Christ Aqua Pharma & Biotech
Turnkey solutions for the pharmaceutical & biotech industry
2 | Christ Aqua • Turnkey solutions for the pharmaceutical & biotech industry
Water – our elixir of life
The UN estimates that by 2050 the current world population will climb from roughly 6.6 billion to 9.2 billion. Yet average
water consumption, currently 625 m2 per year, is growing on a per capita basis, meaning that the water consumption will rise
disproportionately. More than a billion humans lack clean drinking water worldwide. In 25 years as many as 6 billion humans
will suffer from unsafe water supplies.
The demand for improved water quality has been a fundamental need since time immemorial and is also a precondition for
optimal results in various aspects of work and life. The technological and legal requirements for optimal water treatment are
The BWT – Best Water Technology Group was formed in 1990 and today is Europe’s leading water technology company. The
goal of our 2,500 employees in 70 subsidiaries and associates is to provide private, industrial, business, hotel, hospital and
municipality customers with innovative, ecological and efﬁcient technologies that deliver a maximum safety, hygiene and health
in their daily contact with the elixir of life, water.
BWT – The Water Company | 3
CHRIST AQUA –
Partner for Turnkey Solutions in the Pharma & Biotech Industry
Water is the most widely used material within the Pharma & Biotech Industry. Most processes require water and other clean
media which meets legal standards deﬁned in pharmacopoeias. CHRIST AQUA provides systems of pharmaceutical water
from the feedwater supply to the point-of-use. Furthermore, we offer complete sterile manufacturing systems including
solution preparation, CIP/SIP and wastewater inactivation.
As a leading supplier to this market, Christ Aqua Pharma demands at tender stage. Evaluating the information
& Biotech has many years of experience and possesses a and providing the best solution to meet the project and
comprehensive spectrum of technologies for producing customer demands encompasses all aspects of the project from
all the grades of water required in R&D and production speciﬁcations, drawings, programme and budgets to
environments as well as handling the waste produced. conditions of contract, etc. When all this is evaluated
correctly at tender stage, experience dictates that projects
With its integration into the BWT Best Water Technology are executed harmoniously, on time and within budget. It is
Group, the newly formed division Christ Aqua Pharma & our aim to work with our customers as partners.
Biotech has access to BWT’s international R&D facilities
as well as to a comprehensive worldwide R&D partner After all we all want the same thing – a successful project,
network. constructed on time and within budget. As partners we
introduce our Key Performance Indicators which are our
Our manufacturing facilities in Europe, Asia and the joint mechanism for monitoring all aspects of the project
United States provide equipment, skid mounted systems, on a regular basis. This allows senior management of both
tanks and vessels. Christ Aqua Pharma & Biotech supplies companies to monitor and inﬂuence the success of the pro-
key components such as vessel manufacture from own ject. We continually work with our customers, ensuring that
production, orbital welding of pipework for equipment, their requirements and expectations are met in line with the
software programming and control panel manufacturing. project programme.
Furthermore, Christ Aqua is the only European supplier
of EDI modules. The unique, patented EDI spiralwound Markets and partners
module SEPTRON® is the core component of many modern Projects are carried out in partnership with pharmaceu-
water treatment systems. tical manufacturers, pharmaceutical plant designers and
other specialist leading engineering companies. Among our
Understanding Project Execution customers are AstraZeneca, Sanoﬁ-Aventis, Boehringer
To achieve a consistent level of solid Project Execution Ingelheim, Eli Lilly, Glaxo Smith Kline, Novartis, Novo
you must ﬁrst of all understand the customer and project Nordisk, Pﬁzer, Roche, Bayer-Schering and Merck-Serono.
4 | Christ Aqua • Turnkey solutions for the pharmaceutical & biotech industry
Components for turnkey systems
Validation and documentation engineers accompany each project through all steps of the V-model, starting with the URS and
ending with FAT, SAT / IQ, OQ. CHRIST AQUA can also support the customer in the PQ phase.
CHRIST AQUA turnkey services and products include Advantages of turnkey projects
æ Concept Design, Basic Design, consultancy services, æ Uniform high product quality with high-end components
case studies æ Seamless project execution without interfaces, shorter
æ Assistance for User Requirement Speciﬁcation (URS) project cycles, one communication for partners
æ Detail Design æ Single warranty for products and quality
æ PW, HPW, WFI and pure steam production æ Consistent documentation and validation package
æ Storage and distribution systems æ Lean & cost efﬁcient service and recalibration
æ Complete sterile manufacturing systems including æ Simpliﬁed spare parts storage
solution preparation, CIP/SIP and wastewater æ Easier and safer operation due to uniform HMI user inter-
inactivation face (e.g. with our LIPROCONTROL software modules)
æ Ozone and heat sanitisation for distribution systems æ Uncomplicated acceptance by authorities
æ PLC systems and SCADA (supervisory control and data
acquisition) according to 21 CFR Part 11, GAMP
æ Design, maintenance & consultancy services
æ Qualiﬁcation, validation & full documentation
packagesaccording to cGMP
Consultancy by Support by
Concept & Basic Design URS PQ
CHRIST AQUA CHRIST AQUA
Typical limit of supply
Quality & Project Plan Service Contract
System Acceptance Test
Mechanical & Electrical IQ
Hardware Design Speciﬁcation Hardware Acceptance Test
Software Design Speciﬁcation Software Integration Test
Quality Software Module
Software Module Test
System Build – Control System Programming / Code Review
BWT – The Water Company | 5
Components and Systems, including Qualiﬁcation and Validation
In the areas of pharmaceuticals, biotechnology, cosmetics and health care, and in the contributing and
accompanying processes, there are requirements for water of many different qualities, such as potable water, process
water, Aqua Puriﬁcata / Puriﬁed Water, Aqua Valde Puriﬁcata / Highly Puriﬁed Water and Aqua Ad Iniectabilia / Water
Knowledge of customer requirements and expectations; Research and development, future-oriented thought proces-
understanding of legal requirements such as USP, EP and ses and the ﬂexibility and innovative power of the staff
JP; appreciation of the demands of inspection authorities ensure that CHRIST AQUA can meet the continually incre-
such as the FDA and various local authorities; compliance asing demands with respect to the latest quality standards
with GMP standards and familiarity with state-of-the-art while complying with responsibility for sustainable actions
processes and technologies all combine to characterize and for protecting the environment.
CHRIST AQUA as a competent specialist supplier and
partner for turnkey process water systems. CHRIST AQUA is thus certiﬁed in accordance with ISO
The worldwide presence of CHRIST AQUA and our growth 9001.
in these markets demonstrate competence and reﬂect long-
term satisfaction of our customers.
Processes and products
æ Single- and double-stage reverse osmosis systems
æ Electrodeionisation with patented SEPTRON® spiral
æ Ultraﬁltration systems ULTRASTIL TW for pre-treatment
of raw water
æ Ultraﬁltration systems ULTRASTIL for depyrogenation of
pure and ultrapure water
æ Compact water treatment systems OSMOTRON®
æ Distillation systems MULTITRON
æ Pure steam generators VAPOTRON
æ Combined distillation and pure steam generation
æ UV systems BEWADES for disinfection, TOC reduction
and destruction of ozone
æ Electrolytic ozone generation systems STERITRON
æ Storage and distribution systems LOOPO for ultrapure
media, made of stainless steel or PVDF
æ LIPROLINE CIP/SIP and solution preparation systems
æ LIPROLINE wastewater decontamination systems
æ LIPROCONTROL process and point-of-use management
æ AQU@VIEW data archiving & remote control software
6 | Christ Aqua • Turnkey solutions for the pharmaceutical & biotech industry
Products, Processes and Brands
PW HPW 1
ULTRASTIL 2 3 5
Ultraﬁltration depyrogenation Compact water treatment systems
systems OSMOTRON® is the world‘s most
ULTRASTIL post-treatment systems popular skid-mounted water treat-
are used for HPW production e.g. ment system for production of PW
4 with existing ion-exchanger systems and HPW. The new PRO version
HPW/PW æ Lower operation costs & invest- focuses on ergonomics and energy
distribution ment than for distillation units efﬁciency.
æ Safe operation guaranteed
æ Integrity test applicable
Pure steam WFI
Pure steam WFI
Pure steam generators Combined pure steam
8 VAPOTRON pure steam generators generation / distillation
are available from 50 to 5.000 COMBITRON reduces investment
kg/h. An integrated degassing costs and footprint by up to 30 %
stage allows for compliance with in comparison with individual WFI
NCG applications. and PSG systems.
BWT – The Water Company | 7
2 3 5
SEPTRON 4 6
Patented spiral-wound Storage and distribution systems Distillation systems
EDI modules for cold and hot media MULTITRON distillation systems
SEPTRON® is the only EDI module LOOPO skids contain all compo- are available for capacities from
manufactured in Europe and is a nents which are necessary for the 100 to 17.000 l/h. Highest ener-
product of genuine Swiss quality. distribution of PW, HPW and WFI. gy efﬁciency can be achieved with
Each module is tested in the fac- Ozone and hot water versions are output control ranging from 10 to
tory and delivered with a factory available. 100 %.
and test certiﬁcate.
CIP / SIP and solution Electrolytic ozone generation Single- and double-stage
preparation systems systems reverse osmosis systems
LIPROLINE process solutions meet a STERITRON produces ozone from OSMOSTIL units are available for
wide range of pharmaceutical high-purity water and guarantees pre-treatment, post-treatment and
applications such as WIP/CIP and automatic and cost-effective PW/HPW applications. OSMO-
SIP as well as solution preparation microbiological protection of the STIL can either be sanitized with
systems, storage tanks and process distribution loop. hot water or with chemical agents.
8 | Christ Aqua • Turnkey solutions for the pharmaceutical industry
Comprehensive Services for Successful Projects
International experience and practically-oriented construction of
standard and customer-speciﬁc systems form the basis for good
Staff members who are familiar with the latest regulations and
directives of all applicable authorities ensure that the current FDA
and GMP requirements are implemented.
Planning and dimensioning
The spectrum of available services includes mass balance consi-
derations with the aid of the most modern tools, pressure drop
calculations in distribution systems, 3D design, P+I diagrams with
the generation of the corresponding parts lists, on-site inspection
of the planned site and the inclusion of speciﬁc requirements.
CHRIST AQUA also has novel approaches to reducing the quan-
tity of water wasted from a system and the power consumpti-
on, thus increasing the economy of clean media generation and
Validation and documentation
In the beginning of a project a Quality & Project Plan is set up
to show the Quality Control in the project, together with scope,
responsibilities, communication routes, submittals etc. This docu-
ment is given to the customer for approval.
The water treatment systems are validated according to FDA,
cGMP, GAMP, USP and Ph. Eur. requirements. CHRIST AQUA
also follows the ISPE Engineering Baselines for Water and Steam
Systems, and Commissioning and Qualiﬁcation. The systems are
Skid-mounted systems leave the factory after a successfully exe-
cuted FAT in order to shorten commissioning and validation on
site. The FAT is carried out together with the customer under real
conditions. For turnkey projects, the required equipment skids are
installed as a complete system. Commissioning and qualiﬁcation
are then performed before the ﬁnal handover to the customer.
BWT – The Water Company | 9
The critical area of automation is handled using only in-house
resources. Unlike many suppliers CHRIST AQUA employs own
specialist departments for the design and construction of the
control cabinets and for the development and programming of
software. Pre-validated software modules are used for fail-safe
operation in accordance with GAMP guidelines.
HMI visualisation with modern touch-screen panels at the unit
level, process visualisation via networked PLC structures and PC
visualisation of the entire turnkey project are implemented on a
wide range of platforms. Where customised software is required
the end-users control personnel can work directly with CHRIST
AQUA personnel to prepare this software on a project speciﬁc
Assembly and full production facilities
All CHRIST AQUA factories use the latest technology for the pro-
duction of the systems.
Most of the water treatment systems are manufactured with the
aid of orbital welding machines (for stainless steel (316 L) appli-
cations) and BCF machines (for PVDF applications), if necessary
under cleanroom conditions.
The ﬁnal assembly of the systems in the factory, including com-
missioning and the FAT (carried out together with the customer)
results in pre-qualiﬁed complete systems.
IQ, OQ, SAT and training
After erection of the systems the IQ (Installation Qualiﬁcation) is
verifying the installation, the OQ (Operational Qualiﬁcation) the
correct functionality. After completion of IQ/OQ the SAT (Site
Acceptance) is carried out together with the customer.
Training of the operating personnel in the individual system func-
tions and more complex applications makes it easier to handle
the system and to ensure reliable and trouble-free operation.
10 | Christ Aqua • Turnkey solutions for the pharmaceutical & biotech industry
Scope of Services
By the integration of all process steps, CHRIST AQUA offers its customers a complete concept extending from project identi-
ﬁcation, validation and production up to commissioning and start-up, training, customer services and operation of plants.
Services during the entire project cycle
æ Quality & Project Plan / Validation Plan æ PQ support
æ Validation strategy æ SOP preparation
æ Traceability matrix, design veriﬁcation æ Review of certiﬁcates, technical documentation,
æ Validation protocols executed tests, etc.
æ Execution of tests such as FAT, SAT æ Change control documentation
æ IQ, OQ, validation
BWT – The Water Company | 11
Customer Service Project Developement
and Operation and Financing
Validation GLOBAL Presentation
and Training SERVICE CENTER
To support our customers in maintaining highest system reliability and availability, CHRIST AQUA offers full customer
Scope of our customer services
æ Service upon request with cGMP trained staff æ Operating personnel training
æ Short, medium or long term maintenance agreements æ Plant operation and maintenance agreements
æ Calibration agreements for measuring devices (such æ Laboratory analyses
as for conducitivity, pressure, ﬂow, temperature, TOC,
æ Plant audits (plant and process optimisation)
æ Modernisation, upgrade and refurbishment services
æ Service hotline (24 hours, 365 days a year)
æ Change control documentation
æ Spare parts service
æ Validation services incl. retrospective validation
æ Plant operation supervisor agreements
æ Plant remote maintenance & control
BWT – The Water Company
The Best Water Technology Group was formed in 1990 and a building (at the “Point of Entry”) or at the tapping point (“Point
today is Europe’s leading water technology company. The goal of Use”), BWT products “made in Europe” have proven their
of our 2,500 employees in 70 subsidiaries and associates is to quality million times. With new table water ﬁlters for preparing
provide private, industrial, business, hotel, hospital and tea or coffee, ﬁlters for optimizing water for coffee machines,
municipality customers with innovative, ecological and efﬁcient water ﬁlters for baking and steam ovens and vending machines,
technologies that deliver maximum safety, hygiene and health in under-the-sink particle-ﬁlters as well as micro-ﬁlters, water
their daily contact with the elixir of life, water. dispensers, reverse osmosis and UV devices BWT also offers
compact and innovative products for end consumers for best
BWT offers state-of-the-art water treatment technologies and water quality.
services for drinking water, pharma water, process water,
heating water, boiler water, cooling water and water for air- Best technologies and permanent product development
conditioning systems as well as swimming pool water. For the materially contribute to grow the company and reputation of the
technological superiority in all areas of water treatment, the inter- market-leading regional brands BWT, Cillit, HOH, Permo and
national BWT innovation centers continuously research, Christ Aqua.
develop and optimize processes for ﬁltration, limescale
protection, softening, dosing, disinfection (UV, ozone, chlorine With unique high efﬁciency membranes for the fuel cell, the
dioxide, advanced oxidation), membrane technology energy converter of the 21st century, BWT is working for a
(microﬁltration, ultraﬁltration, nanoﬁltration, reverse osmosis) and cleaner energy supply.
special ﬁlters for the prevention of legionella.
BWT – The Water Company - is our vision to provide our
Tens of thousands of service employees, plumbers, planners, customers and partners with the best products, systems and
architects and sanitation experts constitute the BWT water technologies and services in all areas of water treatment. Water
partner network. Whether at the entrance of the water pipe into is the elixir of life and limited resource. Water is our challenge.
BWT – The Leading International Water Technology Group.
Christ Pharma & Life Science Christ Water Technology
GmbH, Germany Shanghai Co.Ltd.,P.R., China
+49 7042 910 0 +86 10 8448 3654