Particle Size Engineering
Catalent Micron Technologies – The First Name in Micronization™
Catalent Micron Technologies is a leading international provider of particle size reduction and analytical services. We deliver first-class pharmaceutical contract micronization, milling and analytical services combining quality, speed of response and know-how.
Micron Technologies has more than 25 years experience handling pharmaceutical materials and is a leader in air jet milling micronization. We are capable of processing both R&D and commercial volumes alike and are equipped with state of the art systems to ensure total product containment and quality.
Proven, dependable, and extremely versatile, micronization is the most efficient, cost effective way to achieve top quality particle size reduction results.
Key benefits of micronization with Catalent Micron Technologies:
- Proven – leading know-how, established process used for decades, well understood by regulators
- Versatile – working effectively across a wide range of oral and inhaled products
- Scalable – enabling optimization and control of particle size, from R&D to commercial scale
- Dependable – producing high yields consistently compared to alternate particle size technologies
- Precise – using critical process parameters to support regulatory submission expectations
Catalent Micron Technologies is the preferred solution provider for the most complex, specialized requirements in micronization, we have the expertise to handle your toughest specifications.
Full range of capabilities in particle size reduction including:
- Mechanical milling
- Cryogenic milling
- Highly potent and cytotoxic compounds
- Comprehensive analytical services
Bioavailability Solutions Toolkit
Catalent can now support your R&D teams earlier in the development cycle with an unrivaled set of bioavailability solutions in the industry.
From API optimization, particle size optimization and formulation services, to drug delivery technology selection and final dose form design services, Catalent can help you at the earliest stages of the drug development process and provide end-to-end solutions to accelerate your programs to clinic and to market, utilizing our broadest expertise, best technologies and rigorous science including:
- Optiform® API screening and optimization platform
- FormProRx™ selection tool for optimal finished dose
- Preformulation/Formulation expertise including:
- Clinical packaging and integrated clinical supply solutions
- Global clinical and commercial manufacturing capabilities
- Highly potent and cytotoxic drug handling
Quality by Design (QbD)
Catalent Micron Technologies understands the challenges in technology transfer and lean manufacturing and will provide expertise in milling/micronization to assist our clients with their Quality by Design (QbD) initiatives. We will develop screening and optimization Design of Experiment (DOE) protocols, conduct well-defined milling/micronization runs, and provide insightful risk assessment to custom develop the optimal design space individualized to our client's product. Our QbD offerings are in response to our dedicated customer support to help our client's in their continuous process improvements, cost savings, and regulatory flexibility.
Catalent Micron Technologies operates two state-of-the-art facilities cGMP facilities, and employs approximately 100 people across its 84,000 sq. ft. facility in Malvern, PA and its 19,000 sq. ft. facility in Dartford, U.K. Both facilities have successfully passed all required regulatory inspections and their quality systems have been successfully audited by more than 200 pharmaceutical companies worldwide.