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
