Zimeng-ZMP930Accurate detection of insoluble particles in inhaled aerosolswithRoticasonefor example

As a commonly used inhalation preparation for the treatment of asthma and chronic obstructive pulmonary disease, the insoluble particle content of fluticasone inhalation aerosol is directly related to the safety and therapeutic effect of airway medication. The 2025 edition of the Chinese Pharmacopoeia CP0903 "Insoluble Particle Inspection Method" has made key adjustments to the detection standards for inhalation preparations (especially suspension preparations). The ZMP930 fully automatic microscopic counting method insoluble particle analyzer independently developed by Shanghai Zimeng Technology provides a professional solution for inhalation aerosol particle detection with its precise detection ability and compliance design for complex preparations.

one、 Technical advantages of ZMP930 for detecting inhaled fluticasone

Roticasone inhalation aerosol due toSuspended particles are prone to settling, the formula is prone to producing bubbles, and the viscosity is relatively highThe characteristics of traditional detection equipment often face challengesParticle missed detection, counting deviation, and cumbersome operationWait for the question.ZMP930Through targeted technical design, accurately solve such pain points:

（1） Compatibility of complex formulations: breaking through physical interference

The detection range of ZMP930 covers1-3000μm， The minimum resolution is 0.1 μ m, which can accurately capture suspended particles of fluticasone and trace impurities (such as debris from container detachment and fibers during production). Its X, Y, and Z-axis automatic scanning platform can achieve the entire filter membraneOmnidirectionalScanning, combined with the ultra depth of field Z-axis autofocus function, ensures clear imaging of each particle even in the presence of bubble interference in the formulation, avoiding counting errors caused by focus blur.

（2） Pharmacopoeia compliance: Full dimensional matching of new regulations requirements

1. Particle recognition accuracy:Microscopic Counting Insoluble Particle Analyzer ZMP930Equipped with intelligent AI algorithms, it can automatically distinguish between white particles, non white particles, as well as irregular impurities such as fibers and spherical particles - which may be present in the inhaled aerosol of fluticasoneDrug crystal particles, metal debrisThe identification requirements for particle types are highly compatible to avoid misjudgment or omission.

2. Data compliance assurance:The operating software complies with the requirements of 21CFR Part 11 regulations, has audit tracking and user level permission setting functions, and can fully recordSampling volume, scanning parameters, analysis results, operatorsWaiting for complete process information to meet the strict requirements of the 2025 Pharmacopoeia for data integrity.

3. Standardization of report output:It can automatically generate reports in both Chinese and English that comply with standards such as the 2025 Pharmacopoeia CP0903 and USP788, directly presenting key indicators such as "≥ 10 μ m and ≥ 25 μ m particle counts" without the need for manual secondary sorting, reducing data transcription errors.

（3） Detection efficiency and stability: the core support for cost reduction and efficiency improvement

1. High testing efficiency:ZMP930 IntegrationAutomatic filtering drying scanning data analysisThe full process function takes only 2-8 minutes for testing, which is more than 10 times more efficient than the traditional manual microscopic counting method (which takes 1-2 hours).

2. Accurate test results:The instrument has a repeatability error of ≤ 5% and an accuracy of ≤ 3%, which can ensure the consistency of multiple batches of fluticasone inhalation aerosol detection results and avoid deviations caused by manual operation differences.

3. Simplify the testing process：The instrument comes standard with 25mm/13mmImported Millipore filter membrane, specializedmatchingGlass filtration device, no need to purchase additional consumables.

3、 Standardized testing process for inhaled fluticasone aerosol (based on ZMP930)

Based on the integrated design of ZMP930, the detection of inhaled fluticasone aerosol can fully comply with the operating specifications of the 2025 edition of the Pharmacopoeia. The specific process is as follows:

1. Sample preparation:Take fluticasone inhalation aerosol, shake well according to pharmacopoeia requirements, extract the contents, and prepare a 25ml uniform suspension sample to avoid particle settling affecting the test results;

2. Automatic filtering:Inject the sample into the standard 25mm filter membrane filtration device of the instrument, and achieve complete filtration through a suction pump to intercept insoluble particles;

3. Membrane drying:Transfer the filtered filter membrane to a disposable culture dish using dust-free tweezers, and dry it in a metal bath at the set temperature to prevent moisture from interfering with particle recognition;

4. Intelligent scanning:Place the dried filter membrane on the Z-axis autofocus platform, activate the 9-megapixel high-definition color camera for full filter membrane scanning, and the AI algorithm synchronously captures and identifies particles;

5. Data analysis and reporting:The instrument automatically counts the number of particles in the particle size range of ≥ 10 μ m, ≥ 25 μ m, etc., and generates particles containingParticle size distribution, particle type, detection timeThe pharmacopoeia format report provides data that can be directly used for GMP compliance audits.