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?
I don't have the standard ver 6 to hand but i guess you are referring to something like this -
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
• 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 -
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 ( ), eg starting
(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 -
An overt RA example in a, nominally, SQF packaging thread was afaik provided here (Scampi) although it is actually designed for food -
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..