“The Development of an Isolator Based Flexible Filling System for all Containers” Primary parenteral packaging has for years been produced in bulk and sold to pharma companies, where the bulk packaging was washed, sterilized, filled and sealed. This arrangement required different types of processing and filling equipment at the pharma companies for each type of… continue reading
Tech, health care, manufacturing firms honored for contribution to Mass. economy By Megan Woolhouse Globe Staff November 19, 2015 Growing technology, health care, and manufacturing companies dominated this year’s MassEcon Economic Impact Awards, an annual event honoring businesses that have “made an outstanding contribution to the Massachusetts economy.” This is the 12th year the Watertown… continue reading
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 state-of-the-art clean rooms, quality control and microbiology laboratories, workrooms for product formulation, final inspection, and packaging. The new Berkshire Corporate Center is equipped with the… continue reading
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 10 483 observations in 2014. His focus was on sterile manufacturing facilities and how this compared to 2009. In this summary only the items that FDA… continue reading
On September 10th BSM’s CEO and head of engineering travelled to Sellersville, PA for the ceremony which marked the opening of Fedegari’s new technology center in the U.S.A. We heard from speakers within the industry, including the Italian consulate in Pennsylvania, about the new center and its mission.   The center will give “hands-on” training to companies… continue reading
LEE, Mass. – 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 will have played a role in the transformation, according to a news release. BSM, which provides the safest sterile drug products possible for clinical… continue reading
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 Massachusetts Economic Impact Awards have been presented since 2003 to honor companies that have made a significant impact on the Massachusetts economy. Past honorees have included IBM,… continue reading
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