Water purification, Water for Injection (WFI)

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Measuring point	Product	Alternatives
Purified water inlet	Proline Promass K 10 Coriolis flowmeter	Proline Promass P 100 Coriolis flowmeter	Proline Promass F 100 Coriolis flowmeter	Proline Promass P 300 Coriolis flowmeter
Coolant inlet temperature	iTHERM TrustSens TM371 Compact thermometer	iTHERM TrustSens TM372 Compact thermometer	iTHERM ModuLine TM411 Hygienic modular thermometer	iTHERM ModuLine TM412 Hygienic modular thermometer
Coolant inlet pressure	Absolute and gauge pressure Cerabar PMP21	Absolute and gauge pressure Ceraphant PTP31B	Absolute and gauge pressure Cerabar PMC21
Coolant outlet temperature	TMR35 Compact thermometer	iTHERM ModuLine TM411 Hygienic modular thermometer	iTHERM ModuLine TM412 Hygienic modular thermometer	iTHERM ModuLine TM401 Hygienic modular thermometer
Evaporator pressure	Cerabar PMP43 – hygienic pressure transmitter	Cerabar PMP51B - pressure transmitter
Evaporator temperature	iTHERM TrustSens TM371 Compact thermometer	iTHERM TrustSens TM372 Compact thermometer	iTHERM ModuLine TM411 Hygienic modular thermometer	iTHERM ModuLine TM412 Hygienic modular thermometer
Evaporator maximum level detection	Liquiphant FTL43 – hygienic point level switch for liquids	Liquiphant FTL63 – hygienic point level switch for liquids
Evaporator minimum level detection	Liquiphant FTL43 – hygienic point level switch for liquids	Liquiphant FTL63 – hygienic point level switch for liquids
Steam temperature	iTHERM TrustSens TM371 Compact thermometer	iTHERM TrustSens TM372 Compact thermometer	iTHERM ModuLine TM411 Hygienic modular thermometer	iTHERM ModuLine TM412 Hygienic modular thermometer
Steam inlet pressure	Cerabar PMP43 – hygienic pressure transmitter	Cerabar PMP51B - pressure transmitter
Steam inlet	Proline Prowirl F 200 vortex flowmeter
WFI conductivity	Digital conductivity sensor Memosens CLS16E
WFI temperature	iTHERM TrustSens TM371 Compact thermometer	iTHERM TrustSens TM372 Compact thermometer	iTHERM ModuLine TM411 Hygienic modular thermometer	iTHERM ModuLine TM412 Hygienic modular thermometer
B1-14-Analysis	Low-range TOC analyzer CA79

Flow measurement in: Purified water inlet

Endress+Hauser offers a suite of analytical instruments ideal for this stage.

Picture of Coriolis flowmeter Proline Promass K 10 for multivariable measurement in utilities

Proline Promass K 10 Coriolis flowmeter

Flowmeter with minimized total cost of ownership with easy-to-use operation concept

Alternatives:

Picture of Coriolis flowmeter Proline Promass P 100 / 8P1B for the life sciences industry

Proline Promass P 100 Coriolis flowmeter

The specialist for life sciences with an ultra-compact transmitter

Picture of Proline Promass F 100 / 8F1B with highest measurement performance for liquids and gases

Proline Promass F 100 Coriolis flowmeter

The flowmeter with premium accuracy, robustness and an ultra-compact transmitter

Picture of Coriolis flowmeter Proline Promass P 300 / 8P3B for the life sciences industry

Proline Promass P 300 Coriolis flowmeter

Specialist for life sciences with a compact, easily accessible transmitter

General Requirements:

Cleanability, no dead legs
Fully self-drainable in horizontal installations
Design according to ISPE "Water and Steam Systems"
Low delta ferrite content
High reproducibility over a large flow range

Technical requirements:

Measuring task: Liquids/Density/Concentration
Process pressure: 0 to 16 bar (0 to 232 psi)
Max. process temperature: 40 °C (104 °F)
Max. sanitization temperature: 80 °C (176 °F)
Density: 0.8 to 1.25 g/cm³

Temperature measurement in: Coolant inlet temperature

Endress+Hauser offers a suite of analytical instruments ideal for this stage.

Compact sanitary RTD - iTHERM TrustSens TM371

iTHERM TrustSens TM371 Compact thermometer

Metric RTD thermometer with self-calibration technology for hygienic applications

Alternatives:

iTHERM TrustSens TM372 Hygienic compact thermometer, US Style

iTHERM TrustSens TM372 Compact thermometer

Imperial RTD thermometer with self-calibration technology for hygienic applications

Sanitary digital thermometer iTHERM TM411

iTHERM ModuLine TM411 Hygienic modular thermometer

Metric RTD thermometer with or without thermowell for hygienic applications

Hygienic thermometer iTHERM TM412 - Imperial version US Style

iTHERM ModuLine TM412 Hygienic modular thermometer

Imperial RTD thermometer with or without thermowell for hygienic applications

General Requirements:

Installation in thermowell
Easy calibration
Long-term stability
Linearity over the measurement range

Technical requirements:

Measuring task: Thermometer
Process pressure: 0 to 16 bar (0 to 232 psi)
Max. process temperature: 40°C (104°F)
Max. sanitization temperature: 80°C (176°F)
Density: 0.8 to 1.25 g/cm³

Pressure measurement in: Coolant inlet pressure

Endress+Hauser offers a suite of analytical instruments ideal for this stage.

Absolute and gauge pressure Cerabar PMP21

Cost-effective pressure transducer with metal sensor for measurement in gases or liquids

Some variants in stock

Alternatives:

Ceraphant PTP31B - Absolute and gauge pressure

Absolute and gauge pressure Ceraphant PTP31B

Cost-effective pressure switch with welded metal sensor for measurement in gases, steams or liquids

Absolute and gauge pressure Cerabar PMC21

Cost-effective pressure transducer with ceramic sensor for measurement in gases or liquids

Some variants in stock

General Requirements:

Front flush mounting for drainability
Fast temperature shock response
High linearity

Technical requirements:

Measuring task: Pressure
Process pressure: 0 to 16 bar (0 to 232 psi)
Max. process temperature: 40°C (104°F)
Max. sanitization temperature: 80°C (176°F)
Density: 0.8 to 1.25 g/cm³

Temperature measurement in: Coolant outlet temperature

Endress+Hauser offers a suite of analytical instruments ideal for this stage.

Product picture hygienic compact thermometer TMR35

TMR35 Compact thermometer

Metric RTD 4-20 mA compact thermometer for hygienic applications

Alternatives:

iTHERM ModuLine TM411 Hygienic modular thermometer

Metric RTD thermometer with or without thermowell for hygienic applications

iTHERM ModuLine TM412 Hygienic modular thermometer

Imperial RTD thermometer with or without thermowell for hygienic applications

Product picture hygienic RTD thermometer TM401

iTHERM ModuLine TM401 Hygienic modular thermometer

Fundamental metric RTD direct contact thermometer for hygienic applications

General Requirements:

Installation in thermowell
Easy calibration
Long-term stability
Linearity over the measurement range

Technical requirements:

Measuring task: Thermometer
Process pressure: 0 to 16 bar (0 to 232 psi)
Max. process temperature: 40°C (104°F)
Max. sanitization temperature: 80°C (176°F)
Density: 0.8 to 1.25 g/cm³

Pressure measurement in: Evaporator pressure

Endress+Hauser offers a suite of analytical instruments ideal for this stage.

Cerabar PMP43 – hygienic pressure transmitter

Particularly compact, highly reliable and the perfect fit for demanding hygienic applications

Alternatives:

Cerabar PMP51B - pressure transmitter

Smart pressure transmitter with metal membrane for highly accurate measurement of liquids and gases

General Requirements:

Front flush mounting for drainability
Fast temperature shock response
High linearity

Technical requirements:

Measuring task: Pressure
Process pressure: 0 to 16 bar (0 to 232 psi)
Max. process temperature: 150°C (302°F)
Density: 0.8 to 1.25 g/cm³

Temperature measurement in: Evaporator temperature

Endress+Hauser offers a suite of analytical instruments ideal for this stage.

iTHERM TrustSens TM371 Compact thermometer

Metric RTD thermometer with self-calibration technology for hygienic applications

Alternatives:

iTHERM TrustSens TM372 Compact thermometer

Imperial RTD thermometer with self-calibration technology for hygienic applications

iTHERM ModuLine TM411 Hygienic modular thermometer

Metric RTD thermometer with or without thermowell for hygienic applications

iTHERM ModuLine TM412 Hygienic modular thermometer

Imperial RTD thermometer with or without thermowell for hygienic applications

General Requirements:

Cleanability, no dead legs, front flush mounting
Installation in thermowell
Easy calibration
Long-term stability
Linearity over the measurement range

Technical requirements:

Measuring task: Thermometer
Process pressure: 0 to 16 bar (0 to 232 psi)
Max. process temperature: 150°C (302°F)
Density: 0.8 to 1.25 g/cm³

Level measurement in: Evaporator maximum level detection

Endress+Hauser offers a suite of analytical instruments ideal for this stage.

Liquiphant FTL43 – hygienic point level switch for liquids

Proven in the field, particularly compact and perfectly suitable for hygienic applications

Alternatives:

Liquiphant FTL63 – hygienic point level switch for liquids

Proven in the field, easy to use and perfectly suitable for hygienic applications.

General Requirements:

Cleanability, no dead legs, front flush mounting
No interaction with agitator operation

Technical requirements:

Measuring task: Point Level / Liquids
Process pressure: 0 to 16 bar (0 to 232 psi)
Max. process temperature: 150°C (302°F)
Density: 0.8 to 1.25 g/cm³

Level measurement in: Evaporator minimum level detection

Endress+Hauser offers a suite of analytical instruments ideal for this stage.

Liquiphant FTL43 – hygienic point level switch for liquids

Proven in the field, particularly compact and perfectly suitable for hygienic applications

Alternatives:

Liquiphant FTL63 – hygienic point level switch for liquids

Proven in the field, easy to use and perfectly suitable for hygienic applications.

General Requirements:

Cleanability, no dead legs, front flush mounting
No interaction with agitator operation

Technical requirements:

Measuring task: Point Level / Liquids
Process pressure: 0 to 16 bar (0 to 232 psi)
Max. process temperature: 150°C (302°F)
Density: 0.8 to 1.25 g/cm³

Temperature measurement in: Steam temperature

Endress+Hauser offers a suite of analytical instruments ideal for this stage.

iTHERM TrustSens TM371 Compact thermometer

Metric RTD thermometer with self-calibration technology for hygienic applications

Alternatives:

iTHERM TrustSens TM372 Compact thermometer

Imperial RTD thermometer with self-calibration technology for hygienic applications

iTHERM ModuLine TM411 Hygienic modular thermometer

Metric RTD thermometer with or without thermowell for hygienic applications

iTHERM ModuLine TM412 Hygienic modular thermometer

Imperial RTD thermometer with or without thermowell for hygienic applications

General Requirements:

Installation in thermowell
Fast response time
Easy calibration
Long-term stability
Linearity over the measurement range

Technical requirements:

Measuring task: Thermometer
Process pressure: 0 to 16 bar (0 to 232 psi)
Max. process temperature: 150°C (302°F)

Pressure measurement in: Steam inlet pressure

Endress+Hauser offers a suite of analytical instruments ideal for this stage.

Cerabar PMP43 – hygienic pressure transmitter

Particularly compact, highly reliable and the perfect fit for demanding hygienic applications

Alternatives:

Cerabar PMP51B - pressure transmitter

Smart pressure transmitter with metal membrane for highly accurate measurement of liquids and gases

General Requirements:

Front flush mounting for drainability
Fast temperature shock response
High linearity

Technical requirements:

Measuring task: Pressure
Process pressure: 0 to 16 bar (0 to 232 psi)
Max. process temperature: 150°C (302°F)

Flow measurement in: Steam inlet

Endress+Hauser offers a suite of analytical instruments ideal for this stage.

Picture of Vortex flowmeter Proline Prowirl F 200 / 7F2C for utilities

Proline Prowirl F 200 vortex flowmeter

Versatile flowmeter with detection of wet steam conditions and best-in-class accuracy

General Requirements:

Turbulent constant flow
Robust sensor technology against water hammer
Wet steam detection and measurement
Temperature and pressure compensation
Ready for energy measurement solution

Technical requirements:

Measuring task: Steam
Process pressure: 0 to 16 bar (0 to 232 psi)
Max. process temperature: 150 °C (302 °F)

Analysis measurement in: WFI conductivity

Endress+Hauser offers a suite of analytical instruments ideal for this stage.

Memosens CLS16E - Digital, contacting conductivity sensor with certified hygienic design

Digital conductivity sensor Memosens CLS16E

Memosens 2.0 contacting conductivity sensor for hygienic applications in life sciences and food

General Requirements:

Cleanability (CIP/SIP), no dead legs
Design according to ISPE "Water and Steam Systems"
USP <645> functionality
Low range, non-temperature-compensated

Technical requirements:

Measuring task: Conductivity
Process pressure: 0 to 16 bar (0 to 232 psi)
Max. process temperature: 40°C (104°F)
Density: 0.8 to 1.25 g/cm³

Temperature measurement in: WFI temperature

Endress+Hauser offers a suite of analytical instruments ideal for this stage.

iTHERM TrustSens TM371 Compact thermometer

Metric RTD thermometer with self-calibration technology for hygienic applications

Alternatives:

iTHERM TrustSens TM372 Compact thermometer

Imperial RTD thermometer with self-calibration technology for hygienic applications

iTHERM ModuLine TM411 Hygienic modular thermometer

Metric RTD thermometer with or without thermowell for hygienic applications

iTHERM ModuLine TM412 Hygienic modular thermometer

Imperial RTD thermometer with or without thermowell for hygienic applications

General Requirements:

High accuracy and repeatability
Cleanability, no dead legs
Installation in thermowell
Easy calibration
Long-term stability

Technical requirements:

Measuring task: Thermometer
Process pressure: 0 to 16 bar (0 to 232 psi)
Max. process temperature: 40°C (104°F)
Density: 0.8 to 1.25 g/cm³

Analysis measurement in: B1-14-Analysis

Endress+Hauser offers a suite of analytical instruments ideal for this stage.

Low-range TOC analyzer CA79

Precise online TOC monitoring in the life sciences industry

General Requirements:

Technical requirements:

Stainless steel piping and instrumentation in a pharmaceutical water purification system.

Key instrumentation challenges in Water for Injection systems

The biggest challenge in a Water for Injection (WFI) system is to continuously prove that the water remains within specification during generation, storage, and distribution. The instrumentation has to operate reliably in an environment where contamination risk, compliance requirements and validation expectations are extremely high. Some of the key instrumentation challenges in WFI systems are:

Reliable low-level conductivity measurement
Fast TOC detection of contamination events
Temperature accuracy during sanitization
Verification of flow velocity to prevent biofilm formation
Calibration, validation, and audit readiness

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Learn more about the FLEX selections

Proline Promass K 10
Coriolis flowmeter

Flowmeter with minimized total cost of ownership with easy-to-use operation concept

Cerabar PMP43 – hygienic pressure transmitter

Particularly compact, highly reliable and the perfect fit for demanding hygienic applications

iTHERM TrustSens TM371
Compact thermometer

Metric RTD thermometer with self-calibration technology for hygienic applications

Liquiphant FTL43 – hygienic point level switch for liquids

Proven in the field, particularly compact and perfectly suitable for hygienic applications

Absolute and
gauge pressure
Cerabar PMP21

Cost-effective pressure transducer with metal sensor for measurement in gases or liquids

TMR35
Compact thermometer

Metric RTD 4-20 mA compact thermometer for hygienic applications

Digital conductivity sensor
Memosens CLS16E

Memosens 2.0 contacting conductivity sensor for hygienic applications in life sciences and food

Low-range TOC analyzer
CA79

Precise online TOC monitoring in the life sciences industry

Vortex flowmeter - Proline Prowirl F 200

Prowirl F 200, 7F2B

The flowmeter with detection of wet steam conditions, available as compact or remote version. Suitable for a wide range of applications; optimized for steam applications.

FAQ

Frequent questions about the water purification / water for injection (WFI) process

What are the conductivity and TOC limits for WFI water?

For Water for Injection (WFI), the TOC limit is ≤ 500 ppb (0.5 mg/L) according to the major pharmacopeias (USP, EP, JP). The conductivity limit for USP-compliant WFI is ≤ 1.3 µS/cm at 25°C.

How is meeting WFI conductivity/TOC limits managed in water for injection generation?

WFI conductivity and TOC limits are maintained through continuous online monitoring and control of ionic and organic contaminants to ensure compliance with pharmacopoeial requirements. Real-time measurements, trend analysis, and alarm management enable early detection of water quality deviations and support validated WFI generation and distribution processes.

What are the critical process parameters in water for injection generation?

Critical process parameters in WFI generation include conductivity, TOC, temperature, pressure, and flow, as these directly affect water purity, system performance, and regulatory compliance. Continuous monitoring of these parameters ensures validated operating conditions are maintained, enabling early detection of contamination, process drift, or equipment issues.

What are the critical process parameters in purified water (PW) generation via RO/EDI/ion exchange?

In PW generation using RO, EDI and ion exchange, the critical process parameters are conductivity, flow, pressure, temperature and TOC, as they directly indicate purification efficiency, membrane/resin performance and water quality. Monitoring these parameters enables early detection of fouling, breakthrough, leaks or organic contamination, ensuring consistent PW quality and reliable system operation.

How does purified water (PW) generation via RO/EDI/ion exchange work?

Purified water (PW) generation typically uses reverse osmosis (RO) as the primary purification step to remove dissolved salts, organic contaminants, and particles, followed by EDI or ion exchange to further reduce residual ionic impurities and achieve the required water quality. Pretreatment and continuous monitoring of key parameters such as conductivity, TOC, pressure, and flow ensure consistent performance and compliance with pharmaceutical water specifications.

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Key instrumentation challenges in Water for Injection systems

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Frequent questions about the water purification / water for injection (WFI) process

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Water purification, Water for Injection (WFI)

Key instrumentation challenges in Water for Injection systems

Explore our innovations for your water purification process

Frequent questions about the water purification / water for injection (WFI) process

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