8 replies to this topic

[Curious QA]

Our ready-to-eat product is fully cooked above 165 degrees F, chilled to below 40 degrees F, vacuum packaged, and then stored in the freezer.  The freezer may rise in temperature during the day since the door has to be opened frequently, but it goes back down to about 0 degrees after production.

 

Would we need to have a preventive control/CCP to prevent Clostridium botulinum growth after the chill step (chilled below 40 degrees Fahrenheit), since we subsequently package the product in an environment that’s at room temperature? 

 

The chill step only takes about 30 minutes, and the packaging steps last about 30 minutes as well.

After this, the product goes into the freezer.  We have identified the potential for C.Bot during the chill step.  We believe the potential for C. Bot growth during the packaging steps is low, since the product passes through those steps quickly and then gets placed in the freezer until it is shipped within a couple days to another cold storage facility that stays at 0 degrees Fahrenheit.  Any advice?

 

[Tony-C]

Hi Curious QA,

 

I would do some datalogging of the temperature of the product through your process so that you have a temperature/time profile. 

 

Kind regards,

 

Tony

[Shrimper]

Hi Curious QA,

 

Keep in mind that since your product is cooked to 165F, spores of C. bot can survive this level of thermal processing. That along with the further re-processing that occurs after the cooking stage. I would say that this product needs to list C. bot as a hazard and control it at a CCP. 

 

For our items that are vacuum packed, we are fortunate enough to either keep it frozen (with proper labeling for the end consumer) or use 10K OTR film to allow for the necessary oxygen transmission. If you are using non-breathable film (not 10k OTR), I would encourage labeling the packaging with a "keep frozen, thaw under refrigeration" statement. 

 

My 2 cents...

 

Cheers,

Shrimper

[Oleg_87]

This is a very interesting topic related to C.Bot. It’s a great idea to use a film with an oxygen permeability coefficient of 10,000. It’s a bit unclear what product we’re talking about, though.

[Slab]

Much of a risk assessment has to do with knowing the product, intended use, and storage and distribution.  As Tony has advised, a TTM/TTI program is recommended here, however 40°F as a critical limit may not be an adequate control due to the minimum temperature for growth and toxin formation by C. botulinum type E and nonproteolytic types B and F is 38°F (3.3°C). For type A and proteolytic types B and F, the minimum temperature for growth is 50°F (10°C). Outgrowth and toxin development has been observed in type E within 7 days between 37.9 - 41.0°F

 

Additionally, as mentioned by Shrimper, there are requirements for labeling if maintaining product in anaerobic state through distribution and storage.

 

In short, keep frozen, monitor storage temps, and label.

 

 

[jfrey123]

Two thoughts came to mind after reading OP's post:

 

1.  I have a minor concern about the freezer "may rise in temperature" due to frequent openings.  I would make sure there's a monitoring process to keep temps within a range you deem acceptable to your practice.  And after you establish that, if need be, limit the intrusions into the freezer to prevent it from rising too far.  Either a schedule where they only open the freezer and do work once per hour to reduce temp loss, or maybe a threshold of once the freezer rises to 10F it is forbidden to re-open until it reaches 0F again.  Strictly speaking in the real world, I get production and shipping would have a fit and balk at the idea, but some line in the sand needs to be drawn to prevent your freezer from becoming a refrigerator.

 

2.  Your chill step states "about 30 minutes" to chill, and "about 30 minutes" to package.  I'd hope there are some actual hard numbers in your HACCP/FS plan for this PC or CCP, however you deem it.  If the concern is c. bot, then yes, I feel this should be a CCP.  Cooling steps with most cooked manufacturers I've worked with have been deemed CCPs.  And without sharing NDA protected names, I can say I've reviewed batch records from a noodle cooking facility where I could plainly see the cooling CCP checks were not actually being performed and I told them as much, then years later had to shake my head as they ended up in a nationwide recall...  I share only to say cooling CCPs are NOT to be overlooked or pencil whipped.

[Curious QA]

Thanks everyone.  We have always had the chill step as a CCP.  I have told management that we need to change our CCP to 37 degrees F minimum, and we may need to change it a lower temperature than this if we find the product goes above 37 before it is placed in the freezer.  I cannot get the company to be more strict on the temperature of the freezer, because every time we fill up a pallet with boxes of product, the freezer has to be opened to put the pallet inside.  And in the summer, the temperature can rise to 20 degrees F easily.  So I told them we may need to have the freezer storage temperature as a CCP, too, in which we print out the temperature logs (we have a continuous monitoring system, so temperatures are recorded online), and have someone sign off verifying that freezer temperatures stayed below a certain temperature.  

 

 

We do only keep product at our facility for two days and then it gets shipped to a cold storage facility, where it is stored at zero degrees F.  

 

We will also conduct a shelf life study on the products to see how long it can safely stay at refrigerated temperatures, at 37 degrees F.

[qa_maddy]

  And in the summer, the temperature can rise to 20 degrees F easily.  So I told them we may need to have the freezer storage temperature as a CCP, too, in which we print out the temperature logs (we have a continuous monitoring system, so temperatures are recorded online), and have someone sign off verifying that freezer temperatures stayed below a certain temperature.  

 

We do only keep product at our facility for two days and then it gets shipped to a cold storage facility, where it is stored at zero degrees F.  

 

This is similar to what we do and we handle a variety of different Vac Pack items that have C.Bot as their main hazard of concern. We have our CCP temp set at 38F on our HACCP information, all our coolers are set to below that for our operating temperatures, we do temp checks manually every 4hrs throughout the day, and then 24 hour print offs for our checks for both coolers and freezers as we long term store vac pack product as well, but our freezer hangs out around -4F.

 

For not having long-term storage it sounds like you've got some pretty good controls in place - I like our manual monitoring because it lets us know if something is trending warm faster. 

I will also echo the "puncture before thawing" instructions - those are always beneficial for the consumer.  

[Tony-C]

I cannot get the company to be more strict on the temperature of the freezer, because every time we fill up a pallet with boxes of product, the freezer has to be opened to put the pallet inside.  And in the summer, the temperature can rise to 20 degrees F easily. 

 

Hi Curious QA,

 

Presumably you have got air curtains or strip curtains on those doors?

 

Kind regards,

 

Tony