EMP and Site Construction

Two questions here.

1. I joined a company and as I review their EMP I'm beginning to question. They swab for both Entero and Salmonella on zones 2, 3, and 4 and they only do Salmonella for a majority of zone 1, 2, 3. Can someone please explain what reasoning you may find to this. We run low risk product. We essentially just clean the product and send it off for further processing. No RTE present on site. No water introduced at any point of the process or cleaning (exception being deep clean when everything is shut down). I'm new to the industry and am curious why you would swab for both if a fail on entro would indicate the possible presence of salmonella. I also don't understand why you would choose to do salmonella over entero as entero covers more organisms including Salmonella. Do you see any trouble that may come from doing entro swabs on everything rather than the majority salmonella, or both?

2. What sort of things would you take into consideration for site construction. Do you have any examples of risk assessments or things of the sort? Have you ever been audited during construction/equipment moves. How did it go. What extra precautions did/would you take?

Many thanks!

did you see the risk assessment/justification they used to get to that conclusion for swabbing?

As for construction (been there during an audit), make sure workers (3rd party) comply with policies and have SIGNED OFF ON IT (walking paths, doors closed, hairnets) and that they are being monitored on daily GMP checks

If your tarping areas, is the tarp being cleaned/inspected daily.......what about extra pest control in those areas......

You just have to prove you recognize the hazards from construction and that they are being controlled and monitored

I do not see an assessment and no one can provide. I was curious if others did the same. I'd rather just change to Entero swabs all around but I'm not sure if this will raise questions later on (as I said, I'm new to the food industry). I'm using my own knowledge from micro long ago. I figure if you fail Entero testing just clean. I could care less if it was E. coli or salmonella specifically. You've got something on your equipment.

Thank you for the construction advice! Is there any specific documentation you would have. Trying to make sure I have everything ready and good to go.

sorry, i'm at a new post!

swabbing is an expensive endeavor, so I would suggest to ensure it's actually benefiting the company to do so......... I know I know, we can always do better, but we also have to justify our position to the powers that be, and you can spend that money elsewhere!

I'm not a big fan of EMPs generally speaking........too many false negatives====massive recall...i'd rather budget for the properly trained staff, good chemicals applied correctly, really robust cleaning schedule for things like forklifts, truck bay gaskets, drains etc etc etc

UNLESS you've got a company who doesn't care about sanitation, then the swabs are needed so they can SEE the problem

Hi amorable,

As I understand yr query is oriented to BRC Packaging Standard.

I wonder what the "cleaning" referred actually is ?

My first query would be as to which clause is being required to be complied with.

Totally agree Scampi. A part of the reason I want to eliminate the double testing is due to cost. It's not really serving a benefit to swab general and then specific but like I said, I'm just trying to understand the reasoning behind the original plan. I thought maybe there was something I hadn't considered yet. If I can save a little money there, I can spend it on getting better suited equipment that's easier to clean or the things you listed.

Charles, we are not food packaging. We do handle and manipulate the product. I was just simplifying the process to the essentials. I'm just curious about the whole EMP and trying to understand the previous creators reasoning behind their decisions.

Totally agree Scampi. A part of the reason I want to eliminate the double testing is due to cost. It's not really serving a benefit to swab general and then specific but like I said, I'm just trying to understand the reasoning behind the original plan. I thought maybe there was something I hadn't considered yet. If I can save a little money there, I can spend it on getting better suited equipment that's easier to clean or the things you listed.

 

Charles, we are not food packaging. We do handle and manipulate the product. I was just simplifying the process to the essentials. I'm just curious about the whole EMP and trying to understand the previous creators reasoning behind their decisions.

Hi amorable,

The significance of EMP critically relates to what you are doing.

Hi, Amorable.

You may want to consult your microbiologist before switching to entero totally. On my understanding the difference between the analysis of the 2 is that for salmonella you pre enrich you swab samples, meaning if you have one salmonella cell this may turn positive with your analysis (depending on what method you will choose) as you pre enrich the sample (meaning you give its ambient condition to grow at this period of analysis). Where as for entero (EB), you analyze as is (after addition of buffer diluent, meaning what you have in the swab will not grow provided you handle your sample well) and normally what you use depending on the analysis is either <1 cfu/swab or <10 cfu/swab. So in this case, you may have <10cfu/swab but your salmonella swab may turned to be positive. This is only for the point of view of analysis.

Another thing, you may also want to review how you do swabbing. Are you using multiple swab? Wherein you swab first for Entero followed by Salmonella? or you swab at different point or same points? Or you one swab to analyze for both? Depending on the method, you may not see some alignment for the result. In example, you swab one point which on your point of view is heavily contaminated. So "most" of the cell may be removed by the first swabbed, then you swab again at the same spot. It may turn out your first swab will have high counts then your second swab may turn to be negative.

3rd, you may want to review risk assessment. As oppose to other view here, I consider EMP as relevant to "prevent" microbial contamination going to your product as it is perform not to check cleaning only (as it would be cleaning verification) but it also consider other GMP (such as zoning, prevention of microbioligical contamination, routine maintenance, etc.) .The output will be dependent on how you assess your line and what sampling points you will take. The frequency may then be reviewed in according to how high is the risk for your product to support microbial growth. 

In terms of construction, this again will depend on the scope of work. However what is fixed is that permit must be taken before the activity (to which line manager needs to release the area before we allow contractors to go in), installation of enclosure depending on activity, if bringing tools from outside we do sanitize and take samples, and lastly, area will be released in terms of foreign materials and we also take samples after cleaning.

BR