Blue Ocean Nova On-line Proces Analyzers for Solids
Lighthouse Probe (LHP)
Patended process interface with radial orientation of multiple measurement windows, designed for powders and bulk material. The radial orientation if the measurement windows allows for inline cleaning and recalibration.
Moisture in powders and bulk materials
Water is one of the strongest absorbing compounds in the NIR spectral region and can therefore be measured at very low concentrations. NIR spectroscopy is an efficient alternative to traditional analytical methods such as Karl Fisher (KF) titration for quantifying moisture concentrations. Blue Ocean Nova’s moisture sensors are measuring moisture via diffuse reflectance from the powder blend in real-time. The targeted concentration range determines the optical technology in the moisture sensor. In the pharmaceutical industry, the moisture content affects the flow, caking, compaction and strength properties and is usually above 1%. In the chemical industry concentrations of well below 1% are required to maintain the optimal chemical, physical and microbial product properties. Dependent on the target concentration, the sensor utilizes NIR techniques for concentrations down to 1% with +/- 0.3% accuracy, or MIR for concentrations below 1%.
Material properties, such as viscosity, moisture, temperature and pressure, etc., are causing a phenomenon called “window fowling”, a buildup of analyte on the probe window. A patented automatic self-cleaning mechanism allows the prevention of “window fowling” without any interruption of the process and thereby allowing the use in continuous manufacturing processes.
Pharmaceutical powder blends
Due to the FDA’s PAT initiative, NIR spectroscopy has become the most utilized spectroscopy technique for pharmaceutical manufacturing processes, next to UV and fluorescence based techniques. The applications range from various processing operations of powder mixes, such as blend monitoring for homogeneous mixing of APIs and excipients, drying and granulation, to tablet pressing and measuring of content uniformity of the API in the final tablet. NIR spectroscopy is also used for validation of drug authenticity and verification of dosage concentration. UV spectroscopy is mostly used for cleaning validation (CIP) across virtually all manufacturing industries.
Blue Ocean Nova’s products are compliant with all regulatory (FDA) requirements (cGMP, 21CFR part 11).