Pharmaceutical drug manufacturing and biotechnology processing 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.Traceable calibration and verification. 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 penicillin 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. 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 Read more Related articles Webinar How to verify a Vaisala inline process refractometer Learn what equipment and materials are needed, why room temperature is important, and how to ensure the equipment temperature is stable. Register to watch Blog Questions from our refractometer verification webinar We held a brief webinar on how to perform a refractometer verification. We received questions we didn't have time to answer, so along with emailing our answers, we are sharing them in this blog. Learn more eBook Refractive index for pharmaceutical and biotechnology manufacturing The measurement provides profound understanding of the process through continuous data collection, and without the risk of contamination. Download Customer Case Environmental monitoring helps VisionGift provide restored sight & renewed life VisionGift has used the viewLinc Continuous Monitoring System since 2011. Previously, most records of environmental conditions were generated by chart recorders and manual records. Learn more Blog 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. Learn more Webinar 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. Register to watch Webinar The benefits of refractive index (RI) 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. Register to watch 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
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 Read more
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 Read more
