What is the inspection standard for prefilled syringes

Update:15 Apr 2021

Inspection classification of prefilled syringes Product […]

Inspection classification of prefilled syringes

Product inspection is divided into factory inspection, type inspection, and supervision inspection.

Type inspection of prefilled syringes

Type inspection should be carried out in one of the following situations:

a) New product filing;

b) Re-production after a major quality accident occurs;

c) Supervision and random inspection;

d) After the product is discontinued, resume production;

e) Carry out type inspection at least once a year;

Type inspection items should include appearance quality and characteristic indicators.

Plastic syringes are mainly used for the filling and use of medicines. Qualified products need to undergo rigorous testing. Dissolution testing is an important indicator of plastic syringe testing. It mainly includes four tests for pH change, heavy metals, easy oxides and non-volatiles.

Dissolved matter

Preparation of test solution: Take this product (needle) with an inner surface area of ​​600cm2 (split into small pieces of 5cm in length and 0.3cm in width), place them in a stoppered conical flask, add appropriate amount of water, shake and wash the small pieces, discard the water, and repeat the operation Twice. After drying at 30~40℃, soak in 200ml of water (70℃±2℃) for 24 hours, take it out and let it cool to room temperature, use the same batch of test solvent to make up to the original volume as the test solution, and use the same batch of water as the blank solution , Carry out the following tests:

1. pH change value

Take 20ml each of the water test solution and the water blank solution, add 1.0ml of potassium chloride solution (1→1000), and measure according to law, the difference between the two pH values ​​shall not exceed 1.0.

2. Heavy metals

Precisely measure 20ml of the test solution of water, add 2ml of acetate buffer (pH 3.5), and determine according to law that the content of heavy metals shall not exceed one part per million.

3. Easy to oxidize

Accurately measure 20ml of water for test solution, add 20ml of potassium permanganate titration solution (0.002mol/L) and 1ml of dilute sulfuric acid, boil for 3 minutes, and quickly cool to room temperature. Add 0.1g potassium iodide, place it in a dark place for 5 minutes, and titrate with sodium thiosulfate titrant (0.01mol/L). When the titration reaches the end point, add 5 drops of starch indicator solution and continue the titration until it is colorless. In addition, take the water blank solution and operate in the same way. The difference between the two consumption of sodium thiosulfate titrant (0.01mol/L) shall not exceed 1.5ml.

4. Non-volatile matter

Precisely measure 50ml each of the test solution and the blank solution of water and place them in an evaporating dish with constant weight, evaporate in a water bath, and dry to constant weight at 105°C. The difference between the two should not exceed 12.0mg.


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