Microscopic particles are crucial for drug safety and efficacy.

In the field of drug quality control, the control of insoluble particles is directly related to the safety and effectiveness of drugs. In recent years, with the global coordination of pharmacopoeia standards and the continuous advancement of detection technology, microscopic counting method, as one of the key technologies for insoluble particle analysis, has become increasingly important.

This article will be based on the General Principles of "Q-09: Particulate Pollutants" published by the Pharmacopoeia Discussion Group (PDG), combined with YinHuang Technology'sYH-MIP-0205Pro Microscopic Counting Insoluble Particle AnalyzerExplore the principles, applications, and future development trends of this technology.

01 PDG General Rule Q-09: Coordinated Framework for Global Particulate Pollutant Control

The Pharmacopeial Discussion Group (PDG) is composed of pharmacopoeia institutions from the United States, Europe, and Japan (with India as a new member in 2023 and South Korea starting the accession process in 2025), dedicated toCoordinate global pharmacopoeia standards.

The general rules of "Q-09: Particulate Pollutants" coordinated by it (approved on May 2, 2025) are for the detection of insoluble particles in injectionscore standardThis marks an important step towards the standardization of testing procedures in this field worldwide.

This general rule specifies two basic detection methods:

Method 1: Light Obstruation Particle Count Test

Method 2: Microscopic Particle Count Test

The general rules clearly state that when the results of the photoresist method do not meet the requirements or the test sample is not suitable for photoresist method determination, the microscopic counting method should be used for determination, and the results of the microscopic counting method should be used as the final judgment basis. Especially for formulations with high viscosity, easy crystallization, and bubble formation (such as emulsions, liposomes, suspensions, etc.),Microscopic counting method has become an irreplaceable technical solution due to its unique advantages.

02 Technical advantages of microscopic counting method: why is it a key supplement to photoresist method?

Microscopic counting method is not simply "counting", it provides the optical resistance methoddepth information.

Its core advantages lie in:

Strong ability to handle complex samples: Can directly observe and analyze the difficult to handle photoresist methodHigh viscosity formulations, emulsions, suspensions, colloids, liposomesAnd some biological products, to avoid misjudgment caused by "false particles" such as bubbles and silicone oil.

Provide morphological informationNot only can it count, but it can alsoObserve the original morphology of particles(such as fibers, metal shavings, rubber shavings, crystals, etc.)Tracing the source of pollutionImproving production processes is crucial.

The results are more intuitive and reliableDirect imaging is less affected by the optical properties of the sample, such as transparency and refractive index, resulting in more intuitive and reliable results.

03 Yinhuang Technology YH-MIP-0205Pro: An Automation Solution Compliant with New Regulations

Yinhuang Technology'sYH-MIP-0205Pro Microscopic Counting Insoluble Particle AnalyzerThis reflects how to meet the requirements of international standards such as PDG Q-09 through technical equipment.

The core technical features of this device include:

Fully automatic operation: PossessAutomatic filtering, automatic drying, automatic sample loading, automatic scanning, automatic testing, automatic counting, and automatic report issuanceFunction, can significantly reduce human operation errors, improve detection efficiency, and protect the operator's eyes.

Intelligent recognition and traceability: AdoptingSuper resolution algorithm and AI intelligent algorithmIt can automatically identify different types of particles such as metal, fiber, glass, and rubber plugs, helping enterprises trace pollution and control product quality.

Compliance and Data IntegrityThe software system complies withFDA 21 CFR Part 11andGMPThe requirement for data integrity supports audit tracking and multi-level permission management to ensure that all detection data is authentic, reliable, and traceable.

Wide detection range and high precisionTest scope coverage1μm-500μmEquipped with a high-resolution camera (6 million pixels) and multiple magnification objectives (standard 5X, 10X, optional 20X, 50X, 100X), it ensures clear capture and accurate measurement of particles of various sizes.

YH-MIP-0205Pro Core Parameters Overview

04 Application scenarios: From drug quality control to medical devices

Based on the characteristics of PDG Q-09 principle and microscopic counting method, its application fields are wide:

Quality control of complex injectionsAs follows:Liposomes, emulsions, suspensions, protein drugs, vaccine adjuvantsDosage forms that are not suitable for the light blocking method.

Control of Medical Device Particle PollutionPerform full membrane analysis on the eluate of disposable infusion sets, syringes, and other medical devices to accurately identify non risk particles such as silicone oil agglomerates and reduce false detection rates.

Aseptic powder and colored injection solutionThese samples are also important application scenarios for microscopic counting methods.

05 Future outlook: smarter and more accurate particle analysis

With the increasingly strict regulations and continuous technological progress, the field of insoluble particle analysis is also continuously developing:

Deep application of artificial intelligenceAI algorithms will perform more accuratelyParticle classification and recognitionEvenPredicting process deviationsTo achieve more intelligent quality assurance.

Continuous coordination and updating of standardsOrganizations such as PDG will continue to promote the coordination of global pharmacopoeia standards, and more regions may join in the future. Testing methods and acceptance standards may also be optimized and updated accordingly.

High throughput and automationThe throughput and automation level of detection equipment will be further improved to meet the requirements of large-scale productionEfficient and preciseQuality control requirements.

The revision of the PDG "Q-09" general rules and the technological innovation of enterprises such as Yinhuang Technology (such as YH-MIP-0205Pro) jointly mark the entry of particle pollutant control in drugs and medical devicesA more precise and standardized new stageFrom standard coordination to technical implementation, from single counting to comprehensive morphological analysis and pollution tracing, strict control of insoluble particles, ultimately serving the noble goal of ensuring patient medication safety and improving product quality.