Contract manufacturing
PharmIdea's production capacity is up to one million sterile vials per year
Capacity and vial size
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 |
- (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
Investigational medicinal products (IMP) manufacturing
- Sterile IMP (including cytotoxic) manufacturing in vials for phase I – III studies
- Clinical trial material labelling, release, dispatching and shipping