Zimeng - Multi functional Particle Size AnalyzerZML320Inraw materialmedicinetestinAdvantage analysis

The particle size and shape characteristics of raw materials directly affect the solubility, stability, and bioavailability of formulations, and are key indicators for drug development and quality control. Although traditional laser particle size analyzers can quickly obtain particle size distribution data, theyReal state recognition of particles and multidimensional feature analysisThere are limitations in various aspects. The ZML320 multifunctional particle size analyzer from Zimeng Technology is based on the microscope method, integrating precise detection technology and compliant design to provide a full scenario solution for raw material testing. Its core advantages can be deeply reflected in the following four dimensions:

1、 Multi dimensional accurate representation, restoring the true attributes of particles

Laser particle size analyzer can only derive particle size distribution through the principle of light scattering,Unable to distinguish between particle aggregation and real particles, and also difficult to capture particle shape and colorWaiting for key features. ButMulti functional particle size analyzerZML320 relies on 'Microscopic observation+intelligent analysisThe core logic of 'achieves comprehensive coverage from single particle size to multi-dimensional features:

1. Accurate and comprehensive particle size detection:Scope of detection coverage200nm-3000μm, can accurately outputVolume average particle size D1/D10/D50/D90/D97/D100The key parameters meet the full range testing requirements of raw materials from micro nano to millimeter level, with data segmentation far exceeding traditional equipment.

2. Deep analysis of granular features:carry, mount, equip, deployRoundness, sphericity, convexitywaitmanyThe shape parameter analysis function can quantify the consistency of particle morphology.InIn the testing of active pharmaceutical ingredients, the average roundness, average sphericity, minimum and maximum characteristic values clearly show differences in particle morphology, providing direct basis for optimizing the crystallization process of active pharmaceutical ingredients - this is the core advantage that laser particle size analyzer cannot achieve.

3. Visual traceability without blind spots:Equipped with a 20 megapixel high-definition color camera and recording function, it can restore the original state of particles in real time, capture and archive particle images, and effectively distinguish themAgglomerated particles and independent particlesTo avoid particle size misjudgment caused by agglomeration in traditional methods. Simultaneously supporting colorsdistinguishIt can analyze impurities particles of different colors separately to further improve quality control accuracy.

2、 Compliant design+traceability calibration, reliable and traceable data

The testing of active pharmaceutical ingredients must strictly follow pharmacopoeia standards and quality control specifications. ZML320 meets the compliance requirements of pharmaceutical companies throughout the entire process from technical design to data output

1. Compliant with standards:strictly implementChinese Pharmacopoeia CP0982 Method 1Adapting to the new requirements of the 2025 Pharmacopoeia, the testing process and data format meet the needs of drug application and daily quality control. Calibration was performed using NIST traceability standard particles, with an accuracy error of<3% and a repeatability RSD of<3%. The data has been recognized.

2. Full process quality control traceability:built-inUser management, permission grading, audit trackingFunction,supportData backup and historical record queryMeets GMP compliance requirements. Test report according toParticle size, shape, colorGenerate specialized analysis results with equal dimensions, and output particle content and characteristic parameters to meet the requirements of R&D data traceability and quality inspection report standardization.

3. Adequate representativeness of the sample:Support continuous capture of multi view images to ensure that the total number of test particles is ≥ 10000, far exceeding the pharmacopoeia requirementsAt least 300 particlesRequirement: The statistical results should be more scientific and representative.

IIIIntelligent operation+strong adaptability, reducing testing threshold

In response to the pain points of complex sample morphology and difficult sample preparation in raw material testing,ZML320Through intelligent design and supporting equipment, the entire testing process is convenient and efficient:

1. Automation improves efficiency:possessAutomatic photography, automatic particle recognitionFunction, recognition accuracy of over 98%, particle statistics and analysis can be completed without manual intervention, significantly reducing operational errors. Simplify the testing process toSample preparation observation capture analysisFour steps, even beginners can quickly get started.

2. Standardization solution for sample preparation:Paired with vacuum powder disperser ZMD800 and semi-solid standard sampler ZMD-801, it effectively solves the industry pain points of raw material powder agglomeration and uneven sample thickness. The vacuum disperser can achieve powder monodispersion, and the standard sampler supports adjustable thickness of 10 μ m-3mm with a pressing force of less than 10Kg, ensuring consistent sample preparation conditions for different operators and greatly improving data repeatability.

3. Adapt to multiple types of active pharmaceutical ingredientsWhether it is solid powder API, microsphere active pharmaceutical ingredient, or semi-solid intermediate of active pharmaceutical ingredient, testing can be completed without changing equipment to meet the testing needs of multiple categories of active pharmaceutical ingredients.

4. Extensive customer verification:We have served Qilu Pharmaceutical, WuXi AppTec, Huadong Pharmaceutical, and othersmanyHome pharmaceutical companies have accumulated rich application cases in API API particle size and shape testing, with mature and reliable technical solutions.

5. Customized service capability:We can provide exclusive testing plans and experimental supplies according to the special needs of pharmaceutical companiesBama fragrant pig skin, nude mouse skinWaiting for supporting facilitiesconsumablesProvide one-stop support for extended testing such as transdermal absorption of active pharmaceutical ingredients, and assist in research and quality control upgrades.

In the current era of increasingly strict quality requirements for active pharmaceutical ingredients, the microscope method is used toVisualization, multidimensionality, high precisionIts advantages are gradually becoming the preferred quality control solution for pharmaceutical companies. Zimeng Technology ZML320 Multi functional Particle Size Analyzer willCompliance, accuracy, and convenienceDeep integration not only solves the technical limitations of traditional laser particle size analyzers, but also provides scientific and reliable detection tools for raw material drug research and quality control through full chain technology support, helping pharmaceutical companies achieve refined product quality control and enhance core competitiveness.