In-line 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 to use of 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 K-PATENTS® Pharma Refractometer is specially designed for pharmaceutical and biotechnology processes offering reliable, continuous in-line 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 K-PATENTS Pharma 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 K-PATENTS Pharma Refractometer can reduce drug development time. 
 

Continuous and accurate in-line measurements

Vaisala K-PATENTS Pharma 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. 

Blogs, webinars and success stories

Vaisala K-PATENTS process refractometers for pharmaceutical manufacturing

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. 

 

Fast and efficient viral vaccines purification by sucrose density gradient

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.

K-Patents Webinar: The Benefits of Refractive Index (RI) in Development and Production of Active Pharmaceutical Ingredients (APIs)

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. 

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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.