Active Pharmaceutical Ingredients
The key to efficient, reliable milling for the production of active pharmaceutical ingredients (APIs) is the ability to tightly control particles sizes. Even more important; it’s the capacity to consistently achieve narrow particle size distribution (PSD) ranges. New drug developers know that particle size is a crucial API parameter, which can affect essential drug properties such as bioavailability and stability. Given the trend toward the development of ever more potent molecules, it has become increasingly important to achieve the narrowest possible PSDs.
Of course, operator safety and ease of maintenance are also factors that drive the decision to choose appropriate API manufacturing equipment. Quadro Engineering offers:
- All stainless steel construction
- Convenient in-line tri-clamp connections
- Contained fine grinding
- Small, low-weight components
- Equipment that follows Good Manufacturing Practice (GMP) guidelines
Taken together, these features combine to ensure optimal safety, ease of use, and convenient maintenance and process changeover.
We pioneered the conical mill revolution in API manufacturing decades ago, and we’ve never rested on our laurels. Quadro Engineering’s innovations have streamlined the drug manufacturing process: We have enabled drug manufacturing clients to achieve smaller particle sizes — and tighter particle size distributions — than are possible using standard conical mills, hammer mills or pin mills. Of course, tighter PSDs mean less out-of-spec waste. That means a better bottom line. Our equipment design and construction are based on Current Good Manufacturing Practices (CGMPs) and are consistent with USDA, CE, and OSHA guidelines and regulations.
The magnitude of size reduction achieved by a given mill depends on the energy generated within the milling chamber. Our energy-amplifying innovations, which include re-engineered drives, extend the performance range from d50s of 150-300 μm down to the sub-150 μm range. We’ve also enhanced product flow efficiency: The all stainless steel H20 High Energy Comil, for example, delivers more product on spec: Expect 30% – 60% improvement over other fine milling technologies.
Expertise in Challenging API Applications
API (Active Pharmaceutical Ingredients) manufacturing requires that special attention be paid to processing equipment design, hygiene and safety. The goal is to find the most efficient processing equipment that produces the highest product quality, optimal particle size distribution, and desired production volume, while ensuring operator safety. Whether you are producing tablets or dispersing active ingredients, Quadro Engineering has the experience and technical expertise to solve your API size reduction needs.
Quadro API Equipment
Our H20 High Energy Comil® is a revolutionary approach to API and fine chemical milling. The H20 Comil® shifts particle size distributions to finer results, improves on-spec milling by 30% – 60% and helps adjust and control final PSD targets. This allows API manufacturers to maximize the amount of milled product within the desired target, reducing the need for screening over- and under-sized particles, which results in less waste.
For even finer milling results in active pharmaceutical ingredients processing applications, the Quadro® Fine Grind F10 provides consistent particle sizing with tight particle size distribution, sanitary design and ease of cleaning, and adaptability to a wide variety of base materials.
- Size reduce newer, more potent drugs to smaller particle sizes
- APIs/excipients compacted by rollers, then size reduced prior to tableting
- Bin-to-bin drug milling for high-potency API manufacturing
Fine Grinding & Validation
- Fine grind Benzocaine
- Fine grind anti-parasitic APIs
- Fine grind and validate narcotics
- Dust-free conveyance, milling and classification of API products
- Control Operator Exposure Limits (OELs) within strict industry standards
- Contain high-potency APIs and limit their explosion potential