5 replies to this topic

[bsilverstein]

We currently produce a product with two critical control points (CCPs) related to temperature. The product is liquid tea extracts.  

Processing Time/Temperature: Greater than or equal to 165°F for greater than or equal to 5 minutes.
Packing Temperature: Greater than or equal to 165°F.
We have scientific evidence supporting the effectiveness of these CCPs in preventing significant pathogen growth.

However, we've faced internal challenges regarding the identical minimum temperature requirements for both CCPs. While it's theoretically possible to process and pack a product at the same temperature, in practice, the product will begin to cool down immediately after processing, especially if ambient temperatures are lower than 165°F.

Therefore, we ensure that the processing temperature is higher than the packing temperature to maintain a safe product throughout the process.

Given our scientific evidence and the practical considerations of temperature control, would FDA regulations require us to increase the processing temperature requirement to meet the packing temperature requirement or are the 2 CCPs treated independently? 

[jfrey123]

I think FDA is pretty wide open when it comes to a matter like this.  I kinda see where your auditors are questioning the two temps being greater than or equal to the same temp, you're basically saying you need to heat the product higher in processing than the second CCP to ensure it doesn't drop below 165F during packaging.

 

I'd review previous batches to see what temps you're actually getting in processing while still meeting the second CCP's minimum temp.  Also determine how long you can keep the batch above 165F before you risk it dropping below that temp.  Without knowing your process, I almost wonder if the CCP should only be at packaging.

[bsilverstein]

I appreciate the response.  Before diving into historical data, I believe the reason for having the CCP at Processing in addition to the filling CCP is because the Processing CCP is temperature and time (greater than or equal to 165F for at least 5 min) whereas at fill, it's just temperature (no time requirements)

[jfrey123]

Gotcha, yeah brain fart there.  I see no issue with purposely overrunning the CCP1 temp to ensure CCP2 is still recorded at a good temp.  The time and temp at CCP1 is a critical limit for minimum, but so far as there's no additional problems by exceeding it, it doesn't matter if you decide to run up to 180F for 10 minutes to help ensure the CCP2 temp stays above the limit.

 

They do have a point that if you allow 165F to pass at CCP1, you'd need some secondary heating for CCP2 as you are relying on CCP1's temp to meet that goal.  It could be that CCP2's procedure is to run your processing tanks up to a higher limit after CCP1 is met, meaning the temps at CCP2 will meet the critical limit.  Just spitballing here, but you'd need some data from your process showing that x higher temp with your standard batch size is sufficient for keeping the product above 165F for the duration of your packaging step.

 

My first job in QA included a sterlization business where we used dry steam in a vacuum chamber to heat treat spices and dehydrated veg.  We had time/temp controls for the validated items, verified by placing 4 different probes in product at the known cold spots.  We regularly overran the time to ensure we had a good sufficient kill, but defaulted to our minimum time/temp as the critical limit.

[Tony-C]

Hi bsilverstein,

 

 

Welcome to the IFSQN forums.

 

I don’t see a problem with having both Processing Time/Temperature: Greater than or equal to 165°F for greater than or equal to 5 minutes and Packing Temperature: Greater than or equal to 165°F as CCPs.

 

What I would do for practical purposes is have a SOP that instructs the operator at the end of the 5 minutes processing stage to elevate the temperature to ensure that 165°F is achieved at a minimum on filling. Your knowledge of typical the temperature drop on filling would ensure an adequate temperature elevation is targeted.

 

Kind regards,

 

Tony

[bsilverstein]

Thank you jfrey123 and Tony-C.  I appreciate your inputs and I totally agree