In pharmaceutical manufacturing, precision is non-negotiable. From bioavailability to dosing uniformity, particle size plays a central role in how active pharmaceutical ingredients (APIs) perform. As regulatory expectations tighten and formulation demands grow more complex, manufacturers require micronization equipment that delivers ultra-fine powders with exacting consistency batch after batch.
Sturtevant’s Pharmaceutical Micronizer is the industry’s most widely adopted jet mill for pharmaceutical applications, trusted by top global producers for its ability to reduce particles to sub-10 micron sizes without heat, contamination, or mechanical wear. Engineered specifically for pharmaceutical-grade materials, it supports everything from early-stage development to validated commercial production, offering scalable performance and documented compliance every step of the way.
With a sanitary, tool-free design that meets USDA and FDA standards and the ability to process materials down to 0.25 microns, the Micronizer sets the standard for pharmaceutical micronization, supporting better dissolution, enhanced absorption, and more predictable therapeutic outcomes.
Why Micronization Is Essential in Pharma
In pharmaceutical manufacturing, micronization is not simply a method—it is a requirement for performance, consistency, and regulatory compliance. Reducing particle size down to the micron or sub-micron level directly influences how a drug behaves once administered. The science is clear: finer particles increase surface area, which improves solubility, bioavailability, and absorption.
For APIs that are poorly soluble or require precise dissolution timing, micronization provides critical control over delivery rates and therapeutic impact. Narrow particle size distribution (PSD) ensures uniform mixing, consistent flow, and reliable dosing, particularly in formulations where even minor variation can compromise efficacy or safety.
Regulatory expectations around process validation and product consistency have made repeatable, contamination-free particle size reduction essential at every stage of pharmaceutical production. Jet mills like Sturtevant’s Micronizer support these standards with validated design, inert gas processing capabilities, and tool-free cleaning that enables faster, safer changeovers between materials.
Micronization not only improves drug performance, but also helps pharmaceutical manufacturers meet the quality, compliance, and scalability demands of modern production.
Sturtevant’s Pharmaceutical Micronization Equipment
Sturtevant’s Micronizer Jet Mill is the most widely used fluid energy mill in the pharmaceutical industry. Purpose-built for pharmaceutical applications, this jet mill achieves particle size reduction through high-velocity particle-on-particle collisions in a precisely engineered vortex. With no moving parts, no grinding media, and no heat generation, the Micronizer delivers ultra-fine powders with exceptional purity and uniformity.
Engineered to meet the highest cGMP standards, the Pharmaceutical Micronizer features a USDA-accepted sanitary design that disassembles without tools for rapid cleaning, sterilization, and product changeover. It supports scalable performance from early-stage R&D to full-scale commercial manufacturing, making it a reliable solution across the entire product lifecycle.
Key Features
- Particle size range from 0.25 microns to 45 microns
- No heat buildup, ideal for temperature-sensitive APIs
- No metal-to-metal contact, eliminating risk of contamination
- Sanitary, FDA- and USDA-compliant design
- Tool-free disassembly for fast cleaning and minimal downtime
- Compatible with compressed air or inert gas for safe processing of oxidizing or explosive materials
- Available in multiple sizes to support lab testing, pilot production, and high-volume manufacturing
Ideal for
- Active Pharmaceutical Ingredients (APIs)
- Inhalable and injectable products
- Fine excipients and additives
- Nutraceutical and biological compounds
Designed with precision, built for compliance, and backed by over six decades of jet milling expertise, the Pharmaceutical Micronizer sets the global standard for ultra-fine pharmaceutical processing.
Benefits of Working with Sturtevant
Choosing a micronization partner is not just about equipment—it is about trust, technical depth, and long-term support. With over 140 years of engineering excellence and more than six decades of jet milling innovation, Sturtevant brings unmatched experience to pharmaceutical powder processing.
Why Leading Pharmaceutical Manufacturers Trust Sturtevant
Deep Technical Expertise
We invented the Micronizer Jet Mill more than 60 years ago and remain the global leader in fluid energy milling. Our in-house team works directly with customers to test materials, refine process parameters, and ensure optimal performance from R&D through production.
Regulatory Readiness
Sturtevant’s Pharmaceutical Micronizer is designed to meet FDA and USDA standards. We provide full validation documentation (IQ/OQ/PQ) to support cGMP compliance and accelerate qualification timelines.
Full Lifecycle Support
From lab trials and scale-up consulting to field service and training, our team supports every phase of your equipment lifecycle. Our customer relationships are built on accessibility, responsiveness, and results.
Proven Performance
With thousands of installations worldwide and a customer base that includes some of the top pharmaceutical and biotech companies, Sturtevant is recognized for equipment that delivers repeatable results, process stability, and long-term value.
Made in the USA
All Sturtevant equipment is manufactured in the United States using domestic components. We operate under one roof for faster turnaround, tighter quality control, and more agile customer service.
Frequently Asked Questions
What is pharmaceutical micronization?
Pharmaceutical micronization is the process of reducing powders to ultra-fine particle sizes—typically below 10 microns—to improve solubility, bioavailability, and dose uniformity. It is commonly used for active pharmaceutical ingredients (APIs) and excipients that require precise control over particle size distribution.
What equipment is best for micronizing pharmaceutical materials?
Jet mills, particularly the Sturtevant Micronizer, are widely regarded as the optimal solution. With no moving parts, no grinding media, and no heat generation, the Micronizer delivers consistent, contamination-free results with sub-micron capability.
Is the Micronizer suitable for heat-sensitive or reactive compounds?
Yes. The Pharmaceutical Micronizer uses compressed air or inert gas for processing, making it ideal for materials that are sensitive to heat, oxidation, or mechanical stress. Its sanitary design also supports rapid cleaning and sterilization between runs.
Can this equipment be used for cGMP production?
Absolutely. The Micronizer is available in USDA-accepted, FDA-compliant models and is supported by full validation documentation (IQ/OQ/PQ) to meet pharmaceutical regulatory requirements.
Ready to Optimize Your Pharmaceutical Process with Micron-Level Precision?
Whether you are scaling up a new formulation or seeking tighter control over existing processes, Sturtevant’s Micronizer Jet Mill delivers the reliability, performance, and compliance your operation demands.
Fill out the form below to learn more about how Sturtevant can revolutionize your operations.