Your sterile manufacturing partner – we can help supply your clinical trial and commercial product demands
With dedicated project management, we ensure on-time and dependable fill-finish manufacturing projects that meet the most rigorous regulatory standards.
Our facility offers both aseptic and terminally sterilized manufacturing processes for:
| Format | Active Capabilities | Capabilities Range |
|---|---|---|
| Cartridges (Bulk) | 0.5 – 3ml | 0.5ml – 10ml |
| Vials (RTU) – 2024 | 2R, 6R, 10R | 2R – 50R |
| Pre-Filled Syringes (RTU) – 2024 | 1ml long | 1ml – 2.25ml |
| Cartridges (RTU) – 2024 | 3ml | 1.5ml – 10ml |
| Microvials | Unit-Dose Vial | Unit-Dose & Bi-Dose Vial |
Manufacturing Highlights:
- 200,000+ square feet of cGMP Operations
- High-potent API (HPAPI) handling down to 0.01µg/m3
- Both semi-automatic and automated visual inspection
- Fully automated labelling, blistering and packaging lines
- Full serialization and aggregation capabilities
- Cartridge / injection pen device assembly experience
- 2 – 8 degree cold chain and ambient storage and logistics
- ISO 5 (Grade A – aseptic filling)
- ISO 7 (Grade C – terminally sterilized filling)
- CNC packaging areas
- Isolator force sterility testing
- Controlled substance license
Your sterile manufacturing partner – we can help supply your clinical trial and commercial product demands
With dedicated project management, we ensure on-time and dependable fill-finish manufacturing projects that meet the most rigorous regulatory standards.
Our facility offers both aseptic and terminally sterilized manufacturing processes for:
| Format | Active Capabilities | Capabilities Range |
| Cartridges | 0.5ml – 3ml | 0.5ml – 10ml |
| Vials | 2R – 20R | 2R – 50R |
| Microvials | Unit-Dose Vial | Unit-Dose & Bi-Dose Vial |
Manufacturing Highlights:
200,000+ square feet of cGMP operations
High-potent API (HPAPI) handling down to 0.01µg/m3
Both semi-automatic and automated visual inspection
- Fully automated labelling, blistering and packaging lines
- Full serialization and aggregation capabilities
2 – 8 degree cold chain and ambient storage and logistics
ISO 5 (Grade A – aseptic filling)
ISO 7 (Grade C – terminally sterilized filling)
CNC packaging areas
Isolator force sterility testing
Controlled substance license