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Subject:
From:
Donald English <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 27 Mar 2023 19:08:31 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (126 lines)
Instead of ozone, I would suggest that pw system be converted to hot water circulating system.  If you are going to use ozone, you will need to use ozone detectors in the environment to detect the presence of leakage of ozone gas from the pw system.  Periodic sanitization of the pw system will work with ozone will work, but it will not prevent the re-establishment of Bcc contamination in the system if you did not determine the source of Bcc contamination.    I will admit that I like to use ozone in a pw system 100% of time with uv neutralization at the time of use. FYI, injection of ozone into a pw system will cause the water temperature to rise. You will need use a heat exchanger to lower the temperature of the circulating pw.

Don

Donald J. English Microbiological Quality Consulting LLC 
Florham Park, New Jersey 07932

Sent from my iPhone

> On Mar 27, 2023, at 3:35 PM, Jeanne Moldenhauer <[log in to unmask]> wrote:
> 
> Neil
> 
> BCC is easily remediated with ozone or ozonated water.  There are services
> that can periodically sanitize your system using ozone.  It is different
> from other chemicals, as it is smaller and gets into the nooks and crannies.
> 
> Jeanne Moldenhauer
> 
>> On Mon, Mar 27, 2023 at 8:50 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/

Microbiologics, Inc. - http://www.microbiologics.com

Novatek International https://ntint.com/

Steris - http://www.sterislifesciences.com/

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.

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