In-line Liquid Concentration Measurements

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.

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.

Timely measurements for the development and monitoring of biopharmaceuticals processing such as fermentation, cell culture, protein buffer solutions and concentration.

Wound dressing, medical implants manufacturing and medical protective wear.