There are two basic system approaches
used to sterilize medical devices with electron beam technology
-- In-line or stand-alone systems.
In-Line - An in-line system is
integrated directly into the production process. This can be accomplished
with a small electron beam system dedicated to each production
line or several lines feeding a single electron beam system. In
either configuration the electron beam system can be designed
to process cartons or single products in their sterile packaging
(Figure 2).
Stand-Alone - A stand-alone system
differs from the in-line approach in that the electron beam system
is not directly integrated into the production process. This approach
is generally used to process many different types of products
in their final shipping carton configurations. Stand-alone systems
come in many sizes and are generally classified according to the
power of the accelerator (small 1-5 kW, medium 10-20 kW, and large
25-50 kW) -- the larger the power, the more product volume can
be processed. Power ranges above 35 kW are available but are seldom
applied to medical device sterilization applications due to the
difficulty in control issues at such high process rates.