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- 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
Lee, MA, US
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.
Lee, MA, US
Facility Highlights
Contract Services
Sterile Filling
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- Vial filling
- Syringe filling
- Cartridge filling
- Lyophilization
- Low-loss filling
- Specialty filling
- Terminal sterilization
Development
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- 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
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- 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
Contact
480 Pleasant Street
Lee MA 01238
United States
Tel: 413-243-0330
info@berkshiresterile.com
Explore more of our facilities
Allentown, PA, US – Building 1
7451 Keebler Way, Building 1, Allentown, PA 18106 United States
+1-610-395-5800Allentown, PA, US – Building 4
7384 Penn Drive, Building 4
Allentown, PA 18106
United States
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