Sturtevant Pharmaceutical Micronizer® Reduces Particle Size for Efficient Production of APIs and Excipients
Background/Challenge
An international manufacturer of active pharmaceutical ingredients (APIs) and excipients approached Sturtevant to manufacture a Pharmaceutical Micronizer® jet mill to be used in their pharmaceutical manufacturing facility. The company manufactures compressed tablets and must reduce the particle size of several solid pharmaceutical ingredients. The manufacturer needed a mill that could reduce their ingredients to a uniform size of less than 10-microns. Reducing to a uniform particle size increases surface area which enhances dissolution rate and bioavailability. The rate of dissolution of the tablet or capsule is crucial and inadequacies in bioavailability can mean that the ingredients are ineffective or worse, potentially dangerous, leading to toxic overdose. It is also imperative while milling to avoid degradation and change in polymorphic form caused by excessive heat generation.
Sturtevant® Performance
The pharmaceutical company consulted with Sturtevant, the company that invented the Micronizer, having over 75 years of experience with Micronizing. Sturtevant operates a full-service testing facility to analyze material characteristics, verify results, and to aid in specifying the right equipment solutions. Sturtevant can test APIs in batches of 2 grams up to several hundred pounds with excellent yields. The Pharmaceutical Micronizer is scalable from initial R&D phases through commercial launch and is listed with the USDA as compliant with the standards for sanitary design and accessibility.
Equipment Recommendations
| Sanitary Micronizer® | |||
|---|---|---|---|
|
MILL SIZE |
AIR COMPRESSION SIZE
¹Compressed Air SCFM (SCMH) |
²bhP |
CAPACITY LBS/HR (KG/HR) |
|
Qualification |
8 (13.6) |
2 |
1/8 – 1 (.05 – .5) |
|
2" |
20 (34) |
5 |
1/2 - 2 (.2 - .9) |
|
4" |
55 (93.5) |
13 |
2 - 40 (.9 - 18) |
|
8" |
130 (221) |
31 |
10 -100 (4 - 45) |
|
12" |
260 (442) |
62 |
30 - 250 (13 - 113) |
¹-Volume of free air at 60°F (16°C), 14.7 psi compressed to 100 PSIG. Includes air consumed by feed injector nozzle.
²-Brake HP necessary to generate 100 PSIG compressed air.
Micronizer® Benefits
Predictable Performance
- 1000+ installations and over 50 years of experience
- Sole-source responsibility with complete systems availability
Product Quality
- No heat build-up: process heat-sensitive materials
- Minimized product contamination:
- A variety of speciality ceramic, low carbon steels, and polymeric liners available for adherent or abrasive materials
- No media contamination
- No lubrication contamination
- Uniformity: Products spherical particle shape for reduced agglomeration
Safety
- Processes materials susceptible to oxidation or explosively; easily adapts to inert gas and super-heated steam operations
Simple Operation
- Preassembled, with optional clamp connections available
- Grinds and sizes in one step; no additional classifier needed
- Operates in any orientation
Low Maintenance
- No moving parts
- No lubrication required
- Designed for easy access and cleaning
- Abrasion-resistant liners available
- Robust design
Flexibility
- Variety of product collection configurations available with integral cyclone, separate high-efficiency cyclone collector, single batch bag, or continuous cleaning dust collector
- Sizes from wheeled, portable lab units of 2″, 4″ and 8″ to production systems of 42″
Summary
Once testing was complete, Sturtevant recommended the 4-inch Pharmaceutical Micronizer to best meet the customers’ specific needs. The Pharmaceutical Micronizer reduced the particle size of the customer’s APIs and improved the flow properties of their raw materials and tablet-to-tablet content uniformity. The increased surface area enhanced the actives dissolution rate and bioavailability and improved color and active ingredient dispersion in tablet excipients. The Pharmaceutical Micronizer protects sensitive materials, it does not generate heat and can micronize any pharmaceutical ingredient, even those with a very low melting points.
Time to make your particle reduction process more efficient!
Let the SepSol team help match your needs to the quality solutions and equipment by Sturtevant Inc.
