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Microbiological risk analysis of polyethylene flexible packaging

Micro risk analysis

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#1 David Shaffer

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Posted 10 May 2017 - 09:00 PM

Dear Forum,

 

I am curious how others evaluate and justify "the microbiological risk in PE packaging".  

 

We  feel it is low based upon extrusion temperatures, air filtration, employee hygiene requirements, cleaning practices, limited contact with exposed surfaces, packaging, handling and storage practices, extremely low moisture content, and past history.  I have no micro data to support.  

 

Does anyone in the Forum have a Microbiological Hazard and Risk Analysis for PE flexible packaging that could be used as a template or starting point?  I am pretty certain I will have to perform some environmental monitoring or sampling.  Any hints or advise how I might justify low risk?

 

Thank you 


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#2 qualityfishgirl11

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Posted 10 May 2017 - 09:25 PM

Are you manufacturing the PE packaging or using it to package a product?


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#3 Charles.C

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Posted 11 May 2017 - 02:54 AM

Dear Forum,

 

I am curious how others evaluate and justify "the microbiological risk in PE packaging".  

 

We  feel it is low based upon extrusion temperatures, air filtration, employee hygiene requirements, cleaning practices, limited contact with exposed surfaces, packaging, handling and storage practices, extremely low moisture content, and past history.  I have no micro data to support.  

 

Does anyone in the Forum have a Microbiological Hazard and Risk Analysis for PE flexible packaging that could be used as a template or starting point?  I am pretty certain I will have to perform some environmental monitoring or sampling.  Any hints or advise how I might justify low risk?

 

Thank you 

 

Hi David,

 

Indeed yr temperature assumptions are typically used to support initial sterility prior to any env. contamination, etc etc.

 

You might usefully study (a) some typical IT haccp plans for packaging although (b) BRC has added some of its usual "special attractions".

 

Both items are discussed/referenced at some depth in the relevant sub-forum.

 

For example -

 

https://www.iopp.org...cfm?pageID=2267

 

and this parallel current thread -

 

http://www.ifsqn.com...of-pet-bottles/


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Kind Regards,

 

Charles.C


#4 David Shaffer

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Posted 11 May 2017 - 05:20 PM

Are you manufacturing the PE packaging or using it to package a product?

We are printing on PE film and converting the printed film into bags for food packaging.  Thanks


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#5 FurFarmandFork

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Posted 11 May 2017 - 06:12 PM

Microbial data is easy to collect, and you can do it once every couple years to re-"validate" that your post-extrusion controls mentioned prevent microbial contamination. Contact a local lab and have them send you some swabs to take for general bacteria (APC/SPC/HPC).

 

I recommend this because it will make you sexy if you can provide this data to other GFSI certified customers as part of your vendor approval materials. And should make your CB happy as well.


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For discussions related to food safety, production, and agriculture. Check out my blog at http://furfarmandfork.com/.

 


#6 DN_QAMGR

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Posted 17 May 2017 - 10:55 PM

I really need to comment how QA Manager responded that it will make "you sexy" if you can provide that data.

 

My question: Am I correct to use data from microbiological test with finished products (every 3 months (incl. E. Coli, Listeria, Salmonella, Staph, APC, Yeast & Mold)) to support that there is no microbiological risk with polyethylene or my finished product? 

 

Additionally, I've search the FDA/USDA/CDC for any recalls on Polyethylene packaging as support to the risk of polyethylene. 

 

I'm working with Suppliers on letters stating that they have not had any recalls or food borne illnesses with extruded blown film polyethylene bags/sheets. 

 

Lastly, would I need to validate my Lab test to verify that they are performing all the test accurately (or does their Certifications support their test)? 

 

thanks,

 

DNQAMGR


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#7 FurFarmandFork

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Posted 18 May 2017 - 05:29 PM

Am I correct to use data from microbiological test with finished products (every 3 months (incl. E. Coli, Listeria, Salmonella, Staph, APC, Yeast & Mold)) to support that there is no microbiological risk with polyethylene or my finished product

 

You could do the pathogen testing, but honestly you should just have low counts on the material in general for "indicator organisms". Which are cheaper and just as compelling in most cases. And yes, the "validation" is the fact that you have extrusion temperatures etc., The micro analysis is a "verification" that these processes are working to keep the material clean.

 

Additionally, I've search the FDA/USDA/CDC for any recalls on Polyethylene packaging as support to the risk of polyethylene. 

 

Good for you to know. Not going to be compelling to your customers. They're auditing you, not your industry. We know deep down it's super low risk and just want to make sure we see evidence that you treat it as a food contact material instead of generic plastic products.

 

I'm working with Suppliers on letters stating that they have not had any recalls or food borne illnesses with extruded blown film polyethylene bags/sheets. 

 

Not a bad way to go, this could be more compelling. I would instead look towards a letter of guarantee that states that the product should be free of hazards that could pose a danger in food, or compliance with Title 21 in general tends to work.

 

Lastly, would I need to validate my Lab test to verify that they are performing all the test accurately (or does their Certifications support their test)? 

 

Use an accredited lab (ISO, or some sort of state-accreditation  like EPA) and you're covered. They'll use an appropriate method.

 

Oh, and one more comment, be prepared to deal with surprise results BEFORE you start testing. Have a plan in place for what would be unacceptable and what you plan to do about it. Stuff happens. :)


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For discussions related to food safety, production, and agriculture. Check out my blog at http://furfarmandfork.com/.

 


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#8 Charles.C

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Posted 18 May 2017 - 07:48 PM

I really need to comment how QA Manager responded that it will make "you sexy" if you can provide that data.

 

My question: Am I correct to use data from microbiological test with finished products (every 3 months (incl. E. Coli, Listeria, Salmonella, Staph, APC, Yeast & Mold)) to support that there is no microbiological risk with polyethylene or my finished product? 

 

Additionally, I've search the FDA/USDA/CDC for any recalls on Polyethylene packaging as support to the risk of polyethylene. 

 

I'm working with Suppliers on letters stating that they have not had any recalls or food borne illnesses with extruded blown film polyethylene bags/sheets. 

 

Lastly, would I need to validate my Lab test to verify that they are performing all the test accurately (or does their Certifications support their test)? 

 

thanks,

 

DNQAMGR

 

Hi DNQAMGR,

 

May i suggest that the traditional (HACCP) requirement for yr product (which i assume is a direct fcs) is to assure / demonstrate that it is "Food Grade" ?.

 

IMEX countries often define what characteristics are required to qualify the item to make such a claim. i have no idea as to the USFDA's viewpoint though ?

 

I anticipate (ie Post 3) that the production temperature auto-nullifies intrinsic micro.hazards (=Prerequisite1?) hence the focus shifts to chemical ones (Prerequisite2?), eg migration data.


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Kind Regards,

 

Charles.C


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#9 DN_QAMGR

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Posted 18 May 2017 - 08:05 PM

Thank you QA Manager/FS Blogger & Charles & all for your continued support and comments.

 

My concerns are based on validating my microbiological risk and I thank you for your input. All the comments have been great and I'll have to work with my supply group to get more documentation as support. 

 

Migration data, due to cost, is something that i'm trying to find any data to support why I do not need a OML (Overall Migration Limits) or SML (Specific Migration Limits).

 

BRC Issue 5 requires migration, but the auditor reported that, in lieu of test, I can use historical data to prove my non-printed bags do not have any concerns of migration. 

 

I still have a few months left until my audit, and I am sure I'll have more questions.

 

Once again, Thank YOU!!!

 

DN


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#10 Quality & Food Safety

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Posted 05 June 2017 - 09:49 PM

Hi David,

 

This is a great question and a great topic of discussion. I will provide my input for the extrusion area / material and perhaps you may find it useful or at the very least informative.

 

Extrusion  

Raw materials - Biological Risk

What steps are you taking to reduce the likelihood of that hazard?

- Supplier Approval Program:  

`Provide supplier with a survey that addresses (Transportation & Distribution, Controls of Operations, General Programs, Manufacturing Facility & Equipment, Facility Maintenance, GMPs & Sanitation) Complete the survey for each manufacturing site that supplies a raw material to your facility. This must be refreshed on an annual basis

`Require a letter of guarantee from supplier of raw materials

`Request a copy of any certifications they may have (ISO, BRC...)

`Require compliance letters and information from supplier regarding the raw material and its compliance with various 21 CFR articles (General Indirect Food Additives (21 CFR 174), Adhesives and Components of Coatings (21 CFR 175), Paper and Paperboard Components (21 CFR 176), Polymers (21 CFR 177), Adjuvants, Production Aids, and Sanitizers (21 CFR 178), Irradiation in the Production, Processing and Handling of Food (21 CFR 179) and of course 21 CFR 110

`Test run of my material to evaluate chemical and physical properties

`Maintaining a relationship with supplier

-Receiving inspections:

`Inspect each incoming load of the material

`Keep retains

-Handling/Storage of the raw materials:

`Does your facility have automatic lines that feed into your hoppers? If so, that would be ideal. There's no extra handling that could potentially introduce any potential contaminant. This would also be applicable for the storage of that raw material.

-Processing:

`Processing the material requires extremely high temperatures =or> than 350 degrees which is not suitable for the growth or maintenance of microorganisms

-Environmental Monitoring:

`Create a program to evaluate microbial growth in high risk areas in your facility (frequency: at least annually) - to demonstrate that your SSOPS are effective and that the finished product is not going to be compromised -these areas should include where the product come into direct contact, known microbial carriers like hilos, packaging areas, storage areas

`The implementation of a surrogate test such as ATP (while it will not tell us whether whats found is microbial we can understand that it's related but not correlated based of the amount of organic material found)

-Historical examples:

`Demonstrate history of such issues

 

All of the points above then need to be evaluated on a risk analysis assessment to demonstrate how each of these things controls the possible risk. 

 

Let me know what you think!


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