Scale Up To Production

It is a fairly complex leap from research and development to production sized batches.  Whether your recipes which work well for small scale can be 5 to 10 times scale up depends upon many factors.  Some of these factors are:

  • Size differences between the R&D and production system
  • Performance differences between the R&D machine as concerns delivered cool down rate, evacuation
  • Small differences in freezing morphology
  • Differences in dynamic loading capacity of the condensers
  • Pressure difference between chamber and condenser due to the main valve size
  • Mass transfer and heat transfer coefficient differences between machines
  • Whether process parameters are defined or not

Applewood Scientific can provide assistance in sorting out these differences, suggesting alternatives, and assisting with hands on management for the first validation.

Scal_RD_Peptide_dryer_01.jpg

 

Customer: Typical Customer
DESCRIPTION Dim  Unit   Dim  Unit Dim  Unit Dim  Unit    
50cc 50cc 50CC 50CC 50CC
Vial Diameter (max) 46 mm 46 mm 46 mm 46 mm 46
Shelf Width 1420 mm 1420 mm 1420 mm 1420 mm 1420
Shelf Depth 1550 mm 1550 mm 1550 mm 1550 mm 1550
Tray Width 1420 mm 1420 mm 1420 mm 1420 mm 1420
Tray Depth 1550 mm 1550 mm 1550 mm 1550 mm 1550
No of Trays/Shelf 1 1 1 1 1
Total No of Shelves 8 9 11 14 8
Total Shelf Area 13.00 sq m 19.81 sq m 24.21 sq m 30.81 sq m 17.61
ROWS ACROSS WIDTH
No of Vials 30 30 30 30 30
No of Rows 38 38 38 38 38
Total Vials/Tray 1,140 1,140 1,140 1,140 1,140
Total Vials/Shelf 1,140 1,140 1,140 1,140 1,140
Total Vials in Freeze Dryer 9,120     10,260     12,540     15,960     9,120    
Vial Height 38 mm 49 mm 64 mm 95 mm 95
Requested no. Vials 100,000 0 0 0 0
Variance -90,880   10,260 12,540 15,960 9,120
Fill/Vial 1.3 ml 5.5 ml 3 ml 15 ml 15
Concentration 0.00% 0.00% 0.00% 0.00% 0.00%
Water load/batch 12 Kg 56 Kg 38 Kg 239 Kg 137
Vial Weight 6.00 g 10.50 g 38.00 g 92.00 g 92.00
Total Glass Weight 55 kg 108 kg 477 kg 1468 kg 839
Stopper Weight 1.00 g 2.00 g 2.00 g 3.00 g 3.00
Total Stopper Weight 9 kg 21 kg 25 kg 48 kg 27
Fence Height 25 mm 25 mm 25 mm 25 mm 25
Total Fence Weight 16.58 kg 18.66 kg 22.80 kg 29.02 kg 16.58
Batches Per Year
Yearly Production 0 0 0 0 0
Trays/Batch 8 9 11 14 8

 

 

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