TABLE II

Cool Point Determination for Commodities

Equipment DescriptionNumber of Times in the Coolest 10 Items by Parameter
Total F0Maximum Temperature AttainedLag Time from Expose to ≥ 121.1 °CTime at ≥ 121.1 °CTotal Times in Top 10 Coolest
Filters KA4NFP1551516
Filters SLK7002PFRP440412
1.5-in cleaning hose with valve on one end (Teflon with stainless steel over-braided hose)530210
Stoppering outer bowl, stainless steel22149
50-cc pump (spare, no tubing attached)14038
Vent filters KA2PFRP132038
25-cc pump assembly (includes manifold, pump, nozzle with associated tubing)21047
50-cc pump assembly (includes manifold, pump, nozzle with associated tubing)40037
25′ Braided Silicone Tubing32016
MPGL20CL3 vent filter (bag closed)11024
MPGL20CL3 vent filter (bag open)11024
Tool box (set up tools)10034
25′ silicone tubing02013
Stainless steel “U” tube11002
6″ silicone tubing2002
Stoppering inner disk, stainless steel11002
Pressure indicator with swage lock valve11002
Spill tray (small) with tubing11002
Tool box (fill tools)11002
Vacuum manifold with tubing (large)01012
25-cc spare pumps 110001
6-cc pump assembly (includes manifold, pump, nozzle with associated tubing)10001
Stopper feeder chute, stainless steel01001
Stopper hopper, stainless steel10001
Intermediate tank with inlet and outlet tubing attached01001
Stoppering transfer disk, stainless steel00011
Vacuum manifold with tubing (small)01001
Intermediate tank vent filter capsule01001
  • The items in the NON-shaded areas are the recommended items for TC/BI challenge during PQ based on the frequency with which they are observed as being the hardest to heat.