We specialize in isolator-based fill/finish of vials, cartridges and syringes from clinical phase through small to mid-scale commercial production. Sharp’s Sterile Manufacturing business (formerly Berkshire Sterile Manufacturing) is a specialist CDMO providing sterile injectable development and manufacturing services including:
- 100% Isolator-Based Sterile Filling
- Lyophilization
- Formulation Development
- Analytical Support
- Stability Studies
- Terminal Sterilization
All lines are equipped with Colanar™ fillers offering the flexibility for vials, syringes and cartridges to be filled on the same line. From clinical to commercial, our team has the deep technical expertise, broad experience and end-to-end manufacturing, packaging and distribution solutions to seamlessly accelerate your injectable to market.
Technical Capabilities
- Formulation suites
- Filling rooms with isolator-based sterile filling lines
- Filling of syringes, vials and cartridges
- Lyophilization capability
- Viscous and complex formulations
- 100 to 60,000 units filling capacity
- Wash rooms/component prep rooms
- Fully equipped analytical lab for onsite analytical support and stability studies
- Onsite microbiology lab for in-house microbiology testing
