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

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Page 1: E+H - Global Offering for LIfe Sciences

Products Solutions Services

Global offering for the Life Sciences industryInnovation and compliance

Page 2: E+H - Global Offering for LIfe Sciences

2 Global offering for the Life Sciences industry

Contents 3 Achieving excellence together

5 Ensure compliance and reliable process monitoring

6 Media preparation 8 Fermentation11 Sensor management tool Memobase Plus12 Separation and filtration14 Chromatography 16 Water purification18 Water for injection, sterile steam 19 Water distribution loop20 Buffer tanks / Storage24 Cleaning-in-place CIP / Sterilization-in-place SIP

27 Compliant services and advanced technologies

For more information:www.us.endress.com/life-sciences

Page 3: E+H - Global Offering for LIfe Sciences

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 togetherTrust a reliable partner who considers cost, quality and compliance as binding links to market.

Achieving excellence together

Page 4: E+H - Global Offering for LIfe Sciences

4 Global offering for the Life Sciences industry

Page 5: E+H - Global Offering for LIfe Sciences

Overview of the Endress+Hauser product range of process measuring instruments

Level Flow Liquid analysis Pressure Temperature MonitoringMedia 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

Page 6: E+H - Global Offering for LIfe Sciences

TLS

LS

F

F

F

F

pH

T

T

Y

Media preparation process map

F Flow LS Level Switch T Temperature

Molasses

Nutrition

Sterile steamsupply

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 preparationControl 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

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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

Page 8: E+H - Global Offering for LIfe Sciences

WT

F

F

FF

WT

WT

WT

DCO2

Air / CO2

Air

FoamLevel F

F

F

F

LCSC

SIC

O2

N2

CO2

pHDO

P

T

Fermentation process map

DO Dissolved OxygenF FlowLC Level ContinuousP PressureSC Speed ControllerSIC Speed Indicator ControllerT TemperatureWT 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.

FermentationGet the most accurate measurement information in challenging conditions

Page 9: E+H - Global Offering for LIfe Sciences

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

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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

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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 PlusMeasure, calibrate and document with one single tool

Page 12: E+H - Global Offering for LIfe Sciences

SIC

SIC

Mixer

HeatExchanger

Filter

P

P P

T

T

F

W

FT

Filtration process map

F FlowP PressureSIC Speed Indicator ControllerT TemperatureWT 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 filtrationThe right operating conditions

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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

Page 14: E+H - Global Offering for LIfe Sciences

pH UV

LSHLSL

PTPT

PT

PT

PT

F

F

F

T

T

T

C

A

SC

SC

SC

PT Pressure TransmitterSC Speed ControllerT Temperature

A AnalysisF FlowC ConductivityLS 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.

ChromatographyHigh or low pressure columns, control at all steps

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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

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F

F

C

C

Redox

Redox

LS

YY

Y

Y

Bisulfite

Sodiumhydroxide

Chlorine

Multimediafilter

Watersoftener

F

F

LS

LS

P

P

T

P

P P PpH

P PressureT Temperature

F FlowC ConductivityLS Level Switch

City water

Chlorineinjection

Cartridgefilter

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 purificationProcess parameter measurements to ensure smooth operation and conformity to regulations

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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

Page 18: E+H - Global Offering for LIfe Sciences

Vapo

rSe

para

tor

Vapo

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para

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LSHLSL

LSHLSL

LSHLSL

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por

Sepa

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Vapo

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para

tor

Condenser

F P

P

C

AFP

T T

T

T T

T

LS Level SwitchP PressureT Temperature

A AnalysisF FlowC 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 steamCritical measurements to ensure that water quality level is achieved and maintained

iTHERM® temperature measurement

iTHERM® QuickSensShortest 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® QuickNeckDivisible neck with quick release:• Removal with the insert without tools• Easy to calibrate, time saving

for operations

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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

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YY

Y

LS

F

F

T P

PP

P

C

T

F FlowC ConductivityLS Level SwitchP PressureT 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

Clea

n st

eam

Condensatereturn

Condensatereturn

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 loopAvoiding 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

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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

Page 22: E+H - Global Offering for LIfe Sciences

Y

LC

LSP

P

P

A AnalysisF FlowC ConductivityLS Level SwitchP PressureT Temperature

Buffer tanks / storage process map

Chilled waterreturn

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 / StorageTaking process conditions and diversity into account for optimum and reliable measurement

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23Ensure compliance and reliable process monitoring

Deltapilot S FMB70 - hydrostatic pressure levelHydrostatic 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

Page 24: E+H - Global Offering for LIfe Sciences

Acid

Y

Caustic Water

LSH

LSL LSL LSL

C

C

C

F F

LSH LSH

C

C ConductivityF FlowLS 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 SIPCritical process measurement, data recording and storage to meet regulations and compliancy

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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

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26 Global offering for the Life Sciences industry

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Compliant services and advanced technologiesImprove 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

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SO00

202L

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EN/0

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(07.

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USA

Endress+Hauser, Inc.2350 Endress PlaceGreenwood, IN 46143Tel: 317-535-7138Sales: 888-ENDRESS (888-363-7377)Service: 800-642-8737Fax: [email protected]

Canada

Endress+Hauser Canada1075 Sutton DriveBurlington, ON L7L 5Z8Tel: 905-681-9292800-668-3199Fax: [email protected]

Mexico

Endress+Hauser México S.A. de C.V.Fernando Montes de Oca 21 Edificio A Piso 3Fracc. Industrial San Nicolás 54030 Tlalnepantla de BazEstado de MéxicoMéxicoTel: +52 55 5321 2080Fax: +52 55 5321 [email protected]

Other locations

www.addresses.endress.com

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Additional documentation

• CM01012L Life Sciences Industry Perspectives magazine

• CP01062L A Partner to Help You Stay Compliant