For any kind of packaging bottle, testing the vertical axis deviation index is of vital importance to the quality of the bottle, which is more important in the quality of medicinal glass bottles. The quality and safety of drugs are directly linked to the health of patients. Once the quality of the bottle itself causes the quality of internal drugs, not only the personal life of the crisis, but also the panic of the society, so the vertical axis deviation test is related to the medical glass bottle. Manufacturers must and must do.
Taking into Jinan race developed "RBT-A tester vertical axis deviation" for example, lyophilized powder for vertical axis deviation of a bottle of pharmaceutical companies to provide for a special test. Through the detailed records of the test process, test results and other data , it provides a reference direction and method for the majority of enterprises in need .
Key words : medicinal glass bottle , sterile powder injection bottle, vertical axis deviation test, medicinal glass bottle axis deviation detection, powder injection bottle vertical axis deviation test, medicinal glass bottle round runout tester, vertical axis deviation tester
1. Purpose of testing
Clinically, powder injections are a typical dosage form, and more precisely, they should be called "injections." Because it is always required to be diluted with the glucose solution before it can be used for injection. At the beginning of medical research and development, in order to make it easier to transport and preserve, scientists will mix drugs and reagents, and then form a powder injection after disinfection and drying. This is the origin of powder injection. According to the different preparation principles, the powder injection is divided into two types: aseptic powder and lyophilized powder. Although there are some differences in appearance, it is required to prepare in the aseptic workshop in the production process.
Aseptic powder injection bottle is a typical representative of medicinal glass bottles. Once the vertical axis deviation index is inappropriate, it is easy to cause the bottle to break and burst during the process of transportation, transportation or storage. Therefore, in order to ensure that the internal drug will not be cramped due to the quality of the bottle, the relevant production drug manufacturer must perform the vertical axis deviation test according to the relevant national standards.
2, the implementation of standards
YBB00192003 "Vertical Axis Deviation Measurement Method"
3 , test sample
Medicinal powder injection bottle ( Note: This sample is provided by customers of Jinan Saicheng )
4 , testing equipment
The “ RBT-A Vertical Axis Deviation Tester †independently developed by Jinan Saicheng has met and complied with various national and international standards: “QB2357-1998 Polyester (PET) Non-sparkling Beverage Bottleâ€, “QB/T1868-2004†Standards for polyethylene terephthalate (PET) carbonated beverage bottles, national pharmaceutical packaging containers YBB00192003 "Vertical axis deviation measurement method".
5, the test process
(1) First clamp the sample on the horizontal rotating chassis, make the bottle mouth contact with the dial indicator, and rotate 360° to read the large value and the small value. The difference between the large value and the small value is 1/2. Deviation value. (Remember: if using a bottom plate with a V-shaped block, hold the sample against the V-shaped block and apply a downward pressure to the sample in the direction of 45° from the horizontal plane and rotate the glass bottle. Cans 360°)
(2) Make a note of the large and downward distance between the outside of the edge of the bottle and the fixed point. The vertical axis deviation is half the difference between the measured large value and the small value.
(3) The accuracy of the measured value shall be not less than 0.1 mm.
( 4 ) Correct the vertical axis deviation obtained from the actual measurement according to the accuracy.
6, test results
According to the standard, the final value of zui cannot be less than 0.1mm, otherwise it needs to be retested.
7. Conclusion
The “ RBT-A Vertical Axis Deviation Tester †developed by Jinan Saicheng uses imported core components, which makes good use of the high concentricity of the three-jaw self-centering chuck, with a set of heights that can be adjusted freely. The bracket with degree of freedom can meet the verticality deviation detection of important parts such as bottle body and bottle shoulder, and has the advantages of high centering precision and high measurement precision. It is widely used in scientific research units, food, medicine and other industries. Bottle container manufacturer.
In addition, according to national and industry standards, in addition to the vertical axis deviation, the indicators for testing the medicinal powder injection bottles need to be sealed, polarized internal stress, wall thickness, puncture force, opening force, tensile strength and other indicators. Test, and Jinan Saicheng as a domestic old-fashioned pharmaceutical packaging material testing enterprise, has developed nearly one hundred instruments in more than ten years, which can fully meet the testing needs of users for different test indicators.
For more information about the instrument, please call Jinan Saicheng Technology directly . Strength is professional, professional brand is created, quality is achieved, and the future is achieved. Perseverance persists behind the support and trust of thousands of customers. We welcome your calls and look forward to your sincere cooperation!
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