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AK!

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Posted 23 December 2020 - 01:24 AM

How long can a CLEANED food manufacturing line be down before it has to cleaned again vs just sanitized for startup? (FDA/FSMA or BRC guidance would be appreciated) I'm assuming the activities between shutdown & startup would go into play but I'm not familiar with any mandates. 


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jdpaul

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Posted 23 December 2020 - 02:21 PM

There are a lot of factors that could trigger another cleaning or sanitizing of the equipment after extended downtime; I don't think it is a one size fits because all foods have different properties and propensities for allowing biological contamination; the environment (air quality, traffic, layout in regards to other lines, etc.) also plays a role in this. 

 

What is the normal time period in which the line would be down? What monitoring activities do you perform to ensure cleaning and sanitizing was effective (e.g. atp, air sampling, total count, yeast and mold, etc.)?


Edited by jdpaul, 23 December 2020 - 02:21 PM.

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The Food Scientist

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Posted 23 December 2020 - 02:36 PM

Depends on target microorganisms and contamination routes. 

 

Can you tell us what the facility does exactly?


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Ryan M.

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Posted 23 December 2020 - 06:53 PM

In my dairy experience the only thing I have ever seen in writing on this is in the Pasteurized Milk Ordinance (PMO) as it relates to transport tankers.  If a transport tanker is empty and has been cleaned and sanitized it must be re-sanitized prior to use if empty for 72 hours or longer.  Other than this, I have never seen a reference from any other regulation.

 

If anyone has a reference to this from a regulatory standpoint please share.


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Charles.C

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Posted 23 December 2020 - 08:25 PM

How long can a CLEANED food manufacturing line be down before it has to cleaned again vs just sanitized for startup? (FDA/FSMA or BRC guidance would be appreciated) I'm assuming the activities between shutdown & startup would go into play but I'm not familiar with any mandates. 

 

I agree with Post 2 inasmuch as Risk Assessment is surely involved.

 

Effective cleaning must occur before sanitising, as sanitisers may not work as well if the food contact surface or utensil has not had all visible contamination removed.

https://ww2.health.w...-food-equipment

(the quotation itself implies one possible exception.  Perhaps + ATP testing as a further precaution in such a case)

 

One (specific situation) contender for time period - Wet, day-by-day batch processing using post-Production Sanitation IMEX typically implements overnight delays with ATP checks next day.


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Charles.C


AK!

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Posted 09 January 2021 - 04:26 AM

There are a lot of factors that could trigger another cleaning or sanitizing of the equipment after extended downtime; I don't think it is a one size fits because all foods have different properties and propensities for allowing biological contamination; the environment (air quality, traffic, layout in regards to other lines, etc.) also plays a role in this. 

 

What is the normal time period in which the line would be down? What monitoring activities do you perform to ensure cleaning and sanitizing was effective (e.g. atp, air sampling, total count, yeast and mold, etc.)?

 

We are a small plant with NO activity on the weekends which is the target concern. So, we would be done cleaning on Saturday morning at about 2:30 a.m. and Pre-Op on Monday morning at about 4:00 a.m.  It is a brand new building (about a year old). Our air quality is excellent. 


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AK!

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Posted 09 January 2021 - 04:32 AM

Depends on target microorganisms and contamination routes. 

 

Can you tell us what the facility does exactly?

Plant based vegan. Our target micro is listeria, botchalism, E. coli. There's others but thats off the top of my head.


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Charles.C

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Posted 09 January 2021 - 04:55 AM

We are a small plant with NO activity on the weekends which is the target concern. So, we would be done cleaning on Saturday morning at about 2:30 a.m. and Pre-Op on Monday morning at about 4:00 a.m.  It is a brand new building (about a year old). Our air quality is excellent. 

 

I assumed sanitising without cleaning had already been "rebutted". This answers the OP ?

 

Re weekend frequency - Cleaning/Sanitising -  if probability of contamination considered low and assuming no specific official/unofficial guidelines exist, conservatism + validation data is often (initially) recommended.

 

Step 1 - define acceptable micro. conditions or ATP  for yr surfaces. Preferably both.

 

Step 2 implement some ATP testing to comparitively evaluate the before/after situation. (I daresay you are familiar with ATP already ?).

 

Step 3 If step 2 OK, do micro testing.

 

(Of course, if you have an in-house micro. lab, add step 3 to step 2)

 

Evaluate the results.

 

Prom a purely practical POV, the value of the exercise might relate to the amount of re-cleaning/sanitising work involved, eg if negligible be auto-conservative ?.


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Charles.C


AK!

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Posted 09 January 2021 - 06:01 AM

I assumed sanitising without cleaning had already been "rebutted". This answers the OP ?

 

Re weekend frequency - Cleaning/Sanitising -  if probability of contamination considered low and assuming no specific official/unofficial guidelines exist, conservatism + validation data is often (initially) recommended.

 

Step 1 - define acceptable micro. conditions or ATP  for yr surfaces. Preferably both.

 

Step 2 implement some ATP testing to comparitively evaluate the before/after situation. (I daresay you are familiar with ATP already ?).

 

Step 3 If step 2 OK, do micro testing.

 

(Of course, if you have an in-house micro. lab, add step 3 to step 2)

 

Evaluate the results.

 

Prom a purely practical POV, the value of the exercise might relate to the amount of re-cleaning/sanitising work involved, eg if negligible be auto-conservative ?.

We use Charm ATP with a RLU max of 500. We conduct visual inspections then sanitize after we clean for the weekend to keep any residual micro at bay and conduct ATP on Monday before Pre-op. 99%+ of our ATP's on Monday morning are "0" We've been sanitizing only on Monday morning and not cleaning. We've been doing this for about 7 months with great success on our 3rd party lab results for food and validation of our cleans. However, I do understand that the idea is risk based but wasn't sure if in the BRC or FSMA standards there are stricter and/or obscure bits of info I might be overlooking. Thanks to everyone for your comments


Edited by AK!, 09 January 2021 - 06:02 AM.

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Charles.C

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Posted 10 January 2021 - 10:40 PM

We use Charm ATP with a RLU max of 500. We conduct visual inspections then sanitize after we clean for the weekend to keep any residual micro at bay and conduct ATP on Monday before Pre-op. 99%+ of our ATP's on Monday morning are "0" We've been sanitizing only on Monday morning and not cleaning. We've been doing this for about 7 months with great success on our 3rd party lab results for food and validation of our cleans. However, I do understand that the idea is risk based but wasn't sure if in the BRC or FSMA standards there are stricter and/or obscure bits of info I might be overlooking. Thanks to everyone for your comments

 

Hi AK,

 

Actually ATP data does not, per se, validate or verify if a satisfactory micro.condition.

 

I don't quite understand why, on Monday morning, you would either C/S or S if the ATP data was satisfactory.

 

If the ATP data was unsatisfactory then IMO you should C/S, not S.


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Charles.C


kfromNE

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Posted 11 January 2021 - 12:39 PM

We use Charm ATP with a RLU max of 500. We conduct visual inspections then sanitize after we clean for the weekend to keep any residual micro at bay and conduct ATP on Monday before Pre-op. 99%+ of our ATP's on Monday morning are "0" We've been sanitizing only on Monday morning and not cleaning. We've been doing this for about 7 months with great success on our 3rd party lab results for food and validation of our cleans. However, I do understand that the idea is risk based but wasn't sure if in the BRC or FSMA standards there are stricter and/or obscure bits of info I might be overlooking. Thanks to everyone for your comments

The plant I work at doesn't work weekends either. The facility is cleaned on Friday night. We do a deeper cleaning on Friday. Monday morning during pre-op everything is re-sanitized. We have had a full extensive inspection by the FDA (swab-a-thon, here for a week). Our facility is older and we produce RTE items. We do Zone 1 testing weekly along with visual inspection. The FDA had no issues with our cleaning procedures. So in terms of FSMA - you should be fine.


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Charles.C

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Posted 11 January 2021 - 12:57 PM

The plant I work at doesn't work weekends either. The facility is cleaned on Friday night. We do a deeper cleaning on Friday. Monday morning during pre-op everything is re-sanitized. We have had a full extensive inspection by the FDA (swab-a-thon, here for a week). Our facility is older and we produce RTE items. We do Zone 1 testing weekly along with visual inspection. The FDA had no issues with our cleaning procedures. So in terms of FSMA - you should be fine.

 

Hi kfromNE,

 

I deduce, unlike AK, that you do not do any routine ATP testing on the Monday morning . Seems strange, especially in view of RTE, etc.

 

Yr usage of RTE items involves (maybe) an additional risk factor. And also (maybe) age of premises ( IMEX, RTE production can indeed be operationally/auditorially "problematic" in old facilities; depends on the specifics, product/process, of course).

 

JFI what does" re-sanitized" involve, eg what chemical(s) applied ?. (I assume yr "sanitize" does not include "cleaning" albeit some interpretations [FDA?] may differ).

 

PS - Did FDA simply expect you to automatically (minimally) resanitize after stopping for the weekend, regardless of any other aspects ? If so, then I guess it's a "fait accompli" as far as the OP is concerned.  :smile:


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Charles.C


Jim E.

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Posted 21 January 2021 - 08:44 PM

In our facility we do not have any regular shut downs for extended periods of time 1 or 2 day shutdowns are the norm.  However, if we do run an extended shutdown 3-4 days or more, maybe for maintenance or new equipment install. We will do our regular cleanup with no sanitizer and when we return we will conduct a full clean again with sanitizer. Then we do our ATP and micro checks.

 

I should further mention that if we go down for emergency of more than 4 hours we will rinse lines down and sanitize before we start up as well.


Edited by Jim E., 21 January 2021 - 08:46 PM.

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Charles.C

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Posted 21 January 2021 - 11:30 PM

In our facility we do not have any regular shut downs for extended periods of time 1 or 2 day shutdowns are the norm.  However, if we do run an extended shutdown 3-4 days or more, maybe for maintenance or new equipment install. We will do our regular cleanup with no sanitizer and when we return we will conduct a full clean again with sanitizer. Then we do our ATP and micro checks.

 

I should further mention that if we go down for emergency of more than 4 hours we will rinse lines down and sanitize before we start up as well.

 

Hi Jim,

 

^^^(red) - Seems illogical, is there a reason ? (other than saving costs)


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Charles.C


Jim E.

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Posted 22 January 2021 - 03:06 PM

We do not apply sanitizer at start of extended break knowing a full clean will be conducted again before restart. I guess they consider it a cost saving.


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Charles.C

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Posted 22 January 2021 - 10:53 PM

We do not apply sanitizer at start of extended break knowing a full clean will be conducted again before restart. I guess they consider it a cost saving.

 

Hi Jim,

 

Thks reply.

 

From a hygiene POV, I would categorize it as a questionable cost saving. Must be an interesting SOP for auditors.


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Charles.C




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