Automated Pharma API Particle Size & Distribution Analysis Software PHARMA PRO
Microscopic size and shape analysis of particles can be performed by using powerful “Pharma Pro” Image Analyse software. Thousands of Particles are automatically being detected & analysed in a matter of few seconds. Measurement methods are easily set-up in advance and performed using intuitive software wizard features, easily following the required operating procedures. Access to system configuration, calibration and measurement set-up are managed ensuring “FDA 21 CFR Part 11” compliancy. Results are displayed in both graphical and tabular format, stastical parameters and comparisons for particle size and shape Manufacturing are calculated.
Need for particle size control in the manufacture of Pharmaceutical industry attempts to capitalize on some with less than ideal solubility profiles. The interest in particle size measurements will remain high, particularly in view of FDA trends toward recommending more through descriptions of particle size distributions in submissions in which the emphasis of a drug product claim is based in tightly controlled particle size.
Microscopes and digital image Analyse can be used for:
Determination of particle size distribution.
Particle shape e.g. aspect ratio (ratio between breath and length) which gives valuable extra information.
Overview of particles dispersed in liquid or air.
Observation of foreign particles in the sample (pollution).
Measurement of object sizes e.g. mesh size of sieves.
API Particle Classification
Count and Classification of particle
Detailed Report of Classification
Pharma Pro Software With Microscope
FDA 21 CFR Part 11 Compliance
Unique user IDs with permissions managed by administrators. Admins create new accounts and recover passwords.
Limited module access for permitted user accounts only.
Actions logged in event history; pdf reports featuring electronic signatures.
Timestamped Audit Trail maintains user details and actions for traceability.
Centralized database ensures efficient record storage, preventing data loss and change of data
Dimensional Analysis Methods: The software incorporates three distinct methods for particle identication—interactive, auto-bright, and auto-dark. These methods enable accurate detection of particles based on their intensity levels, ensuring exibility across different conditions and scenarios.
Comprehensive Measurements: Once particles are identified, the software provides an extensive suite of calculations and measurements. These include fundamental parameters such as area, perimeter, and length, as well as more advanced metrics like minimum and maximum radii, diameter, circularity, elongation, aspect ratio, and polygon index. This comprehensive set of measurements offers a thorough characterization of particle morphology.
Particle Classification: The software's particle classification functionality is based on either area or length. This enables the software to categorize particles into distinct size ranges, aiding in the understanding of particle populations within a sample.
Automated Size Distribution Metrics: The software streamlines the generation of crucial particle size distribution metrics. Metrics such as D10, D50, and D90 are automatically calculated based on particle diameters. These metrics provide insights into the distribution of particle sizes and are pivotal in understanding the overall particle makeup of a sample.
Pharmaceutical Focus: Tailored specifically for the pharmaceutical industry, this software addresses the stringent requirements of particle analysis within drug development and quality control. It facilitates compliance with industry standards and regulations by offering a robust platform for characterizing particles used in pharmaceutical products
Decision-Enhancing Tools: Designed to support decision-making, the software equips pharmaceutical professionals with precise data and visual representations. These insights assist in informed choices regarding product quality, efficiency, and safety.
Quality Control and R&D Support: The software's capabilities extend to quality control processes and research and development activities. It empowers users to effectively evaluate particle attributes, contributing to the enhancement of product formulations.