9 replies to this topic

[martinez80598]

We continue to get high APC counts above 50,000 cfu/g in our finished product ice cream desserts. There is no kill step. Mix that we use already comes in pasteurized. We have done extensive ATP swabbing of zone 1, mix samples and they all come back clean. What can be the issue?  

 

[Marshenko]

Perform APC swabbing of Zone 1.

Take APC samples of the mix.  What's the spec say for APC?  Pasteurized doesn't mean sterile.
Have you looked at your packaging materials?  Both as they come in as they're first opened, and after they've been opened - how are they handled/stored?

[kconf]

Also do APC air monitoring if you haven't already. 

Do you add anything to the mix at all? 

[martinez80598]

Perform APC swabbing of Zone 1.
Take APC samples of the mix. What's the spec say for APC? Pasteurized doesn't mean sterile.
Have you looked at your packaging materials? Both as they come in as they're first opened, and after they've been opened - how are they handled/stored?

[martinez80598]

Perform APC swabbing of Zone 1.

Take APC samples of the mix.  What's the spec say for APC?  Pasteurized doesn't mean sterile.
Have you looked at your packaging materials?  Both as they come in as they're first opened, and after they've been opened - how are they handled/stored?

Hello Marshenko, 

 

We have performed APC of Zone 1 and they come back clean. We have also collected samples of mix and they also come back clean. We have also done ATP swabbing of all packaging material and have also come back clean. 

[martinez80598]

Also do APC air monitoring if you haven't already. 

Do you add anything to the mix at all? 

Hello kconf, 

 

We have done APC on the air, and it come back within range. We add vanilla flavor to the mix, which we have also sent in for testing and comes back clean. 

[kconf]

Hi martinez,

When did you start noticing this trend? Has it always been like this? Any changes to GMP? 

 

It could also be related to lab techniques which you may not have much control over unfortunately. 

[Marshenko]

Hi martinez,

When did you start noticing this trend? Has it always been like this? Any changes to GMP? 

 

It could also be related to lab techniques which you may not have much control over unfortunately. 

Indeed.

Consider sending multiple split-samples of the same lot(s) to different laboratories and compare results?

[Marshenko]

Hello kconf, 

 

We have done APC on the air, and it come back within range. We add vanilla flavor to the mix, which we have also sent in for testing and comes back clean. 

 

Let's also look at this vanilla flavor addition step.  Can you describe when and how this is added?

I worked at a facility that would do this post-pasteurization in the tanks before filling.  They'd literally pop open the lid and dump bag(s) of whatever flavor directly into the holding tank. 

There's definitely a LOT of room for operator error here.

Edited by Marshenko, 10 October 2024 - 01:46 PM.

[ChristinaK]

If your food materials, zone surface, and packaging materials are coming back with acceptable APC limits, but your finished product is showing high APC...There were no positives for indicator organisms (salmonella, ecoli, etc)? Time to check the production environment to see where these are coming from.

 

Have you looked at your production workers? Could they be introducing something via smock/uniforms, improperly washed/dried hands, unclean gloves? If the APC of the finished product is not usually this high, then you want to check that nothing has changed with the aforementioned items. Same hand soap, no change in potable water test results, same paper towels, same gloves, same laundry service for smocks/uniforms.