What are the contents of the factory inspection of prefilled syringes

Update:20 Apr 2021
Summary:

As a new type of drug packaging method, plastic syringe […]

As a new type of drug packaging method, plastic syringe has the characteristics of simple use and convenient operation. High-quality plastic syringes need to undergo various inspections such as appearance, tightness and lubricity, and the safety and stability of the product can be guaranteed only if the inspection is qualified.

Appearance Quality

Take an appropriate amount of this product, and in a bright place with natural light, the observer's eyes are about 300mm away from the sample, and the appearance of the observed sample meets the requirements of Table 1.

Tightness

Take an appropriate amount of this product, add half of the water (or colored solution) to the needle tube, match the push rod to drive out the air, make sure that there is no air in it, wear a protective cap, pass the push rod, and apply an axial pressure of 30N on the push rod piston , Keep for 30 seconds, there should be no leakage at the seal of the protective cap and the seal of the piston.

Lubricity

Take an appropriate amount of this product, insert the push rod (push rod with piston) into the needle tube, and push the push rod into the entire needle tube. The push rod piston should move smoothly without sudden pause.

The factory inspection of prefilled syringes is very important in the inspection. The factory inspection standards are mainly composed of the following 4 parts.

1. Each batch of prefilled syringe products can be delivered only after the manufacturer's quality inspection department has passed the inspection and the product qualification certificate is attached.

2. The factory inspection items are subject to product inspection according to the requirements of appearance quality, adhesion, lubricity, and sterility. The inspection items include appearance quality, characteristic indicators, etc.

3. According to the normal inspection one-time sampling plan in the standard, the inspection items and acceptance quality limit AQL level inspection level are shown in the following four inspection items.

Exterior

Tightness

Lubricity

Sterile

4. In the inspection results of prefilled syringes, according to the sampling inspection procedure by attributes Part 1: Retrieved by the acceptance quality limit, the batch-by-batch inspection sampling plan determines that the sealing is unqualified, then it is judged as unqualified; if there are unqualified in other items Yes, double sampling is allowed for re-inspection of unqualified items. If there are still unqualified items in the re-inspection, the batch of products shall be judged as unqualified.

https://www.syringeassemblymachine.com/

0
Conatct US