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 and $41,926 for API facilities within the US.  These annual fees are assessed for as long as the company produces these commercial products.  The fees… continue reading
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 to warm the chamber by putting steam through prior to starting a cycle. This eliminates the condensation that normally occurs on the walls of the… continue reading
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 air filtration – talks about the HVAC system’s need to filter air into space which is controlled by this regulation.  Most drug products are good… continue reading
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 remain sterile. On December 17, 2014 Pall Corp. held a webinar on their Kleenpak II connectors which covered uses, stability, and validations performed on these… continue reading
MassDevelopment has issued a $4,083,000 bond on behalf of Berkshire Sterile Manufacturing, Inc., which will help the biopharmaceutical startup buy and renovate portions of a 116,000-square-foot building in Lee. Renovation plans for a new manufacturing facility include clean rooms, labs, and work rooms for product formulation, final inspection, and packaging. The company will also use… continue reading