Inline liquid concentration measurements for pharmaceutical drug manufacturing and biotechnology processes: Increase yield, produce on-spec products always and lower production costs Drug development and manufacturing is highly regulated to ensure safety, efficacy, and quality. An important initiative to boost innovation and support efficiency is the Process Analytical Technology (PAT) by the FDA. It is a framework for innovative pharmaceutical development, manufacturing, and quality assurance. PAT encourages using the latest scientific advantages and technology in pharmaceutical manufacturing as well as continuous, real-time quality assurance during processing. Continuous manufacturing (CM) is the new industry trend with many identified benefits over traditional batch-based manufacturing. Successfully implementing PAT or CM requires real-time sensors and measurement equipment. Vaisala Polaris Process Refractometer is suitable for pharmaceutical and biotechnology processes offering reliable, continuous inline concentration measurements for a wide range of applications, such as Active Pharmaceutical Ingredients (API), vitamins, herbal-based medicine, vaccines, penicillin as well as medical protective wear, wound dressings, and medical implants manufacturing. Quality, safety and efficacy by design The reliable measurement and data provided by the Vaisala Polaris process refractometer help to understand critical process parameters (CPP), process conditions, and elevate process understanding and fully supports continuous manufacturing. Importantly, this refractometer can help to meet the regulatory requirements for validating, quality, and controlling the manufacturing processes. In addition, continuous in-line measurements, and provided data help to reduce production cycle times, increase production capability, prevent rejects, abolish human errors in manufacturing and provide high quality and safe products with minimum variability. In drug manufacturing, this technological innovation can be used from laboratory-scale to pilot batches that are used in process development to the production-scale batches needed to support commercialization. In the R&D phase, using the Vaisala Polaris process refractometer can reduce drug development time. Continuous and accurate inline measurements Vaisala Polaris process refractometers provide continuous and accurate, reliable, repeatable, and reproducible measurements for applications aligned with Process Analytical Technology (PAT) manufacturing methods. • Process data for every batch or lot via Ethernet. • Aids in compliance with cGMP (Current Good Manufacturing Practice) • Sanitary 3-A and EHEDG certified. • Audit trail and access controls for 21 CFR Part 11 compliance. • Traceable calibration and verification. • IQ/OQ documentation for validation. Applications in pharmaceuticals manufacturing Active Pharmaceutical Ingredients (API) production and pharmaceuticals processing at all scales in small molecules medicines manufacturing, and throughout the manufacturing line from reaction monitoring to downstream processes such as crystallization and filter cake washing. Download our application notes for more information. Production of Active Pharmaceutical Ingredients (API) Real-time concentration measurements during reaction, crystallization, separation and purification, filter cake washing, solvent swap and solvent exchange for the development and production of APIs. Solvent swap or solvent exchange Monitor your solvent swap operation during API production by measuring the concentrations of the original and swap solvents. Pharmaceutical crystallization Determine exact seeding point and yield only high-quality crystals during API production. Filter cake washing Acquire deep process understanding by measurement data, develop unique washing profiles and find the most suitable washing solvent for increased yield and maximum wash result. Aspirin crystallization Measure liquid phase in aspirin (acetylsalicylic acid) crystallization and control your crystallization process. Pharmaceutical extraction: herbal-based medicine Always achieve your target extract concentration during solid-liquid extraction (leaching). Applications in biotechnology processes Timely measurements for the development and monitoring of biopharmaceuticals processing such as fermentation, cell culture, protein buffer solutions and concentration. Download our application notes for more information. Pharmaceutical fermentation Measurement solutions for standardizing and automating processes. From fermentation profile design to scale-up and for determining the endpoint of fermentation instantly and reliably with no deviations on full-scale production. Vaccines production Collect only the virus fraction with correct density for best yield in purification operations/downstream processes. Protein concentration and filtration Control retentate concentration for good permeability even with the smallest of particles. Penicillin production Measure concentration of raw penicillin, monitor fermentation process and maintain optimal conditions with high yield during production. L-Lysine evaporation process Control your evaporation process with an industrial process refractometer. Blood plasma intermediate ultrafiltration Measure protein concentration safely inline and real-time, control retentate concentration precisely for optimal permeability Medical applications Wound dressing, medical implants manufacturing and medical protective wear. Download our application notes for more information. Alginate wound dressings and fabrics Monitor alginate dope solution and coagulation bath concentrations in wet-spinning for operations for best fiber quality. Medical implants and device surface treatments Monitor and control acid (for example nitric acid HNO3) during medical parts passivation to meet product specifications. Dipping baths in rubber and medical gloves manufacturing Ensure protective clothing's critical final quality and durability by measuring Total Dissolved Solids (TDS) in liquid latex, nitrile, vinyl or synthetic polyisoprene dipping baths. Pharmaceutical drug manufacturing and biotechnology processing related products Vaisala Polaris™ PR53AC Process Refractometer Measure Brix and other liquid concentrations with instant productivity and material gains, and simplified process operation for food, beverage, dairy and brewery manufacturing Blogs, webinars and success stories Blog | Feb 4, 2023 Questions from our refractometer verification webinar In December we held a brief webinar on how to perform a refractometer verification. We received questions we didn't have time to answer, so... Read more Blog | Dec 14, 2022 Perfecting solvent swap processes with refractive index trend data This blog is first in a three-part series on how in-line process refractometers can optimize API processes. The creation of Active... Read more Blog | Mar 15, 2022 Questions & Answers on using refractive index in blood plasma intermediate ultrafiltration In case you missed our webinar “Using refractive index to ensure quality & safety in blood plasma intermediate ultrafiltration” you can watch... Read more Blog | Jan 26, 2021 Built to fit: Medical gloves and Vaisala K-PATENTS® Process Refractometers COVID has created unprecedented demand for medical gloves that may outlast the pandemic. Many factories are turning to process refractometers to... Read more Blog | Jan 13, 2021 Measurement technologies making a difference during the COVID-19 pandemic PDF version Supporting pharmaceutical quality, safety, and efficacy Even before the coronavirus pandemic, health and well-being featured highly... Read more Blog | Jun 23, 2020 Q&A from our webinar: Fast and efficient viral vaccines purification by sucrose density gradient In this blog, we answer questions we received during our webinar "Fast and efficient viral vaccines purification by sucrose density gradient"... Read more Blog | May 19, 2020 The six most important things to consider when selecting an in-line liquid measurement device for pharmaceutical drug manufacturing Pharmaceutical and medicine manufacturing are among the most regulated industries with pharmacovigilance or in short drug safety, quality and... Read more Blog | Feb 19, 2020 Making viral vaccines: Path to improved health Vaccinations are important for public health, preventing the spread of contagious, dangerous, and potentially deadly diseases, such as polio... Read more Customer case Developing and manufacturing accurate reproducible APIs The measurement of refractive index (RI) is employed by a wide variety of industries to determine the level of dissolved solids in liquids. This... Read more Blog | Sep 13, 2019 A deep-dive into the technology of liquid concentration measurements with refractive index End of 2018, Vaisala acquired Finnish K-Patents Group, a pioneer in in-line liquid measurements for industrial applications. The acquisition... Read more Blog | May 24, 2019 Liquid Measurements in Pharma Manufacturing: Refractive Index as a PAT Tool A fundamental transformation has started in the pharma industry with a change in the regulatory environment towards supporting the adoption of... Read more How to verify a Vaisala inline process refractometer In this webinar, Vaisala product engineer Maria Nyman demonstrates verification of a Vaisala refractometer. Learn what equipment and materials are needed, why room temperature is important, and how to ensure the equipment temperature is stable. Learn more Refractive index for pharmaceutical and biotechnology manufacturing Ensure safe, consistently high-quality products with minimal variability with Vaisala's robust measurement technology. In-line, real-time measurement is the prerequisite for PAT. Read from our eBook how manufacturers can monitor critical quality attributes, prevent rejects and ensure high-quality products with minimum variability. Download the eBook Fast and efficient viral vaccines purification by sucrose density gradient In this 30-minute webinar (+ 15 minutes for Q&A), Vaisala's Liquid Measurements pharmaceutical experts will explain the benefits of the refractive index technology and how it helps downstream processes during purification of viral vaccines manufacturing. Watch the webinar Refractive index in development and production of Active Pharmaceutical Ingredients (APIs) Learn from real customer cases how in-line process refractometers can be used as a PAT tool for standardizing and scaling-up APIs production. Watch the webinar Can't find your application? Only some examples of our refractometer applications are listed here. There are still hundreds more! Our application experts will help you. Tell us a bit more by filling the form or contact us. Contact Form Liquid concentration measurement Vaisala offers a wide range of products tailored to liquid measuring needs of different industries. Learn more about the refractometer technology and its applications, and visit the library of product related assets. LEARN MORE
Inline liquid concentration measurements for pharmaceutical drug manufacturing and biotechnology processes: Increase yield, produce on-spec products always and lower production costs
Quality, safety and efficacy by design The reliable measurement and data provided by the Vaisala Polaris process refractometer help to understand critical process parameters (CPP), process conditions, and elevate process understanding and fully supports continuous manufacturing. Importantly, this refractometer can help to meet the regulatory requirements for validating, quality, and controlling the manufacturing processes. In addition, continuous in-line measurements, and provided data help to reduce production cycle times, increase production capability, prevent rejects, abolish human errors in manufacturing and provide high quality and safe products with minimum variability. In drug manufacturing, this technological innovation can be used from laboratory-scale to pilot batches that are used in process development to the production-scale batches needed to support commercialization. In the R&D phase, using the Vaisala Polaris process refractometer can reduce drug development time.
Vaisala Polaris process refractometers provide continuous and accurate, reliable, repeatable, and reproducible measurements for applications aligned with Process Analytical Technology (PAT) manufacturing methods. • Process data for every batch or lot via Ethernet. • Aids in compliance with cGMP (Current Good Manufacturing Practice) • Sanitary 3-A and EHEDG certified. • Audit trail and access controls for 21 CFR Part 11 compliance. • Traceable calibration and verification. • IQ/OQ documentation for validation.
Applications in pharmaceuticals manufacturing Active Pharmaceutical Ingredients (API) production and pharmaceuticals processing at all scales in small molecules medicines manufacturing, and throughout the manufacturing line from reaction monitoring to downstream processes such as crystallization and filter cake washing. Download our application notes for more information. Production of Active Pharmaceutical Ingredients (API) Real-time concentration measurements during reaction, crystallization, separation and purification, filter cake washing, solvent swap and solvent exchange for the development and production of APIs. Solvent swap or solvent exchange Monitor your solvent swap operation during API production by measuring the concentrations of the original and swap solvents. Pharmaceutical crystallization Determine exact seeding point and yield only high-quality crystals during API production. Filter cake washing Acquire deep process understanding by measurement data, develop unique washing profiles and find the most suitable washing solvent for increased yield and maximum wash result. Aspirin crystallization Measure liquid phase in aspirin (acetylsalicylic acid) crystallization and control your crystallization process. Pharmaceutical extraction: herbal-based medicine Always achieve your target extract concentration during solid-liquid extraction (leaching).
Production of Active Pharmaceutical Ingredients (API) Real-time concentration measurements during reaction, crystallization, separation and purification, filter cake washing, solvent swap and solvent exchange for the development and production of APIs.
Solvent swap or solvent exchange Monitor your solvent swap operation during API production by measuring the concentrations of the original and swap solvents.
Pharmaceutical crystallization Determine exact seeding point and yield only high-quality crystals during API production.
Filter cake washing Acquire deep process understanding by measurement data, develop unique washing profiles and find the most suitable washing solvent for increased yield and maximum wash result.
Aspirin crystallization Measure liquid phase in aspirin (acetylsalicylic acid) crystallization and control your crystallization process.
Pharmaceutical extraction: herbal-based medicine Always achieve your target extract concentration during solid-liquid extraction (leaching).
Applications in biotechnology processes Timely measurements for the development and monitoring of biopharmaceuticals processing such as fermentation, cell culture, protein buffer solutions and concentration. Download our application notes for more information. Pharmaceutical fermentation Measurement solutions for standardizing and automating processes. From fermentation profile design to scale-up and for determining the endpoint of fermentation instantly and reliably with no deviations on full-scale production. Vaccines production Collect only the virus fraction with correct density for best yield in purification operations/downstream processes. Protein concentration and filtration Control retentate concentration for good permeability even with the smallest of particles. Penicillin production Measure concentration of raw penicillin, monitor fermentation process and maintain optimal conditions with high yield during production. L-Lysine evaporation process Control your evaporation process with an industrial process refractometer. Blood plasma intermediate ultrafiltration Measure protein concentration safely inline and real-time, control retentate concentration precisely for optimal permeability
Pharmaceutical fermentation Measurement solutions for standardizing and automating processes. From fermentation profile design to scale-up and for determining the endpoint of fermentation instantly and reliably with no deviations on full-scale production.
Vaccines production Collect only the virus fraction with correct density for best yield in purification operations/downstream processes.
Protein concentration and filtration Control retentate concentration for good permeability even with the smallest of particles.
Penicillin production Measure concentration of raw penicillin, monitor fermentation process and maintain optimal conditions with high yield during production.
L-Lysine evaporation process Control your evaporation process with an industrial process refractometer.
Blood plasma intermediate ultrafiltration Measure protein concentration safely inline and real-time, control retentate concentration precisely for optimal permeability
Medical applications Wound dressing, medical implants manufacturing and medical protective wear. Download our application notes for more information. Alginate wound dressings and fabrics Monitor alginate dope solution and coagulation bath concentrations in wet-spinning for operations for best fiber quality. Medical implants and device surface treatments Monitor and control acid (for example nitric acid HNO3) during medical parts passivation to meet product specifications. Dipping baths in rubber and medical gloves manufacturing Ensure protective clothing's critical final quality and durability by measuring Total Dissolved Solids (TDS) in liquid latex, nitrile, vinyl or synthetic polyisoprene dipping baths.
Alginate wound dressings and fabrics Monitor alginate dope solution and coagulation bath concentrations in wet-spinning for operations for best fiber quality.
Medical implants and device surface treatments Monitor and control acid (for example nitric acid HNO3) during medical parts passivation to meet product specifications.
Dipping baths in rubber and medical gloves manufacturing Ensure protective clothing's critical final quality and durability by measuring Total Dissolved Solids (TDS) in liquid latex, nitrile, vinyl or synthetic polyisoprene dipping baths.
Pharmaceutical drug manufacturing and biotechnology processing related products Vaisala Polaris™ PR53AC Process Refractometer Measure Brix and other liquid concentrations with instant productivity and material gains, and simplified process operation for food, beverage, dairy and brewery manufacturing
Vaisala Polaris™ PR53AC Process Refractometer Measure Brix and other liquid concentrations with instant productivity and material gains, and simplified process operation for food, beverage, dairy and brewery manufacturing
Blogs, webinars and success stories Blog | Feb 4, 2023 Questions from our refractometer verification webinar In December we held a brief webinar on how to perform a refractometer verification. We received questions we didn't have time to answer, so... Read more Blog | Dec 14, 2022 Perfecting solvent swap processes with refractive index trend data This blog is first in a three-part series on how in-line process refractometers can optimize API processes. The creation of Active... Read more Blog | Mar 15, 2022 Questions & Answers on using refractive index in blood plasma intermediate ultrafiltration In case you missed our webinar “Using refractive index to ensure quality & safety in blood plasma intermediate ultrafiltration” you can watch... Read more Blog | Jan 26, 2021 Built to fit: Medical gloves and Vaisala K-PATENTS® Process Refractometers COVID has created unprecedented demand for medical gloves that may outlast the pandemic. Many factories are turning to process refractometers to... Read more Blog | Jan 13, 2021 Measurement technologies making a difference during the COVID-19 pandemic PDF version Supporting pharmaceutical quality, safety, and efficacy Even before the coronavirus pandemic, health and well-being featured highly... Read more Blog | Jun 23, 2020 Q&A from our webinar: Fast and efficient viral vaccines purification by sucrose density gradient In this blog, we answer questions we received during our webinar "Fast and efficient viral vaccines purification by sucrose density gradient"... Read more Blog | May 19, 2020 The six most important things to consider when selecting an in-line liquid measurement device for pharmaceutical drug manufacturing Pharmaceutical and medicine manufacturing are among the most regulated industries with pharmacovigilance or in short drug safety, quality and... Read more Blog | Feb 19, 2020 Making viral vaccines: Path to improved health Vaccinations are important for public health, preventing the spread of contagious, dangerous, and potentially deadly diseases, such as polio... Read more Customer case Developing and manufacturing accurate reproducible APIs The measurement of refractive index (RI) is employed by a wide variety of industries to determine the level of dissolved solids in liquids. This... Read more Blog | Sep 13, 2019 A deep-dive into the technology of liquid concentration measurements with refractive index End of 2018, Vaisala acquired Finnish K-Patents Group, a pioneer in in-line liquid measurements for industrial applications. The acquisition... Read more Blog | May 24, 2019 Liquid Measurements in Pharma Manufacturing: Refractive Index as a PAT Tool A fundamental transformation has started in the pharma industry with a change in the regulatory environment towards supporting the adoption of... Read more
Blog | Feb 4, 2023 Questions from our refractometer verification webinar In December we held a brief webinar on how to perform a refractometer verification. We received questions we didn't have time to answer, so... Read more
Blog | Dec 14, 2022 Perfecting solvent swap processes with refractive index trend data This blog is first in a three-part series on how in-line process refractometers can optimize API processes. The creation of Active... Read more
Blog | Mar 15, 2022 Questions & Answers on using refractive index in blood plasma intermediate ultrafiltration In case you missed our webinar “Using refractive index to ensure quality & safety in blood plasma intermediate ultrafiltration” you can watch... Read more
Blog | Jan 26, 2021 Built to fit: Medical gloves and Vaisala K-PATENTS® Process Refractometers COVID has created unprecedented demand for medical gloves that may outlast the pandemic. Many factories are turning to process refractometers to... Read more
Blog | Jan 13, 2021 Measurement technologies making a difference during the COVID-19 pandemic PDF version Supporting pharmaceutical quality, safety, and efficacy Even before the coronavirus pandemic, health and well-being featured highly... Read more
Blog | Jun 23, 2020 Q&A from our webinar: Fast and efficient viral vaccines purification by sucrose density gradient In this blog, we answer questions we received during our webinar "Fast and efficient viral vaccines purification by sucrose density gradient"... Read more
Blog | May 19, 2020 The six most important things to consider when selecting an in-line liquid measurement device for pharmaceutical drug manufacturing Pharmaceutical and medicine manufacturing are among the most regulated industries with pharmacovigilance or in short drug safety, quality and... Read more
Blog | Feb 19, 2020 Making viral vaccines: Path to improved health Vaccinations are important for public health, preventing the spread of contagious, dangerous, and potentially deadly diseases, such as polio... Read more
Customer case Developing and manufacturing accurate reproducible APIs The measurement of refractive index (RI) is employed by a wide variety of industries to determine the level of dissolved solids in liquids. This... Read more
Blog | Sep 13, 2019 A deep-dive into the technology of liquid concentration measurements with refractive index End of 2018, Vaisala acquired Finnish K-Patents Group, a pioneer in in-line liquid measurements for industrial applications. The acquisition... Read more
Blog | May 24, 2019 Liquid Measurements in Pharma Manufacturing: Refractive Index as a PAT Tool A fundamental transformation has started in the pharma industry with a change in the regulatory environment towards supporting the adoption of... Read more
How to verify a Vaisala inline process refractometer In this webinar, Vaisala product engineer Maria Nyman demonstrates verification of a Vaisala refractometer. Learn what equipment and materials are needed, why room temperature is important, and how to ensure the equipment temperature is stable. Learn more
Refractive index for pharmaceutical and biotechnology manufacturing Ensure safe, consistently high-quality products with minimal variability with Vaisala's robust measurement technology. In-line, real-time measurement is the prerequisite for PAT. Read from our eBook how manufacturers can monitor critical quality attributes, prevent rejects and ensure high-quality products with minimum variability. Download the eBook
Fast and efficient viral vaccines purification by sucrose density gradient In this 30-minute webinar (+ 15 minutes for Q&A), Vaisala's Liquid Measurements pharmaceutical experts will explain the benefits of the refractive index technology and how it helps downstream processes during purification of viral vaccines manufacturing. Watch the webinar
Refractive index in development and production of Active Pharmaceutical Ingredients (APIs) Learn from real customer cases how in-line process refractometers can be used as a PAT tool for standardizing and scaling-up APIs production. Watch the webinar
Can't find your application? Only some examples of our refractometer applications are listed here. There are still hundreds more! Our application experts will help you. Tell us a bit more by filling the form or contact us. Contact Form
Liquid concentration measurement Vaisala offers a wide range of products tailored to liquid measuring needs of different industries. Learn more about the refractometer technology and its applications, and visit the library of product related assets. LEARN MORE
