Manufacture of Micronized Compounds
Capsugel’s Center of Excellence for micronization and nano-miling of biopharmaceutical compounds is located in Quakertown, PA (USA). We are a full service provider of particle size reduction and particle size control technologies that can be required for optimized dissolution rate, stability, flowability and other performance parameters.
Formerly Powdersize, Inc., Capsugel Quakertown has more than two decades of manufacturing experience in developing robust processes, and supplies micronized API throughout the product development from R&D assessments to ongoing commercial scale supply.
- FDA registered
- Excellent inspection record
- 115,000 square foot facility
- 7cGMP suites with independent air-handling units, HEPA filtration, temperature and humidity controls
- Phase-appropriate mill designs and processing
- High containment capability
Micronization through jet-milling is used for APIs that require 1-10 micrometers average particle size to achieve target performance. Particle sizing and distribution is optimized by the variation in mill pressure, feed rate and proprietary mill design attributes.
High Potency Compounds
High containment capabilities support particle size reduction of highly potent or cytotoxic compounds. A range of mechanical and jet milling capabilities are available within an isolator designed to meet containment levels down to 1 microgram / m3 at scales from 2-100 kg batch sizes. The isolator provides a negative pressure nitrogen environment, double HEPA filtration, RTP transfer ports and CIP capability.
A Netzsch Delta Vita media mill, a nanoparticle milling solution, provides additional size reduction to nano-scale particles where required. The Delta Vita is utilized for wet grinding of batches ranging from 15mL to 60mL, and complements our wet-milled suspension equipment and overall bioavailability technology offering.