Micronization
Leading the way in advanced micronization.
Our scalable micronization services ensure reproducibility and precision, offering flexible solutions that meet the unique demands of our API’s to ensure better bioavailability and stability.
Cutting-Edge Technology:
From controlled crystallization to advanced jet milling, we employ a multi-step process to achieve precise, reproducible particle sizes.
Customization Capabilities:
We tailor particle sizes to your specific needs, whether for tablets, injectables, topicals or intricate inhalation devices.
Expertise in Action:
Our specialized knowledge shines in our work with inhalation molecules, where particle size directly impacts drug delivery and efficacy.
Precision and control.
We meticulously monitor each step of the micronization process, ensuring precise particle size distribution and surface characteristics that meet your exact specifications.
Integrated, In-Line Micronization: Our micronization is not an isolated step that relies on third party facilities. Instead, it’s seamlessly integrated into our production line.
Classified ISO-7 Clean Rooms: All processing is done in controlled environments with stringent limits to ensure microbial micronized molecules are processed in optimal condition.
State-of-the-Art Analysis: We utilize Laser Diffraction technology for rapid, accurate, and consistent particle size measurements across a wide range.
Rigorous and Adaptable Validation: Our particle size methods undergo stringent validation to ensure accuracy, reliability, and consistency in every batch.
Our proven micronization process.
Cutting-edge particle size testing and validation.
Laser Diffraction Technology
We use laser diffraction, the gold standard in particle size testing, offering rapid, consistent results across a wide range of sizes.
Validated Testing Methods
From sample preparation to final testing, we rigorously validate each step, ensuring reliability and accuracy that meet regulatory requirements.
Transferability of Client Methods
We can seamlessly adopt and validate your established testing methods, ensuring smooth integration with your production process.
Delivering excellence at every step.
Approved GMP Facilities: Our facilities are FDA and EU GMP-compliant, ensuring quality and safety for global pharmaceutical markets.
Regulatory Filings and Global Approvals: We manage regulatory filings and approvals across major markets including the U.S., EU, and emerging regions, streamlining your path to global compliance.
