How a Jet Mill Improves Pharmaceutical Particle Size Reduction

Pharmaceutics, like all areas of pharmacology, operates under strict regulations. Compliance depends on upholding the highest standards of quality, safety, and reliability.

Active pharmaceutical ingredients (APIs) and excipients in product formulations need to unfailingly perform to these standards. Otherwise, patients, healthcare professionals, and pharmaceutical manufacturers could be put at considerable risk.

To ensure consistent performance and efficacy, APIs and excipients must behave predictably. Particle size reduction plays a key role in bioavailability, solubility, flowability, texture, and shelf life. A toll processing partner’s expertise in particle technology and jet milling is essential for achieving successful, compliant outcomes.

Jet Milling and Particle Size Reduction

In simple terms, particle size reduction makes solid particles smaller to enhance key pharmaceutical characteristics like compression, dissolution, and flowability. Jet milling is a popular solution for this process.

Jet mill particle size reduction uses high-pressure, compressed gas to create high-velocity collisions between particles of raw material. These collisions fracture the particles into smaller pieces.

Final particle size dictates which of the two jet mill models will be used:

• Fluid bed jet mills (FBJMs) have built-in air classifiers that can be precisely adjusted to the desired particle size and shape
• Circular (or spiral) jet mills have internal classification action within the grinding chamber

Jet milling doesn’t generate heat like mechanical milling methods, making it ideal for softer powders and sensitive materials commonly used in pharmaceuticals. As particles are reduced to a finer scale for formulations, it's crucial to manage the process to ensure proper efficacy and yield. This is where particle size classification and distribution, supported by advanced particle size reduction equipment, play a vital role.

The Science of Particle Size Classification

Particle size classification involves separating particles that meet specific size and shape requirements during particle size reduction. The classification method depends on the milling technique used, with common practices including:

• Air classification uses high-speed, nozzle-fed gas to accelerate particles, causing collisions and fracturing within a jet mill until the particles reach the desired size according to preset specifications
• Sieving is much like screening, but the method relies on particles being shaken in a mesh sieve to separate particles for size classification
• Fluidization suspends particles in a grinding chamber pressurized by forced gas and gravity. Particles within the desired size range are collected in a classifier, while the remaining particles undergo further jet milling until they meet the requirements
• Screening passes particles through a mesh or screen to separate particles for size classification

Particle size classification isn’t arbitrary. The highly precise process is a necessary step in reaching desired particle size distribution and, ultimately, product efficacy.

The Significance of Particle Size Distribution

Dosing can be ineffective if the active ingredient in a drug is not properly aligned within the formulation, potentially leading to suboptimal benefits, user frustration, and brand mistrust. Overcoming these challenges requires careful particle size classification and attention to particle size distribution.

Through effective particle size reduction, particularly with methods like jet milling, manufacturers can ensure that active ingredients are incorporated in the precise quantity and density needed for optimal quality and performance. Smaller particle sizes result in a larger surface area, enhancing the effectiveness of the pharmaceutical product.

How Particle Classification and Distribution work together

Particle size classification and distribution go hand in hand, with effective distribution relying on precise classification. Both processes require the expertise of an experienced toll processing partner and the right particle size reduction equipment. Entrusting a toll processor with particle classification and distribution is essential for ensuring the quality and performance of pharmaceuticals. A toll processor skilled in jet milling and proven particle size reduction methods enhances desired outcomes and helps avoid challenges like flowability issues.

Inaccurate particle classification, poor particle size distribution, and agglomeration can hinder flowability, leading to ingredient separation, sedimentation, dosing issues, and a subpar user experience that can harm brand success.

A toll processor with jet milling expertise can prevent these issues. Their practical knowledge and experience in the pharmaceutical industry make them an ideal partner for pharmaceutical manufacturers, ensuring optimal outcomes and product quality.

5 Ways CPS supports Pharmaceutical Manufacturers with Jet Milling

Custom Processing Services has a proven track record in the pharmaceutical industry. Over the years, we've identified five key ways our jet milling services optimize pharmaceutical particle size reduction and benefit manufacturers:

1. Enhanced product performance: Jet milling typically reduces particle sizes to 1-10 microns (micronization), with capabilities for even smaller particles or larger ones above 10 microns. Fine particle size reduction increases surface area, improving dissolution rate, taste, texture, and other key properties.
   
   
2. Virtually no contamination risk: Jet milling doesn’t depend on mechanical processes or grinding media to achieve particle size reduction. High pressure compressed air powers high velocity collisions that cause particle fractures and ultimately smaller, uniform particle size. 
   
   With no moving parts in the grinding chamber, there’s no wear and tear that could introduce contaminants. The simple mill design is easy to clean and sanitize, minimizing contamination risks through clean room procedures, stainless steel equipment, and purified air during jet milling.
   
   
3. Consistent, repeatable outcomes:  At CPS, we have the latest jet milling equipment and cutting-edge technologies to handle even the most precise particle size reduction projects. This ensures manufacturers achieve consistent, repeatable outcomes—essential for optimal pharmaceutical product performance.
   
   Additionally, our smaller-scale equipment is perfect for in-house sample testing. Manufacturers can conduct tests on small batches of raw materials to gain insights into their behavior, make adjustments before scaling up, or use testing to keep large-scale projects on track and ensure targeted results.
   
   
4. Improved quality control: The CPS team is made up of skilled designers, engineers, and operators, all supported by our state-of-the-art GMP facility. Our team’s expertise is backed by key certifications: GMP ISO 9001, FSSC 22000, Hemp US FDA cGMP, PA Certified Organic, Kosher, and Halal. Rigorous certification and regulatory compliance procedures, along with detailed documentation and reporting, ensure strict quality control at every step of the process.
   
   
5. Efficient supply chain and cost management: CPS provides comprehensive custom toll processing services, helping pharmaceutical manufacturers move products from raw materials to end users without the hassle of managing complex supply chains. Our in-house capabilities, including engineering, lab services, repackaging, and logistics, create time and cost efficiencies that set us apart from other toll processors.

Pharmaceutical manufacturers can’t afford to take a relaxed approach to product formulation or the toll processor they rely on for particle size reduction. With so much at stake, precision and reliability are crucial.

Pharmaceutical regulations often require partnering with a toll processor compliant with FDA cGMP. Evaluate cGMP milling service providers and their efficiencies with insights from the Food & Pharma Guide to Jet Milling & Advanced Particle Size Reduction. Get your copy to learn more!