The PartiGen Particle Analyzer integrates a high-sensitivity detection system, high-precision image recognition, and an advanced database retrieval function. It enables precise particle size analysis, and accurate identification, instructing traceability control in biopharmaceutical samples, ensuring product quality and regulatory compliance.

• Aqueous Solution Friendly for Non-Destructive Analysis

  Allows direct liquid sample loading onto the XtremSig Parti Particle Detection Chip without the need for filtration or separation, enabling real-time particle detection and identification in the liquid state.

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  In-Situ Analysis of Visible Particles

  With exceptional optical transmittance and confocal performance, the system enables in-situ detection of larger visible particles through transparent container walls, significantly enhancing analytical efficiency.

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  Wide Application Scenarios

  Compatible with membrane filtration methods, enabling precise identification and traceability of particulate contaminants in injectables. For small molecules, it can realize API composition analysis, and the distribution assessment of API and excipients.

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  Pharmaceutical Industry Professional Database, Supports Custom Database Creation

  Includes core databases for proteins, Tween degradation, production process materials, packaging materials, and more. Additionally, users can create custom databases based on their specific requirements.

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  Compliant with 21 CFR Part 11

  Ensures the authenticity, integrity, and traceability of data, providing reliable assurance for the drug product quality.