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Varying limits in an oPRP

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Pete_Rev

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Posted 19 February 2018 - 09:56 PM

Hi all,

 

I'm updating our oPRP document for in-line screens. The document states: "The Control limit for concentrate screening in packaging is an intact 200µm screen.  The use of a screen smaller than 200µm is also allowable."

 

Now, i realise that oPRPs do not technically require critical limits. And of course "allowing" a screen size smaller than the nominal limit is better than allowing a larger size.

 

But I feel like it is not best practice to say "this is the limit, but the limit can also be smaller sometimes"

 

We make juice concentrates non aseptically filled into drums.

 

Interested in others thoughts.



FurFarmandFork

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Posted 19 February 2018 - 10:28 PM

I think that's okay. Sometimes an upper limit isn't critical. For example, using steam to sanitize a steel surface. There may be a lower limit for temperature to make sure it's effective, but then it can pretty much be any amount hotter. The risk changes to damage to equipment and efficiencies, but the biologcial hazard is controlled by a minimum, and maximum has no bearing.

 

Similarly, I might have an E. coli microbial specification that has a specification limit of <10CFU/gram, you can use a test method that provides that level of detection but you could also use presence absense or MPN to go even lower, makes no difference to me.


Austin Bouck
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Pete_Rev

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Posted 19 February 2018 - 11:00 PM

Ok, follow up question (which i am pretty sure i know the answer to)

 

The process looks like this essentially: Pastuerisation -> 200um screen -> mag trap -> 100um screen -> filling

 

So the last point of control (for foreign objects) is the 100um screen, so this should be the oPRP. 

 

The way the document is written currently it sounds like the 200um screen can be substituted with a smaller screen size for whatever reason. This doesn't take away from the fact that there is a subsequent step that is controlling the hazard.



FurFarmandFork

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Posted 20 February 2018 - 12:18 AM

Depends on what hazard the screen is controlling...but yeah, if you wouldn't run if you didn't have that 100 screen in your process, it sounds like that's the limit. If you know you would run without it and instead use a 200, then you're just doing a little extra which is also fine. Your haccp plan doesn't need to have your limits replicated on the line, they just need to be the same or stricter.


Austin Bouck
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Charles.C

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Posted 20 February 2018 - 09:02 AM

Hi Pete,

 

"A rose by any other name would smell as sweet".

 

As per iso22000's text,  oprp's are not associated with "critical limits" but the perennial requirement is the choice of a "limit" so as to validate them.

 

There are several extended discussions here over screen arrays such as you describe, eg (a) whether to designate CCP or OPRP (or PRP), (b) which item is the CCP or the OPRP etc etc. Multiple metal detectors have also generated related arguments.

 

In line with HACCP being subjective the discussion usually ends up as being a "matter of opinion" (note that iso22000 standard also accepts combination control measures).


Kind Regards,

 

Charles.C


Tony-C

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Posted 22 February 2018 - 04:50 AM

Thanks for Charles and FurFarmandFork for the useful posts.
 
Technically if the filter is to remove a foreign body choke hazard then this could be a CCP. Given the nuances of 22000 for the assessment of control measures one could make a case for PRP, OPRP and CCP.
Typically in most processes I have carried out this assessment the filter has been controlled as an OPRP, a maximum size specified, the filter to be check to ensure it is in place, seated properly and intact (at start and end of production run)
 
When we come to Clause 7.4.3 Hazard assessment onwards we need to decide if control measures for a hazard fall into the category of needing to be controlled through operational PRP(s) or by the HACCP plan.
Clause 7.4.4 Selection and assessment of control measures elaborates further:
The selection and categorization shall be carried out using a logical approach that includes assessments with regard to the following:
a) its effect on identified food safety hazards relative to the strictness applied;
b) its feasibility for monitoring (e.g. ability to be monitored in a timely manner to enable immediate corrections);
c) its place within the system relative to other control measures;
d) the likelihood of failure in the functioning of a control measure or significant processing variability;
e) the severity of the consequence(s) in the case of failure in its functioning;
f) whether the control measure is specifically established and applied to eliminate or significantly reduce the level of hazard(s);
g) synergistic effects (i.e. interaction that occurs between two or more measures resulting in their combined effect being higher than the sum of their individual effects).
Control measures categorized as belonging to the HACCP plan shall be implemented in accordance with 7.6. Other control measures shall be implemented as operational PRPs according to 7.5.
 
As Charles has pointed out there is a need to have a limit or to specify a standard in order to comply with 8.2 Validation of control measure combinations.
There is limited information available to specify acceptable limits for foreign bodies, the FDA previously published guidance for seizure based on an object being 7 - 25mm, RTE and not for special groups. Clearly your specified filter sizes are more than acceptable by this standard. Some useful info here:
 
If we take glass as the hazard then this hazard could be controlled by a combination of glass policy, glass checks, breakage procedures and filtration.
The important thing for me is not the classification of the control measure but that the hazard is adequately controlled.
 
Kind regards,
 
Tony


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