PharmaIdea

Production technologyMain production stepsVial sizeProduction batch size
Cytotoxic productsNon-cytotoxic products
Freeze-dryingPreparation of intermediate product8 mlup to 1550up to 6550
Sterilizing filtration of solution10 mlup to 1550up to 5470
Vials aseptic filling30 mlup to 490up to 3430
Freeze-dryingDepends on freeze-dryer capacity (2)Depends on freeze-dryer capacity (2)
Vials aseptic stoppering and sealing
Aseptic fillingPreparation of intermediate product2 mlUp to 20 L solution volume (3)Up to 350 L solution volume (3)
Sterilizing filtration of solution6 ml
Vials aseptic filling8 ml
Vials aseptic stoppering and sealing10 ml
30 ml
Terminal sterilisationPreparation of intermediate product2 mlUp to 20 L solution volume (3)Up to 350 L solution volume (3)
Sterilizing filtration of solution6 ml
Vials aseptic filling8 ml
Vials aseptic stoppering and sealing10 ml
Terminal sterilisation by steam30 ml

(1) Any other size of vials in range 1-100 ml may be considered

(2) Batch size for other vials size may be requested separately

(3) More detailed calculation can be done, knowing the specific size of vials and fill volume