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cleanrooms, iso 14644 - cleanrooms and controlled environments, microbial tests, plastic parts, medical devices (general), microbiology (general), customer requirements
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  #1  
Old 7th January 2011, 08:54 PM
Germandeming Germandeming is offline
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Please Help! Is Microbiological Monitoring required for Clean Room?

I have a big confusion

We produce plastic parts for many customers that eventually go into Medical Device. Now, we have one customer who is asking us to do microbiological monitoring of our ISO Class 8 because his product is to be ETO sterilized.

I checked ISO 14644 but no mention of microbiology test there.

Is this test required ? What are the general criteria under which microbiological test has to be performed ?

Pls help

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Old 7th January 2011, 09:05 PM
harry harry is offline
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Re: Is Microbiological monitoring required for Clean Room ?

Welcome to the Cove.

Have a look at the details suggested this thread: Bioburden tests duration and Monitoring of gloves
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Old 7th January 2011, 11:13 PM
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Re: Is Microbiological monitoring required for Clean Room ?

It's not unheard of for an environmentally controlled area production process for pre-sterilization medical devices to be microbiologically monitored, even though the devices subsequently will be sterilized and the sterilization process is already known via validation to be able to deal with the typical contamination profile of the parts. It's an extra expense, though.

Perhaps your customer is thinking that if the microbiological status of the production environment is tracked, presumably in addition to the normal tracking of airborne and working-surface particulate counts that I assume you're already doing, they'll have yet another series of data that would show a deviation from norm in the event that the process broke down in some manner, thereby providing a warning that sterilization outcome was in question.

Considering that particulate data is generally regarded as sufficient for that process stability tracking, it's surprising that they think the additional expense is justified...or are they expecting you to absorb the extra cost?
Thanks to MIREGMGR for your informative Post and/or Attachment!
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Old 7th January 2011, 11:35 PM
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Re: Is Microbiological monitoring required for Clean Room ?

Thanks MIREGMGR.

Yes, the rationale of the customer is to assure that the bioburden is low before they ETO sterilize and yes, they want us to absorb the cost. Its pretty expensive to get contract lab to get the tests done.

Is there a way out or we have to do microbiology tests ?
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Old 7th January 2011, 11:53 PM
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Re: Is Microbiological monitoring required for Clean Room ?

Is there anything about your particulate count data series that suggests process inconsistency or operational or facility design issues?

What are they going to do with the microbiological data? Are they going to re-validate their sterilization process to integrate that second data stream as a mandated qualification for incoming parts, akin to the requirement they presumably have integrated regarding particulate count data?

Suppose the microbiological data shows a minor deviation, but the particulate count data is consistent and well within the sterilization process validation bounds. That could happen, for instance, in a seasonal change of the external environment from winter to summer, with a stable population of particles that are shed by the workers but with more of them harboring viable organisms.

What action would the customer expect to take, or expect you to take?

Quote:
Is there a way out or we have to do microbiology tests ?
The point of the questions is that the only "way out" is to convince the customer that they're being excessive and cost-wasteful, and that requires a good argument.
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Old 8th January 2011, 02:30 AM
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Re: Is Microbiological monitoring required for Clean Room ?

Quote:
In Reply to Parent Post by Germandeming View Post

Thanks MIREGMGR.

Yes, the rationale of the customer is to assure that the bioburden is low before they ETO sterilize and yes, they want us to absorb the cost. Its pretty expensive to get contract lab to get the tests done.

Is there a way out or we have to do microbiology tests ?
MIREGMGR has given you a good insight.
An other "way out" is ask your customer more questions...
1. Air bioburden or swab sample bioburden on surface ?
2. To what standard ?
3. What limits are acceptable ?
4. Which specific bioburden count or only gram negative ? Reason ?
5. Is a bioburden of your finished device ever done by customer? if so ask the result to be shared with you.
How does the customer respond back ~~~

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Best Regards...
Somashekar BV, INDIA
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Old 8th July 2012, 08:38 PM
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Re: Is Microbiological monitoring required for Clean Room ?

Hi Harry,

Our product is a PTCA ( Percutaneous Transluminal Coronary Angioplasty/Stent Placement ) which will be manufactured under class 10k and class 100k clean room. I am located in Johore/Malaysia. We were advised by our India counterpart to set up a microbiological lab in our class 100k clean room to perform in house microb lab test. However, our ISO13485 consultant think otherwise,. His rational is the cost of the set up & manpower, and most importantly, the risk to contaminate the clean room and ultimately the product.

I kind of agreed with the consultant. However, I would like to have second opinion on this before we finalize on our decision.

Thanks.
  #8  
Old 16th August 2012, 05:40 PM
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Re: Is Microbiological monitoring required for Clean Room ?

Quote:
In Reply to Parent Post by wsong0808 View Post

Hi Harry,

Our product is a PTCA ( Percutaneous Transluminal Coronary Angioplasty/Stent Placement ) which will be manufactured under class 10k and class 100k clean room. I am located in Johore/Malaysia. We were advised by our India counterpart to set up a microbiological lab in our class 100k clean room to perform in house microb lab test. However, our ISO13485 consultant think otherwise,. His rational is the cost of the set up & manpower, and most importantly, the risk to contaminate the clean room and ultimately the product.

I kind of agreed with the consultant. However, I would like to have second opinion on this before we finalize on our decision.

Thanks.
Hi,

Sorry for the late response, but if it's still relevant --

1. I don't see how an in-house microbiological test lab would contaminate the clean-room. "In-house" doesn't mean it has to be inside the clean-room, it only means you own it, i.e. it's not a third party lab. It could be in the same building but separated from the clean-room, in another building, or even on another site of yours, quite far away (as long as the samples get there with no significant delay). Samples would be taken inside the clean room and then processed in the lab. The sampling process does not involve introduction of bio materials into the clean-room, other than the humans that are there anyway.

2. I don't understand why your customer cares who owns/runs the lab; the only important issues are that the lab operates according to accepted standards, and that this is assured in a reliable way (e.g. accreditation). Source a proper 3rd party lab near you, and have them do the tests. They can also handle the sampling in your clean-room if they have the qualifications, or you could do it yourself, following applicable standards. Make sure all this is properly controlled and documented.

Cheers,
Ronen.

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Thanks to Ronen E for your informative Post and/or Attachment!
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