The mood at the annual ISPE Washington DC conference was one of cautious optimism.  The near halting of pharmaceutical manufacturing capacity expansion in 2009 has given way to new projects and the evaluation of new manufacturing technologies.  This optimism was tempered by impending consolidations in the industry and a still relatively meager drug pipeline.  That said, interest in new technologies for aseptic manufacturing remains a top interest.

The conference included a two-day forum on barrier isolation technology complete with case studies and new technology presentations.  Barrier isolators are used for aseptic manufacturing of injectable drug products, where primary packaging containers, including vials and syringes, are filled in a sterile filling environment with automated filling equipment.  The convenience and safety advantages offered by pre-filled syringes vs. traditional vials, such as the elimination of risk from contamination each time a dose is drawn from the vial, are driving significant market growth and demand for barrier isolator filling systems.  A recent report, Pre-Filled Syringes and Related Systems: World Market Outlook 2010-2025, forecasted continued double-digit growth rates in pre-filled syringes for a range of injectable products.  

AEB supplies low energy electron beam systems that sterilize containers of prefilled syringes.  Electron beam sterilization offers dramatic advantages over the conventional manual approach of spraying and wiping containers with a chemical sterilant.  Over the past two years, several barrier isolator systems equipped with AEB technology have been deployed and the first lines are ramping to full capacity.  Cilag AG of Switzerland delivered a case study documenting its deployment and ramp-up to production scale of a barrier isolator system from Metall+Plastic Gmbh that uses AEB's electron beam emitter technology.  They reported long runs with reliable sterilization performance from the electron beam tunnel with over 1500 hours of operation in a production environment.  This represents an important milestone in proving the efficacy of this application. 

The growing need for high performance sterilization technologies in the pharmaceutical and medical device manufacturing industries points to increased consideration in incorporating electron beam technology.   Electron beams provides a practical approach for aseptic transfer applications like prefilled syringe tub sterilization and a solution for direct sterilization of materials during packaging or aseptic manufacturing.  For more information, download our ebook here