Measurement Technologies in the Pharmaceutical Industry
Measurement technologies in the pharmaceutical industry play a crucial role in meeting the high quality and safety requirements of pharmaceutical products. Sterile processing is a key component that significantly influences the efficiency and safety of production processes in both upstream and downstream processing. Also, in subsequent steps up to cleaning and sterilization, a contamination-free process management is a critical quality factor. This requires a combination of modern hygienic design and high measurement accuracy in measuring instruments.
Conformity with GMP guidelines (Good Manufacturing Practice) is important for measuring instruments. They must meet the stringent requirements of various authorities and standards, such as:
- The Food and Drug Administration (FDA)
- The European Hygienic Engineering & Design Group (EHEDG)
- 3-A Sanitary Standards, Inc.
- ASME BPE (Bioprocessing Equipment)
- ATEX (Directive for equipment and protective systems intended for use in potentially explosive atmospheres)
To demonstrate compliance with FDA requirements and national authorities, an extensive program of certificates is required. For the continuous verification of measuring instruments as part of quality management, a wide range of calibration equipment and calibration services are available.
In terms of process connections, manufacturers offer a comprehensive range of industry-standard and specific process connections in hygienic design, including:
- Clamp connections, Tri-Clamp, DIN 32676, ISO 2852, ASME BPE
- Aseptic connections DIN 11864
For handling toxic, bioactive, or particularly sensitive substances, there are special instrumentation options to integrate measuring instruments into the systems without using elastomers.
- Sensor can be calibrated without having to open the process
- Simple and fast electrical connection via M12 x 1 plug connector
- With direct sensor output (Pt100/Pt1000 in 3 or 4-wire version) or integrated transmitter with 4 ... 20 mA output signal, individually parameterisable with free-of-charge WIKAsoft-TT PC configuration software
- Wetted parts from stainless steel 1.4435
- Self-draining and dead-space minimised, materials and surface finish qualities in accordance with standards of hygienic design
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- Compact design for space-saving fitting
- Simple and fast electrical connection via M12 x 1 plug connector
- With direct sensor output (Pt100/Pt1000 in 3 or 4-wire version) or integrated transmitter with 4 ... 20 mA output signal, individually parameterisable with free-of-charge WIKAsoft-TT PC configuration software
- Materials and surface finish quality in accordance with standards of hygienic design
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- Double-diaphragm system prevents contamination of process and environment
- Hygienic process connections in different designs
- Signal transmission and configuration with only one cable per measuring location
- Minimal installation costs, even with retrofitting
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- Double-diaphragm system to ensure the separation of the process and the pressure measuring instrument
- Clamp connection easy to open for cleaning and seal replacement
- Suitable for SIP and CIP
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- Safety via mechanical pressure transmission
- Case and wetted parts in hygienic design
- Suitable for SIP and CIP, autoclavable version available
- Easy zero point setting
- High overpressure safety
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- Integrated diaphragm element monitoring with status display (patent, property right: e.g. DE102016005568)
- Two barriers for secure separation of the process from the atmosphere
- Mechanical pressure transmission without transmission fluid
- Completely autoclavable, suitable for CIP and SIP
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- Pt100 probes for -50 ... +250 °C [-58 ... +482 °F]
- Accuracy: < 0.2 K (complete measuring chain)
- Integrated data logger
- GSoft data logger evaluation software available
- Incl. calibration certificate
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- Process- and procedure-specific solutions possible
- Operating limits: - Operating temperature: T = -80 ... +200 °C [-112 ... +392 °F] - Operating pressure: P = Vacuum to 25 bar [362,6 psi] - Limit density: ρ ≥400 kg/m3 [25,0 lbs/ft3]
- Wide variety of different electrical connections, process connections and materials
- Optionally with programmable and configurable head-mounted transmitter for 4 ... 20 mA field signals, HART®, PROFIBUS® PA and FOUNDATION™ Fieldbus
- Explosion-protected versions (option)
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- Pressure ranges: -1 ... 210 bar (-15 ... 3,045 psi)
- Control speed 10 s
- Control stability < 0.005 % FS
- Accuracy to 0.02 % IS (IntelliScale)
- Precision 0.008 % FS
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- For cleaning easy to open
- Quick cleaning of measuring point, without residue
- Suitable for SIP and CIP
- 3-A certified
- Flush, welded diaphragm
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- Quick cleaning, without residue
- Clamp connection easy to open for cleaning and seal replacement
- Suitable for SIP and CIP
- EHEDG certified and 3-A compliant
- Compliant per ASME BPE
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- Compact, robust, easily cleanable design (patent, property right: DE102008042455)
- Dry measuring cell, no transmission fluid
- Flush, welded diaphragm
- Suitable for SIP and CIP, autoclavable version available
- Large selection of process connections
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- Fully welded and dead space free
- Operating limits: - Operating temperature: T = -40 ... +250 °C - Operating pressure: P = Vacuum to 10 bar
- Insensitive to foaming, ideal for interface measurement
- High-precision level measurement: Accuracy < 0.5 mm
- Wide variety of hygienic process connections
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- For direct, quickly removable installation in pipelines
- Self-draining in all mounting positions
- Quick cleaning, without residue
- Suitable for SIP and CIP
- Dead-space free installation in pipes
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Special Features
- Total measurement uncertainty to 0.006 % of reading
- Extremely flexible instrument with a wide range of single and dual-range piston-cylinder systems
- Dual-range piston-cylinder systems with fully automated changing between ranges
- Factory calibration includes traceability to national standards, as standard, with UKAS calibration possible as an option
- Fast and safe replacement of the piston-cylinder system via patented ConTect quick-release system as an option
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- Dead space free
- Hygienic design
- Materials and surface finish qualities in accordance with pharmaceutical industry directives and standards
- 3-A compliant
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- Pressure ranges: from 0 ... 25 mbar up to 0 ... 2,890 bar [0 ... 0.36 up to 0 ... 42,000 psi]
- Accuracy down to 0.008 % of IS (IntelliScale)
- External pressure ranges from 25 mbar ... 1,000 bar [0.36 ... 15,015 psi]
- Precision 0.004 % FS
- Removable/interchangeable sensors
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- Dead space free
- Hygienic design
- Aseptic process connections
- Material and surface finish quality in accordance with pharmaceutical industry directives and standards
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- Excellent load-cycle stability and shock resistance
- All stainless steel construction
- German Lloyd approva
- Scale ranges up to 0 … 1,600 bar
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- TÜV zertifizierte SIL-Version für Schutzeinrichtungen entwickelt nach IEC 61508 (Option)
- Einsatz in Sicherheitsanwendungen bis SIL 2 (einzelnes Gerät) und SIL 3 (redundante Verschaltung)
- Konfigurierbar mit nahezu jedem offenen Soft- und Hardwaretool
- Universell für den Anschluss von 1 oder 2 Sensoren - Widerstandsthermometer, Widerstandssensor - Thermoelement, mV-Sensor - Potentiometer
- Signalisierung gemäß NAMUR NE43, Sensorbruchüberwachung gemäß NE89, EMV gemäß NE21
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Switch contacts (electrical alarm contacts) make or break circuits dependent upon the pointer position of the indicating measuring instruments.
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- Dead-space free, direct installation in pipes
- Easy to open, self-draining in all mounting positions
- Quick cleaning, without residue
- Suitable for COP, SIP and CIP
- Autoclavable version
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- Scale ranges from -70 ... +600 °C
- For extreme ambient temperatures
- Maintenance-friendly bayonet case
- All stainless steel construction
- Individual stem length from 63 ... 1,000 mm
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- Case and wetted parts in hygienic design
- Suitable for SIP and CIP
- Clamp connection easy to open for cleaning and seal replacement
- Easy zero point setting
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- Pressure ranges: -1 ... 210 bar (-15 ... 3,045 psi)
- Control speed 15 s
- Control stability < 0.003 % FS (typical 0.001 % FS)
- Accuracy down to 0.01 % IS (IntelliScale)
- Precision 0.004 % FS
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- Quick cleaning, without residue
- Milk thread fitting per DIN 11851
- Suitable for cleaning out of place (COP)
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- Process- and procedure-specific solutions possible
- Operating limits: - Operating temperature: T = -90 ... +450 °C [-130 ... +842 °F] - Operating pressure: P = vacuum to 100 bar [1,450.4 psi] - Limit density: ρ ≥ 400 kg/m3 [25.0 lbs/ft³]
- Resolution < 0.1 mm
- Wide variety of different electrical connections, process connections and materials
- Explosion-protected versions
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- Quick cleaning, without residue
- Process connection per Svensk Standard SS 1145
- Suitable for cleaning out of place (COP)
- Sterilisation-in-Place (SIP) up to max. 130 °C [266 °F]
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- Quick cleaning of measuring point, without residue
- Certified hygienic design
- Suitable for SIP and CIP
- EHEDG certified and 3-A compliant
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- Quick cleaning, without residue
- Clamp connection easy to open for cleaning and seal replacement
- Suitable for SIP and CIP
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- Quick cleaning, without residue
- Clamp connection easy to open for cleaning and seal replacement
- Suitable for SIP and CIP
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- Quick cleaning, without residue
- Suitable for SIP and CIP
- EHEDG certified and 3-A compliant
- Certified hygienic design
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- Quick cleaning, without residue
- Suitable for SIP and CIP
- EHEDG certified and 3-A compliant
- For installation into VARINLINE® access units
- 100 % material traceability for wetted parts
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- Materials and surface finish quality in accordance with the standards of hygienic design
- Fully welded
- Can be combined with models TR21-A and TR22-A electrical resistance thermometers, measuring insert exchangeable
- Can be combined with mechanical thermometers, resistance thermometers and DiwiTherm®
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- Safety version with solid baffle wall designed in compliance with the requirements and test conditions of EN 837-1
- Excellent load-cycle stability and shock resistance
- Completely from stainless steel
- Scale ranges from 0 … 0.6 to 0 … 1,600 bar
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- No configuration necessary due to "plug-and-play"
- Signal transmission per NAMUR
- Measuring ranges 0 ... 0.6 bar to 0 ... 1,600 bar
- Easy-to-read analogue display with nominal size 100 or 160
- Safety version S3 per EN 837
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- Scale ranges from -200 ... +700 °C [-328 ... 1.292 °F]
- Fast response behaviour
- Case and stem from stainless steel
- Various connection and case mounting designs
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- For direct, quickly removable installation in pipelines
- Self-draining in all mounting positions
- Quick cleaning, without residue
- Suitable for COP, SIP and CIP
- Dead-space free installation in pipes
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- Cost-effective “2 in 1” temperature measurement
- Compact design
- Application ranges from -200 ... +700 °C
- “Plug-and-play”, thus no transmitter configuration necessary
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- Zero point correction in front
- Completely from stainless steel
- With liquid-filled case for applications with high dynamic pressure loads and vibrations (model 633.50)
- Low scale ranges from 0 ... 2.5 mbar to 0 ... 600 mbar or 0 ... 1 inH2O to 0 ... 240 inH2O
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- Manual pressure generation of -0.85 … +25 bar [12.3 ... +360 psi]
- Accuracy: 0.025 % FS (incl. calibration certificate)
- Generation/measurement of 0 ... 24 mA and voltage supply DC 24 V
- Data logger with high measuring rate and large memory
- Intrinsically safe version
- High accuracy of 0.03 K with Pt100
- One- and two-channel versions
- Connection possibilities for various probe types
- Intrinsically safe version Ex ib IIB T4 Gb
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- Multi-functional display
- Simple menu navigation
- Conductive plastic case
- Large LC display, rotatable
- Approvals for hazardous areas
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- Accuracy up to 0.1 K (complete measuring chain)
- One- and two-channel versions
- Connection possibilities for various probe types
- Intrinsically safe version Ex ib IIB T4 Gb
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- Compact and space-saving design
- Output signal 4 ... 20 mA (NAMUR NE43) or HART® ver. 6
- Operating limits: - Operating temperature: T = -40 ... +250 °C - Operating pressure: P = Vacuum to 40 bar - Limit density: ρ ≥ 580 kg/m3
- Explosion-protected version (option)
- Vibration resistant version (option)
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- Up to 4 switch contacts per instrument
- Also available with case filling for high dynamic pressure loads or vibrations
- Instruments with inductive contacts for use in hazardous areas
- Instruments with contacts for PLC applications
- Instruments optionally available in safety version S3 per EN 837
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- Dead-space free installation in pipes
- Self-draining in all mounting positions
- Quick cleaning, without residue
- Suitable for SIP and CIP
- EHEDG-certified and 3-A-compliant
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- Case and wetted parts from stainless steel
- Wide choice of special materials
- High overload safety up to the 10-fold full scale value
- Process connection thread or open flange
- Scale ranges from 0 … 16 mbar
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- High measurement accuracy
- Freely scalable measuring ranges
- Developed in accordance with the SIL 2 requirements
- Seven different case variants
- Configuration via DTM (Device Type Manager) in accordance with the FDT (Field Device Tool) concept (e.g. PACTware™)
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- Model OTMT84: PROFIBUS® PA profile 3.02
- Model OTMT85: FOUNDATION™ Fieldbus H1
- Explosion-protected version Ex ia (intrinsically safe/FISCO) and Ex ec available
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- Dual mV/V display
- 2x digital input and 4x digital output
- Integrated multiple signal outputs available
- Serial interface, RS-232 or RS-485
- Ingress protection IP65
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- nominal pressure: from 0 ... 100 mbar up to 0 ... 40 bar
- accuracy: 0.5% / 0.35 % (opt. 0.25 %) FSO
- IO-Link according to specification V 1.1
- Smart sensor profile
- Data transfer 38.4 kBaud
- signal output switchable: PNP / NPN / 4 … 20 mA / 0 … 10 V
- indication of measured values on a 4-digit LED display
- rotatable and configurable display
- parametrization by IO-Link or set menu system (VDMA-conform)
- additional information via IO-Link
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The SITRANS P300 offers measuring precision and ruggedness. Its stainless steel housing with laser-printed nameplate, together with a wide range of hygienic process connections, mean that it is highly suitable for use in the food & beverages industry as well as for pharmaceutical processes.
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- Robust stainless steel drive-through scale for rapid weighing of e.g. laundry carts, container trolleys, roller containers, etc. Ideal for hospital laundry services, goods inwards, hospital kitchens, etc.
- Low platform height and integrated access ramps on both sides facilitate access.
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Weighing bridge: made entirely of stainless steel, extremely resistant to bending due to material thickness, protection against dust and water splashes IP68, 4 welded stainless load cells. Also available as component without the display device, KERN KFD-V40
- Ideal for the pharmaceutical and chemical industries
- Your support in a HACCP-compliant quality system
- Stainless steel display device with protection against dust and water splashes IP65: KERN KFN-TM
- For easy and hygienic cleaning
- Our floor scales are delivered in a robust wooden box. This protects the high-quality weighing technology from environmental influences and stresses during transportation.
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Installation instructions Drive-through balance
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- Ideal for the ever-increasing hygienic requirements in the food, pharmaceutical and chemical industries
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Ideal for the robust industrial applications
- Your support in a HACCP-compliant quality system
- High mobility: thanks to battery operation, compact construction and low weight, it is suitable for use in several locations such as production, kitchen, sales office etc.
- Stainless steel design of the housing and weighing plate. Its smooth surfaces make it simple to clean
- Recessed grips on the underside of the scale for easy transportation
- protection against dust and water splashes IP65 (only when using rechargeable battery pack)
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A combination of robust conductivity pocket meter and data logger for all who want to automatically capture and evaluate measured data with the help of a computer.
- Covers all standard and special measurements
- Pure water measurement according to pharmacopeia
- With built-in memory and data logger
- The versatile Cond 3310 is designed for conductivity measurements in changing media with different 2 and 4 pole measuring cells. With its large memory and its
- waterproof USB interface, this meter is ideal for the capture of large data volumes, e.g. for groundwater pumping tests including date, time and ID number. Via the
- interface, the data can be transferred to the computer and processed as needed.
The scope of delivery includes the MultiLab® Importer to collect data via Excel®.
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- Measuring ranges from 0 … 6 to 0 … 16 bar [0 ... 100 to 0 ... 200 psi] and from 0 … 200 to 0 … 400 bar [0 ... 3,000 to 0 ... 5,000 psi]
- Output signals 4 … 20 mA, DC 0 … 10 V, DC 0 … 5 V, DC 1 ... 5 V, DC 0.5 … 4.5 V ratiometric
- Oxygen clean in accordance with international standards
- Available in four levels of cleanliness
- Three packaging variants
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- nominal pressure: 0 ... 6 bar up to 0 ... 600 bar
- accuracy: 0.5 % FSO
- indication of measured values on a 4-digit LED display
- rotatable and configurable display module
- 1, 2 or 4 independent PNP contacts, freely configurable
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- Adjustable zero and span
- Oil fill meets FDA requirements
- Accuracy better than +/- 0.5%
- DyMaxTM coated convoluted SST wetted parts
- 0 - 5 Vdc output
- Internal 80% shunt calibration
- Easily adapt transmitter to process conditions
- Ideal for medical and food extrusion
- Repeatable, reliable pressure measurements
- Superior abrasion resistance
- Direct input to supervisory control systems
- Easy to set up
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- Simple, practical health tool for measuring body temperature
- Measurement accuracy less than 0.5 °C
- High temperature detection function based on the average of the people tested
- Minimized risk with a distance of 1.5 m maintained between the operator and the person tested
- Quick setup in any environment thanks to the tripod insert
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- 3.33 mV/V full scale output
- Accuracy of better than ±0.5%
- Pressure ranges from 0 - 500 psi to 0 - 10,000 psi
- All welded stainless steel with washdown capability
- FDA recognized safe (GRAS) for food and medical applications
- Available with hermetic connector or conduit fitting
- Internal 80% shunt calibration
- CE approved
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