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China's Vial COVID-19 vaccine receives orders from multiple countries

Sinovac Research & Development Co., Ltd. specializes in the research and development and technical services of human vaccines and related products, providing technical support for the prevention and control of major infectious diseases. The company is currently developing COVID-19 vaccines and multiple combined vaccine varieties.


Recently, Sinovac has deployed 1 billion COVID-19 vaccine production capacity and has received orders from Indonesia, Turkey, Malaysia, Singapore, the Philippines and other countries. Currently, the COVID-19 vaccine has two packages, vials and prefilled syringes. A COVID-19 inactivated vaccine from the laboratory to the market requires seven steps: cell culture, virus culture, inactivation, purification, proportioning (semi-finished products), filling, and packaging. There are more and more detailed steps in each step, and quality control testing runs through the whole process. Pharmaceutical packaging aluminum-plastic combination caps and vials play a major role in the quality of vaccines. So what physical performance tests do the vials used for the COVID-19 inactivated vaccine need to do? JINAN HORIZON technicians will give a brief introduction:


Aluminium-plastic combination Caps


1. Opening Resistance Test of Combination Covers:also called plastic removal force/tearing force of ZD or OD type caps

Appropriate amount of combination caps are tested on the electronic tensile testing machine at a test speed of 100mm/min±10mm/min.



Nominal size

(mm)

Minimum removal force of plastic parts (N)

Maximum removal force of plastic parts  (N)

Maximum tearing force  (N)

13

6

25

30

20

6

35

40



2. Puncture force of rubber stopper:


      Install 10 rubber stoppers to be tested on matching injection bottles. Add the aluminum cap, seal with a manual capping machine, open the puncture site of the aluminum cap, put the bottle into the puncture device, so that the center of the rubber stopper can be punctured vertically, and use an injection needle (outer diameter 0.8mm) at 200±50mm/min Puncture at a speed. Record the force applied to pierce the rubber stopper, and repeat the puncture step until all the rubber stoppers are pierced once. The force required to puncture the rubber plug shall not exceed 10N.

TST-01H Medical Packaging Tester 


Vials


1. Internal stress: The optical path difference caused by the maximum permanent stress after annealing must not exceed 40nm/mm.


2. Vertical axis deviation: meet the following regulations.


Nominal volume (ML)

2

3

4

5

6

8

10

15

20

25

30

50

Vertical axis deviation

(Shoulder bottle a )

1.00

__

1.00

__

1.20

1.50

__

Vertical axis deviation (Shoulder bottle a )

1.00

1.20

__

1.30

_

_

1.40

__

1.50

1.80



3. 98℃,121℃ Water resistance of particles:



If the bottle is a tube vial, the following two indicators need to be tested:


a. Thermal shock resistance: The vials will not break when subjected to a thermal shock test with a  temperature difference of 42°C

b. Resistance to internal stress: the vials will not break under 600kPa internal pressure


Jinan Horizon tester is committed to the physical testing of pharmaceutical packaging materials, providing professional testing instruments and technical services for the pharmaceutical manufacturers and pharmaceutical packaging material manufacturers.