In pharmaceutical manufacturing, product performance is only as reliable as the process behind it. From bioavailability to batch-to-batch consistency, particle size directly impacts critical quality attributes (CQAs). For manufacturers operating in highly regulated environments, precision milling is not just preferred; it is required.
Sturtevant is one of the most trusted pharmaceutical milling equipment manufacturers globally. With over 140 years of particle engineering experience and decades of pharmaceutical application expertise, we offer equipment designed for compliance, accuracy, and repeatability. Our solutions meet the rigorous demands of cGMP production, from R&D through commercial scale, with performance that aligns with FDA, USDA, and ICH Q8/Q9/Q10 expectations.
Whether you’re working with sensitive APIs, scaling a formulation for commercial use, or enhancing particle uniformity for dose control, Sturtevant delivers the validated performance and lifecycle support you need.
What Sets Leading Pharmaceutical Milling Equipment Manufacturers Apart
The pharmaceutical industry requires more than just size reduction. It demands validated, contamination-free processing, strict control over particle size distribution, and seamless integration into quality management systems. Here’s what distinguishes high-performance pharmaceutical milling equipment manufacturers:
- Regulatory-Ready Design
Compliant with FDA, USDA, and cGMP standards, equipment must include sanitary construction, tool-free disassembly, and clean-in-place options to support quick changeovers and eliminate material cross-contact. - Ultra-Fine Particle Size Capability
Advanced formulations often require particles under 10 microns. Our jet milling solutions can reach sizes as low as 0.25 microns, with narrow particle size distributions ideal for oral solids, inhalables, and parenteral drugs. - Contamination and Heat Control
Sturtevant’s fluid energy mills operate without mechanical grinding components, preventing metal contamination and minimizing thermal degradation of sensitive compounds. - Validation and Documentation Support
IQ, OQ, and PQ support is built into our process. We help ensure that your milling operation satisfies regulatory expectations and is ready for inspection, audit, or technology transfer. - Scalable Engineering
Systems must perform consistently at all scales, from bench trials to full commercial production, with reproducible PSD and process parameters.
Sturtevant’s Pharmaceutical Milling Solutions
Micronizer Jet Mill
The Micronizer Jet Mill is the most widely used fluid energy mill in the pharmaceutical industry. It produces ultra-fine powders with narrow particle size distribution, down to as small as 0.25 microns, without heat buildup or contamination.
Key features:
- No moving parts or grinding media
- Contamination-free processing
- USDA-accepted sanitary design
- Ideal for APIs, inhalables, and excipients
- Tool-free disassembly for cleaning and product changeover
- Scalable from R&D to full production
Sanitary Design Micronizer
Developed specifically for pharmaceutical and nutraceutical applications, the Sanitary Design Micronizer adds enhanced accessibility and cleanability features. It supports multi-product facilities where rapid changeover and sterility are essential.
Use cases:
- Facilities processing multiple APIs or classes
- Sensitive biologics and cytotoxic materials
- Rapid batch changeover requirements
FCM Classifier Mill
The FCM Classifier Mill provides an efficient, versatile option for pharmaceutical powders that require fine grinding and integrated classification. It delivers a controlled particle size distribution and is ideal for excipients and bulk ingredients.
Applications include:
- Fine excipients for tablet or capsule use
- Blended or granulated pharmaceutical additives
- Nutritional powders and over-the-counter formulations
Each solution is supported by in-house testing, validation services, and a global network of sales and technical professionals committed to long-term performance.
Why Pharmaceutical Manufacturers Choose Sturtevant
Pharmaceutical manufacturers around the world choose Sturtevant for more than just precision equipment. They rely on us as a trusted partner throughout the entire lifecycle of their production process. Our combination of engineering expertise, regulatory alignment, and customer-focused support sets us apart.
Proven Industry Experience
Sturtevant has been perfecting particle size reduction and air classification technologies for over 140 years. With thousands of installations and decades of pharmaceutical application knowledge, we bring a level of insight and reliability that few can match.
Regulatory and Compliance Expertise
Our equipment is designed to meet FDA, USDA, and cGMP requirements. From sanitary design features to IQ, OQ, and PQ support documentation, we help customers navigate the demands of regulated environments with confidence.
In-House Testing and Validation
Our fully equipped testing lab allows customers to trial their materials on our equipment prior to scale-up. We offer sample analysis, process recommendations, and data to support regulatory submissions and performance guarantees.
Scalable Solutions
Sturtevant offers equipment that scales from laboratory R&D through pilot and full-scale production. This flexibility allows customers to streamline development, minimize risk, and maintain process consistency from start to finish.
Long-Term Support
From installation and training to service and optimization, we support your operation at every stage. Our responsive field service team and global distribution network ensure your systems perform reliably for the long term.
Applications We Serve
Sturtevant’s pharmaceutical milling equipment supports a broad range of applications across drug development, formulation, and production. Whether working with delicate APIs or high-volume excipients, our systems are engineered for precision and process integrity.
Active Pharmaceutical Ingredients (APIs)
Achieve consistent dissolution and bioavailability with ultra-fine, contamination-free particle sizes. Ideal for oral, injectable, and inhalable dosage forms.
Inhalables and Injectables
Micron-level control is essential for drug delivery via lungs or bloodstream. Our Micronizer Jet Mill provides the narrow particle size distribution these applications demand.
Excipients and Tablet Fillers
Ensure even mixing, uniform dosing, and smooth tablet compression with precisely milled excipients. Our FCM Classifier Mill delivers targeted control for flow and compressibility.
Nutraceuticals and OTC Products
Support clean-label and high-performance formulations for vitamins, supplements, and powders. Our equipment provides food-grade milling capabilities without compromising pharmaceutical standards.
Biotech and Complex Formulations
Sensitive biologics and specialty compounds require precise, gentle milling. Sturtevant solutions can be operated with inert gas to protect material integrity and avoid degradation.
Testing, Validation, and Lifecycle Support
Pharmaceutical production demands more than equipment. It requires assurance, documentation, and a partner who understands regulatory expectations. At Sturtevant, we support our customers with a complete suite of services that span from process development through long-term operation.
In-House Testing and Trials
Our fully equipped laboratory allows customers to test their materials on Sturtevant equipment under real-world conditions. We help determine optimal configurations, analyze particle size results, and generate data to support decision-making and scale-up.
Validation Support
We provide detailed documentation and technical assistance to support IQ, OQ, and PQ. This ensures your equipment meets regulatory requirements and internal quality standards.
Start-Up and Training
Our experienced service engineers assist with equipment installation, commissioning, and on-site training to ensure your team is prepared to run and maintain systems confidently and safely.
Maintenance and Optimization
Beyond start-up, we offer process evaluations, routine inspections, and maintenance programs to help you sustain optimal performance. Our field service team can diagnose issues, recommend upgrades, and ensure your system stays production-ready.
Choosing the Right Equipment Manufacturer for Pharma Milling
Selecting a pharmaceutical milling equipment manufacturer is a critical decision that impacts every stage of production, from research and development to market delivery. In a highly regulated industry, the right partner provides more than machinery. They offer reliability, expertise, and alignment with your quality standards.
What to Look For
- Compliance-Ready Design
- Proven Track Record
- Testing and Data Support
- Scalability and Flexibility
- Service and Partnership
Why It Matters
Choosing the wrong equipment can lead to costly rework, regulatory delays, and inconsistent product quality. Partnering with an experienced manufacturer like Sturtevant ensures that your investment supports your goals for quality, compliance, and operational excellence.
Let’s Optimize Your Pharma Process with Micron-Level Precision
Whether you’re developing a new formulation or scaling up commercial production, Sturtevant provides the equipment, expertise, and support to help you achieve your pharmaceutical milling goals with confidence.
Fill out the form below to discuss your application, schedule a material test, or learn more about our solutions for precise, contamination-free particle size reduction.