CMO’s Beware of GDUFA Fees

The FDA instituted a new program in 2013, to charge API and finish drug product facilities who manufacture generic drugs an annual fee of $247,717 for finished drug product facilities…

BSM’s Amazing Steam Sterilizer

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 exchangers that can be used…

Understanding new regulations for HVAC validations

The FDA issued a new guidance document in 2011, General Principles and Practices for air filtration which speaks about process validation of your HVAC systems.  The 21 CFR 211.46 for…

Sterile Connections in Non-Sterile Environments?!

Pall Corporation has accomplished the impossible?  Yes, you can perform sterile transfers of products and do tangential flow as well in a non-sterile environment with assurance that your products will…