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PureSteamforPharmaceuticalSterilizers PDF
PureSteamforPharmaceuticalSterilizers PDF
Pharmatec GmbH
Pharmatec GmbH
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Pharmatec GmbH
Pharmatec GmbH
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Classification of steam
Characteristic of Quality / Differences of Quality
Standards and Guidelines for Steam
Typical Applications for Steam
Pharmatec GmbH
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Classification
Plant Steam
Industrial Steam
Utility Steam
Technical Steam
Process Steam
Clean Steam
Pure Steam
Pharmaceutical Steam
Pharmatec GmbH
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Classification
Plant Steam:
Plant Steam is steam used for heating systems and not be in contact with sterile
goods
Process Steam:
Process Steam is steam produced from pre-treated water, which contains no parts
from corrosion-inhibitors and anti-scaling-additives
Process steam is steam with small soiling, suitable for direct effect on sterilizer
goods like group I according DIN 58950
Pharmatec GmbH
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Pharmatec GmbH
Pharmatec GmbH
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disposal such as copying and passing on to third parties.
Pharmatec GmbH
Pharmatec GmbH
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disposal such as copying and passing on to third parties.
Pharmatec GmbH
Pharmatec GmbH
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Pharmatec GmbH
“The sterilizer shall be designed to operate with dry saturated steam containing
not more than 3,5 % V/V non-condensable gases …”
EN 285 is based upon HTM 2010 and is the European standard for sterilization
and steam sterilizers, it describes the steam quality tests and is regarded as the
definitive reference.
Pharmatec GmbH
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Pharmatec GmbH
Typical Applications
Kind of Steam Examples for application Branch of Industry
Plant Steam Heat up from liquids, Food Industry, Pharmaceutical
Warm Water Generation, Industry, Biotechnology, Hospitals
Pure Steam Generation,
WFI-Generation with
WFI-stills
Process Steam SIP, air-humidifying in Food Industry, Pharmaceutical
clean rooms, Sterilization Industry, Biotechnology, Hospitals
from CIP-equipment,
Sterilization from aseptic
equipment, pipes,
storage tanks
Pure Steam Sterilization of product, Pharmaceutical Industry,
SIP from process tanks, Biotechnology
air-humidifying in „critical
clean rooms“
Pharmatec GmbH
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Pharmatec GmbH
Pharmatec GmbH
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Pharmatec GmbH
USP 30
Ph. Eur.
Eur. Status 2000
Pharmatec GmbH
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Pharmatec GmbH
PLANT STEAM
IN L E T
EVAPORATOR
CONDENSATE
O UTLET
D O U B LE
TUBE SHEET PURE STEAM
O UTLET
S P IR A L
C Y L I N D R IC A L
SPACE
R IS E R S P A C E
O B S E R V A T IO N
G LA SS
BLO W DO W N
O UTLET
FEED W ATER
C IR C U L A T IO N
Pharmatec GmbH
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Pharmatec GmbH
Pharmatec GmbH
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disposal such as copying and passing on to third parties.
Pharmatec GmbH
Pharmatec GmbH
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Pharmatec GmbH
Industrial steam
automatic water
circulation
condensate
Pharmatec GmbH
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disposal such as copying and passing on to third parties.
Pharmatec GmbH
Pharmatec GmbH
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disposal such as copying and passing on to third parties.
Pharmatec GmbH
Pharmatec GmbH
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disposal such as copying and passing on to third parties.
Pharmatec GmbH
Pharmatec GmbH
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Pharmatec GmbH
Pharmatec GmbH
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Operating M odes
B y changing the partial pressure of the gas w e can either rem o ve
from or dissolve gas into w ater.
Low er the partial pressure, the gas w ill be rem oved from the w ater
Increase the partial pressure, the gas w ill dissolve into the w ater
Gas Gas
To
Vacuum
Pum p To
Vacuum
W ater W ater W ater
Inlet Inlet Inlet
Pharmatec GmbH
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Pharmatec GmbH
• Patented D esign
• FD A C om pliant
(W ith Appropriate O -Rings)
Pharmatec GmbH
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Pharmatec GmbH
Pharmatec GmbH
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Pharmatec GmbH
Pharmatec GmbH
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Pharmatec GmbH
Pharmatec GmbH
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disposal such as copying and passing on to third parties.
Pharmatec GmbH
Pharmatec GmbH
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disposal such as copying and passing on to third parties.
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Pharmatec GmbH
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Pharmatec GmbH
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