PHARMA & BIOTECH

MULTITRON – VAPOTRON – COMBITRON

WFI & Pure Steam Production

MULTITRON – multiple-effect distillation units

VAPOTRON – pure steam generators for the pharmaceutical industry
COMBITRON – combined pure steam and WFI production
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BWT Pharma & Biotech offers reliable and the most energy-efficient, multi-effect equipment for the production of Water for
Injection (WFI) and Pure Steam. Each system complies with the latest cGMP requirements and includes features that enable
integration into an overall system. The state-of-the-art control package complies with GAMP requirements (optional) and
can be operated intuitively via a touch-screen panel. Each system is fully equipped to be able to be hooked up to an overall
building management or 21 CFR Part 11 data storage system.

MULTITRON – Multi-Effect Distillation Units

WFI from the pharmaceutical water specialist
MULTITRON is a uniquely designed, multi-effect distillation
unit with a superior energy efficiency and an extremely
reliable WFI water quality. You are guaranteed the best
technologies in multiple-effect distillation, an energy-saving
design with from 1 to 8 columns, plus years of experience
and specialist know-how.

BWT Pharma & Biotech has designed a unique double-

tube-sheet evaporator, which is integrated into each of
the columns without any fixed points. The entire heat ex-
changer is submerged below the preheated feed water,
thus eliminating the risk of scaling or rouging, and uses all
the energy that is fed into the shell side of the evaporator.

Economic and efficient

Latest control techniques, coupled with proven BWT engi-
neering, provides decisive advantages:

   Maximum efficiency through optimised cGMP-compliant

design
   Total reliability through proven distillation technique
   Lowest consumption of heating steam and cooling water
guaranteed
   High-quality manufacture via orbital welding and smooth
surface polishing
   Optimum operational reliability and easy operation
using PLC control with touch-screen operator interface
   Plant steam, hot water or electrically heated systems
available
   Performance can be set between 20 and 100 % as an
The MULTITRON distillation units meet all special pharma­ option for optimised energy-efficient operation
copoeia specifications, such as European and the USP
regulations.
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High standards with optional features

MULTITRON distillation units consist of 1 to 8 columns. Continuous monitoring and documentation of the distillate via the
control system guarantees automatic rejection of, for example, distillate with excessively high conductivity or an unaccep-
table temperature.

MULTITRON distillation units are characterised by customer-

oriented performance features:
   Compact design. All parts mounted in a stainless steel    Standard control components
frame    Standard fittings, metering and control engineering
   No moving parts, hence minimal maintenance    User-friendly control panel with easy-to-read display
   All parts in acid-resistant stainless steel and continuous indication of the process status. Stan-
   Feed water pump and feed water pre-heater integrated dard in all BWT units and skid-mounted systems
in the frame
   Low steam velocity All parts in contact with the product are made of high-quality
stainless steel (AISI 316 L) 1.4404/1.4435 and all joints
   Pure steam can be taken from the first column either
have an aseptic TC connection. Calculation, design and
when producing WFI or independently (COMBITRON
production of the pressure vessels are based on PED manu­
version)
facturing and inspection guidelines of PED or ASME rules.
   Unique three-phase droplet separation system
   Optional automatic sterilisation available
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VAPOTRON – for Efficient Pure Steam Production

BWT Pharma & Biotech offers both separate pure steam gen-
erators (VAPOTRON) for the production of sterile, pyrogen-
free steam and combined systems (COMBITRON) for pure
steam and WFI in a single unit.

VAPOTRON meets the strict requirements for dry, pyrogen-

free pure steam for the following applications:
   Equipment Sterilisation-in-Place (SIP)
   Sterilisation of piping systems
   Operational heating source for GMP sterilisers
   Sealing of GMP gaskets, such as Biotech fermenters
   Air humidification of clean rooms

To meet these needs, BWT Pharma & Biotech offers the

fully cGMP-compliant VAPOTRON pure steam generators.
For pure steam requirements complying with EN 285 for
sterilisation in an autoclave, the plants can be equipped
with a degasifyer mounted in the same skid.

Higher capacity – fully automatic

The basic principle of a VAPOTRON pure steam generator
is the same as the first column of a multiple-effect distillation
unit. It uses identical technology to provide the best pos-
sible level of production efficiency and the most reliable
pure steam pressure to feed into the pure steam network.
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COMBITRON – The Perfect Combination

A combined pure steam and distillation unit simplifies the
provision of ultrapure media: pure steam and Water for
Injection (WFI) can be generated with COMBITRON in a
single instead of two units. This is made possible by the
use of a specially designed first column that has a bigger
diameter and uses the natural circulation principle.

The media can be produced simultaneously or separately

with an output of about 1,000 kg of pure steam and up
to 4,000 litres of WFI per hour. The ratio of pure steam
to WFI can be adjusted in the range 2:1 to 1:4 to match
individual project requirements. Customer-specific versions
with higher outputs and with individual configurations are
available.

Reduced investment costs – smaller footprint

Since the COMBITRON produces two ultrapure media
from a single unit, the investment costs for the system and
its periphery are reduced by up to 30 per cent, and the
combined unit requires considerably less space than two
separate units.
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The Right Solution for Every Need

User-friendly and Individually Programmable

MULTITRON distillation units, VAPOTRON pure steam gen- Quality control is then performed at every stage of the project
erators and COMBITRON skids, equipped with a Siemens
   Design review
or similar control, can be individually programmed for spe-
cific requirements. An additional touch-screen panel ena-    Inspection of incoming goods
bles simultaneous operation and process monitoring of the    Software review
whole distillation unit. Production and process data can be
   Pre-inspections of control cabinet
scanned, documented and updated at any time.
   Manufacturing inspections as per ISO 9001
As recommended by the FDA, fully automatic production of procedures
the distillate guarantees rejection of the first product after    Factory Acceptance Testing (FAT)
restart-up.
   Site Acceptance Testing (SAT)

Validation, quality control and documentation

At the beginning of each project a Quality & Project Plan is
created to show the quality control elements, together with
scope, responsibilities etc. It is given to the customer for
approval. This process ensures that the project will run
smoothly.

MULTITRON, VAPOTRON and COMBITRON are validated

in compliance with FDA, cGMP, GAMP, USP and Ph. Eur.
requirements. BWT Pharma & Biotech also follows the ISPE
Engineering Baselines for Water and Steam Systems,
and Commissioning and Qualification. The systems are
CE-marked according to the relevant directives, such as
PED, EMC, LV and the Machinery Directive.

The validation engineers remain with each project through

all steps of the V-model, starting with the URS and ending
with FAT/SAT prior to handing the unit over.

Our skid-mounted distillation units and pure steam

generators leave the manufacturing site after a successfully
executed FAT with test-run checking capacities. The units can
be commissioned quickly and easily and are finally vali-
dated on site to start producing WFI and/or pure steam.
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Highest Level of Reliability

BWT Heat Exchanger Designs – technical advantages that have proved themselves time
and time again

Stress-free heat exchangers Drainability

The heat exchangers are immersed completely in feed ­water BWT´s design allows full drainability of each column and
and the heating steam, that is at a constant temperature all heat exchangers.
through the entire column, allows free and uniform expansion
heat exchanger tubes and of the outer jacket. The advantage Large expansion area for the steam
of this is minimal stress within the heat exchanger and weld-
Half the column height is available for expansion of the
ings. The risk of corrosion is also reduced to a minimum,
steam and for droplets to form in the upper column area.
considerably extending the life of the product. Optimal pro-
cess engineering ensures that vibrations and thermal stress
for heat exchangers and installed equipment are avoided. FDA-approved double-plate tubular heat exchangers with
seamless tubes
Thorough testing The double-plate tubular heat exchangers are supplied with
   Dye penetration testing of tube/tube end plate welds seamless tubes. The FDA recommends their use where a less
pure medium is available at a higher pressure than the purer
   Hydrostatic testing and final inspection in compliance
medium. For example, the first column, condenser, cooler
with PED
and pre-heater in our distillation units.
   Radiography of the main welds in compliance with
German regulations The heat exchanger tubes are then rolled into the inner
tube plate and welded into the outer tube plate. Our heat
Reduced risk of scaling exchanger­design is characterised by longer service intervals
and fewer spare parts (no gaskets), considerably extending
Scaling is kept to an ideal minimum, particularly in
the life of the equipment.
the case of feed water containing silicates, as the heat
exchangers are immersed completely in feed water and
the tubes are always wet.

BWT Pharma & Biotech – Your Partner for Sterile Technologies

Skilled employees
All BWT Pharma & Biotech systems are manufactured by
highly qualified fitters and welders. Development, production
and pressure tests take place in accordance with the strictest
regulations and under official supervision. Before being
commissioned the plants are fully tested and pre-validated
during the FAT (Factory Acceptance Test). This means that all
BWT Pharma & Biotech employees comply with ISO 9001
and 14001 and guarantee the highest quality for our cus-
tomers. Every BWT system is delivered with a declaration of
conformity and the CE mark.
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BWT – the Company
Best Water Technology Group (BWT) is Europe’s leading water These innovations, among others, include: SEPTRON ®, the
technology company. Our water partner network comprises world’s first electrodeionisation module (EDI) with spiral wrap;
the group’s 3,300 employees and thousands of plumbers, manganese oxide activation (MDA) – a method for effective
planners, architects and hygiene experts. Our Research & manganese removal; AQA total bipolar technology for
Development teams, using state-of-the-art methods, work on chemical-free limescale protection; SANISAL – the world’s first
new processes and materials to create products that are both regeneration salt for softening water systems, which also works
ecological and economical. Looking ahead, a key develop- as a disinfectant; and the new, revolutionary Mg2+ technology
ment issue is a reduction in the products’ use of operating that improves the taste of filtered water, coffee and
resources and energy consumption and the tea. Through its unique, high efficiency
resulting minimisation of CO2 emissions. membranes for fuel cells and batteries,
BWT is creating a cleaner, more
Whether at the place where the sustainable energy supply for the
water pipe enters the building 21st century.
(‘point of entry’) or at the tap-
ping point (‘point of use’),
BWT’s trend-setting ‘Made in
Europe’ products have proved
their quality millions of times BWT – For You and Planet Blue
over in the treatment of: signifies that our mission is to take
drinking water, mineral water ecological, economical and s
and ultrapure water for the ocial responsibility, to provide
pharmaceutical industry; water for our customers and partners with
swimming pools; heating and pro- the best products, systems, techno-
cess water; boiler and cooling wa- logies and services in all areas of
ter; and water for air-conditioning. water treatment and, at the same
BWT’s wide-ranging innovations guaran- time, to make a valuable contribution to
tee maximum safety, hygiene and health in the preserving the global resources of our
daily use of water – that precious elixir of life. blue planet.

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