8 replies to this topic

[RazM4tt]

Hello!

 

I am working on a project for my facility in regards to having part of the building leased out. Upstairs (above production) we have a large empty space that we will be leasing out for 6 people to work. The current plan is to keep the foot traffic outside of production, so they will not directly be passing through the production space. In the break room, we have a transition area with a foot scrubber/sprayer and automatic handwashing. The new residents are required to use the foot scrubber/sprayer and handwashing machine, and instead of entering production will take the stairs up to the space they will be using. At no point will they enter our production area.

 

The task I have been assigned is to create a sampling plan to track and monitor their activity to justify or rationalize that their presence in the building will not have any effect on the (microbial) safety of our facility. How necessary is it to do APC/Coliform/Salmonella/Listeria or could I simply swab for Salmonella/Listeria. My plan is to section off the foot traffic to 5 foot sections and do a swab in each section, creating a "path" to monitor the APC values. To have cost savings, I will then composite 5 sections at a time and do Listeria detection (I don't anticipate any Listeria, but I cannot ignore it either).

 

My budget is 1,200 and the length of this study is not determined. What would an auditor need to see to make sure we have a justified answer. 2x per week for 4 weeks. 3x per week for 3 months? Thank you for your expertise, any literature that you could point me towards would be much appreciated.

 

 

[mgourley]

A couple of questions:

 

1. What standard are you being audited to?

2. What is the hygienic zoning category of the area where the people will be transiting to reach their workspace?

3. What swabbing do you currently do in this transition area?

4. What will they be "doing" in this space and what is the risk of them bringing things into your shared area?

 

Marshall

[kconf]

You can start with APC, Sal, List, E.coli/coli and as you have enough data to prove that your APC is consistently below limit, you can drop it. Then continue with pathogen and EC. 

 

If you keep testing negative, you can then reduce your frequency of swabbing. But first you must collect enough data to demonstrate risk. With that budget, you can play around with testing for each swab, instead of testing all for everything. Good luck! 

[RazM4tt]

A couple of questions:

 

1. What standard are you being audited to?

2. What is the hygienic zoning category of the area where the people will be transiting to reach their workspace?

3. What swabbing do you currently do in this transition area?

4. What will they be "doing" in this space and what is the risk of them bringing things into your shared area?

 

Marshall

1. The standard is to provide a study showing that their presence is not going to have any negative impact to the bacterial levels in the facility

2. It will be Zone 4, they will not be operating past any transition zones. The concern is that the authorized employees that will enter production areas have traffic pathways that overlap with theirs.

3. Currently I do quarterly zone 4 swabbing and have never had an issue with pathogen/bacteria levels (historically when I wasnt here, the past 4 years have cleared zone 4 standards). The standard for zone 4 swabs is set to be under 1x10^6 APC which should not be hard to maintain. 

4. Unfortunately Im not exactly sure what will be going on, but I believe it will be mostly desk work and botanical testing. I will need to review with their team once they move in how they plan to contain/dispose any samples that they bring in to the facility. 

 

Thank you for the expertise and feedback!

[RazM4tt]

You can start with APC, Sal, List, E.coli/coli and as you have enough data to prove that your APC is consistently below limit, you can drop it. Then continue with pathogen and EC. 

 

If you keep testing negative, you can then reduce your frequency of swabbing. But first you must collect enough data to demonstrate risk. With that budget, you can play around with testing for each swab, instead of testing all for everything. Good luck! 

That sounds like a good plan, what would (in your opinion) be enough results to reduce testing. 3 weeks of activity tracked 2x per week? My worry is the budget will catch up to me fast. Reducing testing will reduce costs and allow me continue testing for a longer period of time which would be beneficial. I am confident the pathogen swabs will consistently come back negative but that would also be the most cost effective way to monitor their presence if the APC values prove to be no concern. I also am having cameras installed in their authorized spaces so we can ensure that they are following correct hand/shoe cleaning procedure. My thought process behind this is, if we have been functioning just fine for the past 10 years following these procedures and our new residents follow the same procedures then theoretically there should be no issues. It is just a cost effective way to track and investigate any problematic results. Would an auditor go for the same thought process? Thanks for the help!

[kconf]

I would do every other week in the beginning, then once a month, quarterly, etc. Again, you must show that your sanitation program is efficient in eliminating microbes. I would do pre clean, and post clean too to see effectiveness. 

[mgourley]

1. The standard is to provide a study showing that their presence is not going to have any negative impact to the bacterial levels in the facility

2. It will be Zone 4, they will not be operating past any transition zones. The concern is that the authorized employees that will enter production areas have traffic pathways that overlap with theirs.

3. Currently I do quarterly zone 4 swabbing and have never had an issue with pathogen/bacteria levels (historically when I wasnt here, the past 4 years have cleared zone 4 standards). The standard for zone 4 swabs is set to be under 1x10^6 APC which should not be hard to maintain. 

4. Unfortunately Im not exactly sure what will be going on, but I believe it will be mostly desk work and botanical testing. I will need to review with their team once they move in how they plan to contain/dispose any samples that they bring in to the facility. 

 

Thank you for the expertise and feedback!

 

I think the previous suggestions pretty much cover it.
The answer to #4 above is certainly relevant and may nudge you in a different direction.

 

Marshall

[KellyQA]

Personally, I would not bother with APC for this indicator organism. I would use Enterobacteriaceae (EB) because it is a large group of bacteria that includes pathogenic E. coli and salmonella. Although APC can be used to gauge the quality of sanitation, APC does not directly correlate to the presence of pathogens and the safety of the product. EB can be used to monitor hygiene and sanitation practices. 

 

You stated they are not entering the production areas; they will be in zone 4 locations. I would just test the common areas that the non processing employees would enter and share. I personally think that you may not have to test for APC/EB, but rather just test for pathogens, Listeria and Salmonella. 

 

Swab areas such as the stairs they walk on, the railing on the staircase they may touch walking up or down, the common floor that they all walk on, the door entering into the production area, etc. If you receive any positive results from any of these swabs, complete vector swabbing to see if it is a resident or transient isolate. If access to upstairs is restricted to just those 6 workers, I would not think to swab their offices, unless the stairs/rail area are positives.

 

I would also have them complete visitor GMP requirements or any other requirements you may ask visitors who walk your facility to complete. Keep it on file, have them complete it annually. This will help aid you in ensuring they will follow protocols (even if they do not enter the facility). 

 

With the budget you have, I would think testing at least 4 swabs once a week for a month should be sufficient. However, if I received any positive results during that time, and the pathogen is deemed a resident isolate (from vector swabbing), I would extend that swabbing study out maybe another month to help rule out if it was brought into the facility by the 6 people who work up there or if it was a resident due to poor facility sanitation in general.

 

[RazM4tt]

Personally, I would not bother with APC for this indicator organism. I would use Enterobacteriaceae (EB) because it is a large group of bacteria that includes pathogenic E. coli and salmonella. Although APC can be used to gauge the quality of sanitation, APC does not directly correlate to the presence of pathogens and the safety of the product. EB can be used to monitor hygiene and sanitation practices. 

 

You stated they are not entering the production areas; they will be in zone 4 locations. I would just test the common areas that the non processing employees would enter and share. I personally think that you may not have to test for APC/EB, but rather just test for pathogens, Listeria and Salmonella. 

 

Swab areas such as the stairs they walk on, the railing on the staircase they may touch walking up or down, the common floor that they all walk on, the door entering into the production area, etc. If you receive any positive results from any of these swabs, complete vector swabbing to see if it is a resident or transient isolate. If access to upstairs is restricted to just those 6 workers, I would not think to swab their offices, unless the stairs/rail area are positives.

 

I would also have them complete visitor GMP requirements or any other requirements you may ask visitors who walk your facility to complete. Keep it on file, have them complete it annually. This will help aid you in ensuring they will follow protocols (even if they do not enter the facility). 

 

With the budget you have, I would think testing at least 4 swabs once a week for a month should be sufficient. However, if I received any positive results during that time, and the pathogen is deemed a resident isolate (from vector swabbing), I would extend that swabbing study out maybe another month to help rule out if it was brought into the facility by the 6 people who work up there or if it was a resident due to poor facility sanitation in general.

Thank you! I like the idea of keeping it simple. I feel that APC values arent very useful (except for showing off trending results), but if we arent changing the sanitation program at all, then it shouldnt be something of concern. The main concern is the pathogens, and doing detection testing will be cheap/allow me to monitor more space. Thank you for the advice, happy Friday!