The Importance and Method Analysis of Sealing Test for Penicillin Bottles with Butyl Rubber Stopper Based on YBB00052005-2015

In the packaging system of sterile powder injections, freeze-dried preparations, and other drugs, the tightness between penicillin bottles and butyl rubber stoppers directly determines whether the drugs can effectively block the entry of external microorganisms, gases, and liquids during the storage period. This not only affects the stability of drugs, but also relates to medication safety. Therefore, in the quality control of drug production, it is an important step to verify the sealing of the joint between the rubber stopper and the glass bottle.

According to YBB00052005-2015 "Halogenated butyl rubber stoppers for sterile powders for injection", the stopper must maintain good sealing with the matching penicillin bottle under high temperature sterilization and pressure conditions. According to standard requirements, enterprises can use the MFY-05S penicillin bottle stopper sealing tester developed by Sanquan Zhongshi to conduct systematic sealing tests on products, ensuring the reliability of the packaging system.

1、 Standard requirement: Overview of sealing test between rubber plug and container

According to the 2015 version of drug packaging material YBB00052005-2015, the following test procedure is required for the tightness verification of halogenated butyl rubber plugs:

1. Pre treatment of rubber plugs

Take 10 rubber plugs:

• Boil water in a beaker for 5 minutes;

• After removal, dry at 70 ℃ for 1 hour

• Cooling standby.

This step is used to simulate the possible deformation state of rubber plugs after sterilization and drying processes, ensuring that the testing is more closely related to actual production conditions.

2. Add water to the penicillin bottle and seal it with a stopper

• Take another 10 matching injection bottles and add water to the labeled capacity;

• Tighten the processed rubber plug as described above;

• Cover the matching aluminum cover and complete the pressing operation.

This process simulates the actual packaging state of drugs after filling.

3. Sterilization treatment

Sealed penicillin bottle:

• Put it into a high-pressure steam sterilizer,

• Maintain at 121 ℃± 2 ℃ for 30 minutes

• After cooling to room temperature, let it stand for 24 hours

This step conforms to the conventional sterilization process in actual drug production.

4. Vacuum leakage test (methylene blue method)

Invert the sample and place it in a vacuum container containing 10% methylene blue solution, such as the MFY-05S penicillin bottle stopper sealing tester of Sanquan Zhongshi:

• Use MFY-05S penicillin bottle stopper sealing tester to evacuate to 25 kPa

• Maintain for 30 minutes

• After returning to normal pressure, let it sit for another 30 minutes

• Remove and rinse the bottle, observe if methylene blue enters the bottle.

If there is no blue liquid inside the bottle, it is judged to be sealed properly.

2、 The application advantages of MFY-05S penicillin bottle stopper sealing tester in Sanquan Zhongshi

To ensure the controllability, repeatability, and scientificity of the above experimental process, enterprises usually use professional instruments to complete vacuum leakage tests. The MFY-05S penicillin bottle stopper sealing tester independently developed by Sanquan Zhongshi is developed specifically for the sealing testing needs of pharmaceutical packaging, and meets multiple drug packaging material inspection standards, including the YBB class standard mentioned in this study.

The main advantages include:

• Precise vacuum control: The vacuum degree can be stably adjusted to 25 kPa to ensure the accuracy of the test conditions;

• Sealed testing space design: reduces environmental interference and makes methylene blue leakage test results more reliable;

• Automatic hold and timing function: Ensure accurate placement time during the 30 minute pressure holding period and after returning to normal pressure;

• Suitable for multi specification penicillin bottles and stoppers: strong compatibility, meeting the testing needs of multiple varieties of products in pharmaceutical factories;

• Simple operation and intuitive results: convenient for quality inspectors to quickly judge the sealing effect.

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3、 Sanquan Zhongshi: A professional provider of drug packaging material testing solutions

Since its establishment in 2007, Sumspring has been dedicated to the research and development of pharmaceutical packaging material testing instruments. Its products are widely used in pharmaceutical factories, drug testing institutions, quality inspection centers, and other units. The company has obtained more than 30 and 20 software copyrights, and has passed ISO 9001 quality system certification. It has mature technical advantages and standardized output capabilities in the field of drug packaging material testing.

Around the pharmaceutical packaging systems such as penicillin bottles, stoppers, ampoules, and oral liquid bottles, Sanquan Zhongshi has formed a system that covers:

• Sealing performance

• Headspace residual oxygen

• Tension

• Resistant to internal pressure

• Heat sealing strength

• A complete quality control solution including puncture performance.

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4、 Conclusion: Ensuring reliable sealing is essential for ensuring drug safety

The sealing performance of penicillin bottles combined with butyl rubber stoppers directly affects the sterility and stability of the formulation. Conducting standardized testing according to YBB00052005-2015 is not only a regulatory requirement, but also an important component of the drug quality system. With the help of a series of professional equipment such as the MFY-05S penicillin bottle stopper sealing tester from Sanquan Zhongshi, the testing process of enterprises can be more standardized, accurate, and efficient.

In the future, Sanquan Zhongshi will continue to promote industry development through technological innovation and provide more comprehensive and reliable testing solutions for quality control of pharmaceutical packaging materials.