The Model HWS is a hybrid pharmaceutical quality
autoclave with stopper
washer sterilizer capability. The Direct Impact Cleaning
drum with CIP/SIP
assembly is inserted into the center of the autoclave for use as a
dedicated
stopper processor. The insert can be removed for use as a standard
pharmaceutical autoclave (as shown below).
The pressure chambers and pressure vessels are
manufactured in
Switzerland. The Swiss factory has robotic welding and x-ray
capabilities
as well as orbital clamp welding machines for the pipe work.
The
Swiss factory is ISO 9001 certified.
(click image to view larger)
The stopper processor capacity ranges from 100 liters to 250
liters.
The pressure chamber volumes range from 1080 to 1800 liters.
The pressure vessel is designed according to ASME code,
PED97-23-EG (Pressure Equipment Directive), Regulation Rules AD2000
and other codes.
The HWS has several process control
alternatives.
SAIA PLC with WS
8450 - which consists of a
PLC, PC with
color screen, keyboard and color printer.
Allen Bradley LOGIX
- which
consists of a PLC, PC with color
screen, keyboard and color printer.
Because
the drive is outside the autoclave chamber and
the seal meets all sections of the most stringent hygiene
requirements of
the FDA, no metal abrasion is possible
inside, as with gear drives.
Only
this mechanical seal meets the current FDA
requirements and guarantees sterility during pressure
and vacuum including leak test.
There are no
mechanically moving parts during the process,
and no metal abrasion, only highly cleaning turbulence
of
DIRECT IMPACT CLEANING, washing each stopper
individually.
Optimal
temperatures during each process step, max.
uniformity of temperatures during sterilization by patented
system of steam inlet and distribution.
Effective
vacuum drying with immediate removal of water
drops from deep holes through occasionally
intermittent
shifting of stoppers (patented) providing
uniform low residual moisture.
Loading
from non-sterile side. Ergonomic unloading at
sterile side, even into containers for direct transport to
stoppering machine.
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.
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