Berkshire Sterile Manufacturing – Sterile drug or medical device manufacturing services

We are a fill finish service offering the highest level of sterility assurance and quality achievable.

Sterile Filling

Our isolator-based flexible fillers offer you container choice in your drug product. We fill vials, syringes, cartridges, and we lyophilize.

Stability Programs

Our expert quality team will develop and execute robust stability protocols to determine your drug product’s stability.

Analytical Services

We will transfer your methods and develop more reliable and durable methods to ensure your testing meets cGMP standards.

Why BSM?

Quality

70% of contaminated drug product is due to human contamination. At BSM, we use isolators to remove the manufacturer from the filling process and dramatically reduce your product’s risk

Flexibility

Most manufacturers may not fill your container choice. Our state-of-the-art flexible fillers are capable of filling syringes, cartridges, and vials as well as specialty containers. We give you options.

Expertise

BSM has experience in complex formulations, ranging from viscous filling and formulation to conjugant formulation. We will tackle complex formulations where others may shy away.

Communication

We welcome our clients onsite to watch their fill and speak with the staff directly involved in their drug production process. You will find full transparency throughout your project.

Start Your Fill Finish Project