13 replies to this topic

[miniaczka90]

Hey All, 

 

I have been looking for exactly plan for env swabs ( zone 1 - weekly how many swabs ) , from the FDA website, but unfortunately I am not able to find any info . can somebody please help me ?

[Hank Major]

Typically the FDA does not prescribe exact numbers or timing.  It is expected that the facility will use science and statistics to determine the procedures that will best protect the public health.

[Jpainter]

I agree with Hank. You should be deciding swab locations and frequency based on scientific evidence, facility history, and risk assessment. You should be swabbing enough sites, and at a frequency, that you feel comfortable if FDA came to your facility and conducted their "swab-a-thon" they would return with no positive results. 

[AHJ]

We were told to start with more than we need and once we have sufficient data to support the claims that "our sanitation program proves to be consistently effective in eliminating threats of pathogens" then we would be able to reduce the number of swabs and frequency. Overall, the point of the environmental monitoring swabs is to confirm that you are properly cleaning and sanitizing your equipment and processing areas. If you can do that with numbers and lab reports then you have validated your sanitation program. After that you just need enough data on a regular basis to show consistency. We have 14 lines in our facility and our EMP policy says that we will conduct 20 swabs in processing zones every two weeks. The areas are on a rotational schedule. This is down from twelve months of 40 swabs every two weeks. 

 

This depends on your process and whether it is a high risk process or not, but as a way to test frequency, it was recommended to us that we should do a sanitation validation study. In other words, swab every hour during production times. The number of pathogens/indicator molecules will be consistent (preferably very low) until it exponentially increases. Thus, the hour before that increase is when you should conduct a CIP on that line. Production runs (how long you run) should not exceed that exponential point. 

 

From that point on after CIP and a thorough cleaning, sanitize the area, let it dry, then swab for environmental pathogens to confirm that you've cleaned/sanitized the area properly. 

[Charles.C]

Hey All, 

 

I have been looking for exactly plan for env swabs ( zone 1 - weekly how many swabs ) , from the FDA website, but unfortunately I am not able to find any info . can somebody please help me ?

 

Can have a browse through the schedules here -

 

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

[MM12]

Hi there, miniaczka90! Environmental swabbing frequency will depend on your product (water activity, pH, temperature, RTE or not) and working conditions. If you don't have historic data about it, you should do a risk assessment and include as many places as possible on your first sampling. Also, I would recommend doing sampling on zone 2 and zone 3, not zone 1. If you're planning on sampling FCS you need to first establish what is going to happen if you find a positive, are you willing to throw away all the involved product? If so, you should sample after a cleaning and hold the product until you have all of your results in case you find something +.

 

Hope it helps! 

[Charles.C]

Hi there, miniaczka90! Environmental swabbing frequency will depend on your product (water activity, pH, temperature, RTE or not) and working conditions. If you don't have historic data about it, you should do a risk assessment and include as many places as possible on your first sampling. Also, I would recommend doing sampling on zone 2 and zone 3, not zone 1. If you're planning on sampling FCS you need to first establish what is going to happen if you find a positive, are you willing to throw away all the involved product? If so, you should sample after a cleaning and hold the product until you have all of your results in case you find something +.

 

Hope it helps! 

 

red ^^^ -  A popular choice, but from a risk assessment POV, surely a reprehensible Policy ??

[zanorias]

Hi there, miniaczka90! Environmental swabbing frequency will depend on your product (water activity, pH, temperature, RTE or not) and working conditions. If you don't have historic data about it, you should do a risk assessment and include as many places as possible on your first sampling. Also, I would recommend doing sampling on zone 2 and zone 3, not zone 1. If you're planning on sampling FCS you need to first establish what is going to happen if you find a positive, are you willing to throw away all the involved product? If so, you should sample after a cleaning and hold the product until you have all of your results in case you find something +.

 

Hope it helps! 

 

If product or FCS is positive, surely swabbing would inform you and allow you to act appropriately, and yes - depending on the situation - it may be necessary to dispose of the product. These situations should be rare at most though will sufficient hygiene and procedures etc. If FCS were failing swabs then I'd suggest something needs changing!

[Jeffrey Ort]

If you are unsure of the quantity of swabs or locations requried for the program, you can consult with a micro lab to have someone come and assist in setting you up. You should have all zones in the plan, and could start with post sanitation verification for all zones, and once the program grows, move into operational checks. The current FDA guidance is for the facility to find the issue and correct it before it goes mainstream. 

[Chris347]

Hi All, 

 

I have a similar question with the zone 1 testing. We are a cocoa melting facility that is low risk and are currently doing zone 1 swabs for our production tables. We had a customer audit recently that recommended getting rid of zone 1 testing. After doing some research I have seen that it is up for debate on whether to do zone 1 testing or not. We have never had any issues about this on our SQF audits. My concern if we get rid of zone 1 testing is then this will bring up questions on our audits. Can anyone offer any advice on this?

 

Thank you!

[TimG]

I ran into similar, Chris. I believe if you get a positive in zone 1, you have to treat all material since last swab as possibly contaminated. I was TOLD this means yes, recall if product has left facility. It was explained to me that a checking for indicator organisms in zone 2+ would be an option, whereby if you get a hit on the indicator you can have the lab test it for pathogen. If there is then a pathogen, you would do a vector test to determine where it originated and THEN do a zone 1 test. The idea was that you should find anything long before it gets to zone 1 and go to defcon.

Fortunately for me, I discontinued my research when I determined the nature of my product (a chemically produced salt) negates bio as a hazard (we don't perform swabs). That being said, I'm going to follow this thread and see if anyone finds some type of guidance doc on the subject.

[FurFarmandFork]

   Start with your highest risk areas (wettest, most product on floor, handles poduct post-kill step if applicable) and go depth first. There's no hard and fast rule other than you not getting anyone sick and doing environmental monitoring to do just that.

 

I had a very limited budget so when I started a program for the first time dropping 10k for a facility-wide deep dive and follow up on each potential positive was unreasonable. Come up with a long term written plan to take it room by room and collect enough swabs (25-30) per production area to give you a clear picture of whether you have any sneaky harborage areas. Then schedule as finances allow and focus on the work that needs to be done rather than the swabbing.

 

My other tip, unless you're processing raw agricultural products, swab the room while it's dirty. You're way more likely to find positives that point you to problem areas, rather than just pat yourself on the back for sanitation.

[Charles.C]

I ran into similar, Chris. I believe if you get a positive in zone 1, you have to treat all material since last swab as possibly contaminated. I was TOLD this means yes, recall if product has left facility. It was explained to me that a checking for indicator organisms in zone 2+ would be an option, whereby if you get a hit on the indicator you can have the lab test it for pathogen. If there is then a pathogen, you would do a vector test to determine where it originated and THEN do a zone 1 test. The idea was that you should find anything long before it gets to zone 1 and go to defcon.

Fortunately for me, I discontinued my research when I determined the nature of my product (a chemically produced salt) negates bio as a hazard (we don't perform swabs). That being said, I'm going to follow this thread and see if anyone finds some type of guidance doc on the subject.

 

I suggest a browse through some of the implementations detailed in my link of Post 5.

 

As sort of implied in Post 11 (and some of the reference schedules), the zone 1 / no sampling element is somewhat of a ("accepted") fudge rather than a rigorous risk-based decision.

 

A comparison with of typical reference schedules suggests that FDA-type sampling schemes can be astronomically heavy duty albeit perhaps statistically justifiable.

 

Operationally the Processor's situation is often Risk/Case-by-Case based from a cost benefit POV. (Can be easier said than done !)

 

Might note that although any (validated) positive pathogen detection usually necessitates follow-up, quantitative data on things like APC is notoriously inaccurate due sampling/analytical factors.

[Ryan M.]

For zone 1 you should do some type of "testing" to both validate the cleaning process and then verify from time to time the cleaning is still effective.

 

Many companies do not do "environmental type" testing because of the time lag between the test and the results and the potential of lost product and/or production time.  Instead they will do various rapid methods of indicator or detection type of testing, such as ATP swabs.

 

I was told by an FDA official if you do any pathogen swabbing of Zone 1 you better be prepared to hold the product produced on the line for the given time, or recall it if it is out in the market.  This person did not recommend Zone 1 swabbing, unless you are validating your cleaning and have the ability to hold the product until test results are confirmed.