Modern ampoules are produced in glass tubes and are commonly used for preparing injectable medications as well as isolating high-purity airborne chemicals. The neck of the ampoule is sealed using an open flame to prevent air exposure, and a marking is applied to the neck. When pressure is applied, the bottleneck breaks to allow access to the liquid inside.
Before opening, a grinding wheel is used to create a scratch on the neck, followed by disinfection. The nipple is then raised to ensure all the liquid flows into the bottle before breaking the neck. Some ampoules are designed with pre-scored areas to make them easier to break by pressing in the designated direction.
It’s clear that the quality and ease of use of ampoules are critical. In response to this, national standards such as GB2637 and YBB00332002 have been established to specify the size and measurement methods for the breaking force of ampoules.
The principle behind measuring ampoule breaking force involves determining the force required to separate the bottleneck from the main body of the ampoule.
Ampoule Breaking Force Table
Specification (ML) | Bracket Distance L=(L1+L2) (mm) | Breaking Force, N (Minimum/Maximum) |
1 | 36= (18+18) | 30 / 90 |
2 | 5 | 100 / 10 |
60= (22+38) | 110 | 20 / 120 |
After breaking, the ampoule should have a flat section. The testing equipment must be accurate to 0.1N and meet specific requirements:
The device is shown below:
Testing Procedure:
Place the two metal brackets at a 90° angle to the central axis of the ampoule. Apply pressure between the brackets. Use an ampoule force tester to apply force until the ampoule breaks and record the breaking force value.
Note: If the scoring point is visible and the ampoule breaks easily, the force should be applied directly in the middle of the score. Otherwise, the breaking force may increase.
Jinan Pu Chuang Electromechanical Co., Ltd. offers ampoule breaking force testers, also known as Anzhen disability instruments. These devices are developed based on standards like GB2637 and YBB00332002, ensuring compliance with all relevant regulations. They are widely used by pharmaceutical companies, ampoule manufacturers, research institutions, drug inspection agencies, and quarantine departments.
For more information or inquiries, please contact us at 15725129662.
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Gaoyou Huasheng Electronics Co., Ltd. , https://www.yzelechs.com