Our Sterile Manufacturing facility in Lee, Massachusetts offers a breadth of aseptic fill-finish solutions, including vial filling, cartridge filling, syringe filling, lyophilization, development services, and analytical services.
Facility Highlights
- 120,000 ft2 facility including GMP production space, warehouse and offices
- Three isolator-based filling lines: a manual, semi-automated, and fully automated filling line
- Room for expansion to house dedicated equipment
Contract Services
Sterile Filling
- Vial filling
- Syringe filling
- Cartridge filling
- Lyophilization
- Low-loss filling
- Specialty filling
- Terminal sterilization
Development
- Terminal sterilization process development
- Lyophilization cycle development
- Lyophilization formulation development
- Aseptic formulation process development
- Filtration studies
- Small and large molecules, including peptides
- Highly sensitive products (oxygen, pH, shear, light)
- Highly viscous solutions
- Complex formulation processes
- Suspension products
- Generic product development
Analytical Services
- Method development
- Method validation
- Container closure integrity testing
- In-process and release testing
- Stability studies at all ICH conditions
- On-site sterility testing
Quality Accreditation
- FDA and QP Inspected
Accommodation Nearby
- Courtyard by Marriot
- Hilton Garden Inn
- Hampton Inn & Suites
- The Inn at Stockbridge
- Holiday Inn Express
- Pittsfield Holiday Inn
Contact
480 Pleasant Street
Lee MA 01238
United States
Tel: 413-243-0330
info@berkshiresterile.com
