Kontraktražošana
SIA "PharmIdea" ražošanas kapacitāte sasniedz līdz 1 miljonam sterilo flakonu gadā
Jaudas un flakonu izmēri
Production technology | Main production steps | Vial size (1) | 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 1150 | 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 |
Eksperimentālās sērijas klīnisko pētījumu vajadzībām
- Injekciju preparātu (ieskaitot ķīmijterapeitisko) eksperimentālo sēriju ražošana I-III fāzes klīniskajiem pētījumiem.
- Eksperimentālo sēriju marķēšana, pakošana un piegāde.