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How Do We Determine the Control Limit in Unconventional Products?


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#1 walabies

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Posted 04 April 2008 - 09:07 AM

Dear all,
As topic, I looked through all the sources I could gather but I cannot find any standards, (biological since I am a microbiologist) for our product, coffee creamer. It isn't categorized as dairy product as it's not milk based. So if there is any guidelines that I could use to determine which limits and tests I should be doing? :helpplease:

I run through some of the COAs of other suppliers, looking for similarities of product, there are "acceptable" and "typical" limits, what does those means? :helpplease:


Edited by walabies, 04 April 2008 - 09:08 AM.

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#2 AL BUNDY

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Posted 04 April 2008 - 02:30 PM

Hi:
In my country the Health authority classify the product according to the legislation.


I will adress: b.cereus, staph a and salmonella. As to the method, look to the AOAC web for powder food or something like that.

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Edited by AL BUNDY, 04 April 2008 - 02:38 PM.

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#3 walabies

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Posted 06 April 2008 - 02:05 PM

I read through your picture. Care to transalate it? :helpplease:


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#4 GMO

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Posted 22 April 2008 - 09:51 AM

I've never made coffee creamer but if I was making it for a retailer, I'd be first guided by their standards. If you're making branded creamer, then I'd obviously target absence of pathogens. Your product presumably cannot be reconstituted and stored and I assume it won't support microbial growth. The one thing to be careful of though is Salmonellae. If detected, remember it can cause illness at v low levels in fatty foods (look at Cadbury in the UK!)

I would look at the values below, look at minimum infective doses and also test to see if the powder can support micro growth. Be wary though because this is what Cadbury's did and assumed levels of 10 cfu per gram of Salmonellae were insufficient to cause illness because it had never done so at that level; however, it had been known to cause illness at 50 cfu per gram so it was a silly assumption to make.

I do happen to have a retailer's spec for dried foods which I think would apply to your product, however, you will need to justify your choice of limits in your HACCP manual.

CLOSTRIDIA SP. IN 0.1G, Target ABSENT (test each batch unless you test the ingredient. If so, drop to monthly). If present, consider risks / possible recall - do a risk analysis.
COLIFORMS Target <10. If you get 100 or more, test for EColi. Presence of EColi or >100 coliforms might cause recall - do risk analysis.
S. AUREUS Target <100. If you get more could cause recall - risk assess.
SALMONELLAE Target ABSENT. If present, I would definitely recall.

It's probably a good idea from a monitoring point of view to test for TVC or similar so you have an idea of how well the process is controlled. In a dried food, I'd expect the TVCs to be very low.


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#5 AS NUR

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Posted 22 April 2008 - 10:07 AM

Dear all,
As topic, I looked through all the sources I could gather but I cannot find any standards, (biological since I am a microbiologist) for our product, coffee creamer. It isn't categorized as dairy product as it's not milk based. So if there is any guidelines that I could use to determine which limits and tests I should be doing? :helpplease:

I run through some of the COAs of other suppliers, looking for similarities of product, there are "acceptable" and "typical" limits, what does those means? :helpplease:


Dear Walalbies...

standard microbiology in coffee creamer.. depend on the regulation in your country (where you from? Australia?)... in my country we have national standard for non dairycreamer (coffee creamer).. the standards state :
TPC is max. 50000 cfu/g;
Coliform is max. 100 Cfu/g
Salmonella is Negative/25 g
Staphylococcus aureus is Negative /g

hope can make you clear :thumbup:
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#6 Charles.C

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Posted 22 April 2008 - 04:33 PM

Dear walabies,

As you can see from the above, the choice depends on what you are doing with yr product. :smile: , eg export or local consumption only ? Either way, you will surely be required to comply with some internal or external regulatory standard/s. Additionally, you may select limits (often based on the nmMc system as per Al's example above) which you personally consider appropriate although these should obviously be validated as would be expected for a "pure" HACCP plan. However if the regulatory limits are more strict than yr chosen data, the former will presumably ( unfortunately) have to be taken as a priority. (It is quite possible to encounter regulatory microbiological limits which seem to have limited scientific justification.)

Rgds / Charles.C


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Charles.C


#7 walabies

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Posted 24 April 2008 - 08:41 AM

Dear Walalbies...

standard microbiology in coffee creamer.. depend on the regulation in your country (where you from? Australia?)... in my country we have national standard for non dairycreamer (coffee creamer).. the standards state :
TPC is max. 50000 cfu/g;
Coliform is max. 100 Cfu/g
Salmonella is Negative/25 g
Staphylococcus aureus is Negative /g

hope can make you clear :thumbup:


Looks like I am too strict to myself in setting the limits... Makes my life hard...
Mine are...
TPC max 3000 cfu/g
Yeast/Mould max 30 cfu/g
Coliform max 3 cfu/g
S.aureus and Salmonella is negative/g

Would the auditors questioned me when I set to more lenient controls? :whistle:
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#8 Charles.C

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Posted 24 April 2008 - 08:36 PM

Dear walabies,

Assuming “non-dairy creamer” is the product involved, googling “microbiological specifications non-dairy creamer” offers a good selection of sets of micro.limits, eg http://www.smpfoodsu...amyLac spec.htm (perhaps you’ve done this already ?) . Unfortunately, although helpful indicators, most of them are incomplete operationally since they hv no associated sampling plan. Al’s previous example illustrates a more satisfactory format.

added - a much less statistically correct but popular option IMEX is to do a rotating selection of products every X days using a small sample size with application of a denser / defined sampling plan in case of any failure of limits. After all, proper HACCP is supposed to reduce the necessity of frequent mic.testing [> verification step] which can also be very expensive / time consuming. However this option may forcibly depend on yr particular product / customer requirements etc.

Rgds / Charles.C


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Charles.C


#9 walabies

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Posted 27 April 2008 - 04:42 PM

Yup I have done research for these quite long ago.
So you mean HACCP do allow 'non-statistically correct' method of sampling plan if the HACCP plan is correct?


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#10 Charles Chew

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Posted 28 April 2008 - 03:41 PM

Looks like I am too strict to myself in setting the limits... Makes my life hard..

Your sampling plan should be designed to validate your process controls in achieving your intended end product performances. And, why should another Country's Micro. Standard be your reference standard when or if your Customers were to demand higher!

So you mean HACCP do allow 'non-statistically correct' method of sampling plan if the HACCP plan is correct?

Your food safety system is therefore validated using incorrect or unreliable methodologies and as such how do you determine whether your HACCP Plan is effectively in control? Perhaps, you may want to consider reviewing your control measure combinations for the whole system again.
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Cheers,
Charles Chew
www.naturalmajor.com

#11 Charles.C

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Posted 28 April 2008 - 03:53 PM

Dear Walabies,

By “much less correct” I meant that many official sampling plans will accept a substantial number of defective lots for any “zero tolerant” species when present at low levels, ie their likelihood of giving a correct result is less than ( I think ) would be typically hoped for. The requirements and practical limitations to their achievance are well-known (including auditors IMEX) and are discussed in the thread I mentioned earlier (and BAM on-line).
This is one reason why it is so important to validate processes like sterilization, pasteurization as demanded by HACCP. Not saying that it is always easy but it is fundamental.

Rgds / Charles.C


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Charles.C


#12 GMO

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Posted 28 April 2008 - 06:49 PM

The thing is though, micro standards are not always governed by safety, the TVC level for example is arbitrary but gives you an early warning if your system is going out of control. I think that was why the question was asked to find out about indicator organisms and also what is considered 'critical' for a pathogen - not to try and avoid using HACCP.


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#13 Charles.C

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Posted 28 April 2008 - 07:42 PM

Dear GMO,

You may be right. I should hv probably stuck it in the other creamer thread. Mind you, there is an almost equal level of debate as to the validity/appropriate levels for various non-pathogenic organisms also. This was attempted to be rationalised in the last batch of EU food regulations. Fecal coliforms is one example. The fact is that most mic. measurements are also not very accurate although, as you say. they can be useful where you hv a good idea of the normal levels as matched to an existing hygiene situation, like staph. aureus in cooked foods. A related problem with the limited accuracy is that accept/reject plans become questionable.

Actually I interpreted walabies query as an attempt to minimise his micro. workload which is a very reasonable objective IMO :smile: .

Rgds / Charles.C


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Charles.C


#14 Charles.C

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Posted 29 April 2008 - 07:18 AM

Dear walabies,

Just a comment on yr original query

I run through some of the COAs of other suppliers, looking for similarities of product, there are "acceptable" and "typical" limits, what does those means?


“Typical” often means values/limits which are usually achievable by yourself but are not to be interpreted as a supplier accept / reject type guarantee. Useful for informative purposes although they should obviously “correlate” to published values or you should be prepared to explain why they don’t.

“acceptable” as applied to limits is meaningless without detailing the particular case, eg originator, sampling plan, methodology, regulatory justification.

(added - for example, referring to Al's post, the "m" could be interpreted as -

m, a microbiological limit which, in a 2- class plan, separates good quality from defective quality or, in a 3-class plan, separates good quality from marginally acceptable quality. Values equal to m, or below, represent an acceptable product and values above it are either marginally acceptable or unacceptable. This value also could be seen as the value considered by those establishing the criteria to be acceptable and attainable through application of GHP and/or HACCP.

(Microorganisms in Foods 7 / ICMSF))

Rgds / Charles.C

added - regarding yr earlier

Looks like I am too strict to myself in setting the limits


I think, though no experience in this product -

yr TPC looks too strict (various values ranged 15000 to 50000 / g)
yr coliform is probably too strict (easier to comment if expressed as MPN/g)
yr Staph.aureus is also probably too strict (easier to comment if expressed as MPN/g)
yr Salmonella is surely not strict enough (usually negative [not detected] in 25g is most lenient option)

(the above should be interpreted within the context of an appropriate sampling plan, something like Al's)
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Charles.C


#15 walabies

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Posted 05 May 2008 - 04:27 PM

Backed from vacation :biggrin:
I think I know what you mean.
Yesterday I just have a discussion the swab test limits of our plant.
I seem can't outtalk them that the plant is 'unhygiene' (from our swab test and air test results), while they plan to do the lazy part.
So is there any prove I can convince them them to do a proper cleaning?


Edited by walabies, 06 May 2008 - 02:12 AM.

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#16 Charles.C

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Posted 06 May 2008 - 06:23 AM

Dear walabies,

'unhygiene'


Target ? Result ?

Other visual monitoring methods are available but, no doubt, at a cost.

Rgds / Charles.C
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#17 walabies

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Posted 07 May 2008 - 04:09 AM

Dear walabies,



Target ? Result ?

Other visual monitoring methods are available but, no doubt, at a cost.

Rgds / Charles.C


It's what the target of limit that I am looking for.
If I were to set my swab test limit at TPC 1000 and Y/M 50 (cfu/g) and air test limits at TPC 30 and Y/M 30 (cfu/g) [sedimentation method] based on my experience, no literature support :helpplease: , they are not very convinced with my judgement. :rolleyes:
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#18 Charles.C

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Posted 08 May 2008 - 07:14 PM

Dear walabies,

here is one official example -

The regulations also lay down requirements for microbiological assessment of both carcases and food contact surfaces.
Schedule 17C (Regulations 8(1)(e), 20(1)(eB) and 20(5) and (6), Paragraph 1 states “Microbiological sampling must take place before production starts, never during production. If visible dirt is present cleaning should be judged as unacceptable without any further microbiological evaluation.” The following requirements are laid down for sampling sites: -
• Minimum of 10 samples per fortnight taken before production on clean surfaces. This frequency may
be reduced by the Official Veterinary Surgeon (OVS) if the results are consistently good).
• Monthly sampling schedule to ensure all equipment is covered.
• Two-thirds of samples from food contact surfaces, three from large objects.
• Use swab/contact plate and test for TVCs – recommended swab area of 20cm ².
• Results recorded on a form and allocated to ‘acceptable’ or unacceptable (Schedule 17C).
• In house or contracted laboratory (recommend accredited or proficiency scheme lab).
Limits for these swabs are: -
Acceptable Range - TVC 0 – 10 / cm², Unacceptable Range> 10 / cm²

Acceptable Range - Enterobacteriaceae 0 – 1 / cm², Unacceptable Range > 1 / cm²
Please remember if the swab area has been 20 cm² then the count should be divided by 20 to give the result in the correct legal format; for example if the total TVC is 120 colony forming units(cfu)/swab then the correct interpretation is going to be 6 cfu/cm².

http://www.holchem.c...d... - 2006.pdf

Another example / suggested methodology for an ATP system is here -

http://www.scanity.c...-de/faq-09.html

Rgds / Charles.C


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#19 AS NUR

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Posted 13 May 2008 - 10:14 AM

It's what the target of limit that I am looking for.
If I were to set my swab test limit at TPC 1000 and Y/M 50 (cfu/g) and air test limits at TPC 30 and Y/M 30 (cfu/g) [sedimentation method] based on my experience, no literature support :helpplease: , they are not very convinced with my judgement. :rolleyes:



Dear Walabies..

Before you set your limit, you must identified class room for your clean room and after that you can set your microbiological limit..

1.ISO have clasification for cleanlines classroom (airborne testing (Particles/ft3))...

2. and for swab test if you using ATP test from MERCK (HYlite), Maximum value for Milk
Industry is ± 200 RLU (Relative light Unit)..

3. IF you using Settling Plate Methode for MIcrobiological test, EUGMP 2002 have standard for class room, for example: class C maximum 50CFU/4Hrs..

:thumbup:

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#20 Cathy

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Posted 13 May 2008 - 11:48 AM

Acceptable limits are those that imply action will be taken when limits are exceeded. Product would be rejected. Typical limits are just an indication of what results one expects to see. If resultsd are atypical, there might be an investigation or long term observation to determine if there is a trend but no product would be rejected.

Many foods don't have clear limits. Processors often need to find what they can, and then base the rest on conducting an in-house base lines study. From there, you know what is typical and can decide if this is an action limit for you or not.

Hoep that helps.


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Cathy Crawford, HACCP Consulting Group
http://haccpcg.com/

#21 walabies

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Posted 13 May 2008 - 05:12 PM

Dear Walabies..

Before you set your limit, you must identified class room for your clean room and after that you can set your microbiological limit..

1.ISO have clasification for cleanlines classroom (airborne testing (Particles/ft3))...

2. and for swab test if you using ATP test from MERCK (HYlite), Maximum value for Milk
Industry is ± 200 RLU (Relative light Unit)..

3. IF you using Settling Plate Methode for MIcrobiological test, EUGMP 2002 have standard for class room, for example: class C maximum 50CFU/4Hrs..

:thumbup:



Acceptable limits are those that imply action will be taken when limits are exceeded. Product would be rejected. Typical limits are just an indication of what results one expects to see. If resultsd are atypical, there might be an investigation or long term observation to determine if there is a trend but no product would be rejected.

Many foods don't have clear limits. Processors often need to find what they can, and then base the rest on conducting an in-house base lines study. From there, you know what is typical and can decide if this is an action limit for you or not.

Hoep that helps.


So based on the charts and tables and documents I read, should I classify food processing plant as Class C? That means the TPC count shouldn't be higher than 50cfu/m3.4hour?
If I follow what Cathy says, we don't have clear limits for the environment test, so can I set my limit higher than it should be? (say... <100cfu/3~4hour)
Hi Charles, do you have any idea of where does that standard comes from?

Edited by walabies, 16 May 2008 - 10:19 AM.

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#22 AS NUR

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Posted 19 May 2008 - 04:50 AM

So based on the charts and tables and documents I read, should I classify food processing plant as Class C? That means the TPC count shouldn't be higher than 50cfu/m3.4hour?
If I follow what Cathy says, we don't have clear limits for the environment test, so can I set my limit higher than it should be? (say... <100cfu/3~4hour)
Hi Charles, do you have any idea of where does that standard comes from?



Dear Walabies...

For standard of class room, depend on your qualifation.. thats (Class C) only sample, that means the TPC maximum is 50 CFU/4 hour (settling plate methode)...
you have to choose which class that suitable for your company...
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#23 Charles.C

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Posted 19 May 2008 - 01:23 PM

Dear Walabies,

Hi Charles, do you have any idea of where does that standard comes from?

Good question. Took some searching. Was an amendment -

http://www.foodstand..._haccp_regs.pdf.

Rgds / Charles.C
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#24 walabies

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Posted 19 June 2008 - 05:25 AM

Thanks Charles. :)


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#25 Charles.C

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Posted 20 June 2008 - 07:42 AM

Dear walabies,

I happened to find another source of recommended limits for hygiene / surface counts -

http://www.hi-tm.com...ech-Sect-4.html

This data is aimed at retail foods. The "satisfactory" levels etc are totally different (>> stricter) as compared to the previous data set which was for a different primary application (raw meat handling). Personally I would have thought that the expectations should not be so different. I think the question as to what is practically realistic is of some interest.

This link also contains some illuminating published data used by the author to set preferred microbiological limits for safe foods. For example, the "estimated illness dose" for "salmonella spp" is 1 - 10exp9 cfu (dose). Other specific species values are also given. Needless to say, the recommended max is <1/25g, ie not detected in 25g.

Would be interested if any other posters hv opinions / links on any of the above items.?

Rgds / Charles.C


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