Innovation and Compliance - process monitoring for LIfe Sciences

1. Products Solutions Services
Global offering for the
Life Sciences industry
Innovation and compliance

2. 2 Global offering for the Life Sciences industry
Contents
3 Achieving excellence together
5 Ensure compliance and
reliable process monitoring
6 Media preparation
8 Fermentation
11 Sensor management tool Memobase Plus
12 Separation and filtration
14 Chromatography
16 Water purification
18 Water for injection, sterile steam
19 Water distribution loop
20 Buffer tanks / Storage
24 Cleaning-in-place CIP / Sterilization-in-place SIP
27 Compliant services and advanced technologies
For more information:
www.us.endress.com/life-sciences

3. 3
Doing more with less is an opportunity Regardless of
your location or the focus of your operation, you can trust
a reliable biotechnology partner with the know how and
skills to help you reduce risk and optimize operational
performance. From pilot to automated production units,
we support you daily in delivering quality on-time through
stable processes.
Simplify your projects, reduce operational costs
Standardize with the largest offering of measurement
instruments to minimize project’s complexity, maintenance
costs and plant downtime. Complexity starts when
process equipment is composed of skids from various
suppliers. Early phase standardization allows you to reduce
engineering complexity for CAPEX projects and deliver
on-time and on-budget. Spare part costs are optimized,
training efforts are limited and documentation is readily
available throughout the entire life cycle. As a result,
operational expenditure (OPEX) is minimized, availability is
increased and you get a faster return-on-investment (ROI).
Profit from the largest compliance offering Benefit
from the largest selection of instruments that meet life
sciences industry standards. GxPs requirements and design
specifications are our focus: the offering is permanently
adapted to current industry regulations such as USP,
ASME BPE (material of construction, internal and external
surface roughness, process connection design). Open
communication standards allow for seamless integration
into all relevant DCS and AMS systems.
Be right the first time with our embedded engineers
In order to manage the complexity of instrumentation and
shorten start-up time, qualified resources and expertise are
key. Experienced Endress+Hauser engineers embedded into
your project engineering team take over responsibility to
select the right product for each application.
With plant availability and reliability in focus, a
specific effort is conducted to facilitate whenever possible
inline calibration and anticipate future steps such as
documentation availability for audits.
Ease standardization through efficient project
management Once the instrumentation standard catalog
is defined, it has to be rolled out and coordinated among all
skid suppliers. This time consuming task is the responsibility
of the Endress+Hauser project manager: One contact partner
for everything, to ease standardization, to coordinate with
third parties and to report any specific issues.
Achieving excellence together
Trust a reliable partner who considers cost, quality and compliance
as binding links to market.
Achieving excellence together

4. 4 Global offering for the Life Sciences industry

5. Overview of the Endress+Hauser product range of process measuring instruments
Level Flow Liquid analysis Pressure Temperature Monitoring
Media preparation
Fermentation Yes
Separation
and Filtration
Yes
Chromatography Yes
Water purification
WFI, Sterile Steam
Water Distribution
Loop
Buffer tanks / Storage Yes
CIP/SIP DAS*
OEM filling machines
Level continuous
Level switch
Cell growth
Bubble and product detector
Conductivity
* Data
acquisition
system
5
Qualification is your top priority We supply process
measurement instruments that fully comply with the
numerous requirements, codes and standards, such as FDA,
ISPE GAMP, ASME BPE, EHEDG, etc. Where required,
we offer:
• Material certificates for the process wetted parts
• Compliance certificates to USP <88> Class VI and
• USP <87>, where applicable
• Calibration certificates
• Surface roughness finish certificates (including
mechanical polishing and electropolishing)
• SOPs for calibration and maintenance
• Completion of IQ and OQ documentation, on request
• Manufacturer’s declaration of TSE compliance
(free from animal derivatives)
For total peace of mind, we have designed training
programs according to the GxPs, thus enabling compliant
operation. Our extended range of sensors, transmitters
and data acquisition systems cover all your main processes.
The table below provides an overview of Endress+Hauser’s
offering. Find more details on the following pages.
Ensure compliance and
reliable process monitoring
Qualified and documented process measuring instruments
for easy integration into automation systems
Reliable instruments that offer easy integration
Ensure compliance and reliable process monitoring

6. T
LS
LS
F
F
F
F
pH
T
T
Y
Media preparation process map
F Flow
LS Level Switch
T Temperature
Molasses
Nutrition
Sterile steam
supply
Condensate
return
Hot DI water
Hot DI water
supply
6 Global offering for the Life Sciences industry
The different media or buffer solutions are
produced and then pre-sterilized. Since sterility
is a crucial aspect of the pharmaceutical and
biotechnological process, the microbiological
quality must be controlled and monitored
in order to avoid any contamination. The
operations have to be conducted under very strict
environmental conditions. The validation of the
process evolution is of utmost importance.
Our offering All our process measuring
instruments are designed for enduring the
process conditions and also sterilization. They
are documented according to the rules for this
part of the process which is particularly critical
regarding the contamination aspects.
Media preparation
Control critical parameters to master solution quality
De-facto standard in process analytics The innovative Memosens
systems provide the ideal solution for safety and operating comfort
in analytical measuring technology. Teamed with all common
fieldbusses, Memosens systems are open for all process control and
asset management systems.
Benefits:
• Lifetime of Memosens sensors up to 40% longer
• Fewer calibration cycles
• Reduction in process downtime as non-specialized staff
can replace the sensor
• More precise calibration in the laboratory under
reproducible conditions
• Predictive maintenance as an integrated part
of the sensor technology

7. 7
Flow measurement
Promag H electromagnetic flowmeter
• Advanced diagnostic functions e.g. variation of
conductivity, abrasion, build-up, air bubbles
• Sterilization in place
• Wide range of hygienic process connections
• EHEDG certificate for Life Sciences process applications
• Roughness up to 0.38 µm electropolished
• Specific versions for dosage applications
pH measurement
Multiparameter transmitter Liquiline CM442
• Easy to commission: Open communication standards
simplify process integration
• Simple to use: One device for all parameters
• Flexible: Upgrade the controller anytime,
up to 8 channels
• Easy maintenance: Pre-calibrated sensors with
Memosens technology
Ensure compliance and reliable process monitoring

8. WT
F
F
F
F
WT
WT
WT
DCO2
Air / CO2
Air
Foam
Level
F
F
F
F
LC
SC
SIC
O2
N2
CO2
pH
DO
P
T
Fermentation process map
DO Dissolved Oxygen
F Flow
LC Level Continuous
P Pressure
SC Speed Controller
SIC Speed Indicator
Controller
T Temperature
WT Weighting System
Off Gas
Nutrient
Antifoam
Base
Medium
Inoculum
CO2
Air / CO2
Harvest
Cell growth
N2
O2
Air
8 Global offering for the Life Sciences industry
The efficiency of the biological process highly depends on
obtaining the right conditions so that the microorganisms
can thrive and yields can be maximized – in a stable and
predictable manner. Therefore, a sophisticated concept
to collect information on what is happening in the
bioreactor needs to be installed. This concept uses suitable
measurement and control equipment.
The most important parameters are pH, dissolved oxygen,
temperature and turbidity. They have to be recorded and
controlled carefully. All our process measuring instruments
are designed to endure the process conditions and also
sterilization. They are documented according to the rules for
this part of the process which is particularly critical regarding
the contamination aspects.
Fermentation
Get the most accurate measurement information in challenging conditions

9. 9Ensure compliance and reliable process monitoring
Cell growth measurement by light absorption
Cell growth sensor OUSBT66
• Measurement of biomass and cell growth
by NIR absorption
• Hygienic design, suitable for CIP and SIP
• Easy calibration
• Easy integration into fermenters
• Determine starting point of propagation
• Regulate feed according to consumption
Transmitter and data manager
Memograph CVM40
• Max. 2 photometric sensors depending on the sensor
• Universal analog channels support combined
multiparameter measurement or recording
• Convenient: Menu-guided calibration
of photometric sensors
• Security package with person-specific access
authorization and electronic signature (FDA 21 CFR 11)
• Integrated Web server, fieldbus (PROFIBUS, Modbus)
• Common standard protocols and interfaces such as USB,
TCP/IP, OPC and Ethernet are supported

10. 10 Global offering for the Life Sciences industry
pH ISFET electrode Tophit CPS471D
• Glass-free ISFET sensor
• Same hygienic ceramic diaphragm as CLS71D
• 3-A certificate
• Memosens technology
• Calibration in laboratory possible; calibration data
stored in the sensor head
• Safe - due to unbreakable PEEK™ body
Dissolved oxygen measurement with Memosens
Dissolved oxygen sensor Oxymax H COS22D
• Hygienic design in stainless steel sensor housing
• Reproducible measurement also after sterilization cycles
• Fast polarization and response time
• Memosens technology
• Calibration possible in laboratory or in-situ
(calibration data stored in the sensor head)
• Precise and reproducible oxygen measurement
• Reliable measurement also in harsh process conditions
pH measurement with Memosens
pH electrode Ceragel CPS71D
• Hygienic design thanks to fine-porous ceramic diaphragm
• Upside down mounting possible
• EHEDG certificate for in-place cleanability,
in-place steam sterilizability and bacteria restriction
• Memosens technology
• Calibration in laboratory possible; calibration data
stored in the sensor head
• Operation with the state-of-the-art transmitter
Liquiline CM42 with all advantages of the
Memosens technology including logbooks
• Easy to clean
• Poison-resistant reference with ion trap
Our offering Endress+Hauser supplies biotech
manufacturers with a wide range of measuring
equipment. All of our process measuring instruments
are designed to support the process conditions
including the sterilization process.
Common benefits
• Hygienic design
• Reliable measurement
• No risk of product contamination
Additional offering suitable for fermentation
processes
• Level measurement (guided radar, hydrostatic
pressure, tuning fork, differential pressure,
capacitance level measurement)
• Flow measurement (Coriolis mass meters,
thermal mass meters)
• Pressure measurement
• Temperature measurement
• Monitoring system

11. 11Ensure compliance and reliable process monitoring
Memobase Plus is the all-in-one management tool for
Memosens sensors. The software does not only calibrate
the sensors and read out sensor data but gives you detailed
reports on sensor history and status.
Memobase Plus features user management and audit trail
that enable you to work according to FDA 21 CFR Part 11:
• Any modification of existing data sets is detected
and marked.
• Memobase Plus saves all measurement, calibration and
sensor-related data in a local and central data base.
• With the “as found – as left” option activated,
Memobase Plus provides a complete performance profile
for the sensors.
• You are also optimally informed about test solutions.
The integrated monitoring system tracks which solution
you are using, when it was opened and when it expires.
Out of this data, you can generate reports of measurement,
calibration and sensor history fulfilling all requirements on
traceability and being perfectly prepared for any audit without
doing any manual paperwork.
Your benefits
• Time saving: Plug & Play with up to four sensors
simultaneously and independent from each other
• Increased product quality: Calibrate under optimum
conditions in the lab or on the work bench, ensuring higher
accuracy.
• Improved quality management: Documented, full
traceability of sensors and reference solutions ensures
compliance with audit guidelines. Manual paperwork is
a thing of the past.
• Data consistency: Identical measurement technology in
process and lab minimizes variability of measured values.
Sensor management tool Memobase Plus
Measure, calibrate and document with one single tool

12. SIC
SIC
Mixer
Heat
Exchanger
Filter
P
P P
T
T
F
W
F
T
Filtration process map
F Flow
P Pressure
SIC Speed Indicator
Controller
T Temperature
WT Weighting System
Inlet
Weighting
system
Coolant
Outlet
12 Global offering for the Life Sciences industry
Separation Industrial centrifugation leads to the
separation of the product from the bulk liquid. The time
spent on the separation (residence time) depends on the
separator’s capacity. In bioproduction, the separation of
cells can be achieved by different steps of filtration using a
variety of microporous materials. Beside filters, micro and
ultrafilters, reverse osmosis and nanofilters technologies
are also used.
Filtration The critical process parameters which are
normally measured during each filtration step are the
residence time, temperature, pH, cell concentration, inlet
and outlet/permeate flows, and the pressures at the inlet
and at the outlets (retentate and permeate). During the
starting phase the pressure drop through the membrane is
monitored as well as the permeate flow in order to prevent
any clogging and runtime.
Separation and filtration
The right operating conditions

13. 13
Additional offering
• Flow measurement: Coriolis flowmeters,
thermal mass meters
• Analysis: conductivity measurement, UV
• Pressure measurement
• Temperature measurement
• Monitoring system
Pressure measurement
Cerabar M PMP51 / PMC51
• USP class VI gasket and ceramic membrane
• Ra < 0.38 μm electropolishing for the wetted parts
• Wide range of hygienic process connections
• All certificates and documents available (material
certificates, 3A, ASME BPE, CoC, roughness, calibration, …)
Differential pressure measurement
Cerabar M FMB50
• Excellent reproducibility and long-term stability
• Ra < 0.38 μm electropolishing for the wetted parts
• Wide range of hygienic process connections
• Hermetically sealed CONTITE™ compensates
temperature effects
• Available with ASME BPE certificate
• Optimized for hydrostatic level measurement
Ensure compliance and reliable process monitoring

14. pH UV
LSH
LSL
PT
PT
PT
PT
PT
F
F
F
T
T
T
C
A
SC
SC
SC
PT Pressure Transmitter
SC Speed Controller
T Temperature
A Analysis
F Flow
C Conductivity
LS Level Switch
Input
Input
Input
Bubble transmitter
Output
Output
Chromatography process map
14 Global offering for the Life Sciences industry
During the different steps, process measuring instruments
are used to control the conditions of the transfer as well
as the properties of the purified medium. Instruments
should not increase the volume of the installation and
avoid dead zones.
Essential measured parameters:
pH and conductivity measurements
• Verify the quality of the buffers on the column
• Control the quality of the gradient
• Detect the separation of phases
• Assure a perfect cleaning and rinsing cycle
of the column
Optical density measurement
• To follow up the outlet of the proteins
• UV: ultraviolet for optimal sensitivity
• Used for the acceptance of the product
Pressure measurements are installed before and after
the filter.
Flow measurement can be placed before the filter,
before or after the column.
Level measurement buffers the effect of pulses of the pump.
Our offering All our process measuring instruments
are delivered with material certificates for the wetted
parts, calibration certificate and roughness (including
electropolishing). We also provide SOPs for calibration and
maintenance, and completion of IQ and OQ, on request.
Chromatography
High or low pressure columns, control at all steps

15. 15
pH measurement with Memosens
pH electrode Ceragel CPS71D
• Hygienic design thanks to fine-porous
ceramic diaphragm
• Upside down mounting possible
• EHEDG certificate for in-place cleanability,
in-place steam sterilizability and bacteria restriction
• Memosens technology
• Calibration in laboratory possible; calibration data
stored in the sensor head
• Easy to clean
• Poison-resistant reference with ion trap
Optical density measurement
OUSAF44 optical density measurement
• Specialized filters for precise wavelengths
• Wide variety of flow cell configurations
• Lowest hold-up volume
• Multiple process connections
(Tri-Clamp®, flanged, welded, etc.)
• Various materials (316L, Titanium, Hastelloy®,
PEEK™, Kynar®, etc.)
• EasyCal™ System for NIST traceable, accurate calibration
• Precision Optical Path length Adjustor
• Optimized lamp coatings
Ensure compliance and reliable process monitoring

16. F
F
C
C
Redox
Redox
LS
Y
Y
Y
Y
Bisulfite
Sodium
hydroxide
Chlorine
Multimedia
filter
Water
softener
F
F
LS
LS
P
P
T
P
P P PpH
P Pressure
T Temperature
F Flow
C Conductivity
LS Level Switch
City water
Chlorine
injection
Cartridge
filter
Bisulfite addition
Sodium hydroxide
Reverse osmosis
stage 1
Reverse osmosis
stage 2
USP water tank
Water Purification process map
16 Global offering for the Life Sciences industry
Treated and purified waters can be classified as:
• Potable water
• Purified water
• Sterile purified water
• Water for injection
• Bacteriostatic water for injection
• Sterile water for irrigation
• Sterile water for inhalation
The purity requirements, production, storage and use
of treated and purified water is defined by international
pharmacopoeias and are heavily scrutinized and regulated
by governing agencies such as the FDA.
Based on tap water, the purification process usually starts
with a water softener, ion exchanger, various fine filters
followed by reverse osmosis, ultrafiltration and membrane
degasification.
The measurement of the different process parameters
ensures a smooth operation. Temperatures have to be
adjusted and flow rates controlled; pressure differences
monitor the quality of the used filters.
Water purification
Process parameter measurements to ensure smooth operation and conformity
to regulations

17. 17
Additional offering suitable for water purification processes
• Level measurement: guided radar, hydrostatic pressure,
tuning fork, differential pressure, capacitance level
measurement
• Flow measurement: Coriolis flowmeters
• Analysis: pH measurement
• Pressure measurement
• Temperature measurement
Our offering The key parameter during water purification
is conductivity. Pharmacopoeias give clear advice on
how to conduct the measurement. Endress+Hauser
supplies biotech manufacturers with a wide range of
measuring equipment. All instruments are delivered
with material certificates for the wetted parts, calibration
certificates and roughness, including electropolishing.
Conductivity measurement
Liquiline M CM42 conductivity transmitter
• Ultra-simple installation with large display
and alarm LED
• Easy, intuitive operation via navigator,
plain-text menu and online help
• Available with hygienic stainless steel housing
• Interfaces: current output, HART®, Profibus® PA,
FOUNDATION™ Fieldbus
• With fault-signalling and preliminary alarm contacts
for WFI and purified water (PW) as per USP
(United States Pharmacopeia)
Condumax CLS16D conductivity measurement
• High measuring accuracy as cell constant
is individually measured
• Hygienic process connections for installation
in pipes or flow chambers
• Easy to clean due to electro-polished measuring surfaces
• Quality certificate stating the individual cell constant
• Available with biological reactivity test certificate
according to USP (United States Pharmacopeia)
Part <87> and <88> Class VI
• Available with inspection certificate
according to EN 10204 3.1
Ensure compliance and reliable process monitoring

18. Vapor
Separator
Vapor
Separator
LSH
LSL
LSH
LSL
LSH
LSL
LSH
LSL
Vapor
Separator
Vapor
Separator
Condenser
F P
P
C
AFP
T T
T
T T
T
LS Level Switch
P Pressure
T Temperature
A Analysis
F Flow
C Conductivity
Water for injection process map
WFI to tank
Coolant inlet
Coolant outlet
Condensate outlet
Steam
inlet
Water inlet
18 Global offering for the Life Sciences industry
In this application, measurement instrumentation is not only
important in controlling the operation of the storage and distribution
loop, it provides the critical measurements required by the regulatory
agencies to prove that water quality is achieved and maintained.
One example is the monitoring of the conductivity. The conductivity
(uncompensated for temperature) of Water for Injection must be
below a certain value for different temperatures for the purified water
to be classified as Water for Injection.
For these critical applications, Endress+Hauser provides highly
accurate hygienic conductivity cells, temperature sensors and
conductivity transmitters with the US Pharmacopeia tables per Section
<645> built into the transmitter software. An alarm output is provided
and is usually set in terms of a percentage of the maximum allowable
conductivity for a corresponding temperature.
Water for injection / Sterile steam
Critical measurements to ensure that water quality level is achieved
and maintained
iTHERM® temperature measurement
iTHERM® QuickSens
Shortest response times worldwide
to temperature changes:
• Fast, high-precision measurements
• Optional display
• Minimization of the needed insertion length
(small piping)
• Use of thermowells without affecting
the measuring performance
iTHERM® QuickNeck
Divisible neck with quick release:
• Removal with the insert without tools
• Easy to calibrate, time saving
for operations

19. 19
TM411 temperature sensor
designed according to ASME BPE guidelines
• Large offering of hygienic process connections
• Mechanically polished or electropolished up to Ra < 0.38 µm
• Very short response time via QuickSens
• Stainless steel housing with display available
• Easy calibration via QuickNeck
• Available with ASME BPE certificate
TMR35 temperature sensor
• Small and compact design in stainless steel only
• Very short response time
• Highly accurate even with short insertion lengths
• Available with T- and corner pieces TMR35F for small
diameter pipes (electropolished up to Ra < 0.38 µm)
Additional offering suitable for WFI processes
• Level measurement: guided radar, tuning fork
• Flow measurement: Coriolis flowmeters
• Analysis: conductivity measurement
• Pressure measurement
• Temperature measurement
Ensure compliance and reliable process monitoring

20. Y
Y
Y
LS
F
F
T P
P
P
P
C
T
F Flow
C Conductivity
LS Level Switch
P Pressure
T Temperature
Water distribution loop process map
Vent line
Nitrogen gas
WFI water
Steam supply
WFI
user 1
WFI
user 2
WFI
user 5
WFI
user 3
WFI
user 4
Cleansteam
Condensate
return
Condensate
return
20 Global offering for the Life Sciences industry
The water distribution loop includes multiple user points.
When the water is not needed, it recirculates to the main
loop. During the usage phase the relevant water valve is
open and the water goes to the process; after use, the valve
is closed again. There can be several active users at the same
time on the distribution loop.
Attention must be paid to the piping’s design:
• All pipes must be sloped in order to provide self-draining
• Dead angles must be avoided
• Potential sources of contaminations must be reduced
All our process measuring instruments are delivered
with material certificates for the wetted parts, calibration
certificate and roughness (including electropolishing).
Water distribution loop
Avoiding contamination is a must
Heartbeat Technology™
Diagnostics with remedy measurements
reduce downtime
• Improved flowmeter reliability through
self-diagnostics
• Immediate indication of flowmeter out of
specification’ and ‘maintenance required’
• Extended calibration intervals
• Online monitoring and diagnostics
• Improved flowmeter confidence

21. 21Ensure compliance and reliable process monitoring
Promass P Coriolis flowmeter
designed according to ASME BPE guidelines
• Certificates CoC, 3.1 for materials, surface finish
• All wetted parts in 316L/ 1.4435
(low delta ferrite < 1%)
• Multivariable instrument: flow, density, temperature
• Fully drainable in horizontal position,
ensuring no hold-up volume
• Designed for CIP/SIP continuous measurement
with fast recovery - no delay
• Fully welded sensor design, no seals/gaskets
• Accredited flow calibration to ISO/ IEC 17025
Promass F Coriolis flowmeter
• Multivariable process parameters instrument:
mass flow, density, temperature, concentration
• Damping of the pumps pulses e.g. peristaltic pumps
• Advanced diagnostic functions: presence of entrained air,
build-up, abrasion, corrosion as examples
• Wetted parts mechanically polished or electropolished
up to Ra < 0.38 μm
• Temperature up to +200°C / +392°F
• Insensibility to vibration
• Fully welded sensor design, no seals/gaskets

22. Y
LC
LS
P
P
P
A Analysis
F Flow
C Conductivity
LS Level Switch
P Pressure
T Temperature
Buffer tanks / storage process map
Chilled water
return
Vent line
Nitrogen gas
USF water
Clean steam
22 Global offering for the Life Sciences industry
Buffers and tanks represent some of the most common
equipment in the manufacturing process and utilities. We
see a wide variety of sizes, volumes, shapes, materials,
contents, applications in the process – starting upstream
to downstream but also storage tanks before media mix as
well as finished products. The tanks and buffers which are
used during the evolution of the process do not only have
to endure the process phases of the medium; according to
the application, they also might need to be sterilizable.
Our offering Endress+Hauser offers the measurement
of critical parameters as well as monitoring, qualification
and documentation, from the smallest buffers
and tanks sizes (few liters/gallons) to the biggest
ones according to Good Practice. All of our process
measuring instruments are delivered with material
certificates for the wetted parts, calibration certificate
and roughness (including electropolishing).
Buffer tanks / Storage
Taking process conditions and diversity into account
for optimum and reliable measurement

23. 23Ensure compliance and reliable process monitoring
Deltapilot S FMB70 - hydrostatic pressure level
Hydrostatic level measurement in tanks is based on
the determination of the hydrostatic pressure which
is generated by the height of the liquid column. The
obtained pressure is thus a direct measure for the level.
• Optimized temperature shock behavior
• Unaffected by dielectric constant, foam,
turbulence and obstacles inside the vessel
• Condensate-proof, watertight and long-
term stable Contite-measuring cell
• Process temperature up to +100°C / +212°F
(+135°C / +275°F short term)
• Measuring ranges up to 10 bar / 150 psi
• Accuracy: 0.1%
Levelflex M FMP53 - guided radar
designed according to ASME BPE guidelines
• Reliable and maintenance free measurement
(high frequency pulses radar) in liquids, also in
turbulent media and foam
• Unaffected by density, temperature,
conductibility and humidity
• Gas layers do not impair measurement
• Process temperatures up to
+150°C / +302°F
• Process pressures up to 40 bar / 580 psi
• Very small blocking distance and
measurement almost down to the tank bottom
• FDA listed and USP Class VI tested gasket
• Electro polished < 0.38 µm 316L
stainless steel rod probe
• Compact, removable or remote housing
(removable housing for in-situ recurrent test)
• Spray ball operation does not affect
the level measurement
• Autoclavable
• Available with stainless steel housing
• Available with ASME BPE certificate

24. Acid
Y
Caustic Water
LSH
LSL LSL LSL
C
C
C
F F
LSH LSH
C
C Conductivity
F Flow
LS Level Switch
CIP / SIP process map
CIP-return flow 1
CIP-return flow 2
Make-up water
To heat
exchanger
CIP-line 2
Sanitizer solution
CIP-line 1
24 Global offering for the Life Sciences industry
Typical pharmaceutical processes consist of mainstream
processing steps associated with different support processes
like cleaning-in-place (CIP) or sterilization-in-place (SIP).
As these support processes can be associated with the
purest processes like water-for-injections (WFI) or other raw
material preparations, CIP and SIP are considered as critical
to the process.
Recording - a necessity All critical parameters regarding
sterilization cycles have to be recorded and stored. The process
measuring instruments’ output values have to be connected
to the PLC and also to the data acquisition system which will
manage the above GxP data according to the 21 CFR part 11
(electronic records and electronic signatures).
Cleaning-in-place CIP / Sterilization-in-place SIP
Critical process measurement, data recording and storage to meet regulations
and compliancy

25. 25
Our offering Endress+Hauser offers measurement of the
critical parameters, our data acquisition systems cover all
your needs regarding traceability for CIP/SIP processes.
All our process measuring instruments are designed for
enduring the process conditions and also sterilization.
Memograph M RSG40 - data acquisition systems
• 21 CFR part 11 compliant data acquisition system
• Functions: recording, visualization, communication,
acquisition
• Up to 20 analog inputs or 40 different measuring points
with Profibus®
• Qualification IQ & OQ, engineering and trainings
on request
• Screen 7” TFT – USB communication ports
• Interface for configuration and data transfer
Additional offering suitable for CIP / SIP processes
• Level measurement: guided radar, hydrostatic pressure,
tuning fork, differential pressure, capacitance level
measurement
• Flow measurement: Coriolis flowmeters
• Analysis: conductivity measurement
• Pressure measurement
• Temperature measurement
• Monitoring system
Ensure compliance and reliable process monitoring

26. 26 Global offering for the Life Sciences industry

27. 27
Compliant services
and advanced technologies
Improve asset performance during operation, continuously optimize
your process and results while maintaining compliance
Assure operational excellence wherever you produce
in the world Our global availability and local support
help you increase efficiency and maintain the required
GMP level. No matter where you are located in the world,
or where you want to be, we are always by your side. Our
global service force of over 1,000 experts is strategically
located worldwide ensuring active local presence to meet all
your service needs.
Application expertise – we understand your business
Because instrumentation is vital for your process, we
capitalize on decades of experience in a wide range of life
sciences applications. Our network of experts is perfectly
positioned to provide your business with the right support.
Training of the process users and technical departments is
performed as required according to the regulations of the
life sciences industry.
People qualified to work at your site Our service teams
are trained and equipped to intervene at your site in
accordance with Good Practice or with any of your specific
health & safety requirements. Also trained on a regular
basis, they work according to defined SOPs and provide
on-site calibration certificates according to ISO 17025.
Traceability of all the services is ensured through the entire
life cycle.
Looking after your business – we care! Because we care,
we add value to your business at every phase of the life
cycle. We are by your side not only to support and to service
but also to optimize your processes. By your side at every
step along the way, we are firmly committed to providing
the right service to fulfill all your needs. Whatever you
require, we have the adapted service answer.
Make the right decision based on valuable information
from the field Advanced data management solutions for
calibration and instrument diagnostics help you reach your
KPIs throughout the entire life cycle. Outstanding calibration
management solutions combining metrology expertise,
instrument technology based on innovation and software.
Compliant services and advanced technologies
“I need full access to the information
about the services provided.”
Our response:
• All actions are traceable
• All documents (calibration certificates, etc.)
are stored in one place
• Data to prove compliance is at your fingertips
Discover the benefits of using W@M Portal
in combination with these services
www.us.endress.com/life-cycle-management

28. SO00202L/24/EN/02.14
(07.14)
USA
Endress+Hauser, Inc.
2350 Endress Place
Greenwood, IN 46143
Tel: 317-535-7138
Sales: 888-ENDRESS
(888-363-7377)
Service: 800-642-8737
Fax: 317-535-8498
info@us.endress.com
www.us.endress.com
Canada
Endress+Hauser Canada
1075 Sutton Drive
Burlington, ON L7L 5Z8
Tel: 905-681-9292
800-668-3199
Fax: 905-681-9444
info@ca.endress.com
www.ca.endress.com
Mexico
Endress+Hauser México S.A. de C.V.
Fernando Montes de Oca 21 Edificio A Piso 3
Fracc. Industrial San Nicolás
54030 Tlalnepantla de Baz
Estado de México
México
Tel: +52 55 5321 2080
Fax: +52 55 5321 2099
eh.mexico@mx.endress.com
www.mx.endress.com
Other locations
www.addresses.endress.com
ISO 9001 Certified
Additional documentation
• CM01012L Life Sciences
Industry Perspectives magazine
• CP01062L A Partner to Help
You Stay Compliant