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Antibiotic and CCP

Antibiotic Bioculture CCP Bio fermentation

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MSifat

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Posted 15 January 2022 - 10:47 PM

In our process, we are using filter to sterilize compressed air before going into the fermentation chamber, we are also sterilizing all the equipment's and media. However, additionally, we are using antibiotic in the chamber to control microorganisms. I am quite confused where I shall put CCP, filter or antibiotic? Note that, compressed air can contain pathogenic microorganism. Use of antibiotic is questionable due to concern for Antimicrobial resistance. 



Charles.C

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Posted 16 January 2022 - 06:35 AM

In our process, we are using filter to sterilize compressed air before going into the fermentation chamber, we are also sterilizing all the equipment's and media. However, additionally, we are using antibiotic in the chamber to control microorganisms. I am quite confused where I shall put CCP, filter or antibiotic? Note that, compressed air can contain pathogenic microorganism. Use of antibiotic is questionable due to concern for Antimicrobial resistance. 

Hi Mazid,

 

2 initial comments.

 

(1) It may depend on what Standard (if any) is involved, eg Regulatory, GFSI (eg BRC, ISO22000), etc.

(2) You will need to do a hazard analysis / Risk assessment in order to determine whether a CCP exists.


Kind Regards,

 

Charles.C


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MSifat

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Posted 16 January 2022 - 11:27 AM

Hi Mazid,

 

2 initial comments.

 

(1) It may depend on what Standard (if any) is involved, eg Regulatory, GFSI (eg BRC, ISO22000), etc.

(2) You will need to do a hazard analysis / Risk assessment in order to determine whether a CCP exists.

We are supposed to get FSSC 22000 certification. I have done Hazard analysis. I found filter at compressed air entry point to the fermentation chamber can be a CCP, but again we are using antibiotic at the chamber to control microorganism. Theoretically, antimicrobial use can be a CCP. But, I cannot be sure actually. Any logical suggestion would be appreciated. 



Charles.C

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Posted 16 January 2022 - 12:18 PM

We are supposed to get FSSC 22000 certification. I have done Hazard analysis. I found filter at compressed air entry point to the fermentation chamber can be a CCP, but again we are using antibiotic at the chamber to control microorganism. Theoretically, antimicrobial use can be a CCP. But, I cannot be sure actually. Any logical suggestion would be appreciated. 

It may depend on the overall process flow chart / product status etc but, offhand, compressed air quality and antimicrobials sound more likely to be involving Prerequisite programs. Unless there is a specific hazard/process step involved.


Kind Regards,

 

Charles.C






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