Rhodes Technologies recently added micronization to our cGMP API manufacturing facility, which is considered to be one of the most advanced micronization suites in the Northeast Pharmaceutical Corridor. Equipped with state-of-the-art jet mills and Fitzmills, these suited became an important addition to ourmanufacturing process allowing us too manufacture world-class products.

Particle size reduction in our jet mills is accomplished by particle-to-particle collisions in a high-velocity stream of nitrogen. Centrifugal forces retain larger particles in the mill while smaller particles meeting specifications are carried out of the mill by a nitrogen stream and are collected in an explosive-resistant dust collector system.

Micronization rooms and equipment designed for thorough cleaning and to prevent cross-contamination

• Separate rooms for gowning, raw materials staging, milling, degowning, and air shower

• Flexible equipment configurations to match process requirements

• Gravimetric feed control system

• Single pass air handling system; temperature and humidity controlled year-round

• Ventilation system designed to prevent cross contamination and provide dust control

• 10 bar PSR design for explosion containment

• Milling with nitrogen gas for moisture or heat sensitive materials

API micronization in our manufacturing process includes and employs:

• Process validation and complete cGMP documentation

• Process development and production batches

• Mill sizes include 2", 8" and 12" air jet mills, for gram to ton lot quantities

• Laser diffraction particle size analyzer