If you are getting BCC in your water system everyday you are out of control. And if you use purified water for nonsterile products, cleaning or other activities in the facility, you can easily spread the contamination to unit operations. I just presented case studies of BCC contamination at PDA and at the CRL QC summit and in many instances the water system was poorly designed and/or poorly maintained or sanitized. You must remediate this issue immediately! Seek out appropriate experts in the industry to assist you. 

Michael 
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> 
> On Mar 27, 2023, at 11:06 AM, Nazlı TEKİN <[log in to unmask]> wrote:
> 
> 
> Dear All,
> I'm working in a Biotechnological Pharma Company. We got BCC in our Purified water system for 1 year. Based on FDA warning Letters or recalls we need to evaluate and eleminate the BCC in our water system if we are using that water during our production process right?
> 
> Our company decided that initiate a deviation about BCC contamination in purified water system. Due to getting BCC in purified water system almost everyday, we can not close this deviation. It seems that biofilm formation 
> We performed hot water and chemical sanitizaation for many times. But it seems that biofilm formation has occured.
> 
> Our product is prepared with WFI and we have not ever seen any BCC in WFI system , do we still have to remove BCC contamination in purified water system?
> 
> 
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Current Sponsors:

Associates of Cape Cod, Inc. - http://www.acciusa.com/

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Novatek International https://ntint.com/

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Veltek Associates, Inc - http://www.sterile.com



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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of the PMF or the sponsors of the list.