BRC Packaging, Issue 6, Clause 4.8.5: Environmental Monitoring

Hi,

I hope I can get the opinion of the Experts in IFSQN for my query below.

We are a flexible plastic packaging company accredited to BRC Packaging since 2013. Though it was not a requirement in the standard previously, we have always conducted Environmental Microbiological testing since 2014 as per the suggestion of our Quality Consultant at the time. The tests that we carried out through an external laboratory were for Enterobacteriaceae and Yeast & Mould – Exposure plates sampled from machine surfaces/ rollers and from the environment in the Clean Room though we did not have a procedure for EM testing. We have always had less than 10 CFU and satisfied the auditors.

Now that it is a requirement in the standard, I am in the process of drafting a procedure.

1) Can anybody share with me a suitable Microbiological Environmental Monitoring Procedure suitable for flexible plastic packaging industry?

2) We use rags soaked with solvent ( Propanol & Propyl Acetate - 80:20) to wipe the printing plates when inks get dried on the plates which makes the print dirty. As these rags are cut pieces from old clothing, is there a risk that there may be microorganisms in them? If so what are the likely microorganisms to be present? Would these microorganisms survive in the solvent when the rags are soaked with solvent. We have done the swab tests on the rollers not too far from the printing plates and the results have not been of any concern in the past. However, I need to be aware of all possibilities for my risk assessment.

3) Use of rags to clean the printing plates is very common in the print industry. Are there any other options you can suggest?

Thank you.

Lakmal

Hi,

 

I hope I can get the opinion of the Experts in IFSQN for my query below.

 

We are a flexible plastic packaging company accredited to BRC Packaging since 2013. Though it was not a requirement in the standard previously, we have always conducted Environmental Microbiological testing since 2014 as per the suggestion of our Quality Consultant at the time. The tests that we carried out through an external laboratory were for Enterobacteriaceae and Yeast & Mould – Exposure plates sampled from machine surfaces/ rollers and from the environment in the Clean Room though we did not have a procedure for EM testing. We have always had less than 10 CFU and satisfied the auditors.

 

Now that it is a requirement in the standard, I am in the process of drafting a procedure.

 

1) Can anybody share with me a suitable Microbiological Environmental Monitoring Procedure suitable for flexible plastic packaging industry?

 

2) We use rags soaked with solvent ( Propanol & Propyl Acetate - 80:20) to wipe the printing plates when inks get dried on the plates which makes the print dirty. As these rags are cut pieces from old clothing, is there a risk that there may be microorganisms in them? If so what are the likely microorganisms to be present? Would these microorganisms survive in the solvent when the rags are soaked with solvent. We have done the swab tests on the rollers not too far from the printing plates and the results have not been of any concern in the past. However, I need to be aware of all possibilities for my risk assessment.

 

3) Use of rags to clean the printing plates is very common in the print industry. Are there any other options you can suggest?

 

Thank you.

 

Lakmal

Hi Lakmal,

I don't have the standard ver 6 to hand but i guess you are referring to something like this -
 

 

4.8.5 

 

Where appropriate, based on risk, a microbiological environmental monitoring programme shall be in place to ensure that the cleaning operations are effective in preventing the risks of microbiological contamination of products. This shall consider the likelihood of microbiological organism survival on packaging materials and its use.

Where a programme is in place this shall include
•  sampling protocol
•  identification of sample locations
•  frequency of tests
•  target organisms (e.g. pathogens, spoilage organisms and/or indicator
organisms)
•  test methods
•  recording and evaluation of results.
•  The programme and its associated procedures shall be documented.

 

After some searching, most discussion here on EMPG for packaging seems to have been SQF oriented (who also require the joker of  "risk-based".)  There have currently been, afaik, 2 SOPs for SQF posted, namely -

https://www.ifsqn.co...ng/#entry121599

https://www.ifsqn.co...ng/#entry121279

Neither of above afai can see have any overt risk assessment but were nonetheless seemingly found acceptable to SQF. Basic approach seems to have been to sort of to do a "general" swab scan for a variety of (intuitive) possibilities then act "accordingly" (negative being typical for indicators/pathogens). TVC will presumably require a suitable intuitive limit, presumably low for a high temp process.

One approach which afaik would effectively answer to the risk element would be via zoning as typically (and discussed in more detail here)  done in food. Bur so far this option seems to have been found superfluous from a Packaging auditorial POV.

For BRC6 packaging, the only substantial  input so far seems mostly to have come from yr goodself ( :smile: ), eg starting

https://www.ifsqn.co...ht/#entry146264

(above thread is, slightly confusingly, intermingled with additional SQF-related comments, although SQF's EMPG requirements for packaging are anyway not too dissimilar)

I did notice this BRC8 Food example for which the basic SOP is admirably concise (template possibilities!)  although I had some reservations concerning the separate risk assessment -

https://www.ifsqn.co...ng/#entry149131

An overt RA example in a, nominally, SQF packaging thread was afaik provided here (Scampi) although it is actually designed for food -

https://www.ifsqn.co...e-2#entry126570

Based on above threads and others so far posted in SQF/BRC cases auditors don't seem to expect a detailed RA matrix etc presumably since everybody seems to agree that the micro risks are typically negligible for high heat processes.

Several posts comment that a "practical" RA  (> acceptable/nil results) was done in an attempt to subsequently avoid any further swabbing. The outcome from this approach seems to have (for SQF) been mostly (but not entirely) unsuccessful from an auditorial POV..

Further input welcome of course. Particularly if BRC-related.

PS - for queries (2,3) the easiest (but not cheapest) solution would be to switch to a non-argumentative "wiper". But maintenance personnel will no doubt protest.

PPS - some suggested micro guidelines (APC/Coliforms/Y&M IIRC) for board/plastic packaging materials exist on this forum. I anticipate you are already familiar with these..

Hi Lakmal

I would expect any bacteria on your rags will be killed by the ethanol content of the propanol.

We also use rags to clean our printing plates. All the rags we use are provided by a waste care company who launder the used ones as hazardous waste and then resupply when cleaned.

regards

Andrew

Hi Charles,

I knew I could rely on you to comment when I posted this topic as I have seen you comment on many topics in the IFSQN Forum. Thank you very much for taking the time to respond. I already looked at some threads that you listed in your comments before I posted this topic but I have found several more in your response which I did not see before. The excel spread sheet that you have painstakingly prepared giving the microbiological limits will be very useful for everyone.

Our audit is in March 2020 and I am preparing a Procedure for EMP and hope to include RA in it. I will provide any updates as I go along.

Thank you once again.

Best regards

Lakmal

Hi Andrew,

Thanks for your comments. It gives me the confidence that the use of rags in the printing industry is standard practice. What type of  printing industry are you in?

I guess, I will have to get more details about what type of washing / laundering our supplier of rags carries out to assess the risk posed by the rags.

Best regards

Lakmal

Hi Charles,

 

I knew I could rely on you to comment when I posted this topic as I have seen you comment on many topics in the IFSQN Forum. Thank you very much for taking the time to respond. I already looked at some threads that you listed in your comments before I posted this topic but I have found several more in your response which I did not see before. The excel spread sheet that you have painstakingly prepared giving the microbiological limits will be very useful for everyone.

 

Our audit is in March 2020 and I am preparing a Procedure for EMP and hope to include RA in it. I will provide any updates as I go along.

 

Thank you once again.

 

Best regards

 

Lakmal

Hi Lakmal,

Thks yr kind words.

I would like to add a few more items to those in Post 2.  I daresay you are already familiar with most of following but may be useful for some other readers. Some of the material  is food oriented but It seems to me that a substantial amount of the basic Principles in food  env. zoning should carry over to packaging. However the pathogen related "content"  may vary. For example, this comment in pdf (2) below -

Most packaging materials are unsuitable for the survival and growth of pathogens and therefore will not require an environmental monitoring programme to be in place.

(1) I noticed this, IMO, highly impressive/practical looking handbook on food environmental monitoring (attached below) from  which I extracted this illustration  -

zoning-risk assessment.png   191.74KB   0 downloads

3M Environmental Monitoring Handbook,2019.pdf   4.46MB   320 downloads

(The cleaning APC micro guidelines in this handbook are more demanding than those typically referenced in my excel compilation but this is always a subjective topic).

(2) BRC have issued a helpful summary on their viewpoint of  Packaging EMPG which indicates a zonal approach may be useful -

BRC - p558-position-statement-environmental-monitoring-v2-30042019.pdf   165.67KB   267 downloads

(3) This thread on SQF Packaging is additionally worth reading -

https://www.ifsqn.co...ng-program-emp/

(4) my PPS (Post2) regarding micro guidelines on finished packaging materials was particularly oriented towards data in these threads -

https://www.ifsqn.co...ing/#entry51255

https://www.ifsqn.co...food-packaging/

(5) Some published EMPG (food) examples are compiled here -

https://www.ifsqn.co...ls/#entry100060

https://www.ifsqn.co...am/#entry119334

From memory the AIB file is particularly compact.

Hi Andrew,

 

Thanks for your comments. It gives me the confidence that the use of rags in the printing industry is standard practice. What type of  printing industry are you in?

 

I guess, I will have to get more details about what type of washing / laundering our supplier of rags carries out to assess the risk posed by the rags.

 

 

Best regards

 

Lakmal

Hi Lakmal

We print food and non food packaging on carton board using sheetfed lithographic presses. 

I also have work to do on Environmental monitoring for BRC issue 6 so this post has been very useful, thanks for the info Charles.

regards

Andrew

Thank you Charles. The attachments and threads you provided in your reply will be immensely helpful.

Regards

Lakmal

Hi Andrew,

We are also a paperboard packaging manufacturer. We produce primarily bakery type packaging and are SQF certified. A risk assessment should include the rags you use for printing. In our case we have a service that cleans the rags using a very high heat process. We have both sheetfed offset and web fed Flexo presses. We have an exemption from this element as it is not mandatory for SQF. If you wish, I could send you the process we used to gain exemption. It might not fit your situation exactly but it couldn't hurt to look at it.

Hi Andrew,

 

We are also a paperboard packaging manufacturer. We produce primarily bakery type packaging and are SQF certified. A risk assessment should include the rags you use for printing. In our case we have a service that cleans the rags using a very high heat process. We have both sheetfed offset and web fed Flexo presses. We have an exemption from this element as it is not mandatory for SQF. If you wish, I could send you the process we used to gain exemption. It might not fit your situation exactly but it couldn't hurt to look at it.

Hi Hoosiersmoke

That could be very useful, thanks. Much appreciated. My email is xxxxx

Hi Andrew,

 

We are also a paperboard packaging manufacturer. We produce primarily bakery type packaging and are SQF certified. A risk assessment should include the rags you use for printing. In our case we have a service that cleans the rags using a very high heat process. We have both sheetfed offset and web fed Flexo presses. We have an exemption from this element as it is not mandatory for SQF. If you wish, I could send you the process we used to gain exemption. It might not fit your situation exactly but it couldn't hurt to look at it.

Hi hoosiersmoker ,

You might preferably consider sharing on the forum.

We are a paper packaging manufacturer.  We currently use ATP testing to ensure our equipment is sterile.  I have not seen anywhere that ATP will be considered appropriate for this new BRC 6 requirement.  Based on the requirement that the new standard requires looking for a "target pathogen."  I figured this would be the case.  We were looking at moving to some sort of testing for Yeast and Molds.  It is just hard to get past the speed and simplicity of ATP testing.  

We are a paper packaging manufacturer.  We currently use ATP testing to ensure our equipment is sterile.  I have not seen anywhere that ATP will be considered appropriate for this new BRC 6 requirement.  Based on the requirement that the new standard requires looking for a "target pathogen."  I figured this would be the case.  We were looking at moving to some sort of testing for Yeast and Molds.  It is just hard to get past the speed and simplicity of ATP testing.  

Hi Kevin,

Unfortunately ATP does not prove sterility. It never did.

I sympathise yr regrets but also refer my (BRC) quote in  Post 6.