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"Guarantees sterile transfer from the HUBER System to each filling
machine placed in an isolator without breaking the sterile chain"
The method stands for unloading by using the HUBER System
Sterile Isolation System SIS with total sterile transfer to the stoppering machines.
Sispic.jpg (47654 bytes)sisinroom.jpg (23135 bytes)UNFOLD~1.JPG (96505 bytes)
(click for larger view)
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 Sterility Assurance Level (SAL) according 
to FDA requirements.

Isolator Technology is only beneficial if a filling/stoppering machine is 
located in an isolator.

    

bulletSIS can be added to all DS S machines at any later date.
bulletSIS needs a building height of only 2500 mm
bulletSIS allows to install DS S machines in a non-clean area, as no 
partition wall is needed.
bulletSIS guarantees great flexibility, as one or more stoppering 
machines can be fed.
bulletSIS guarantees even greater flexibility when using SSS as different 
stopper sizes and aluminum caps can be handled simultaneously. 
bulletSIS guarantees not only sterile transfer within the facility but also 
to other facilities.
bulletSIS and sterile containers can be sterilized by Vaporized Hydrogen 
Peroxide with the same VHP 1000 unit as used for the 
filling/stoppering machine in the isolator.
bulletSIS for sterile unloading of stoppers to avoid human born 
contaminants by using docking ports.

Note: For customers requiring detailed information on SIS, 
please contact us for detailed information with the 
following code (SIS7.EXE). We will send you a CD-ROM.

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Last modified on Friday, July 29, 2011
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Brought to you by: M.Jacobsen
2007 HUBER
 Systems