10 replies to this topic

[superchris23]

Hi to everyone!

 

Having a philosophical dilema here: We are a manufacturer of flexible packaging (extrusion, printing, lamination, bagmaking) for food and non-food contact clients.

 

If I'm not mistaken our product is considered as low risk.

 

My question is: Do we really need a sanitation program or is a good cleaning program enough? Going through different posts, I see that some of you are having swabs tests and I found it to be a bit of an "overkill" for this kind of production process.

 

Your comments will be gratly appreciated.

 

Cristian 

[pooled]

SQF clause 2.5.6 refers to product sampling, inspection & analysis & version 8 is going to have stricter requirements for environmental testing (as has been mentioned on this site), so even though it may seem like overkill some scale of testing should be done at your facility. Perhaps you could set up an annual test based upon a risk analysis. 

[ncorliss]

We do not perform swab testing of our cleaning and sanitation processes, but we do send our product out for testing to ensure product is safe. As mentioned above, your risk analysis can drive you. Have a plan in place in the event a product testing result had failed.

[SQFconsultant]

Yes, you should have a good sanitation program in place, majority of our packaging clients do swabbing and of course compressed air testing.  As mentioned 8.0 will be taking this up a tad as well.  

[mzenas]

Hi to everyone!

 

Having a philosophical dilema here: We are a manufacturer of flexible packaging (extrusion, printing, lamination, bagmaking) for food and non-food contact clients.

 

If I'm not mistaken our product is considered as low risk.

 

My question is: Do we really need a sanitation program or is a good cleaning program enough? Going through different posts, I see that some of you are having swabs tests and I found it to be a bit of an "overkill" for this kind of production process.

 

Your comments will be gratly appreciated.

 

Cristian 

 

We thermoform food contact and non food contact packaging.

 

Our equipment is cleaned prior to running food grade product.  We sanitize all areas of the process that touches the film/product.  Microbiologic testing is performed 2x per year to validate effectiveness of the sanitizing process.

[Charles.C]

We thermoform food contact and non food contact packaging.

 

Our equipment is cleaned prior to running food grade product.  We sanitize all areas of the process that touches the film/product.  Microbiologic testing is performed 2x per year to validate effectiveness of the sanitizing process.

 

Hi Pondo,

 

Is the micro.result (eg APC) on a "food grade" (clean + sanitized) surface any difference for the same surface if you only clean ?

 

i think all food textbooks will recommend C/S for generic/data convenience. As per the OP, Packaging is maybe a different situation if the baseline is already very low ?.

[mzenas]

Hi Pondo,

 

Is the micro.result (eg APC) on a "food grade" (clean + sanitized) surface any difference for the same surface if you only clean ?

 

i think all food textbooks will recommend C/S for generic/data convenience. As per the OP, Packaging is maybe a different situation if the baseline is already very low ?.

 

We are going through a bit of a learning curve (a good learning curve) on this subject currently.  For example, we discovered that our cleaners have a one week shelf life - and subsequently we had no controls.  We also tested the handles on our tape dispensers and found to be in the same range as "cleaned" surfaces. (Which I would say confirms the operators are following good hygiene practices)

 

Our test results are better on sanitized surfaces (tooling and conveyance) as compared to only cleaned surfaces.

[Charles.C]

We are going through a bit of a learning curve (a good learning curve) on this subject currently.  For example, we discovered that our cleaners have a one week shelf life - and subsequently we had no controls.  We also tested the handles on our tape dispensers and found to be in the same range as "cleaned" surfaces. (Which I would say confirms the operators are following good hygiene practices)

 

Our test results are better on sanitized surfaces (tooling and conveyance) as compared to only cleaned surfaces.

 

Hi Pondo,

 

Thks for response. Are the results significantly different ?

 

My (food) experience is that for SS surfaces the (cfu/cm2) absolute range of 3 measurements for APC will often be >=,  (+/-) 50% about the average, eg there may be no statistical significance between two successive averages of 100,000 and 50,000.

 

On the other hand, if you observe a run of averages within, say 50,000 - 100,000 with cleaning only and 5000 -10,000 after adding sanitizing, probably significant.

[InventoSteve]

I'm curious what the concensus is about cleaning requirements for packaging which is washed by the copacker prior to being filled. 

[mzenas]

Hi Pondo,

 

Thks for response. Are the results significantly different ?

 

My (food) experience is that for SS surfaces the (cfu/cm2) absolute range of 3 measurements for APC will often be >=,  (+/-) 50% about the average, eg there may be no statistical significance between two successive averages of 100,000 and 50,000.

 

On the other hand, if you observe a run of averages within, say 50,000 - 100,000 with cleaning only and 5000 -10,000 after adding sanitizing, probably significant.

 

 

I am going to have to hide behind my learning curve statement...  When I asked my QE she stated there was an improvement...but when I looked at the CoA's it does not represent that.  We are moving in the right direction in trying to understand what the heck we are suppose to be doing, but we still have a ways to go. And a wrench was thrown in due to our last 2 sample/tests not being cold enough once they reached the testing lab.  It sounds like I need to regroup and ensure we are methodically, in a controlled manner, on track to confidently understand where we stand.

[Charles.C]

 

I am going to have to hide behind my learning curve statement...  When I asked my QE she stated there was an improvement...but when I looked at the CoA's it does not represent that.  We are moving in the right direction in trying to understand what the heck we are suppose to be doing, but we still have a ways to go. And a wrench was thrown in due to our last 2 sample/tests not being cold enough once they reached the testing lab.  It sounds like I need to regroup and ensure we are methodically, in a controlled manner, on track to confidently understand where we stand.

 

Hi Pondo,

 

You're right. There is always a learning curve. For food there are often semi-anecdotal rules-of-thumb like the cleaning step achieves 70% of total bacterial reduction while sanitizers add the rest. Obviously the absolute level of initial contamination and the cleaning system used are relevant. + the effort/time put in.

 

I'm not a Packging person so i don't know if there is a textbook answer like there is for food where C/S is a sort of process standard. The 2 micro. contamination scenarios are presumably rather different in absolute terms. And from a product POV presumably related to the presence of a thermal killing step as usually present, i think.

 

I anticipate that for packaging, cleaning is routine (= GMP) but not necessarily sanitising. The latter is maybe likely to depend on factors such as (a) any related P. Standard, (b) the micro. Specification of the Finished product (if any), (c) the nature of the specific Packaging process, (d) the intended application.

 

With or w/o sanitising, I assume the cleaning requires validation for which micro.testing is I guess the logical choice. Ideally the surface level after cleaning should  be substantially lower than the product on it ( a food rule-of-thumb is at least one tenth [not always achieved IMEX] but this probably unrealistic for packaging)

 

As previously noted there is often a substantial scatter in micro.results due sampling technique/random variation/low levels involved but it is obviously initially important that the "level" is "reasonable" compared to yr target/product spec. (Some published packaging micro.specs are quoted elsewhere on his forum)

 

 @ Superchris/Christian - Apologies that yr SQF aspect has got a bit meandered. My guess without checking is that the text in Packaging Module (and Gudance) is relevant.