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Perfect Laboratory Technical & Quality Advantages Product's Quality & Safety Patents & Inventions
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Perfect Laboratory

Yian Medical has a complete physical and chemical laboratory, we has more than 100 square meters of microbial, aseptic and positive test rooms with 100 levels of purification, we also have a wide range of sterility testing equipment, In addition to the perfect testing system, many serious and strict microbial inspectors, all of these ensure the safety and reliability of our products.

Technical & Quality Advantages

Make partners feel at ease, let patients feel comfortable.

Innovative Technology

· Yian Medical has a number of projects invention, utility model patent, We have unique and exquisite technology in the research and development and manufacturing of all kinds of filters.


· Yian Medical develops all kinds of fully automatic production lines and testing equipment independently, with unique One-Piece technology, to ensure product quality and delivery stability.


Reliable Quality

· Using ultra high performance PES liquid filter membrane: with high flow rate and high dirt-holding capacity.

· Using high performance PTFE hydrophobic breathable membrane: Ensure no leakage of long-term lipids and anticancer drugs.

· Unique one-Piece injection molding process: ensures ultra-high pressure resistance for each filter.

· 100% filter membrane welding integrity inspection: The mature welding process ensures that the welding line is clear and detectable.

· 100% gas film integrity test: high pressure full test of sterilizing water and positive pressure to ensure no impact on welding.

· 100% filter air tightness test: full inspection of air tightness to ensure that the finished product is free of defects.

· 100% full appearance inspection and online performance sampling inspection, eliminate foreign bodies and defects to ensure batch stability.


Product's Quality & Safety

Filter hole diameter & Filtration efficiency

Flow rate and Throughput

Bubble removal and automatic liquid stop function

Filter Integrity Inspection (filter membrane, finished product assembly)

Drug compatibility (chemical compatibility, precipitation, adsorption)

Biological safety

Chemical requirement

Filter hole diameter & Filtration efficiency

According to the size and characteristics of filtering particulate pollutants in different clinical situations, it is necessary to select a suitable size of filter hole.

Yian Medical uses high-throughput asymmetric structure PES liquid filtration membrane with the filter hole size of 0.2μm, 1.2μm, 2.0μm, 3.0μm, 5.0μm.


Flow rate and Throughput

The effective filtration area of the filter membrane (i.e., the porosity per unit area of the filter membrane) determines the flow rate and throughput of the filter.Flow rate refers to the standard volume of solution that can pass through the filter at a specific pressure per unit time. Throughput refers to the total volume of different drug liquids that can pass through the filter before plugging.

Yian Medical uses PES membranes with high flow rate and high throughput to ensure the long-term stability of drug liquid filtration in clinic. Depending on the different of effective filtration area and membrane aperture of each type of filter, the flow rate will also be different, please refer to the product specification for specific data.

Bubble removal and automatic liquid stop function

Yian Medical's filters are designed to remove air bubbles and automatically stop fluid, The filter after normal exhaust (0.2μm, 1.2μm, 5.0μm) can completely remove the air bubbles upstream of the filter at any position and under the condition of multiple bottle changes to prevent gas enter into the patient's body. At the end of infusion, the medicine liquid will rest at the liquid membrane to avoid re-exhaust when changing the infusion bottle again.

Filter Integrity Inspection (filter membrane, finished product assembly)

100% weld line integrity CCD visual full inspection: Yian Medical's mature filter production technology ensures that the welding line of the drug film is clear and transparent, and the welding integrity of the filter film is judged by CCD visual inspection.

Bubble point test: The bubble point is the minimum air pressure required to discharge the liquid in the wet filter membrane, which can directly evaluate the integrity of the combination of the filter membrane and the filter, and indirectly evaluate the filter hole size and filtration performance of the filter membrane. The bubble point depends on the liquid wetting the filter membrane, the bubble point of the liquid with higher surface tension (such as water) is higher than the liquid with lower surface tension (such as isopropyl alcohol), and the larger the filter hole size of the filter membrane of the same process material, the lower the bubble point. Yian Medical uses purified water to test the bubble point of the filter, the specific parameters are detailed in the product specification.

Water break through: Water break through refers to the pressure required when water passes through the maximum aperture of the dry hydrophobic filter membrane. The larger the aperture, the smaller the water pressure resistance.

The integrity of the filter gas membrane determines whether the filter will leak and the bacteria resistance ability of the filter. Yian Medical uses certain purified water to maintain positive pressure, which has no adverse effects on the welding firmness of the gas membrane. Both full inspection and random inspection ensure the integrity of each gas film. The specific parameters are detailed in the product specification.

Yian Medical uses sterile gas to test the air tightness of each filter to ensure the tightness of the outer shell and ensure that the filter can cope with various high-pressure situations.

Drug compatibility (chemical compatibility, precipitation, adsorption)

Drug compatibility includes assessment of chemical compatibility, precipitation and adsorption.

Chemical compatibility refers to the ability of the filter to tolerate the drug liquid, maintain technical parameters, and maintain the same performance. More comprehensive chemical compatibility also includes contaminants produced by the filter itself, such as particles that fall off and migrate to the liquid precipitates.

The precipitates can contaminate the medicine liquid, possible contaminants include the hydrophilic agent in the filtration process, the chemical residue after the sterilization of the filter, and the chemical composition of the filter. The precipitates produced by filtering different medicine liquid are also different.

Absorbability is the ability of the filter membrane to absorb the active ingredients of the medicine liquid. Low adsorbability is critical to ensure consistency of therapeutic dose.

The raw materials used in Yian medical have good chemical compatibility, very low precipitation and adsorption.

Biological safety

Yian Medical's raw materials (shells, filters) and products meet the standards of ISO10993 and GBT16886. Products belong to external access devices, blood, long-term exposure classification, through the test of cytotoxicity, sensitization, irritation or intradermal reaction, systemic toxicity, blood compatibility. The raw materials of the product meet the biosafety requirements of the United States Pharmacopeia USP in Vivo<88>.

Chemical requirement

According to the requirements of ISO8536-4 and GB8368, Yian Medical's products meet the relevant chemical requirements, that is, reducing substances (easy oxides), metal ions, acid-base titration, evaporation residue, UV absorbance of the extract these five requirements. The third party test report were issued by SFDA.

Patents & Inventions

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