Pharmatec Pure Steam Presentation
Pharmatec Pure Steam Presentation Pharmatec Pure Steam Presentation
1 Packaging Technology Pharmatec GmbH Pharmatec GmbH PADD / September 2007 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of disposal such as copying and passing on to third parties.
- Page 2 and 3: 2 Pharmatec GmbH Pharmatec GmbH Exp
- Page 4 and 5: 4 Pharmatec GmbH Classification �
- Page 6 and 7: 6 Pharmatec GmbH Characteristic of
- Page 8 and 9: 8 Pharmatec GmbH Standards and Guid
- Page 10 and 11: Pharmatec GmbH Standards and Guidel
- Page 12 and 13: Pharmatec GmbH Package Unit Pure St
- Page 14 and 15: Pharmatec GmbH � Falling Falling
- Page 16 and 17: Pharmatec GmbH � Integrated Integ
- Page 18 and 19: Pharmatec GmbH Pharmatec GmbH 18 PA
- Page 20 and 21: Pharmatec GmbH Package Unit Pure St
- Page 22 and 23: Pharmatec GmbH Membrane Degassing S
- Page 24 and 25: Pharmatec GmbH Pharmatec GmbH 24 PA
- Page 26 and 27: Pharmatec GmbH Package Unit Pure St
- Page 28 and 29: Pharmatec GmbH Package Unit Pure St
- Page 30 and 31: Pharmatec GmbH Different Types of P
- Page 32 and 33: Pharmatec GmbH Measurement of non-c
1<br />
Packaging Technology<br />
<strong>Pharmatec</strong> GmbH<br />
<strong>Pharmatec</strong> GmbH<br />
PADD / September 2007 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of<br />
disposal such as copying and passing on to third parties.
2<br />
<strong>Pharmatec</strong> GmbH<br />
<strong>Pharmatec</strong> GmbH<br />
Expert’s Congress 13.-14.09.2007<br />
<strong>Pure</strong> <strong>Steam</strong> for Pharmaceutical Sterilizers<br />
Albrecht Albrecht Albrecht Albrecht Albrecht Albrecht Albrecht Albrecht Voigt Voigt Voigt Voigt Voigt Voigt Voigt Voigt / / / / / / / / <strong>Pharmatec</strong> <strong>Pharmatec</strong> <strong>Pharmatec</strong> <strong>Pharmatec</strong> <strong>Pharmatec</strong> <strong>Pharmatec</strong> <strong>Pharmatec</strong> <strong>Pharmatec</strong> GmbH GmbH GmbH GmbH GmbH GmbH GmbH GmbH<br />
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3<br />
<strong>Pharmatec</strong> GmbH<br />
<strong>Steam</strong> for Pharmaceutical Application<br />
� Content:<br />
Content:<br />
Classification of steam<br />
Characteristic of Quality / Differences of Quality<br />
Standards and Guidelines for <strong>Steam</strong><br />
Typical Applications for <strong>Steam</strong><br />
Package Unit <strong>Pure</strong> <strong>Steam</strong> Generator<br />
Different types of evaporators<br />
Package Unit <strong>Pure</strong> <strong>Steam</strong> Generator with Membrane Degassing System<br />
Package Unit <strong>Pure</strong> <strong>Steam</strong> Generator with Thermic Degassing System<br />
Measurement of Non-Condensable Gases according to EN 285<br />
Measurement of <strong>Steam</strong> Quality according to EN 285<br />
<strong>Pharmatec</strong> GmbH<br />
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4<br />
<strong>Pharmatec</strong> GmbH<br />
Classification<br />
� Plant <strong>Steam</strong><br />
<strong>Pharmatec</strong> GmbH<br />
� Utility <strong>Steam</strong><br />
� Process <strong>Steam</strong><br />
� Pharmaceutical <strong>Steam</strong><br />
� Industrial <strong>Steam</strong><br />
� Clean <strong>Steam</strong><br />
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� Technical <strong>Steam</strong><br />
� <strong>Pure</strong> <strong>Steam</strong>
5<br />
<strong>Pharmatec</strong> GmbH<br />
Classification<br />
� Plant Plant <strong>Steam</strong>:<br />
<strong>Steam</strong>:<br />
Plant <strong>Steam</strong> is steam used for heating systems and not not be in contact with sterile<br />
goods<br />
� Process Process <strong>Steam</strong>:<br />
<strong>Steam</strong>:<br />
Process <strong>Steam</strong> is steam produced from pre-treated water, which contains no no parts<br />
from corrosion-inhibitors and anti-scaling-additives<br />
Process steam is steam with small soiling, suitable for direct effect on sterilizer<br />
goods like group I according DIN 58950<br />
� <strong>Pure</strong> <strong>Pure</strong> <strong>Steam</strong> <strong>Steam</strong> (Clean (Clean <strong>Steam</strong>):<br />
<strong>Steam</strong>):<br />
Pyrogen free dry, saturated <strong>Steam</strong> that is generally produced by a <strong>Pure</strong> <strong>Steam</strong><br />
Generator and which when condensed shall meet the requirements of WFI<br />
<strong>Pure</strong> steam is steam with small soiling, suitable for direct effect on sterilizer goods<br />
like group II according DIN 58950<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
6<br />
<strong>Pharmatec</strong> GmbH<br />
Characteristic of Quality / Differences of Quality<br />
Quality of <strong>Steam</strong><br />
Chemical Chemical requirements<br />
requirements<br />
pH-value<br />
Conductivity<br />
Non-condensable gases<br />
Chemical Chemical requirements<br />
requirements<br />
Temperature, pressure<br />
Moisture<br />
Superheat<br />
Biological Biological requirements<br />
requirements<br />
Bacterial endotoxins<br />
<strong>Pharmatec</strong> GmbH<br />
Plant <strong>Steam</strong><br />
Only Only Only examples examples from from<br />
from<br />
important important values<br />
values<br />
no declaration<br />
no declaration<br />
no declaration<br />
Only Only examples examples from<br />
from<br />
important important values<br />
values<br />
correlation with dry<br />
saturated steam<br />
< 10%<br />
< 10°C<br />
Only Only examples examples from<br />
from<br />
important important values<br />
values<br />
no test<br />
Process <strong>Steam</strong><br />
max. 10 µS/cm<br />
7<br />
<strong>Pharmatec</strong> GmbH<br />
Characteristic of Quality / Differences of Quality<br />
According DIN 58950-7<br />
sterilizer goods group<br />
Examples for sterilized goods<br />
Quality of steam<br />
<strong>Pharmatec</strong> GmbH<br />
Clothes and textiles in<br />
general, sterile<br />
equipment and material<br />
for Labs, material not in<br />
contact with product in<br />
sterile areas, parenteral<br />
solutions in closed<br />
containers, ophthalmic<br />
Process steam<br />
<strong>Pure</strong> steam<br />
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disposal such as copying and passing on to third parties.<br />
I<br />
II<br />
Clean room clothes,<br />
Primary packing material for<br />
parenteral and ophthalmic,<br />
solutions for aseptic<br />
produced pharmaceuticals<br />
in open containers,<br />
Equipment-parts,<br />
instruments, containers and<br />
material in sterile rooms
8<br />
<strong>Pharmatec</strong> GmbH<br />
Standards and Guidelines for <strong>Steam</strong><br />
� Where Where we we we can can find find important important Definitions:<br />
Definitions:<br />
DIN 58950 (2003) Sterilization – <strong>Steam</strong> sterilizers for pharmaceutical products<br />
Part 7: Requirements on services and installation<br />
DIN EN 13824 (2005) Sterilization of medical devices – Aseptic processing of<br />
liquid medical devices – Requirements<br />
ISPE Water <strong>Steam</strong> Guide<br />
DIN EN 285 (2006) Sterilization – <strong>Steam</strong> Sterilizers – Large Sterilizers<br />
HTM 2010 Sterilization – <strong>Steam</strong> Sterilizers – Large Sterilizers<br />
USP 29-NF24 Supplement No.1 (2006)<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
9<br />
<strong>Pharmatec</strong> GmbH<br />
Standards and Guidelines for <strong>Steam</strong><br />
� In In European European Standard Standard EN EN 285 285 (and (and HTM HTM 2010) 2010) we we can can read: read: read:<br />
“The sterilizer shall be designed to operate with dry saturated steam containing<br />
not more than 3,5 % V/V non-condensable gases …”<br />
� What What is is the the difference difference between between EN EN 285 285 and and HTM HTM 2010?<br />
2010?<br />
HTM 2010 is a UK National Health Document.<br />
It has been created awaiting EN 285.<br />
EN 285 is based upon HTM 2010 and is the European standard for sterilization<br />
and steam sterilizers, it describes the steam quality tests and is regarded as the<br />
definitive reference.<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
Standards and Guidelines for <strong>Steam</strong><br />
� <strong>Pure</strong> <strong>Steam</strong> <strong>Steam</strong> Monograph Monograph (USP (USP (USP 29, 29, valid valid since since since 01.04.2006)<br />
01.04.2006)<br />
<strong>Pure</strong> <strong>Steam</strong> is water that has been heated above 100 degrees Celsius and<br />
vaporized in a manner that prevents source water entrainment.<br />
It is prepared from water complying with the U.S. EPA NDWWR, or with drinking<br />
water regulations of the EU, Japan or with WHO drinking water guidelines.<br />
It contains no added substance.<br />
The level of steam saturation or dryness, and the amount of non-condensable<br />
gases are to be determined by the <strong>Pure</strong> <strong>Steam</strong> application.<br />
[Note: <strong>Pure</strong> <strong>Steam</strong> is intended for use where the steam or its condensate comes in<br />
contact with the article or the preparation. <strong>Pure</strong> <strong>Steam</strong> quality is difficult to asses in<br />
its vapour form; therefore its condensate is used to test its quality. The process<br />
used to collect the condensate for analysis must not adversely impact these<br />
quality attributes.]<br />
Bacterial endotoxins: (85): The condensate contains less than 0.25 EU/ml.<br />
Total organic carbon (643): The condensate meets the requirement.<br />
Water conductivity (645): The condensate meets the requirement.<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
Typical Applications<br />
Kind of <strong>Steam</strong><br />
Plant <strong>Steam</strong><br />
Process <strong>Steam</strong><br />
<strong>Pure</strong> <strong>Steam</strong><br />
<strong>Pharmatec</strong> GmbH<br />
Examples for application<br />
Heat up from liquids,<br />
Warm Water Generation,<br />
<strong>Pure</strong> <strong>Steam</strong> Generation,<br />
WFI-Generation with<br />
WFI-stills<br />
SIP, air-humidifying in<br />
clean rooms, Sterilization<br />
from CIP-equipment,<br />
Sterilization from aseptic<br />
equipment, pipes,<br />
storage tanks<br />
Sterilization of product,<br />
SIP from process tanks,<br />
air-humidifying in „critical<br />
clean rooms“<br />
Branch of Industry<br />
Food Industry, Pharmaceutical<br />
Industry, Biotechnology, Hospitals<br />
Food Industry, Pharmaceutical<br />
Industry, Biotechnology, Hospitals<br />
Pharmaceutical Industry,<br />
Biotechnology<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
Package Unit <strong>Pure</strong> <strong>Steam</strong> Generator<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
Package Unit <strong>Pure</strong> <strong>Steam</strong> Generator<br />
� WFI WFI / / / <strong>Pure</strong> <strong>Pure</strong> <strong>Steam</strong><br />
<strong>Steam</strong><br />
Germs: 10 cfu / 100 ml<br />
Endotoxins: < 0.25 EU / ml<br />
� USP USP 30<br />
30<br />
TOC 0.5 mg / l as total<br />
Conductivity<br />
Conductivity Conductivity<br />
1.1 1.1 µS/cm µS/cm at at 20°C 20°C<br />
20°C<br />
� Ph. Ph. Eur Eur. Eur<br />
. Status Status 2000<br />
2000<br />
TOC 0.5 mg / l limited for a number of substances<br />
Conduct Conductivity<br />
Conduct ivity 1.1 1.1 µS/cm µS/cm at at 20 20 ° ° C<br />
C<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
� Falling Falling Film Film Heat Heat Heat Exchanger Exchanger Exchanger / / Thin Thin Film Film Heat Heat Exchanger<br />
Exchanger<br />
<strong>Pharmatec</strong> GmbH<br />
G A S S E P A R A T O R<br />
D O U B L E<br />
T U B E S H E E T<br />
F E E D W A T E R<br />
IN L E T<br />
F E E D W A T E R<br />
C IR C U L A T IO N<br />
G A S O U T L E T<br />
B L O W D O W N<br />
O U T L E T<br />
P L A N T S T E A M<br />
IN L E T<br />
E V A P O R A T O R<br />
C O N D E N S A T E<br />
O U T L E T<br />
P U R E S T E A M<br />
O U T L E T<br />
C Y L IN D R IC A L<br />
S P A C E<br />
R IS E R S P A C E<br />
O B S E R V A T IO N<br />
G L A S S<br />
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disposal such as copying and passing on to third parties.<br />
S P IR A L
<strong>Pharmatec</strong> GmbH<br />
� External External Heat Heat Exchanger<br />
Exchanger<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
� Integrated Integrated Integrated Natural Natural Circulation Circulation Heat Heat Exchanger<br />
Exchanger<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
� Function Function of of the the the column<br />
column<br />
<strong>Pharmatec</strong> GmbH<br />
Industrial Industrial steam<br />
steam<br />
condensate<br />
condensate<br />
<strong>Pure</strong> <strong>Pure</strong> steam steam<br />
steam<br />
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disposal such as copying and passing on to third parties.<br />
automatic water<br />
circulation
<strong>Pharmatec</strong> GmbH<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
Package Unit <strong>Pure</strong> <strong>Steam</strong> Generator with<br />
Degassing System<br />
� Non Non-condensable Non condensable condensable gases gases (inert (inert gases):<br />
gases):<br />
Mainly NH 3 (Ammonia), CO2 , N 2 , O 2 and halogenated Hydrocarbons<br />
Why we have to test non-condensable gases?<br />
EN 285: The steam quality test, non-condensable gases, is used to demonstrate<br />
that the level of non-condensable gases contained in the steam will not prevent<br />
the attainment of sterilization conditions in any part of the sterilizer load.<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
Package Unit <strong>Pure</strong> <strong>Steam</strong> Generator with<br />
Membrane Degassing System<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
Package Unit <strong>Pure</strong> <strong>Steam</strong> Generator with<br />
Membrane Degassing System<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
Membrane Degassing System<br />
www.liqui-cel.com<br />
12<br />
<strong>Pharmatec</strong> GmbH<br />
Operating Modes<br />
By changing the partial pressure of the gas we can either remove<br />
from or dissolve gas into water.<br />
� Low er the partial pressure, the gas w ill be removed from the w ater<br />
� Increase the partial pressure, the gas w ill dissolve into the water<br />
P56 UPW 2002.Rev-3 (8-02)<br />
Sw eep Gas Mode<br />
W ater<br />
Outlet<br />
W ater<br />
Inlet<br />
Strip<br />
Gas<br />
Vacuum M ode Combo M ode<br />
W ater<br />
Outlet<br />
W ater<br />
Inlet<br />
To<br />
Vacuum<br />
Pump<br />
W ater<br />
Outlet<br />
W ater<br />
Inlet<br />
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disposal such as copying and passing on to third parties.<br />
Strip<br />
Gas<br />
To<br />
Vacuum
<strong>Pharmatec</strong> GmbH<br />
Membrane Degassing System<br />
www.liqui-cel.com<br />
<strong>Pharmatec</strong> GmbH<br />
7<br />
Extra-Flow Mem brane Contactor<br />
P56 UPW 2 002.Rev-3 (8-02)<br />
• Patented Design<br />
• FD A Com pliant<br />
(With Appropriate O-Rings)<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
Package Unit <strong>Pure</strong> <strong>Steam</strong> Generator with Thermic<br />
Degassing System<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
Package Unit <strong>Pure</strong> <strong>Steam</strong> Generator with Thermic<br />
Degassing System<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
Package Unit <strong>Pure</strong> <strong>Steam</strong> Generator with Thermic<br />
Degassing System<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
Package Unit <strong>Pure</strong> <strong>Steam</strong> Generator with Thermic<br />
Degassing System<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
Different Types of <strong>Pure</strong> <strong>Steam</strong> Generators<br />
<strong>Pharmatec</strong> GmbH<br />
Type<br />
pure steam<br />
pressure<br />
[barg]<br />
PSG 50 E 2 50<br />
PSG 100 E 2 100<br />
PSG 200 E 2 200<br />
Quantity of pure steam (kg/h) at<br />
heating steam pressure<br />
4 bar g 6 bar g 8 bar g<br />
PSG 200 2 45 80 105<br />
3 - 50 80<br />
PSG 300 2 190 325 410<br />
3 - 220 330<br />
PSG 400 2 375 650 730<br />
3 - 440 660<br />
PSG 500 2 480 855 1120<br />
3 170 600 890<br />
PSG 600 2 690 1230 1605<br />
3 240 860 1280<br />
PSG 650 2 1130 2000 2905<br />
3 400 1405 2085<br />
PSG 700 2 1650 2650 3800<br />
3 505 2000 3250<br />
PSG 800 2 2110 3770 4940<br />
3 740 2630 3930<br />
PSG 1000 2 2630 4735<br />
3 915 3290 4950<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
Measurement of non-condensable gases<br />
according to EN 285<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
Measurement of non-condensable gases<br />
according to EN 285<br />
<strong>Pharmatec</strong> GmbH<br />
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disposal such as copying and passing on to third parties.
<strong>Pharmatec</strong> GmbH<br />
Measurement <strong>Steam</strong> Quality according to EN 285<br />
Measurement of Non-Condensable Gases<br />
Measurement of <strong>Steam</strong> Dryness Value<br />
Measurement of Superheat<br />
<strong>Pharmatec</strong> GmbH<br />
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