2x faster troubleshooting
out of spec results with clear retest justification
Data quality guidance feature flags possible data quality issues, and provides a list of causes and solutions at all stages of your measurement.
With your Mastersizer 3000+
The Mastersizer 3000+ is your reliable partner for particle size analysis. It consistently delivers robust data – plus digital and Artificial Intelligence-based solutions – to inform critical decision-making in your R&D and manufacturing.
2x faster troubleshooting
out of spec results with clear retest justification
Data quality guidance feature flags possible data quality issues, and provides a list of causes and solutions at all stages of your measurement.
Standardized workflows:
50% faster method development with ICH Q14 compliance
SOP Architect helps to develop repeatable and robust methods 50% faster than traditional methods. It follows a structured workflow, so it is fully aligned with the latest best practice as described in regulatory guidance such as ICH Q14
3x better specificity
for reliable PSD to seperate noise
Size Sure delivers clear particle size analysis by reducing interference from contaminants, bubbles, and dust. These elements can distort the scattering signal and lead to misleading particle size data. By effectively reducing their impact, Size Sure delivers the reliable insights you need to develop robust methods more efficiently.
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OmniTrust is Malvern Panalytical’s framework to help laboratories meet FDA 21 CFR Part 11, EU Annex 11, and GxP standards, supporting quality-driven research, development and manufacturing practices. The software elements support compliance not only when working with Mastersizer, but across Malvern Panalytical portfolio, including Zetasizer (DLS), NanoSight (NTA), Aeris (XRD) and Empyrean (XRD).
OmniTrust modules:
Mastersizer results are recognized as the industry standard, giving you reliable, reproducible data that supports faster approvals, better product quality, and reduced risk.
From excipients to APIs, the Mastersizers optical bench with inbuilt thermal management ensures seamless analysis —even in challenging organic dispersants.
For small-volume early samples, efficient dispersion for agglomerates, to flexible dry dispersion for sticky APIs or fragile granules. Mastersizer offers the range of dispersion units to deliver accurate results without compromise.
Precise particle size control is crucial for ensuring consistent drug delivery and effectiveness. The Mastersizer 3000+ helps measure the size and distribution of drug particles, allowing for the optimization of formulations for targeted release or improved bioavailability.
Active pharmaceutical ingredients and particle sizing during development
Mastersizer 3000+ can help analyze the particle size distribution of a pharmaceutical dosage form, which is a key piece of information in understanding the formulation and potentially developing bioequivalent generics.
Mastersizer 3000+ can assist in ensuring compliance with regulations such as 21CFR Part 11 and the equivalent rule set in Europe (Annex 11), which pertain to electronic records and electronic signatures.
Reliable and robust data that informs critical decision-making throughout R&D and manufacturing processes, which is essential for regulatory compliance.
A guide to the new ICH Q2 r 2 guidance on the validation of laser diffraction measurements
Maintaining consistent particle size throughout the production process is essential for pharmaceutical quality control. The Mastersizer 3000+ provides a rapid and reliable method for measuring particle size distribution, ensuring batches meet quality specifications.
Top tips for successful particle size analysis: methods and measurements
Micronization is a process that reduces particle size. The Mastersizer 3000+ can be used to analyze the effectiveness of micronization techniques in achieving the desired particle size for specific pharmaceutical applications.
Changes in particle size over time can affect a drug's stability and effectiveness. The Mastersizer 3000+ allows for monitoring particle size during stability studies to identify potential formulation issues.
Pharmaceutical formulations often include excipients, inactive ingredients that play a functional role. The Mastersizer 3000+ assists in characterizing the size and size distribution of excipients, which can impact factors like tableting, stability, and drug delivery.
Whether you're optimizing formulations, ensuring data integrity, or supporting generic development, the Mastersizer 3000+ is designed to meet the demands of regulated pharmaceutical environments. Our specialists are ready to understand your specific challenges—be it in R&D, QC, or manufacturing—and show you how the MS3000+ can support your success.
Fill out the form below, and a member of our team will reach out to discuss how we can help you achieve more accurate, compliant, and efficient particle sizing.