News, Events and Insights

CMOs Beware of GDUFA Fees

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

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

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?!

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…