Automated Pharma API Particle Size & Distribution Analysis Software PHARMA PRO
Microscopic particle size and shape analysis is efficiently performed using the advanced Pharma Pro Image Analysis software, a powerful image analysis solution tailored for the pharmaceutical industry. The software automatically detects and analyzes thousands of particles within seconds, enabling high-throughput particle characterization with exceptional accuracy. Its user-friendly interface includes an intuitive software wizard, allowing for quick setup and execution of custom measurement methods aligned with standard operating procedures. Pharma Pro ensures full compliance with FDA 21 CFR Part 11 regulations, offering robust system configuration, calibration, and secure data handling with electronic signatures and audit trails. Analytical results are presented in both graphical and tabular formats, with comprehensive statistical parameters for detailed particle size distribution and morphological comparison.
Accurate control of particle size is critical in pharmaceutical manufacturing, particularly for drug formulations with poor solubility profiles. Consistent particle size measurement enhances bioavailability, stability, and product performance. As regulatory bodies like the FDA emphasize more detailed reporting of particle size data in drug submissions, tools like Pharma Pro become essential for achieving regulatory compliance, product quality, and manufacturing efficiency. This makes the software a vital asset for pharmaceutical companies aiming to meet stringent quality standards and streamline their quality control (QC) and research and development (R&D) processes.
Microscopes and digital image Analysis can be used for:
Accurate determination of particle size distribution, essential for pharmaceutical quality control and formulation optimization.
Analysis of particle shape parameters, including area, perimeter, length, radii, diameter, aspect ratio, etc., providing deeper insight into particle behavior.
Visualization of particles dispersed in solid, liquid and gas, suitable for both wet and dry dispersion methods.
Detection and observation of foreign particles or contaminants, supporting impurity analysis and pollution control.
Fully compatible with FDA 21 CFR Part 11 compliance, ensuring secure, traceable, and validated data handling.
Ideal for use in pharmaceutical R&D, QA/QC laboratories, and other regulated environments requiring high-precision particle analysis.
API Particle Classification
Count and Classification of Particle
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 Pharma Pro Image Analyse software offers three powerful particle detection methods—interactive, auto-bright, and auto-dark—designed for accurate particle identification based on intensity thresholds. These flexible image analysis techniques ensure reliable detection of particles under various microscopy conditions, making the software highly adaptable for pharmaceutical quality control and particle size analysis.
Comprehensive Particle Measurements: Once particles are detected, the software provides a complete suite of morphological measurements critical for particle characterization. These include area, perimeter, length, minimum and maximum radii, diameter, circularity, elongation, aspect ratio, and polygon index. This detailed measurement capability supports advanced analysis of particle size and shape, essential for formulation development, R&D, and regulatory compliance.
Particle Classification: The system enables efficient particle classification based on either area or length, automatically segmenting particles into defined size categories. This aids in analyzing particle distribution, detecting contaminants, and ensuring consistency in pharmaceutical manufacturing. It is especially valuable for meeting FDA 21 CFR Part 11 requirements in regulated laboratory environments.
Automated Size Distribution Metrics: The Pharma Pro Image Analyse software simplifies the generation of essential particle size distribution metrics, automatically calculating key values such as D10, D50, and D90 based on particle diameters. These statistical indicators offer deep insight into particle population characteristics, which are critical for formulation development, drug performance, and manufacturing consistency.
Pharmaceutical Industry Focus: Engineered specifically for the pharmaceutical sector, the software meets the high standards required for particle analysis in drug development and quality control. It supports compliance with regulatory frameworks, including FDA 21 CFR Part 11, by providing validated tools for analyzing and documenting pharmaceutical particle characteristics.
Decision-Enhancing Tools: With built-in data visualization features and precision measurement outputs, the software empowers pharmaceutical scientists and analysts to make informed, data-driven decisions. These tools help ensure product quality, manufacturing efficiency, and patient safety through enhanced analysis of particle size and morphology.
Support for Quality Control and R&D: Whether for routine quality control or advanced research and development, the software delivers high-performance particle evaluation capabilities. By accurately analyzing particle shape, size distribution, and related metrics, it plays a vital role in optimizing formulations and improving product performance in the pharmaceutical pipeline.