Significance of prefilled syringe testing

Update:12 Aug 2020
Summary:

Prefilled syringes, as a kind of simple pharmaceutical […]

Prefilled syringes, as a kind of simple pharmaceutical packaging materials, occupy an increasing share in the aseptic pharmaceutical packaging market, and the quality of domestic prefilled syringes is constantly upgrading.

According to the experimental method stipulated by the standard: take an appropriate amount of this product, connect the push rod and the piston, fully insert the piston into a prefilled syringe lubricated with silicone oil and filled with half of water, remove air, and insert a needle guard on the syringe Cap, slowly withdraw back about 3mm distance. The push rod should remain stable and should not be separated from the piston.

The significance of the compatibility test between the piston and the push rod of the prefilled syringe;

When prefilled syringes are used clinically, the drugs can be directly opened when they are pre-installed in the injection container, which reduces the extraction from the container and can effectively avoid the potential hazards of glass shards and secondary pollution in the air. However, the compatibility between the piston and the push rod plays a very important role in the injection process, so it is of great significance to use professional laboratory testing equipment to detect the compatibility between the piston and the push rod of the prefilled syringe.

 

 

The prefilled syringe is a new type of medicine packaging container with high technical content and suitable for injection and injection dosage forms. Manufacturers of prefilled syringes are very concerned about the quality of the infusion device. How can they be tested and controlled?

First, visually inspect the appearance of the perfusion device. In a bright place with natural light, formally observe it. Because of the uniform color, the surface of the syringe should be smooth and flat; the inner wall of the needle tube should be smooth and non-corrugated, and the head of the syringe should be flat and smooth, without affecting the printing defect.

Second, the pull-out force of the perfusion device cap should be between (4.0-4.5)N. The compatibility of the piston and the push rod; insert the piston completely into the silicone oil lubricated and half-filled infusion device, insert a protective cap on the infusion device, slowly withdraw 3MM distance back, the push rod should be stable, Should not be separated from the piston.

Apply an axial pressure of 30N on the push rod piston again for 30 seconds. There should be no leakage at the seal of the cap and the piston of the infusion device. Use the push rod to push the piston into the entire syringe needle. The push rod piston should move smoothly without sudden pause. It should fall from a height of 1.5 meters to a horizontal rigid and smooth surface, and the infusion device should not be broken.

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