How to measure the circular jumping of ampoules? Analysis of Circular Bounce Testing Method Based on Pharmacopoeia 4020 General Principles

The molding quality of glass ampoules is directly related to the stability of the sealing process and the safety of subsequent use in the production of injectable and oral liquid preparations. Among them, "circular jumping" is an important indicator of the forming accuracy of glass ampoule bottle mouth, commonly used to evaluate the stability of bottle mouth geometry during rotation, and is a testing item in drug packaging quality control.

According to the 2025 edition of Pharmacopoeia 4020 "Determination of vertical axis deviation and circular runout of glass containers", circular runout is defined as:

The change in the outer diameter of the bottle mouth when the glass ampoule rotates around the central axis of the bottom of the bottle once.

This method is specifically designed for measuring the circular runout of ampoules, and provides reliable data support for subsequent processes such as sealing and machine filling by evaluating the stability of bottle mouth deviation. According to the General Principles 4020 of the 2025 Pharmacopoeia, Sanquan Zhongshi has compiled the following content:

1、 The instrument required for measuring circular jumping - ampoule circular jumping tester

The pharmacopoeia clearly stipulates that the circular bouncing tester must meet the following technical requirements: the ZPY-60U ampoule circular bouncing tester from Sanquan Zhongshi can be used to meet the following requirements.

1. Ensure that the bottom of the bottle is level and rotates stably

The instrument should have a way to fix the bottom of the bottle or ensure that it is in full contact with the horizontal plane, so that the ampoule bottle maintains a consistent axis at the bottom during rotation and no additional displacement is allowed.

2. Equipped with a stable rotating chassis or mechanism

The rotating disk should ensure a smooth 360 ° rotation to accurately reflect the geometric changes of the bottle mouth in the measurement data.

3. Equipped with vertical columns and measuring devices

The column should be of appropriate height and strictly parallel to the axis of the bottle bottom, and the following measuring components can be installed on it:

• displacement sensor

• dial indicator

• ruler

The measuring device should be able to stably contact the outer edge of the bottle mouth and have a contact plane parallel to the outer edge of the bottle mouth to ensure accurate measurement of changes.

4. Measurement accuracy requirements

The pharmacopoeia requires a measurement accuracy of no less than 0.1 mm.

2、 Method for Measuring Circular Bounce (Pharmacopoeia 2025 Edition)

Both measurement paths are standard allowed methods, and users can choose the corresponding method based on the device.

(1) Rotating disk measurement method (conventional method)

1. Fix or place the bottom of the ampoule bottle on a horizontal rotating disc.

2. Adjust the measuring device to make contact with the designated measuring point on the outer edge of the bottle mouth.

3. Slowly rotate ampoule bottle 360 °

4. Read the maximum and minimum outer diameters of the bottle mouth.

5. Circular jump=maximum value - minimum value

This method is applicable to the vast majority of circular runout testers.

(2) V-shaped seat measurement method (auxiliary method)

When the rotating disc cannot be used, a "V" groove can be used for measurement:

1. Place the ampoule tightly against the V-shaped groove.

2. Hold the ampoule and apply a slight downward lateral force at a 45 ° angle to the horizontal plane to ensure stable fit between the bottle body and the V-groove.

3. Rotate the bottle body 360 °

4. Read the value and the minimum value, and calculate the circular runout.

3、 Result representation method

The final result of circular jumping is:

The difference between the measured value and the minimum value (unit: mm)

Indicate the degree of bottle mouth deviation.

For example: 0.56 mm, minimum 0.12 mm, then circular runout=0.44 mm

4、 Example Instrument - Ampoule Round Bounce Tester for Sanquan Zhongshi (meets the requirements of Pharmacopoeia 4020)

As a professional manufacturer of pharmaceutical packaging material testing instruments, Sanquan Zhongshi has developed the Ampoule Circular Bounce Tester ZPY-60U, which meets the requirements of the Pharmacopoeia 2025 edition 4020 general rules, to meet the quality testing needs of ampoule molding. It has the following characteristics:

1. The rotating mechanism is stable and the measured values are true and reliable

The highly stable rotating disc structure ensures that the axis of the bottle bottom remains consistent, avoiding human deviation.

2. High precision measurement structure

The accuracy should reach 0.001 mm, as required by the pharmacopoeia and standards, and the measurement accuracy should not be less than 0.1 mm.

3. Easy to operate, suitable for quality inspection agencies and production enterprises

Both glass ampoule manufacturers and pharmaceutical companies can efficiently use it for testing.

5、 The significance of detecting circular jumping in ampoules

• Ensure the quality of bottle mouth molding and avoid deviation

• Excessive circular runout may affect the uniformity of sealing.

• Improve the stability of filling and sealing equipment

• The deviation of the bottle mouth can lead to unstable mechanical clamping and even machine jamming.

• Improve the overall consistency of drug packaging

• Circular jumping control is an important component of the ampoule quality system.

For pharmaceutical companies, circular jumping test is an important link to ensure the smooth operation of the production process, and for glass bottle production enterprises, it is an important indicator for process debugging and improvement of molding quality.

Conclusion: Sanquan Zhongshi assists in the standardized and reliable testing of pharmaceutical packaging materials

The circular jumping test of ampoules is a key step in quality control of glass containers, based on the 4020 general rules of the Pharmacopoeia 2025 edition. Based on more than ten years of technical accumulation in the field of pharmaceutical packaging material testing instruments, Sanquan Zhongshi has independently developed the ZPY-60U ampoule circular jumping tester, which fully meets national standards and industry norms, providing stable, accurate, and reliable testing solutions for pharmaceutical companies, quality inspection centers, and glass factories.