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. 

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.  

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. 

Penicillin production

Measure concentration of raw penicillin, monitor fermentation process and maintain optimal conditions with high yield during production. 

Medical applications

Wound dressing, medical implants manufacturing and medical protective wear. 

Download our application notes for more information. 

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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.