TABLE III

Proposed PQ Challenge for Filling Equipment Maximum Load

Load Configuration
Item DescriptionNumber in LoadAverage Mass (g)Total Mass (g)
Filters KA4NFP1***4520.12080.4
Filters SLK7002PFRP*51250.56252.5
1.5-in cleaning hose with valve on one end (Teflon with stainless steel over-braided hose)*14356.04356.0
Stoppering outer bowl, stainless steel*120990.220990.2
50-cc pump (spare, no tubing attached)*21055.42110.8
Vent filters KA2PFRP*2149.7299.4
25-cc pump assembly (includes manifold, pump, nozzle with associated tubing)*111720.311720.3
50-cc pump assembly (includes manifold, pump, nozzle with associated tubing)*113354.213354.2
25-ft Braided silicone tubing*11427.91427.9
MPGL20CL3 vent filter (bag closed)*1249.1249.1
MPGL20CL3 vent filter (bag open)*1241.3241.3
Tool box (set up tools)*17515.07515.0
100-cc sample tray1635.2635.2
20-cc sample tray1209.8209.8
25-cc Spare Pumps2824.11648.2
3-in nozzle bracket1854.8854.8
Batch record4478.01912.0
Box of screws12228.02228.0
Bulk container bracket12086.42086.4
Fill needles (spare)436.7146.8
Inner disk17914.27914.2
Intermediate tank116260.516260.5
Lyo rake (large)21114.72229.4
Lyo rake (small)5582.92914.5
Pressure indicator with swage lock valve1636.2636.2
Ring gate boxes with 19 gates84603.936831.2
Spare Bracket, 1.5 in1418.6418.6
Spill tray (large) with tubing11849.11849.1
Spill tray (small) with tubing11449.21449.2
Spray wand1331.2331.2
Stopper track15211.45211.4
Tool box (fill tools)14032.74032.7
Vacuum manifold with tubing (large)13357.03357.0
Vacuum Manifold with tubing (small)11163.01163.0
Vacuum Plugs1183.1183.1
Vacuum Wheel18293.28293.2
Z spacers (set of 4)11395.01395.0
Total (g)174,788
  • * One (1) of each of these items was to be monitored with TCs and BIs.

  • ** One of this item was used as the minimum load.