Zimeng Technology disposable infusion device insoluble particulate detection experiment

< Zimeng Technology > The wide use of disposable infusion devices in the clinical treatment of hospitals not only facilitates the operation but also reduces possible cross-infection, which is welcomed by the majority of medical staff.
While disposable infusion devices are in the production process, the tiny particles (plastic chips) in their cavity are basically invisible to the naked eye, and they cannot be metabolized in the body after invading the human body.
Therefore, through intravenous infusion caused by insoluble particles in the blood vessels, the threat to human health has gradually emerged: larger particles can cause local blood vessel blockage or insufficient blood supply, tissue hypoxia, promote phlebitis and edema, granuloma, and even promote the formation of tumors, insoluble particles can also cause allergic reactions and pyrogenic reactions
.

In order to minimize the blockage of capillaries by insoluble particles in the cavity of disposable infusion sets, reduce the damage to the patient's microcirculation, and improve the safety of clinical treatment.
Insoluble particulate testing is required for disposable infusion sets
.

The national standard of "disposable infusion device gravity infusion type" has given the detection method
of insoluble particulates.

Zimeng Technology's self-developed microcount insoluble particulate detector ZMP930 has detected insoluble particles in disposable infusion devices on the market, using microscope counting method
.

1.
First check the blank membrane, place the blank membrane on the test platform, and analyze the entire membrane after scanning to ensure that the
membrane itself is clean.

2.
Select 10 disposable infusion sets, rinse them with distilled water respectively, and the eluate is filtered on the filter membrane placed on the filter
device.

3.
The filter membrane is dried in a metal bath at a drying temperature of 45 ° C, generally about 10 minutes
.

4.
Use special flat-tipped tweezers to place the dried membrane under the microcount insoluble particulate meter ZMP930 for the whole map scan.


to collect insoluble particles Na on the membrane and classify
the insoluble particles according to Table A.
1.

5.
10 parts of blank liquid is also filtered on the filter membrane in the filtration device, dried, and the insoluble particles of the blank liquid Nb.
are obtained under the detection of the insoluble particulate detector ZMP930 by microcounting method and classified
according to Table A.
1.

The total number of Nbs
cannot be greater than 9.

When the value is N≦90, the disposable infusion device is in line with the standard
.

Zimeng Technology independently developed the microcount method insoluble particulate detector ZMP930 for the detection advantages of insoluble particles in disposable infusion set: 1) automatic sample stage - automatic scanning, automatic identification, automatic statistics; 2) Full membrane scanning, saving time and reducing the error of human operation; 3) Automatic particle image analysis; 4) The test results can be reported in accordance with CP, USP, EP, JP and other national pharmacopoeia standards; 5) Customized standards according to demand; 6) Data list presentation, easy to view, at a glance; 7) All pictures are opened directly in the software, which is conducive to auditing; 8) Fully compliant with the pharmacopoeia requirements of magnification 100 times
.