Berkshire Sterile Manufacturing

480 Pleasant Street, Lee MA 01238

Lyophilization

Lyophilization

Some products are simply too sensitive and require lyophilization to maintain appropriate shelf-life and efficacy for their intended patient. BSM has a clean-in-place, steam-in-place lyo. We also have experience with lyophilizing products within a syringe which can reduce costly waste from hold-up volumes. All filling operations and transfer to the lyo are performed in permanently connected isolators.

In early 2022, we will be adding a third filling line that will increase our lyophilization capability to 35,000 10R vials.

Lyophilization Details:

Container Sizes: Client Directed
Capacity: Client Directed – up to 35,000 10 mL vials
Operations: Manual, Semi-Automated, or Automated – all
Components: Client Specified
Fully isolated filling environments
Lyo development and optimization services

Filling Line	Scale	Vial Size
Semi-Automated Line	Clinical up to 3,500 10R	2 mL - 100 mL
Automated Line	Clinical or Commercial up to 35,000 10R	2 mL - 100 mL