Berkshire Sterile Manufacturing Sterility Assurance

Berkshire Sterile – formulation and filling of syringes, vials, cartridges and custom containers – In ISOLATORS

Berkshire Sterile Manufacturing



Did you know that 70% of the contaminants in cleanrooms are generated from people?

Did you know that FDA wants all products requiring aseptic filling to be performed in isolators?

FDA, EMEA and others have stated this for years and due to the lack of flexibility, cost and overall difficulty with employing this technology it has not been widely embraced.  The innovation that has occurred over the past 10 years on both the filling systems and container system side has opened new doors to bring this technology into common use.

Berkshire Sterile is bringing flexible filling and isolator based filling for ALL products to the clinical marketplace. In the past these units have typically been used for cytotoxic or lactam based products due to their decontamination abilities but BSM is bringing this technology forward for ALL products with the EXCEPTION of cytotoxic and lactam based products (BSM does not fill cytotoxic or lactam based products).  This may seem unusual but BSM is targeting to be a leader in surrounding their client’s products with the highest SAL possible.

Join BSM’s clients in making sure you eliminate 70% of the contaminants from your production processes.

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Download our Free Guide: Navigating the Fill Finish Process

Download our free guide! This document offers an introductory overview to the fill finish process, which teams are involved, and key differences in filling environments and equipment commonly employed at CDMOs.