PSG and CSG

Pure Steam and Clean Steam Generators

 Pure Steam and Clean
Steam Generators
from Spirax UltraPURE

Your perfect partner for high purity systems

The design of high purity steam and water systems can
be a complex and highly involved discipline. To ensure
your system is designed to current good manufacturing
practice (cGMP), you need a partner who understands
your application and can support you through the life of
your clean utility project.

With over 100 years experience of system design,

a global network of dedicated technical specialists, and
the broadest range of equipment in the industry,
Spirax UltraPURE is able to fully support you during
your system design and satisfy your equipment needs.
Spirax UltraPURE is your perfect partner.

Documentation and validation

As part of a comprehensive, ASME audited, quality
programme, each Spirax UltraPURE system is
supplied with a detailed operation and maintenance
manual, documenting all aspects of the materials,
manufacturing procedures and testing

Factory Acceptance Testing (FAT)

Each system is subjected to a full wet / hot factory
acceptance test, without exception. This includes
checks of all alarms and interlocks as well as
functional checks of the equipment to demonstrate
performance.

IQ and OQ
As the pharmaceutical industry has evolved, so has
our approach to validation. Where required, Spirax
UltraPURE is qualied to offer complete Installation
Qualication (IQ) and Operational Qualication (OQ)
providing documented evidence that the supplied
system is built and commissioned in accordance
with the your specication as well as FDA and cGMP
standards.

Validation packages are prepared parallel to the

manufacture of the system and are available for review
during the factory acceptance test. Spirax UltraPURE
technicians can also perform these procedures at the
time of start-up and commissioning.

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Overview
Type PSG CSG - Demister CSG

Will produce pyrogen free

pure steam compliant
to the latest versions of
Steam purity 1
International Pharmacopeia
grade water for injection
(WFI) 1
Will produce clean steam
Will produce steam that is
compliant to International
chemically free and with
Pharmacopeia grade
purity dependent on the
puried water standards
purity of feedwater.
(PW) 1

Dryness 99.8% Dryness 99.8%

Non-condensable gases Non-condensable gases
Steam quality compliant to EN 285 and compliant to EN 285 and Dryness typically 95%
HTM 2031 with optional HTM 2031 with optional
degasication unit. degasication unit.

Biopharm - Sterile Biopharm Sterile

applications where applications where Food processing, hospitals,
endotoxin levels are an endotoxin levels are not a Biopharm, and general
Key industries and area of concern. concern. building humidication
applications Electronics Hospital Autoclave - Applications where boiler
Humidication applications applications where EN 285 feedwater chemicals
where low conductivity is and HTM 2031 are to be cannot be tolerated.
required. observed.

Designed in compliance Designed in accordance Designed in accordance

Sanitary design with cGMP, ISPE baseline with industry Good with industry Good
guide and ASME BPE. Manufacturing Practice. Manufacturing Practice.

Internal surface nish 25 microinch Ra. Standard mill nish. Standard mill nish.

Rising lm evaporator,
Reboiler, designed to ASME Reboiler, designed to ASME
Mechanical design designed to ASME code
code and U stamped. code and U stamped.
and U stamped.

Capacity 2 50 6 000 kg/h 50 2 500 kg/h 2 50 2 500 kg/h 2

PID control PLC touch PID control PLC touch PID control PLC touch
Automation
screen interface. screen interface. screen interface.

Wetted materials 316L stainless steel. 316L stainless steel. 316L stainless steel.

Notes :
1. Dependent on supplied feedwater please see relevant Technical Information ( TI ) sheets.
2. Based on 3 bar g (45 psi g) pure / clean steam and 6 bar g (90 psi g) plant steam.

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 Pure Steam
Generator (PSG)
from Spirax UltraPURE

About the pure steam generator (PSG)

The Spirax UltraPure PSG incorporates a unique 3-phase
separation method to produce pyrogen free, pure steam,
compliant to the latest versions of International Pharmacopeia
grade water for injection (WFI).

Each unit is designed and manufactured in accordance with latest

cGMP, following the criteria set out in the ISPE Baseline Guide for
Water and Steam Systems and the current edition of ASME BPE.

All units utilise state-of-the-art control packages compliant

to GAMP 4 that can be linked in to your building management
system (BMS) or 21 CFR Part 11 data storage system.

A combination of features that guarantee

absolute compliance for your critical
application:
Sterilization in place (SIP) Autoclaves
Critical humidication

Rupture disc
Pure steam

Pressure control

Demister

Level control

Plant steam

Operating principle of pure steam

generator
The Spirax Ultrapure pure steam generator
works by the rising lm external evaporator or
thermosyphone principle:

1. Feedwater is pumped through a preheater into

the separation column and circulates into the
evaporation column.
Preheater 2. Plant steam is used to boil the feedwater in the
evaporation column to produce pure steam.
Feedwater
3. The pure steam travels into the upper region of
the separation column via a number of directional
Feedwater Blowdown
pump and velocity changes and nally through a
Condensate
demister device, to remove entrained moisture.

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Key features and benets
Key features Key reasons Key benets

Unique 3-phase 1. Water droplets are removed through Providing you with the driest possible
moisture separation directional changes in ow path. pure steam and a guaranteed Log 4
(10 000 times) endotoxin reduction.
2. As steam enters the separation column
changes in velocity allow water droplets
to fall out.
3. Finally the unique demister ensures
that 99.8% of all remaining moisture
is removed.

External evaporator External evaporator enables disassembly Allows quick and simple disassembly
column of unit with no additional height required. for inspection and maintenance.

Compact / short Short tubes ensure that stress fatigue is Less susceptible to stress fatigue
evaporator column minimal, a common issue with longer tubes resulting in long trouble free life.
used in the falling lm evaporator designs.

Large volume Separation column is designed to absorb Ability to rapidly respond to sudden
separation column uctuations in system pressure and load changes in pressure and loads.
demands, while maintaining dryness.

Part of a dedicated The PSG is only part of a comprehensive Providing customers a single source
high purity product range of products developed specically option for all your high purity needs.
range from for high purity applications.
Spirax Sarco

5
 Clean Steam
Generator (CSG)
from Spirax UltraPURE

About the clean steam generator (CSG)

The Spirax UltraPure clean steam generator is designed to
create clean steam, with plant steam as the energy source.
Typical applications include those where plant steam is not
suitable for your process, due to unacceptable boiler
feedwater chemicals, scale and corrosion particles.

With the addition of a unique demister head, this product is

suitable for generating clean steam in compliance with
International Pharmacopeia grade puried water (PW) for
sterile applications where endotoxin levels are not a concern.

(For pure, endotoxin free steam please refer to Spirax

UltraPURE's range of pure steam generators type PSG).

Each CSG is manufactured from 316L stainless steel to

ensure the integrity of your system and is designed,
constructed and stamped in accordance with ASME code.

Demister

Principle of operation
1. Pre-heated clean feedwater is pumped, via the
Plant steam
optional feedpump unit, into the evaporator.

2. Plant steam boils the feedwater via the U tube

Condensate heat exchanger, to create clean steam.

3. Large surface area and disengagement area

ensures steam is 95% dry steam.

4. Clean steam passes through optional demister

Feedwater pump
head to remove further entrained moisture and
leaving 99.8% dry steam.
Blowdown

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Key features and benets
Key features Key reasons Key benets

Unique demister Ability to remove entrained moisture resulting Ability to produce steam in
head - option in dry steam with a higher purity. accordance with USP grade puried
water.

PID control The CSG range comes with full PID control State-of-the-art control package to
as standard with electronic interface. give the accurate pressure control.

Double tube With standard tube sheet design, potential Double tube sheet allows any
sheet - option failure could cause cross contamination. leakage to vent to atmosphere -
eliminating cross contamination.

Ability to provide Spirax UltraPURE can also provide Providing a single source option for
water pre-treatment pre-lters, softeners, RO and DI equipment all your water treatment needs.
equipment to feed your CSG.

Part of a dedicated The CSG is only part of a comprehensive Providing a single source option for
high purity product range of products developed specically for all your high purity needs.
range from high purity applications.
Spirax Sarco

Food and beverage processing

- Direct injection

- Steam in place

Hospitals

- Autoclave / sterilisation

- Humidication

Pharmaceutical

- Non critical humidication

- Autoclave / sterilisation (non WFI)

- Steam in place (non WFI)

General building humidication

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Some products, services or solutions may not be available in certain markets

Spirax-Sarco Limited Spirax UltraPure

Cheltenham UK
GL53 8ER
t: +44 (0)1242 521361
f: +44 (0)1242 573342
e: cleansteam@SpiraxSarco.com
www.SpiraxSarco.com/cleansteam
1050 Corporate Avenue
Unit 114
North Port, FL 34289
Phone: (941) 473-2422
Fax: (941) 473-2144
www.spiraxultrapure.com

Copyright 2007
SB-S93-01 CH Issue 1 Spirax Sarco is a registered trademark of Spirax-Sarco Limited