When Manual Assembly Goes
High-Tech and Beyond
The changing practices in medical device manufacturing are illustrated in the development of a new piece
of dispensing equipment. Initially, it met with resistance, but over time it has been adopted by the majority
of the companies involved in the manual assembly of disposable plastic circuits. Most recently, of course,
high-volume production that requires a high level of labour has moved to areas of the world where labour
costs are lower.
P. Galavotti, Nexion srl, Mirandola, Italy
The subjectivity of the operator
When I began working in the medical
field around the end of 1985, I visited
several cleanrooms in the Mirandola area,
in northern Italy, in connection with my
work. This area is also known as “Plastic
Valley,” because millions of disposable
extracorporeal circulation circuits (for
dialysis, infusion, transfusion and nutrition) are manufactured there. The main
feature of this industrial area is that a
radius of just a few kilometres contains
the complete production chain for disposable plastic circuits: injection moulding,
tubing extrusion, assembly (mainly manual), packaging and sterilisation.
Back then I was a young engineer
who had just returned from compulsory
military service. After a few short professional experiences in other fields, I began
working for a company that, among other
activities, manufactured equipment for
quality improvement and production
optimisation in the medical device manufacturing sector.
During my first visits to those clean-
rooms, the thing that surprised me the
most was the smell of cyclohexanone. This
is an extremely volatile solvent used for
bonding tubing and plastic connectors
and if you have never had any experience
with this solvent, its odour is similar to
that of acetone, which is used to remove
nail polish. The workers whose job it
was to assemble the disposable plastic
circuits used a ceramic dish holding a
piece of polyurethane sponge soaked with
cyclohexanone to apply this solvent. For
eight hours a day the components to be
bonded were “moistened” with the sol-
vent by means of “dipping” them onto the
sponge and immediately connecting them
to the other component.
Innovation arrives with a solvent
dispenser
In those days, in addition to the popular
system of the ceramic dish, there were
only a few other systems that were inge-
niously designed and built by the compa-
nies themselves. The company I worked
for then started to develop the first com-
mercially available solvent dispenser to
solve a series of typical problems con-
nected with that specific procedure for
applying solvent, including:
