Using SIS, it is unnecessary to
install the machine
into a partition wall. At the unloading side an isolator is
adapted.The closures are unloaded from the machine and
filled into sterile
containers, docked at the sterile connection port. These
sterile
containers have a volume of 20 liters, but can be modified to
customer's requirements. The operator has the ability to
visually inspect the interior
of our DS S machine through the
isolator windows or from the loading side of the
machine.
The Sterile Storage System SSS allows
greater
flexibility,
as several closure sizes can be stored and also several
stoppering
machines can simultaneously be supplied at
the same time.
The entire transfer to the stoppering machine is
effected without
breaking
the sterile chain, as the containers are again docked to
the filling/stoppering machine placed in the isolator and are directly
emptied into the vibrator bowl.
The transfer containers can also be used for
transportation through
gray areas, as they do not loose their sterility because
of the special
lid design.
Even particles from the ambient air can only
deposit on the surface
of the transfer containers, but can neither enter
the transfer containers
nor the isolators when docking the lids to an isolator.
If the filled transfer containers were, e.g., covered with a plastic
bag, welded,
customer's have the option to transport the containers on trucks from
one facility to another without breaking the sterile chain. Before entering the
clean
area, the plastic bag is removed and the
transfer containers which
have a
clean outer surface are then docked to the isolator of the stoppering
machine. During this process, there is not interruption as sterilization of the
docking port surfaces
is unnecessary. This is an interesting variation because
of the low weight and easy material handling of the transfer containers.
The isolators and the sterile containers can be
sterilized on request.
This is done without opening of the isolator.
According to the design of the stoppering
machine, placed in the isolator,
direct docking of the transfer containers from the side above the
vibrator
is recommended.
If the stopper washer sterilizer is placed one
floor above the filling/
stoppering machine, the stoppers can be directly fed
into the bowl
of the filling/stoppering machine through a docked sterile tube by
the SIS.
The SIS can be added to all HUBER System DS S
(Sterilizer) machines at a later date,
as the height of the building is not a factor.
SIS offers validatable 10¯6
Sterility Assurance Level (SAL) according
to
FDA requirements.
Isolator Technology
is only beneficial if a filling/stoppering machine is
located in an isolator.