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.
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.
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.
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.
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.
Monitor your solvent swap operation during API production by measuring the concentrations of the original and swap solvents.
Determine exact seeding point and yield only high-quality crystals during API production.
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.
Measure liquid phase in aspirin (acetylsalicylic acid) crystallization and control your crystallization process.
Always achieve your target extract concentration during solid-liquid extraction (leaching).
Timely measurements for the development and monitoring of biopharmaceuticals processing such as fermentation, cell culture, protein buffer solutions and concentration.
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.
Collect only the virus fraction with correct density for best yield in purification operations/downstream processes.
Control retentate concentration for good permeability even with the smallest of particles.
Measure concentration of raw penicillin, monitor fermentation process and maintain optimal conditions with high yield during production.
Control your evaporation process with an industrial process refractometer.
Measure protein concentration safely inline and real-time, control retentate concentration precisely for optimal permeability
Wound dressing, medical implants manufacturing and medical protective wear.
Monitor alginate dope solution and coagulation bath concentrations in wet-spinning for operations for best fiber quality.
Monitor and control acid (for example nitric acid HNO3) during medical parts passivation to meet product specifications.
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.
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.
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.
Learn from real customer cases how in-line process refractometers can be used as a PAT tool for
standardizing and scaling-up APIs production.
Only some examples of our refractometer applications are listed here. There are still hundreds more!
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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.