Hot fill hold and FDA form 2541e

Here is section “I” of the current version of FDA’s Acidified Process Filing form 2541e.  Here are some hints for completing the form when using a hot fill hold (HFH) process.

  • First, note the blacked out portions.  Nothing needs to be entered in these areas.
  • Column 1 is 01 for your first filing (of the form).
  • Column 2 is 01 for the first step (in this one step process)
  • Column 3 – check the box “Lowest Hold temp.” and below the word Fahrenheit write in the temperature provided by your process authority.  A standardized default value often used is 180F.
  • Column 4 – is the amount of time the HFH food must stay at the temperature indicated in Column 3.  This is usually minutes, so check the box “minutes”.  If the process authority said to invert food container and hold 1 minute; then right-side-up and hold 1 minute (the total time equals 2 minutes).  Write in 2.00 in the box below “minutes”.
  • Column 6 captures the scientific data that the process authority (PA) provides.  It is best not confuse this with processing time and temperature.  Just enter the data.  In almost all cases the “Other F” box is checked.  Write in the values provided by your PA for Ref T, Z, and below that: minutes (t).
  • Lastly, Column 11 is for Other factors.  If the processing time and temperature provided by your PA is valid only for a specific pH range, it will be indicated here.