The ideal combination of a washer, sterilizer and drier for washing of rubber
stoppers and rubber articles of the pharmaceutical
and technical
elastomer industry. Treatment of plastic caps,
screw caps,
and aluminum caps.
The DS S Series are double door, pass through designs which are
similar to the DS D series machines, but sterilize the stoppers. The
stoppers are deposited into the sterile suite ready for use or storage
in sterile storage
systems. The DS S Series range from 50 to
375 liters per batch. See also Size Your Machine.
Steam is supplied through nozzles in the center shaft
(patented).
By the steam sterilization coming from the center, a fast removal
of oxygen rich atmosphere from the pressure vessel is achieved.
On request, a pre-vacuum for sterilization is possible. The steam
continuously and uniformly is supplied via the nozzles which
guarantees an optimum temperature distribution. The machine
quickly reaches the required sterilization temperature of
121 degrees Celsius. During sterilization, the stoppers are
smoothly shifted intermittently. Pressure and temperatures
are permanently recorded according to FDA.
The DS S has the following control system:
Allen Bradley LOGIX - which consists of a PLC, PC with
color screen, keyboard and color printer.
The ideal combination of a washer, sterilizer
and drier to treat the
exterior and interior surfaces of pharmaceutical and technical
elastomer rubber and plastic articles with greatest flexibility.
(Click for larger view)
Most
effective cleaning of highly contaminated articles
as well as articles with deep holes.
Loading from non-sterile side. Ergonomic aseptic unloading at
sterile side, even into containers for direct transport to
stoppering
machine. See Sterile
Isolation System SIS and Total Sterile
Transfer TST
There are no
mechanically moving parts during the process,
and no metal abrasion, only highly cleaning turbulence of
DIRECT IMPACT CLEANING, CIP and/or SIP, washing each
stopper individually.
Precise
siliconization by using silicone oil or silicone emulsion.
Optimal
temperatures during each process step, max. uniformity
of temperatures during sterilization by patented system of steam
inlet
and distribution.
Effective
drying under 0.2 micron sterile filtered air or HEPA
filtered air (optional vacuum) with immediate removal of
water drops from deep holes through occasionally intermittent
shifting of stopper (Patent) providing uniform low residual
moisture (e.g. 0.019% LOD)
Anti-pyrogen
piping of "no weld techniques" and valves.
Anti-pyrogen
walls of inner drum, mirror finish.
Machine
design complying with GMP, WHO and FDA standards,
as well as YOUR requirements.
Great economy
with lowest water consumption per batch and only
nominal compressed air consumption.
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Loading
Loading is effected from the non
sterile side under sterile air stream coming out of the machine. No particles from the room
can thus enter the machine.
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Washing/Detergent
Dosing
After the water supply has reached the
set level, detergent is added by the dosing unit. When the inner drum starts rotating,
simultaneously the heating process starts.
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CIP System
When the washing water is drained off,
the CIP Machine-self cleaning starts. The outer cylinder and inner drum are cleaned
by rotating high pressure jets in order to avoid re deposits of flushed particles and silicone.
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SIP - System
On request, at SIP step can be
integrated. This insures a precise vaporization of the inner wall of the pressure vessel by rotating steam nozzles, thus having a high
cleaning efficiency.
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Rinsing/Siliconization
After refilling the machine with hot
water, the articles are rinsed.
If necessary, the articles can now be siliconized. This is done by adding the required quantity of silicone by means of the dosing unit. Either silicone oil or silicone emulsion can be used.
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Subaqual-Sterilization
On request, the machine can be designed
in such a way that a subaqual pre-sterilization of the stoppers in a water
bath under pressure up to a temperature of about 125 degrees Celsius can
be carried through. Subaqual pre-sterilization serves for extraction of foreign components and for releasing substances which can hardly be removed or chemical
contamination out of the rubber stoppers. Thus, direct positive influence
on leaching of the inner substances of stoppers and thus on drug
stability.
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Sterilization
Steam is supplied through nozzles of
the center shaft
(patented). By the steam stream coming from the center, a fast removal of the oxygen rich atmosphere from the pressure vessel is achieved. On request, even pre-vacuum for sterilization
is possible. The steam continuously and uniformly supplied via the nozzles
guarantees an optimum temperature
distribution and the machine quickly reaches the required
sterilizing temperature of 121 degrees Celsius. During sterilization, the stoppers are smoothly shifted from time
to time. Pressure and temperatures are permanently recorded
according to FDA.
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Drying
The air required for the drying step is
pressed into the machine
via a pre-filter, blower and .02 micron sterile filter (HEPA filtered air
is optional). Drying is done by occasional
intermittent shifting of the stoppers and simultaneously passing through
sterile air, thus avoiding any friction as with other systems. For
products requiring low residual moisture, hot air register and vacuum are
available as a support. With a vacuum unit, automatic leak test can be
carried out. At the end of drying, cooling down of stoppers to unloading
temperature is effected, therefore no after condensation of stoppers in
the filling containers. Instead of inline sterilizable
filter cartridges with 0.2 micron Hepa filters can be used.
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| Unloading
For unloading, stopper transfer and easy feeding to filling lines,
HUBER has available:
Design according to YOUR request are possible.
Sterile Isolation System SIS or Total Sterile Transfer TST permit transfer of stoppers from the DS S
to the filling and stoppering machines without any break in the sterile
chain and on demand, sterile storage for days.
For more information
Stopper Handling
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