12 replies to this topic

[it_rains_inside]

Hi everyone, 

 

So we currently have a chain of custody type certification with an organic customer whom we co-pack for (the facility and some documentation is audited, mass-balance, gmps, etc but the customer holds the certification) we have recently signed on a new customer that requires that we hold the full certification. We are currently in the application process, and Im having a little back and forth with the certification project manager. I'd like to add that the customer who we co-pack for, and the customer that we just signed on are under the same certifying body. SAME . CERTIFYING. BODY.

 

Our current (and until now accepted) practice for showing evidence that sanitizers that aren't on the trainwreck National List are fully removed is to pull a final rinse sample. We titrate values and require that results are <1000ppm. Which is what we have always done... like for years!

 

The certif. project manager wants to know how <1000ppm ensures that all sanitizers are rinsed off the equipment. If we can illustrate that, it would be ok, If 1000ppm would still evidence that the sanitzer is on the equipment then the test is not sensitive enough...  

 

So I asked "What is the lower minimum end ppm that is acceptable?" What if we tested pH on the final rinse water? What is an acceptable +/- variance on pH values for discharged final rinse sample and rinsing water sample?"

 

Essentially her answer was that she could not consult  us on this.... great help lady.

 

Any suggestions? Do we just pH test both samples and require that they are equal to verify all sanitizers have been removed? If not equal, continue rinsing until they do??

 

-Sincerely

I Eat Organic But Don't Understand Its Rules

Edited by it_rains_inside, 25 February 2015 - 02:16 PM.

[fgjuadi]

I would focus on establishing 1000 ppm as the lowest detectable amount.  If your limit in ND, you can only go as low as the test!  Titration is generally better than strips. 

 

In the past I've used P/A test strips

[it_rains_inside]

We wouldn't be using the strips. We have a pH meter in the lab. Essentially we are going to have to test pH values of final rinse water against rinsing water used. When they are equal, all sanitizers have been removed from the system,.. Or so says says Organic nazi project manager

 

<1000ppm is as low as our titration kits go. 1 drop equals 1000ppm. 

[Snookie]

In a previous facility we tested pH of the rinse water and this was acceptable to the largest Organic CB and they had signed off this practice as being acceptable for many years.

[it_rains_inside]

That seemed like the most logical choice instead of ordering more sensitive titration kits. I was just hoping for a simpler (less work for me ) option. lol  

 

I've been re-writing procedures all afternoon, and preparing for the bi***ing! 

[Charles.C]

Dear it-rains-inside,

 

1000ppm sounds like a very high limit of detection (LOQ?).

 

Maybe you need a better analytical procedure.

 

Rgds / Charles.C

[teaks]

We are not in a wash-down environment - we just surface sanitize.  The quat test strips we were using were never sensitive enough to satisfy our auditor, so we had to get different test strips with a range of 0 -10-25-50-100 ppm.  But these strips are really designed to be put into water (not really for surface testing), so I think you could capture final rinse water, dip the strip then you're done!

 

That said, we starting using peracetic acid (OK per the National List), and that also seems to satisfy our auditor.

 

Good luck!  I've found organic certification to be the most "fluid" of standards, and the auditors I have been assigned have been EXTREMELY inconsistent in both knowledge and application of the NOP. 

[Snookie]

Good luck!  I've found organic certification to be the most "fluid" of standards, and the auditors I have been assigned have been EXTREMELY inconsistent in both knowledge and application of the NOP. 

 

Completely agree!!

[it_rains_inside]

Thanks everyone.

 

@Charles, just an FYI, like I was stating in my original post, we have not changed anything about our process, including our test kits. We have been "chain of custody" certified through this same CB for the last 5 years or so. They know what we are doing, that we don't have 100% dedicated equipment, yada yada. I am surprised that this is just now an issue. Every time we have been audited in the past few years ,we've showed the auditors the same records page where titrations are recorded and it's always had the limit of <1000ppm.

 

@ksullivan, it's not so much what chemical we  are using, as they are on the NList, however, it is ensuring 100% removal of before production.

 

Oh well, what is done is done - she seems tempered with us committing to checking final rinse samples with rinse water samples. If the pH value is equal than we're all green lights. My lab techs could use the practice on testing pH anyway.. (look for that silver lining right??)

[Charles.C]

Dear it-rains-inside,

 

it sounds like the 1000ppm was "ad hoc".

 

5years was a good run IMO.

 

If you can npw satisfy the auditor with a shift to pH equality, sounds like an optimum escape route.

 

Rgds / Charles.C

[fgjuadi]

Just out of curiosity - Would 1000 ppm sanitizer change the pH level enough to detect it?  Like, how much sanitizer would you have to put in to change pH?   Wouldn't you have to add more than that?

Edited by magenta_majors, 25 February 2015 - 08:39 PM.

[it_rains_inside]

I am assuming, while "she could not consult" that this was the route to go, she gladly received it with open arms.

 

Also just a tad bit of info that may be helpful - I dont know if this is common in most aseptic systems, or just ours, but very VERY rarely do we ever have a result indication 1000+ppm on final rinse titrations, we also run micro on the samples and have not had any issues since my time here.. (knock on wood) We also do visual inspection and ATP swabbing for residual testing. 

[chris j]

We switched from a chlorine wash system and rinse free sanitizer to Peracetic Acid for the same reason, to satisfy organic requirements. The switch makes our rinse and sanitation systems simpler, safer, and believe it or not, more cost effective. Added benefit is it is better for the environment.