Zimeng-Microscopic counting method insoluble particle analyzer: medical infusion, transfusion, injection equipment(Pipeline category)Compliance solutions for particle detection

Medical infusion sets, blood transfusion devices, extracorporeal circulation pipelines, and other piping equipment, as direct carriers of blood and medication in clinical diagnosis and treatment, have insoluble particle contamination in their lumen that directly affects patient safety - particles entering the human body may cause vascular embolism, inflammatory reactions, and even organ damage. Zimeng TechnologyFull process compliance, high-precision detection, and efficient adaptationAs the core, we provide professional particle detection solutions for pipeline equipment manufacturing enterprises and regulatory agencies.

1、 Core standard requirement: Compliance bottom line for particle detection of pipeline appliances

YY/T1556-2017 and YY 1048-2016 jointly established a "method specification+limit standard" system for particle detection of pipeline instruments, which is the legal basis for detection work.

（1） Core specifications for "pollution prevention and control" in the preparation of testing solutions

YY/T1556-2017：This standard specifies the key prerequisite steps for particle detection in pipeline equipment——Preparation of test solution (eluent)The core objective of the entire process is to avoid introducing additional pollution during the inspection process and ensure the authenticity and reliability of the test results

1. Environmental requirements:All operations must be carried out in a clean environmentChinese(Complies with GB/T25915.1-2010 ISO5 level), operators must wear specialized clean clothing and gloves to avoid contamination from human hair and dandruff.

2. Selection of flushing solution:Differential selection depends on whether the pipeline is silicified - purified water is used for non silicified pipeline, isopropanol or Tween-80 solution of specific concentration can be used for silicified pipeline, and Tween-80 solution is recommended to be used with microscopic counting method because it is easy to produce foam.

3. Blank verification:Before the experiment, a blank test must be conducted, and the particle contamination index of 500mL flushing solution should not exceed 9 to ensure that the flushing solution itself has no interference.

4. 容器要求：The container for collecting eluent needs to be thoroughly washed with distilled water filtered through a 0.2 μ m filter membrane to avoid residual particles in the container affecting the results.

（2） Mandatory standard for "particle limit" of pipeline appliances

YY 1048-2016：As a specialized standard for pipeline products, YY 1048-2016 specifies the upper limit and detection requirements for particle contamination in extracorporeal circulation pipelines and other products

1. Particle limit rigidity index:The number of particles in the inner cavity of the pipeline between 15 μ m and 25 μ m shall not exceed 1/cm ², and the number of particles larger than 25 μ m shall not exceed 0.5/cm ². This is the core basis for determining product qualification.

2. Adaptation of detection methods:Clearly, particulate pollution testing should be carried out in accordance with Appendix A of GB 19335-2003,Support microscopic counting as the core detection and verification method, require testing instrumentsCapable of traceability.

3. Related performance requirements:Particle detection should be combined with physical properties such as leak free pipelines and firm connections to ensure that the detection results match the actual safety of the product during use.

(3) The core pain points of pipeline equipment testing

Combining the requirements of two standards, industry testing generally faces three major challenges:

1) Failure to flush the inner cavity of the pipelinecleanIt is difficult to completely wash away residual particles such as plastic debris and production fibers；

2) When using Tween-80 flushing fluid in silicified pipeline, it is easy to produce foam, which will interfere with particle identification;

3) Artificial microscopic counting has low efficiency (single sample takes over 30 minutes), strong subjectivity, and cannot meet the compliance requirements of YY 1048-2016 for data traceability.

2、 A technical solution that conforms to standards throughout the entire process

Zimeng TechnologyFully automatic microscopic counting method insoluble particle analyzer ZMP930Based on standards as the core design basis, we achieve full chain compliance from preparation of inspection solution to data reporting, and accurately solve the pain points of pipeline detection.

（1） Preparation process of test solution: Match YY/T1556-2017 standard

1. Closed loop control of clean environment:Microscopic Counting Insoluble Particle AnalyzermatchprepareUltra clean table with built-in high-efficiency air filter (pore size 0.45 μ m), achieving a local level 100 clean environment that meets the requirements of the standard for operating environment;

2. Adaptation and purification of rinsing solution:In response to the selection requirements of YY/T1556-2017 flushing solution, the instrument supports the detection and adaptation of three systems: purified water, isopropanol, and Tween-80 solution，Pre treatment of the rinsing solution can be carried out to remove existing particles in the solvent, ensuring that the blank test meets the standard requirement of "500mL rinsing solution pollution index ≤ 9".

3. Design of the entire process of pollution prevention and control:Using disposable sterile culture dishes, dust-free tweezers and other consumables to avoid cross contamination; Inspection liquid collection containerconductSpecialized cleaning process to meet the cleanliness requirements of containers according to standards.

（2） Particle detection process: Accurately meet the limit requirements of YY 1048-2016

1. Full coverage of detection range and accuracy:Microscopic Counting Insoluble Particle AnalyzerThe detection range is 1 μ m~3000 μ m, covering the key intervals of 15 μ m~25 μ m and>25 μ m that YY 1048-2016 focuses on; The repeatability error is less than 5%, the accuracy is less than 3%, the segmentation success rate is greater than 95%, and it can accurately count particles as low as 1/cm ², ensuring that the detection results meet the standard limit judgment requirements.

2. AI intelligent recognition solves interference problems:Equipped with a 9 million pixel high-definition color camera and AI recognition algorithm, it can automatically distinguish target particles such as plastic debris, fiber, glass particles from bubbles, and foam in rinsing solution. Especially for foam interference generated by Tween-80 solution, the recognition accuracy rate is more than 99.2%, solving the problem of misjudgment by traditional methods.

3. Ensuring standardization throughout the entire process:integrationPipeline flushing eluent filtration membrane drying global scanning

end-to-end processservice：

① Rinse through the pipeline to ensure that the eluent fully contacts the inner cavity without any cleaning dead corners;

② The metal bath drying module has precise temperature control to avoid residual moisture in the filter membrane affecting observation;

③ The fully automatic scanning platform for X, Y, and Z axes enables seamless scanning of the entire filter membrane, replacing manual operation,avoidHuman error.

（3） Data traceability process: comply with compliance audit requirements

The instrument operation software complies with the requirements of 21CFR Part 11 regulations and hasUser graded permissions, automatic recording of operation logs, and tamper proof dataand other functions，Instrument calibration records and other information directly meet the requirements of YY 1048-2016 for traceability of testing, support bilingual report output in Chinese/English, and adapt to domestic and foreign regulatory audits.

Under the rigid constraints of YY/T1556-2017 and YY 1048-2016 standards, particle detection of pipeline instruments has become the core defense line to ensure clinical safety. Zimeng Technology's fully automatic microscopic counting method insoluble particle analyzerStandard adaptation as the root, technological innovation as the wing, fromParticle detectionImplementing full process compliance through data tracing not only solves the efficiency and accuracy pain points of traditional testing in the industry, but also provides reliable quality control tools for enterprises, helping toMedical pipeline equipment manufacturing enterprises establish a solid compliance bottom line and safeguard the safety of patients' medication and diagnosis and treatment.