E-Beam—a new transfer system for isolator technology

In every aseptic filling application, the sterile transfer of goods into the aseptic area is a challenge, and there are many different ways to do it.

With isolator technology a higher sterility assurance level (SAL) is achieved. This SAL is only as good as the weakest segment in the chain of manufacturing. The transfer of goods into and out of the isolator is one of these critical segments.

Today different techniques, some already well established, others still very new, are available on the market like: dry heat tunnel, autoclave, pulsed light, rapid transfer systems (RTP), H₂O₂ tunnel, UV light, etc. all these systems are either not applicable for continuous transfer, only good for heat-compatible materials like glass, or do not guarantee a 6 log spore reduction.

E-Beam opens new perspectives in this field. With E-beam technology it is possible to transfer heat-sensitive (plastic), pre-sterilised materials at high speed, continuously into an aseptic area.

E-Beam unifies three different technologies, that result in a very efficient and high-speed decontamination machine designed for the pharmaceutical industry. First, there is the electron beam that decontaminates the goods and an accurate shielding that protects the surrounding from this beam. Second, there is the conveyor system that guarantees the output and the correct exposure time underneath the beam. And third, there is the isolator interface to provide correct differential pressure and clean air inside the tunnel as well as the decontamination of the tunnel with H₂O₂ prior to production.

The E-beam is a low-energy electron beam, capable of decontaminating any kind of surface. It penetrates only a few micrometers into the material and therefore does not deform the packaging media.

Currently, machines are being built to transfer pre-sterilised syringes, packed in plastic tubs with a Tyvek cover into an aseptic filling isolator with the following data: decontamination efficiency of 10⁶ (6 log spore reduction), decontamination speed of 6 tubs (600 syringes) per minute.

This is just one of many applications for this new technology.