High-Quality Granulated Raw Materials

Bulk powder materials often show a tendency towards caking, clumping, and dust formation, which can compromise process efficiency and safety. Granulated raw materials offer enhanced flowability with a reduced likelihood to cake and generate dust, resulting in easier handling and improved processability.
Our portfolio of high-quality granulated materials is specifically designed to minimize process interruptions, quality deviations, and operator safety risks. Whether you are developing generics or novel formulations, our granulated raw materials can enhance process efficiency and safety – especially at large production scales where efficiency is critical.
Key Benefits and Features
Reduced Caking, Improved Processability
Lower tendency to cake or clump, enhancing processability, handling, and flow properties.
Increased Operator Safety
Easier and safer handling as well as reduced dust formation compared to the bulk powder.
Multi-compendial, Low Endotoxin
Emprove® Expert portfolio with multi-compendial compliance and low endotoxin levels for high-risk applications.
The Technology Behind Granulated Raw Materials: Dry Granulation
Our raw materials are produced using dry granulation – specifically, roller compaction – a technique that preserves the intrinsic raw material characteristics. Dry granulation condenses materials through compression force only, without the use of water or additives, making it especially suitable for heat- and moisture-sensitive materials. Granulation improves the flow properties of the raw material and reduces the tendency to cake or clump compared to the ungranulated bulk powder. By utilizing this validated compaction process, we can offer granulated materials that outperform powder materials in terms of processability, performance, and ease of handling, all while meeting the highest quality standards.
Emprove® Expert Portfolio: Meeting Regulatory Requirements of High-risk Applications
Our commitment to advancing pharmaceutical development is backed by the Emprove® Program, which provides comprehensive documentation to expedite your journey to market. For high-risk applications such as parenteral administration, our Emprove® Expert excipient portfolio is particularly well suited as it features specified low endotoxin and bioburden levels to support risk mitigation efforts.
Frequently Asked Questions
What granulated raw materials are used in pharmaceutical manufacturing?
Granulated materials are particularly beneficial when powder materials tend to cake during storage, exhibit poor flow properties, and stick together. Especially when large volumes of material are stored for longer timeframes, caking and clumping can present a significant issue for processability and operator safety. We have identified several key materials where pharma and biopharma manufacturers of liquid dosages benefit most from granulation: ammonium sulfate, glycine, potassium chloride, sodium acetate trihydrate, sodium chloride, sodium dihydrogen phosphate dihydrate, di-sodium hydrogen phosphate heptahydrate, and urea—all of which demonstrate superior performance compared to their ungranulated counterparts. As we continually seek to enhance our offerings, the portfolio of granulated materials may expand in the future.
How do granulated chemicals improve process performance compared to powders?
Compared to standard bulk powder material, granulated products offer improved flowability and reduced tendency to cake or clump, which leads to better handling and increased operator safety. In contrast, caked material can be extremely challenging to weigh or feed into the process, as blocks must first be broken apart. This not only frequently causes time delays but can also result in operator injury. While managing caked material may be more feasible during small-scale development (though still inconvenient), it can lead to process disruptions in large-scale production. Additionally, granulated materials produce less dust, further improving operator safety. Watch our webinar “Addressing Raw Material Handling Challenges by Dry Granulation” to learn more about risks of caking.
What is the difference between granulated and non-granulated materials?
From a chemical perspective, the powder material and our granulated material are identical, as no additives are added during the dry powder compaction process, which is gentle and does not involve high temperatures. However, physical properties of the granulated material differ from the original powder form; granulated material demonstrates increased particle size and improved flowability.
What are the benefits of using granulated materials in pharma and biopharma manufacturing?
Key benefits of granulated raw materials include their significantly reduced caking behavior, improved handling and processability, and increased operator safety due to less dust formation and eliminating the need to manually break apart caked blocks. This results in a smoother process flow and helps avoid time delays and process disruption.
Additionally, all our Emprove® chemicals come with comprehensive technical, regulatory and supply documentation to facilitate risk assessment and regulatory filing. Our Emprove® Expert products feature specified low endotoxin and microbial levels, making them ideal for high-risk applications.
Related Documents
- Flyer: Granulated Materials
Find information on our portfolio of granulated raw materials and their benefits, including less caking and improved process efficiency.
- White Paper: Application of Dry Granulation to Facilitate Raw Material Handling
Download this white paper to learn more about the benefits of granulated raw materials over powder materials, including comparison case studies.
- Raw Materials for Biopharmaceutical Manufacturing Handbook
Learn more about our offering of raw materials and excipients for upstream, downstream, and formulation as well as regulatory hot topics.
Related Articles
- Facilitate Handling of Bulk Powders with Dry Granulation
Handling bulk powders at a large scale in the pharmaceutical, biopharmaceutical, and bioprocessing setting is challenging. Compared to powders, granulated materials experience far less caking, have better flowability, and are easier to handle, even after long-term storage.
- Improving the Handling and Safety of Pharmaceutical Raw Materials Through Dry Granulation
This article discusses how proper granulation can address the typical handling challenges of dry raw ingredients in pharmaceutical manufacturing.
Related Webinars
Discover how dry granulation prevents caking and clumping, improves raw material flow, speeds up manufacturing, and enhances operator safety.
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