Low voltage electron beam sterilization tunnels are main stream technology for sterile transfer into barrier isolator systems. Already the standard for nested syringe tub transfer in parenteral drug fill-finish lines, ebeam tunnels are increasingly being considered for a broader range of drug manufacturing applications.

Overview of Low Voltage Electron Beam Tub Sterilization

Over the past several years, manufacturers of high-value injectable drugs have been moving away from packaging their product in clean rooms to sterile fill-finish operations in restricted access barrier systems (RABS) or barrier isolator systems. The benefits of barrier isolators include an increase in sterility assurance, a reduction in the footprint of the filling operation, and a significant savings in energy.

For syringe filling lines, sealed tubs containing syringes are pre-sterilized at ethylene oxide sterilization facilities. These tubs are transfered into the barrier isolator through a sterilization tunnel. Low voltage electron beams are used to disinfect the exterior of the tub as it moves into the aseptic filling zone as seen here.

AEB partners with leading suppliers of barrier isolator technology including Metal + Plastics and Skan to deliver electron beam barrier isolator solutions. Johnson & Johnson subsidiary Cilag AG announced their line last year and others are anticipated in 2008.

Electron Beam Tunnels for "Universal Tub" Sterilization

Manufacturers using electron beam tunnels are finding that sterile tub transfer can be used for moving a broad range of materials - beyond nested syringes - into a barrier isolator. Since electron beam sterilization is so fast and efficient, it makes sense to leverage an electron beam tunnel for transfering items such as environmental monitoring plates, change parts, and tools into the isolator. This "Universal Tub" sterilization concept was formally discussed at the upcoming ISPE Barrier Isolator Conference.

Opportunities for Direct Sterilization of Primary Packaging Components

Moving beyond tub sterilization, electron beam tunnels can be an option for direct sterilization of many drug packaging components such as vials, syringe barrels, stoppers, or blister packaging. By directly sterilizing packaging components, manufacturers eliminate the need for offsite bulk sterilization and compress the sterilization process into a single step. Besides having significant inventory advantages, this approach allows drug manufacturers to position and orient the packaging outside of the isolator, reducing the need for bulky material handling equipment inside of the aseptic environment.

AEB, our OEM partners, and our customers will be discussing their experience with electron beam sterilization tunnels at the upcoming ISPE conferences in Washington D.C. and in Manchester, UK.

For more information on AEB's solutions for phamaceutical and medical device sterilization, click here.