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Source: Link Testing Instruments Co.,Ltd.

I. Determination of internal pressure resistance of glass containers: a key barrier to protect the safety of drug packaging materials

 

The quality of drug packaging materials is directly related to drug safety, among which the physical strength of glass containers is the core indicator. The internal pressure resistance test conducted in accordance with the China drug packaging material standard YBB00172003-2015 "Determination of internal pressure resistance of glass containers" is a key means to evaluate the ability of glass bottles, ampoules, etc. to resist internal pressure. It is crucial to prevent rupture and leakage caused by pressure during transportation, storage or use, and is the basic line of defense to ensure drug stability and patient safety.

 

II. Analysis of the core requirements of the YBB00172003-2015 standard

 

This standard provides an authoritative and unified test method for the internal pressure resistance of glass containers. The main requirements include:

 

1. Test principle: Using the water pressure method, continuously apply increasing liquid pressure to the sealed glass container until the container breaks or reaches the predetermined pressure value.

 

2. Key indicators - pressure increase rate: The standard strictly stipulates the speed of pressure increase, which is usually required to be 0.4 MPa/s to 0.6 MPa/s (or according to the requirements of specific product standards). A stable and controllable pressure increase rate is a prerequisite for obtaining accurate and comparable results.

 

3. Qualification judgment: The sample must withstand the minimum internal pressure resistance value specified in the standard without breaking. The specific indicator value needs to refer to the drug packaging material standard of the corresponding product (such as the clear requirements for ampoules and infusion bottles of different specifications in the YBB series standards).

 

4. Sample preparation and state adjustment: The sample is required to be clean and undamaged, and the state adjustment is carried out under the specified temperature and humidity conditions to ensure the consistency of the test environment.

 

5. Result expression: Accurately record the bursting pressure value (MPa) of each sample and calculate the average value.

III. Parameters of Link Testing LTGPT-02 Glass Bottle Internal Pressure Tester

LTGPT-02 Bottle Internal Pressure Tester

LTGPT-02 Glass Bottle Internal Pressure Tester is developed and produced by Link Testing Instruments Co.,Ltd. is a professional equipment that meets the requirements of YBB standards. The main technical parameters are as follows:

 

Parameter item of LTGPT-02

• Pressure range        0.5 ~ 7MPa                     Covering the test requirements of conventional glass containers
• Resolution                0.001 MPa                                                   High-precision pressure display
• Test station               Single station                                                    Standard configuration
• Control method       Computer control + touch screen        Convenient and intuitive operation
• Data management    Storage+printing                                   Meet GMP data integrity requirements
• Safety protection       Overpressure protection, rupture protection cover          Protecting operator

 

The instrument is precisely designed, and the pressure rise rate control is stable and accurate, which effectively ensures that the test process strictly follows the YBB standard. The test results are objective and reliable. It is suitable for pharmaceutical companies, pharmaceutical packaging material production and quality inspection agencies to perform quality control and release inspection on the internal pressure resistance of glass containers of different specifications.

 

IV. Conclusion

Strictly implementing the YBB00172003-2015 standard to test the internal pressure resistance of glass containers is an indispensable part of the quality control system of pharmaceutical packaging materials. Choose testing equipment that meets the standard requirements and has reliable performance. LTGPT-02 glass bottle internal pressure tester can complete this key test efficiently and accurately, providing solid protection for the sealing integrity and transportation safety of drug packaging, and ultimately serving drug quality and public health.

For more details please visit www.linktesting.org