Berkshire Sterile Manufacturing opens $10 million facility with cutting-edge pharma technology
Berkshire (US) - Berkshire Sterile Manufacturing (BSM), a bio-pharmaceutical startup with 16 employees and plans to hire approximately 20 more in the coming year, has just finished the construction of…
FDA – Inspection Trends
Summary of presentation by Doug Kovacs, Supervisory Investigator, FDA- New Jersey District At the recent Contract Pharma show, hosted in New Brunswick, NJ, Doug Kovacs spoke about the top 10…
Fedegari Opens Training Facility in Sellersville, PA
Berkshire Sterile Manufacturing by Dr. Andrea Wagner, Senior VP Of Business Development On September 10th BSM’s CEO and head of engineering travelled to Sellersville, PA for the ceremony…
Berkshire Community College and Berkshire Sterile Manufacturing partner as Part of Mass Life Science’s Internship Challenge
In just a matter of weeks Berkshire Sterile Manufacturing's (BSM) warehouse space in Lee has been transformed into clean rooms – and several Berkshire Community College (BCC) students…
Berkshire Sterile Manufacturing (BSM) is named Finalist for the 12th Annual Team Massachusetts Economic Impact Award
Berkshire Sterile Manufacturing (BSM) is named Finalist for the 12th Annual Team Massachusetts Economic Impact Award for the expansion of its operations in Lee. As background, the Team…
CMOs Beware of GDUFA Fees
Berkshire Sterile Manufacturing by Andrea Wagner, PhD The FDA instituted a new program in 2013, to charge API and finish drug product facilities who manufacture generic drugs an…
BSM’s Amazing Steam Sterilizer
Berkshire Sterile Manufacturing BSM’s FEDEGARI autoclave has the capability to terminally sterilize syringes, bags, vials and ampules with a 20,000 unit load capacity. The autoclave has internal heat…
Understanding new regulations for HVAC validations
Berkshire Sterile Manufacturing by Andrea Wagner The FDA issued a new guidance document in 2011, General Principles and Practices for air filtration, which discusses the process validation of…
Sterile Connections in Non-Sterile Environments?!
Berkshire Sterile Manufacturing by Andrea Wagner Has Pall Corporation accomplished the impossible? Yes, you can perform sterile transfers of products and tangential flow in a non-sterile environment with…