What physical properties can the pre-filled syringe tester detect?

Pre-filled syringe packaging dosage form is also known as pre-filled injection dosage form, pre-filled syringe tester is an important testing instrument
for testing pre-filled syringe.

Pre-potted syringe product quality testing performance items: breakage resistance, tightness, leakage, piston sliding, piston lubrication, syringe needle tube residue, indexing capacity accuracy, piston and pusher fit
.

If it is a pre-filled syringe with an injection needle, the additional test items are: rigidity, puncture force, connection force, pull-out force, torque resistance, unscrewed torque, etc
.

In the pre-filled syringe YBB00112004 pre-filled syringe assembly with injection needle standard has made clear requirements
for the physical properties of the syringe.

Weschild Technology elaborates on it
for you.

【Appearance】Take the appropriate amount of this product, in the bright place of natural light, face the visual inspection
.

The glass needle tube sleeve should have no cracks or cracks, and the crimping should be free of deformation; The cone head and crimping should be free of cracks or breaks; The outer surface of the needle tube should be free of spots, stains, and scratches; No printing defects affecting the use; The needle should have no separation, no inversion, no obstruction; The needle and the needle cap must not be separated
.

【Glass needle tube】Should meet the requirements of borosilicate glass needle tube (YBB00062004) for
pre-filled syringe.

【Rubber piston】It should meet the requirements
of chlorinated butyl rubber piston for pre-filled syringe (YBBO0072004) or brominated butyl rubber piston for pre-filled syringe (YBBO0082004).

【Stainless steel injection needle】Should meet the requirements of
stainless steel injection needle for pre-filled syringe (YBBO0092004).

【Needle Guard Cap】Should meet the requirements of polyisoprene rubber needle guard cap (YBBO0102004) for
pre-filled syringe.

【Connection force of needle and needle holder】Take the appropriate amount of this product, fix the syringe on the testing machine, and carry out the pulling test
of the injection needle at a speed of 5mm/min at a speed of 100mm/min soil 5mm/min, under the tensile force of not less than 22N.

The stainless steel injection needle and the needle holder of the glass needle tube must not be loosened or separated
.

【Pull-out force of needle guard cap】 Take an appropriate amount of this product, fix the needle guard cap and injection needle tube on the testing machine and under the fixture, and the test speed is 100mm/min + 5mm/min
.

The pulling force of the needle guard cap should be between
4.
0 and 45.
0 N.

【Fit between the piston and the pusher】(only for the pistons with threads) Take the appropriate amount of this product, connect the pushrod and the piston, completely insert the piston into the pre-filled syringe lubricated by silicone oil and filled with half of the water, exclude the air, insert a needle guard cap on the syringe, and slowly withdraw about 3mm to
the rear.

The actuator should remain stable and should not be separated from
the piston.

【Piston lubricity】Take an appropriate amount of this product, insert the piston into the silicone oil-lubricated syringe needle, and push the piston into the entire syringe syringe needle with a
push rod.

The putter piston should move smoothly and there should be no sudden pauses
.

【Piston sliding performance】Take the appropriate amount of this product, put the pushrod piston into the silicon oil-lubricated needle tube, and push the pusher
at a speed of 100mm/min±5mm/min.

The starting force of the piston sliding and the continuous force of the continuous sliding of the piston should comply with the provisions of
Table 1.

【Body tightness】Take the appropriate amount of this product, inject half of the water into the syringe, insert the piston into the syringe, remove the protective cap, exclude the residual air, and then block the needle with the needle protective cap, through the push rod, apply an axial pressure of 30N on the pushrod rubber plug inside the syringe, and maintain it for 5 seconds
.

There shall be no leakage in the contact between the needle and the needle holder, and there shall be no leakage
in the contact between the piston and the syringe.

【Syringe needle tube residue】Take the appropriate amount of this product, use a balance with an accuracy of 0.
1 mg, weigh the empty syringe weight (W0), inject 20 °C soil 5 °C marked capacity (V0) of water into the syringe, carefully drain the bubbles and ensure that the half-moon horizontal plane of the water is flush with the end of the cone cavity, press down the pushrod until the water is completely discharged, dry the outer surface of the syringe, weigh the weight (W1).


The quality of the syringe after the discharge of water is subtracted from the mass of the empty syringe, that is, the mass of the water remaining in the syringe, and expressed in volume (ml), the density of water (d) is measured
in 1.
000 g/cm3.

Table 2 should be complied
with.

To test the quality of the pre-filled syringe, it is necessary to use the connection firmness tester, the pull-out force tester, the syringe piston sliding tester, the syringe body tightness tester, the injection needle residue tester, the syringe piston thrust tester, the X11040-C Luer locking clamp anti-torque open torque tester, ML11040-C sealing system liquid leakage tester, FL11040-C flange damage resistance tester, DL11040-C Luer cone head breakage resistance tester, BC11040-C Luer locking clamp pull-out force tester, injection needle rigidity tester, injection needle penetration force tester and other pre-filled syringe testers
.

The above content is compiled by Wesa Technology, we hope to help
you.