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CIP Validation References

CIP Validation Guidelines References

Best Answer Charles.C, 28 December 2019 - 04:20 AM

Hi all,

 

I am in need of your collective wisdom and guidance.  I am in the midst of working on our manual CIP SSOP and cannot locate references for flow velocity and circulation times to validate or to provide to our auditors when they come in that provides rationale for our uses.  I am sure we can use data logs such as negative test results, flow rate measurements, titration recordings, etc., but I am really looking for that "golden egg!"  ...Or am I simply on a wild goose chase?

 

Background:  New sauce line implemented that produces then freezes (nitrogen bath) various sauces for customers.  Our CIP is manual.  The flow velocity rate and circulation times used are as recommended by chemical manufacturer; however, when asked about references for recommendations, we are told this comes from years of experience and training in the industry, via email communique which I am not confident in printing and presenting to an auditor as reference.  We are on the BRC track and produce both USDA and FDA items.

 

Links to previous threads regarding CIP that I have come across on the Forum have been helpful, but not definitive when it comes to establishing flow rates and circulation times.  I would welcome and greatly appreciate any further guidance and direction!

 

Blessings,

- Bob.

 

Hi Bob,

 

IMEX, equipment suppliers do not automatically divulge core principles for their operational Validation Procedures since this is often competitive/confidential  information except where perhaps legality factors are involved. Some procedures include  "Rule-of-Thumb" formulae or spreadsheets involved which have been, long-term, developed internally.

 

Not my area of expertise but I seem to recall that some general  basic validation requirements are covered in previous threads here which probably correlate to yr manufacturer's supplied procedures ?  You may have to provide more specific quantitative information/process details as to what you are seeking to get more directly useful answers.

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#1 DYMOND

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Posted 27 December 2019 - 06:24 PM

Hi all,

 

I am in need of your collective wisdom and guidance.  I am in the midst of working on our manual CIP SSOP and cannot locate references for flow velocity and circulation times to validate or to provide to our auditors when they come in that provides rationale for our uses.  I am sure we can use data logs such as negative test results, flow rate measurements, titration recordings, etc., but I am really looking for that "golden egg!"  ...Or am I simply on a wild goose chase?

 

Background:  New sauce line implemented that produces then freezes (nitrogen bath) various sauces for customers.  Our CIP is manual.  The flow velocity rate and circulation times used are as recommended by chemical manufacturer; however, when asked about references for recommendations, we are told this comes from years of experience and training in the industry, via email communique which I am not confident in printing and presenting to an auditor as reference.  We are on the BRC track and produce both USDA and FDA items.

 

Links to previous threads regarding CIP that I have come across on the Forum have been helpful, but not definitive when it comes to establishing flow rates and circulation times.  I would welcome and greatly appreciate any further guidance and direction!

 

Blessings,

- Bob.



#2 IanL

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Posted 28 December 2019 - 01:38 AM

When you say a manual CIP system, I guess I am a bit confused.  Manual in what way?

 

Is it more of an assisted cleaning system?



#3 Charles.C

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Posted 28 December 2019 - 04:20 AM   Best Answer

Hi all,

 

I am in need of your collective wisdom and guidance.  I am in the midst of working on our manual CIP SSOP and cannot locate references for flow velocity and circulation times to validate or to provide to our auditors when they come in that provides rationale for our uses.  I am sure we can use data logs such as negative test results, flow rate measurements, titration recordings, etc., but I am really looking for that "golden egg!"  ...Or am I simply on a wild goose chase?

 

Background:  New sauce line implemented that produces then freezes (nitrogen bath) various sauces for customers.  Our CIP is manual.  The flow velocity rate and circulation times used are as recommended by chemical manufacturer; however, when asked about references for recommendations, we are told this comes from years of experience and training in the industry, via email communique which I am not confident in printing and presenting to an auditor as reference.  We are on the BRC track and produce both USDA and FDA items.

 

Links to previous threads regarding CIP that I have come across on the Forum have been helpful, but not definitive when it comes to establishing flow rates and circulation times.  I would welcome and greatly appreciate any further guidance and direction!

 

Blessings,

- Bob.

 

Hi Bob,

 

IMEX, equipment suppliers do not automatically divulge core principles for their operational Validation Procedures since this is often competitive/confidential  information except where perhaps legality factors are involved. Some procedures include  "Rule-of-Thumb" formulae or spreadsheets involved which have been, long-term, developed internally.

 

Not my area of expertise but I seem to recall that some general  basic validation requirements are covered in previous threads here which probably correlate to yr manufacturer's supplied procedures ?  You may have to provide more specific quantitative information/process details as to what you are seeking to get more directly useful answers.


Kind Regards,

 

Charles.C


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#4 DYMOND

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Posted 30 December 2019 - 02:20 PM

Hi Bob,

 

IMEX, equipment suppliers do not automatically divulge core principles for their operational Validation Procedures since this is often competitive/confidential  information except where perhaps legality factors are involved. Some procedures include  "Rule-of-Thumb" formulae or spreadsheets involved which have been, long-term, developed internally.

 

Not my area of expertise but I seem to recall that some general  basic validation requirements are covered in previous threads here which probably correlate to yr manufacturer's supplied procedures ?  You may have to provide more specific quantitative information/process details as to what you are seeking to get more directly useful answers.

 

Thank you Charles, I seem to have arrived at a similar conclusion on Friday after having spent a few weeks researching this!  Apparently, I had information I gathered from a previous thread on this topic that included the "general basic validation requirements" you mentioned, but just hadn't seen it!

 

Thank you all for your assistance with this - one of the many reasons I love the Forum!







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