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Staph detect infant formula, what action should we take?

Staph

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#1 zeezart

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Posted 25 July 2018 - 03:34 AM

Hi,

 

We have had a staph detect on finished goods and our procedure is not quite clear on what to do. Can anyone please advise what is their procedure for OOS regarding Staph. I am very clear on what to do if it is Salmonella or Listeria.

 

Thanks

 



#2 012117

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Posted 25 July 2018 - 04:20 AM

Hi, Zeezart.

 

What is the profile based on the 3-class plan analysis? Should this be within your local regulation then disposition can be made on the product provided investigation has been completed for possible causes (probably post heat treatment contamination). Otherwise, reject the whole lot. The action on the line will be based on the probable cause the team have come up to coming from the best available data that you have currently (as it could be coming from packaging, handling of scoops if available etc).

 

Btw, what is the APC profile?



#3 Charles.C

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Posted 25 July 2018 - 11:34 AM

Hi,

 

We have had a staph detect on finished goods and our procedure is not quite clear on what to do. Can anyone please advise what is their procedure for OOS regarding Staph. I am very clear on what to do if it is Salmonella or Listeria.

 

Thanks

 

Hi zeezart,

 

It is unclear if you are (a) asking how to do a recall or (b) how to measure Staphylococcus spp. Please clarify. i have tentatively assumed the latter.

 

I presume you are referring to Coagulase Positive (COP) S.aureus ??? This is IIRC the only pathogenic species within the genus.

I presume you are referring to detection by a NZ official organisation or ???

 

COP S.aureus is generally required to comply with a quantitative limit, not a detection ? So what is the Standard ?

 

One official procedure for COP S.aureus is here -

 

https://www.fda.gov/...s/ucm071429.htm

(the second [MPN] method will probably be the appropriate option)


Kind Regards,

 

Charles.C


#4 zeezart

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Posted 25 July 2018 - 08:37 PM

Hi Both,

 

Thanks for your reply. We are rejecting the whole lot and doing product disposition. The recognised agency has been alerted so we do know what to do and thankfully not a recall yet as it has not yet been graded and released

 

Staph was detected and based on our procedure we are to do a count testing on the subsequent lot until 7 days clear.

 

The first 6 subsequent days retest count was <10cfu/g which is still within our country limit (DPC1) but the 7th subsequent day was <15cfu/g which is OOS.

 

I want to change our procedure to only do until 4 days clear and also to make sure the sample(from the bag) taken for the retest is the same sample used for the original test. Also instead of doing a count testing for the retest then we do a Detect/Non-Detect.

 

Hopefully this makes a bit more sense so was thinking if anyone else has a procedure they follow they can share if Staph result is out of specification.

 

Thanks,

Azizah



#5 012117

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Posted 26 July 2018 - 12:47 AM

Hi, Zeezart.

 

Please correct my understanding, we do test for 7 days for the subsequent lot and/or we subsequent test for the lot initially with staph detection exceeding specification?

 

 

 

I want to change our procedure to only do until 4 days clear and also to make sure the sample(from the bag) taken for the retest is the same sample used for the original test. Also instead of doing a count testing for the retest then we do a Detect/Non-Detect.

 

Because I got confused with this one. Because if the former, you are showing due diligence provided you have rectified the probable cause. If it is the latter, I don't think you can test repeatedly. Testing from the same bag already have a risk of having possible out of norms results that could be attributed to sample handling and may possibly bring confusion.

 

Note however that if its not "gross contamination or systematic contamination", you don't normally expect homogenous microbial distribution. Btw, the m for 3 class plan is <10cfu/g? I noticed that what you have is <10 cfu/g (equal to M). May want to check result reporting and analytical limit as it requires you <1cfu/g for m.



#6 zeezart

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Posted 26 July 2018 - 12:59 AM

If we get a staph detect on a product made June 1st for example, we re-test the 7 subsequent lot which will be June 2nd - June 8th lot



#7 012117

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Posted 26 July 2018 - 01:18 AM

btw, this is from the earlier post, dont really know how to quote a sentence only  :ejut: 

 

*Because I got confused with this one. Because if the former, you are showing due diligence provided you have rectified the probable cause. If it is the latter, I don't think you can test repeatedly. Testing from the same bag already have a risk of having possible out of norms results that could be attributed to sample handling and may possibly bring confusion.

 

Note however that if its not "gross contamination or systematic contamination", you don't normally expect homogenous microbial distribution. Btw, the m for 3 class plan is <10cfu/g? I noticed that what you have is <10 cfu/g (equal to M). May want to check result reporting and analytical limit as it requires you <1cfu/g for m.



#8 zeezart

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Posted 26 July 2018 - 01:23 AM

Awesome thank you very much



#9 Charles.C

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Posted 26 July 2018 - 06:06 AM

Hi zeezart,

 

You seem to have some microbiological confusions.

 

As i understand this is the (2015) official NZ spec for this product -

 

Attached File  powdered infant formula.pdf   16.21KB   8 downloads

(Note that the entry for Bacillus cereus had a typo - "m" should be 102/g and "M" should have no entry at all)

(afaik "Staphylococci" would usually refer to S.aureus)

 

It is unclear why exactly the lot you refer has been rejected. And by whom. If above standard is the current one (??)  IMO yr routine testing criterion is highly  questionable.

 

The standard is somewhat oddly stated but should presumably dictate how you evaluate your product.

 

I anticipate that there is an official sampling/analysis procedure associated with the above standard. You need to use a similar procedure or one which is validated to give equivalent results.

 

PS - Note that if lab is initially using a 1:9 dilution of solid followed by traditional plating, this is not  a logical methodology to demonstrate that counts are < 10 cfu/gram (or even lower).


Kind Regards,

 

Charles.C





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