Pharmaceutical Industry

Jet milling micronization reduces particle size through particle-particle impact controlled by classifier wheel speed and feed rate. Pushing the cut point lower can raise amorphous surface content and hygroscopicity in ways a passing PSD result will not reveal. This guide covers the mechanism and the tests that actually diagnose a changed lot.

LED-based particle image velocimetry (PIV) images the velocity field inside a moving powder bed during blending, adding spatial resolution that static angle of repose, Hausner ratio, and shear cell tests cannot provide. Here is what that resolution can and cannot support for a process decision.

Vacuum conveying contains by default: any breach draws air inward rather than pushing powder out. That containment advantage comes with a fixed pressure budget, and filter design competes directly with conveying velocity for every millibar of available driving force.

Co-processing engineers particle morphology, density, and surface structure into a single composite excipient particle. Flow function and compactibility testing show what that buys formulators on continuous direct compression lines, and where it does not.

The power or torque trace in high-shear wet granulation rises and plateaus as granules consolidate, but the signal is a supporting process indicator, not a direct particle size measurement, and its interpretation is bounded by batch size, impeller geometry, and formulation.

A Pharmaceutical Research study trained Random Forest and XGBoost classifiers on particle size, shape, surface energy, and silica dry-coating data to predict powder blend flowability category. The accuracy holds up as a screening tool and breaks down in specific, predictable places.

FDA's proposed hub-and-spoke registration rule treats geographically separate manufacturing units as one establishment. The registration paperwork is new; proving that blend uniformity, granulation endpoints, and moisture behavior actually match between sites is the older, harder problem.

Two lots that pass the same incoming flowability spec can still granulate differently after roller compaction. The reason usually traces to ribbon density, which responds to roll force, gap width, and feed screw speed as an interacting set, not to roll pressure in isolation.

Geldart classification, minimum fluidization velocity, bubble dynamics, droplet-to-particle size ratio, and permeability all determine whether a fluidized bed process delivers controlled granule growth, uniform coating, or consistent drying at production scale.

Process analytical technology combined with machine learning is changing residual moisture control and yield prediction in pharmaceutical and food spray drying. The gains are real but bounded, and the off-line test panel has not been replaced.

Poorly soluble APIs now represent the majority of the pharmaceutical development pipeline. Dissolution and oral bioavailability are determined by molecular solubility, surface wetting behavior, solid-state stability, and how the formulation interacts with the GI environment from first contact onward. Amorphous dispersions, lipid systems, nanocrystals, and co-crystals each rely on different surface mechanisms to deliver their intended advantage.

Universal dust explosivity criteria fail because explosibility depends on dispersion, turbulence, ignition, [...]