Test method for polarizing internal stress of low borosilicate glass ampoules

Test method for polarized internal stress of low borosilicate glass ampoules Abstract: ampoules are made of glass tubes, which are widely used to contain injection preparations and high-purity chemicals that must be isolated from air The nipple of ampoule is sealed with open fire to isolate air, and the bottleneck is marked When pressure is applied, the bottleneck will break, so as to extract the liquid medicine In this paper, the polarized internal stress performance of ampoule bottle is tested by means of searching yly-05 polarizing stress instrument The basic process, testing principle and application scope of testing equipment are introduced, so as to verify the stress value of ampoule bottle and help pharmaceutical enterprises to effectively solve the problem of product packaging acceptance and production line use Problem and parameter setting during production Key words: ampoule bottle, medicine injection bottle, stress value, optical path difference, polarized light stress, internal stress 1, meaning injection refers to a medicine dosage form It refers to that the medicine is made into sterilized solution through extraction, refinement, preparation and other steps, and then put into ampoules for subcutaneous, muscular and intravenous injection After filling the ampoule bottle with medicine, the hot-melt seal is used to achieve the purpose of sealing The whole package forms a closed space, which is conducive to the storage and transportation of medicine content Generally, glass containers are isotropic homogeneous materials, when there is stress, it will show various anisotropy Figure 1 ampoule bottle water injection 2 Executive standard ybb00332002-2015 "low borosilicate glass ampoule" ybb00322005-2015 "China borosilicate glass ampoule" ybb00162003-2015 "internal stress measurement method" 3 Test sample: 3 ampoules of different specifications provided by a pharmaceutical enterprise 4 Test equipment 4.1 YL y-05 polarizing stress instrument independently developed and designed by Jinan Saicheng Electronic Technology Co., Ltd Fig 2 YL y-05 polarized light stress instrument 4.1.1 test principle is an instrument used to check the internal stress of glass or the birefringence effect of crystal by the polarized light interference principle Because the instrument is equipped with sensitive color plate and uses 1 / 4 wave plate compensation method, the instrument can not only measure the internal stress of glass qualitatively or semi quantitatively according to the interference color sequence in polarization field, but also accurately and quantitatively measure the internal stress value of glass 4.1.2 scope of application: it is suitable for pharmaceutical enterprises, Glassworks and laboratories to measure the stress value of optical glass, glass products and other optical materials The internal stress detection of medical glass containers such as glass infusion bottles, ampoules, vials, oral liquid bottles, etc 4.1.3 equipment parameters instrument indication: 0.1 nm polarization field diameter: 150 mm measurement accuracy: level 1-10 (in accordance with gb4545-84) polarizing plate value: 7.5 (corresponding stress level) adjustable range from polarizing mirror to polarizing mirror: 280mm (mm) polarizing plate rotation angle: 360 ° Brightness of light field: no less than 800 lux 4.2 wbt-g wall thickness gauge independently developed and designed by Jinan Saicheng Electronic Technology Co., Ltd Figure 3 Wbt-g wall thickness gauge 4 2.1 instrument features ◆ the auxiliary measuring disk can rotate 360 °, and the auxiliary measuring disk is equipped with scale mark to ensure accurate measurement return ◆ electronic digital display measurement results, easy to record ◆ meet the requirements of two test methods of bottom thickness and wall thickness of glass bottle 4 2.2 scope of application It is suitable for measuring the thickness of bottom and wall of glass bottle in pharmaceutical, food, pharmaceutical and other industries It can be used to test the wall thickness and bottom thickness of infusion bottle, beer bottle, oral liquid bottle, ampoule bottle, Xilin bottle and other products 4.2.3 equipment parameter instrument range: 0-12.7mm graduation value: 0.001mm sample diameter: 5-30mm sample height: ≤ 150 mm during the test process ampoule low internal stress test (1) put a quarter wave plate into the field of view, adjust the zero point of polarizing stress instrument to make it appear dark field of view (2) Place the test object in the field of view, and observe the bottom from the mouth At this time, a dark cross will appear in the field of view (Figure 4) (3) Turn the polarizer so that the dark cross is separated into two arcs moving in the opposite direction (Fig 5) (4) Observe that there will be blue gray on the concave side and brown on the convex side of the arc (5) Rotate the test object around the axis, find out the Zui high stress point, rotate the polarizer until the blue gray is replaced by the brown, record the rotation angle of the polarizer at this time, and measure the thickness of the point Fig 4 Fig 5 B, ampoule bottle wall internal stress test (1) put a quarter wave plate into the field of view, adjust the zero point of the polarizing stress meter to make it appear dark field of view (2) Put the test object into the field of view, make the axis of the test object and the plane of polarization 45 ° (3) observe the big stress area of Zui with different light and shade on the side wall (4) Record the placement angle of the inspection mirror in the large stress area of Zui, and measure the thickness of both sides of the wall (sum of them) Test results standard requirements: [internal stress] take appropriate amount of this product, and the optical path difference caused by the large * stress of Zui annealed according to the internal stress measurement method (ybb00162003-2015) shall not exceed 40nm / min If the stress of the test object is small, the dark cross will be blurred Results calculation: in the formula of δ = t / T = θ x3.14/t, δ is the internal stress of the test sample, nm / mm; T is the optical path difference of the tested part of the test article, nm; t is the total thickness of the light passing through the tested part of the test article, mm; θ is the rotation angle of the polarizer (when measuring the Zui large stress); 3.14 is the constant when using the white light source (the effective wavelength is about 565nm) The results showed that the internal stress of 1, 2, 3, 5 and 10 ml ampoules was very small, and the color change was not obvious When the rotation angle is between 5 ° and 7 °, the internal stress is within grade 1, and the thickness is different with different specifications, the optical path difference substituted into the formula will not exceed 40 nm / min The color change of 20 ml and 25 ml ampoules can be observed The rotation angle is about 8 ° ~ 10 ° The thickness parameters are different with different thickness According to the formula calculation, the optical path difference does not exceed 40 nm / min 7、 Conclusion YL Y-0 5 polarizing stress meter is used to measure the internal stress of ampoules The operation of the test is simple, the time is short and the efficiency is high It can accurately reflect the performance of the internal stress of ampoules Through the inspection of ampoules of different specifications, it is found that all packages meet the requirements of the standard of optical path difference of 40nm / min caused by the large * stress of annealed Zui Pharmaceutical enterprises should carry out sampling inspection in the process of acceptance inspection of ampoule packaging, so as to prevent the batch products from being affected due to the quality problems of ampoules In addition, we should strengthen the key items such as ampule breaking force test and ampule round run out test You can visit www cscii Net to check or consult the relevant testing equipment Jinan Saicheng expects to enhance technical exchanges and cooperation with enterprises and institutions in the industry!