How to measure the vertical axis deviation of powder injection bottles? Professional testing plan for Sanquan Zhongshi based on Pharmacopoeia 2025 General Rule 4020

In the quality control of drug packaging, the accuracy of the bottle mouth position and axial deviation of pharmaceutical molded glass bottles such as powder injection bottles will directly affect the filling blockage, screw cap sealing, and operational efficiency of automated production lines. Therefore, the 2025 edition of the Pharmacopoeia 4020 provides clear requirements for the determination method of vertical axis deviation of glass containers, which has become an important testing basis for pharmaceutical and packaging enterprises.

The ZPY-60U powder injection bottle digital axis deviation instrument independently developed by Sanquan Zhongshi is specified in Pharmacopoeia 4020. It adopts a standardized vertical axis deviation test method and can be used for accurate determination of axis deviation of medicinal glass bottles such as powder injection bottles, oral liquid bottles, penicillin bottles, etc., providing reliable quality monitoring tools for enterprises.

01 Pharmacopoeia 2025 General Rule 4020: Definition of Vertical Axis Deviation

Vertical axis deviation

The horizontal deviation of the center of the bottle mouth relative to the vertical line passing through the center of the bottle bottom.

The specific description of the pharmacopoeia is: when a glass bottle rotates around the central axis of the bottle bottom once, half of the diameter of the circle made at the center of the bottle mouth is the vertical axis deviation.

This indicator directly reflects the "skewness degree" of the bottle and is an important quality parameter for pharmaceutical molded bottles.

Instructions:

Pharmacopoeia 4020 also includes the definition of "circular jumping", but it is applicable to ampoules.

Pharmaceutical molded glass bottles such as powder injection bottles are only tested for "vertical axis deviation" and do not test for circular runout.

Pharmacopoeia Requirements for 02 Vertical Axis Deviation Measuring Instruments

According to the pharmacopoeia, the vertical axis deviation meter should meet the following conditions:

• Can ensure stable horizontal placement of the bottle bottom, and accurate measurement of the offset of the bottle mouth center;

• Having a stable rotating chassis to ensure that the bottom center axis does not shift during the bottle rotation process;

• Configure columns and measuring devices (dial gauges, displacement sensors, etc.);

• The measuring device needs to be in contact with the outer edge of the bottle mouth to ensure consistent and reproducible readings during the rotation process;

• Measurement accuracy not less than 0.1 mm

The ZPY-60U powder injection bottle digital axis deviation meter of Sanquan Zhongshi meets the above requirements in structural design and is further optimized in terms of operability.

Method for measuring vertical axis deviation specified in Pharmacopoeia 03

The entire measurement process is simple and clear, suitable for routine laboratory testing:

1. Fix the bottom of the powder injection bottle onto the horizontal rotating disc of the instrument;

2. Adjust the measuring head to make contact with the outer edge of the bottle mouth;

3. Rotate the bottle body 360 °

4. Read the maximum and minimum values, or have the instrument automatically calculate the deviation value;

The pharmacopoeia stipulates that the expression of results is as follows:

Vertical axis deviation=(maximum reading - minimum reading)/2

The measurement results intuitively reflect the degree of eccentricity of the bottle mouth relative to the bottle bottom.

04 ZPY-60U powder injection bottle digital axis deviation meter: a professional measuring equipment designed for pharmaceutical molded bottles

As a pharmacopoeia compliance testing instrument, Sanquan Zhongshi's powder injection bottle digital axis deviation instrument ZPY-60U introduces industry digital display and automation design on the basis of meeting standard requirements, greatly improving detection efficiency and data accuracy.

★ Automatic lifting probe for easier positioning of measuring points

No need to manually adjust complex mechanisms, the measuring head automatically controls the lifting and quickly aligns the bottle mouth positions of different specifications of powder injection bottles, thus avoiding human operation errors.

★ Automatically calculate maximum, minimum, and deviation values

• The resolution can reach 0.001 mm

• Touchscreen display, intuitive reading

• Automatic reminder at the end of the experiment, reducing human reading errors and improving repeatability.

★ Equipped with professional computer testing software

Meet the requirements of modern pharmaceutical companies for data management:

• auto-storage

• Export and query

• Print inspection report

• Support data traceability for quality system auditing

Truly realizing an intelligent and standardized axis deviation detection process.

05 Sanquan Zhongshi: Provide a comprehensive testing plan that meets the requirements of the pharmacopoeia

Jinan Sanquan Zhongshi Experimental Instrument (Sumspring) has been focusing on the research and development of pharmaceutical packaging material testing instruments since 2007, and has been deeply involved in the research of packaging material related standards and testing methods. The company owns more than 30 software copyrights, and its products comply with the 2025 edition of the Pharmacopoeia, 2015 pharmaceutical packaging materials, and multiple national standards.

For medicinal glass bottles, we can provide:

• Vertical axis deviation tester (ZPY-60U)

• Internal pressure tester (NLY-03)

• Internal Stress Tester (YLY-03S)

• Dimension measuring instrument (AutoCDT-50)

• Thermal Shock Tester (RCY-05)

• Complete quality control solution for molded bottles

The above-mentioned testing instruments for medicinal glass bottles of Sanquan Zhongshi can help pharmaceutical companies improve testing efficiency and ensure stable and reliable production quality.

Conclusion

The vertical axis deviation of powder injection bottles is an important parameter that affects the quality of filling and sealing. The ZPY-60U powder injection bottle digital axis deviation meter from Sanquan Zhongshi is designed according to Pharmacopoeia 2025 edition 4020, which is precise, efficient, and easy to operate. It is an ideal choice for pharmaceutical factories and glass bottle production enterprises to carry out glass bottle testing.