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)
Solvent swap or solvent exchange
Pharmaceutical crystallization
Filter cake washing
Aspirin crystallization
Pharmaceutical extraction: herbal-based medicine
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
Vaccines production
Protein concentration and filtration
Penicillin production
L-Lysine evaporation process
Blood plasma intermediate ultrafiltration
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
Medical implants and device surface treatments
Dipping baths in rubber and medical gloves manufacturing
Pharmaceutical drug manufacturing and biotechnology processing related products
Vaisala Polaris™ PR53AC Process Refractometer
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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.
