochranemurray thank you very much for your valuable comments.

I will take this into account.
First of all I need to tell that our factory is located in China where all the standards differ a bit to those in Europe... :)

As we are just starting the project we are teaching our people how does the system works and what are the required hygiene measures etc.
We started with some connecting tubes etc but intend to launch class IIb products soon.

I am afraid the disinfectants we use are just not good enough.
People wash their hands on entering the clean-room but only with normal soap. What anti-bacterial soaps are used?
The other idea was that the disinfectants used for cleaning of the premises are not good enough. Right now we are launching tests and validation for chlorine dioxide as it seams to be quite promising - have you got any experience?
Of course every 2 hours people are spraying some other disinfectant on their hands while working to reduce the bacteria.

As for now I am not sure what is the main source of the contamination... we are working on it.


Gert, we also sterilize our products but I was wondering if it was not a good idea to use some UV lamps (just like they do in the hospitals) to enhance bacteria killing in the clean-room while people don't work there. Any comments to this?

Considering that hands of the workers could be some source of contamination I was wondering to make them use gloves... how do you do it at your facilities?

:thanx:
 

Ajit Basrur

Staff member
Admin
#7
Re: Maintenance of Class 9/8 clean room

We are running class 9/8 clean room and I am afraid we are having some problems with the level of cleanness in the clean room.
Could you share your experience regarding the maintenance of the clean room? What disinfectants and other cleaning products to you use to clean the premises?
How about cleaning the hands of the personnel? How often do they do it and what disinfectants are used for this purpose?
do they work in gloves or with bear hands?

Do you use UV laps in the whole clean room to enhance the bacteria killing ?
Hi Gereard,

When you say that you are having problems with level of cleanliness, do u mean that the number of particulate contamination is exceeding the limits ? This could be due to the air quality / personnel / materials / process itself. You may also want to have a look at the number of air changes etc. You need to investigate the reasons.

On cleaning hands, apart from cleaning hands with soap (any soap will do. Bactericidal soap not required; a sales gimmick. Soap being alkaline automatically kills bacteria). Ensure that all personnel before entering the cleanroom should sanitise their hands and wear clean attire. Personal hygiene is also of utmost importance.

They can work with bare hands but ensure that they wear gloves while handling the product. At any given time, direct contact by bare hands to the product should be avoided.

I am not in favour of UV lamps as UV is carcinogenic and is harmful to skin and eyes.
 
G

gereard_kgb

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

Thank you for further valuable comments.

In fact we discovered that the products before sterilization are pretty contaminated.
I do not know yet what is the source of this contamination. I am looking for it.

Thank you for the comments on the soap.

As far as UV is concerned I was thinking of it as an additional measure that could be labour-free and could enhance bacteria killing.
Since I remember that UV can cause cancer I am sure it could only be switched on when the premises are empty.


The gloves - this is of some issue to me. In the majority of clean-rooms I've been people used to work with bear hands with appropriate disinfection measures.
Yet I thought this could be of some use to reduce any potential contamination of hands origin :)

As for all the other measures we are OK. People wash their hands before entering the premises and they disinfect them while working.
The cloaks - do you wash them everyday or people wear them for some longer period before washing?

:thanks:
 
G

Gert Sorensen

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

I am afraid the disinfectants we use are just not good enough.
People wash their hands on entering the clean-room but only with normal soap. What anti-bacterial soaps are used?
I'm with Qualityalways on this one. Any standard liquid soap should be sufficient. There are so many things that cause more trouble than soap...

The other idea was that the disinfectants used for cleaning of the premises are not good enough. Right now we are launching tests and validation for chlorine dioxide as it seams to be quite promising - have you got any experience?
I would dig a bit more into how the desinfectants are used. Do you follow the suppliers instructions?

Of course every 2 hours people are spraying some other disinfectant on their hands while working to reduce the bacteria.
Hmmmmmm, I don't like that. How about allergies etc.?

Gert, we also sterilize our products but I was wondering if it was not a good idea to use some UV lamps (just like they do in the hospitals) to enhance bacteria killing in the clean-room while people don't work there. Any comments to this?
I would not get into that. It might be overkill. Look into the air supply - along with hygiene. Do you use the correct HEPA-filters? How good is your over-pressure? Do you have sufficient air-changes?
Remember, your goal is not to have sterile products during production, it is to reduce the contamination.

Considering that hands of the workers could be some source of contamination I was wondering to make them use gloves... how do you do it at your facilities?
Once again, allergies spring to my mind. You may want to have the operators wear full body suits that are being cleaned regularly (and of course hair nets).

Good luck on the challenge :bigwave:
 
G

gereard_kgb

#10
Re: Maintenance of Class 9/8 clean room

Thanks for the next insight.

We are investigation the chlorine dioxide now. We are doing some validation righ now. From the information we got from different manufacturers it should be fine. I hope to know it soon...

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.

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.

Overkill? Hm... is it a problem?
 
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