DEVELOPMENT AND IMP
| Production technology | Main production steps | Vial size | Production batch size | |
|---|---|---|---|---|
| Cytotoxic products | Non-cytotoxic products | |||
| Freeze-drying | Preparation of intermediate product | 8 ml | up to 1550 | up to 6550 |
| Sterilizing filtration of solution | 10 ml | up to 1550 | up to 5470 | |
| Vials aseptic filling | 30 ml | up to 490 | up to 3430 | |
| Freeze-drying | Depends on freeze-dryer capacity (2) | Depends on freeze-dryer capacity (2) | ||
| Vials aseptic stoppering and sealing | ||||
| Aseptic filling | Preparation of intermediate product | 2 ml | Up to 20 L solution volume (3) | Up to 350 L solution volume (3) |
| Sterilizing filtration of solution | 6 ml | |||
| Vials aseptic filling | 8 ml | |||
| Vials aseptic stoppering and sealing | 10 ml | |||
| 30 ml | ||||
| Terminal sterilisation | Preparation of intermediate product | 2 ml | Up to 20 L solution volume (3) | Up to 350 L solution volume (3) |
| Sterilizing filtration of solution | 6 ml | |||
| Vials aseptic filling | 8 ml | |||
| Vials aseptic stoppering and sealing | 10 ml | |||
| Terminal sterilisation by steam | 30 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