Quakertown, Pennsylvania, USA

Powdersize is Capsugel’s Center of Excellence providing expertise in particle size reduction and particle size control technologies intended for powders used within the pharmaceutical, medical and food marketplaces. Our team at Powdersize can develop a robust process at any scale of development, including R&D, pilot scale or commercial scale.

Technology Expertise

GMP Facility

Our state-of-the art facility consists of several suites designed to suit the needs of each project, described below. We also have an immaculate temperature controlled warehouse space with over 30,000 sq ft of storage space. cGMP documentation and handling practices are maintained for materials received and shipped from the facility. Prior to processing, raw material samples can be pulled within a controlled environment for identity or purity testing.

High-Potency Milling Suite

Safe and effective means of micronizing potent compounds is provided by utilizing a universal milling isolator to serve as a primary containment. Verified processing procedures throughout the full range of handing including micronization, QC testing and cleaning demonstrates the ability to safely handle compounds and provide OEL’s < 10 ng/m^3. A range of milling equipment trains are available to accommodate capacities from gram to early stage commercial production.

Processing Suite

Designed for continuous or batch processing, each commercial scale milling suite offers ample space for processing flexibility for both single step or multiple step (milling/classification) unit operations as the need dictates. Input material can be provided in bags, drums or totes while Powdersize is able to output material in a variety of drum sizes or high capacity totes as the customer prefers.

Developmental Suite

The developmental suite is used both to evaluate new products and to process small scale batches for clinical trials or R&D use. With low system loss, the pilot equipment is an ideal choice for high value pharmaceuticals where yield is critical.  Multiple sized jet mills are available within the developmental laboratory depending on incoming batch size.

Analytical Lab

A fully equipped Quality Control Laboratory is available to perform all in-process and final product particle size analyses. Additionally, analytical instrumentation is available to measure product residual levels associated with verification and validation of cleaning procedures. Certificates of Particle Size Analysis are provided for all lots of finished product.

Equipment Cleaning

A state of the art cleaning area is available to ensure a high throughput, streamlined cleaning process. A wide range of validated detergents; sonication baths, high pressure rinse equipment and soaking tubs are available to facilitate the removal of the most difficult materials. The water used to clean the equipment is free from microbial activity through UV-light treatment; micro-filtration; continuous re-circulation at elevated temperatures and monitored with quarterly testing.


A robust set of quality systems are in place to comply with regulations defined in part 210/211 of CFR 21 and the expectations described in ICH’s Q7 guidance for API manufacturing. With continuous dialog with FDA, client’s quality assurance and industry associations Powdersize continually evaluates systems in an effort to improve quality and reduce patient risk.