Low borosilicate glass ampoule bottle polarization internal stress test method
Low borosilicate glass ampoule bottle polarization internal stress test method
Abstract: Ampoules are packaged in glass tubes and are widely used in the preparation of injectable preparations and must be isolated from airborne high purity chemicals . The ampoule's nipple is sealed with an open flame to isolate the air. The neck of the bottle is marked with a mark. When pressure is applied, the bottleneck is broken to extract the liquid. In this paper, the inner race Searching polarization properties of Y-0 5 stress strain gauge test polarization into ampoules YL, describes the basic process, the principle and scope test test test equipment applies the contents, in order to verify the stress ampoules, pharmaceutical help The enterprise effectively solves the problem of product packaging entering the factory , the use of the production line and the setting of parameters in the production process.
Key words: ampoule , medical injection bottle , stress value , optical path difference , polarized stress , internal stress
1, meaning
An injection refers to a pharmaceutical dosage form. Refers to the steps of extracting, refining, and formulating the drug, and preparing the sterilized solution into the ampoule for subcutaneous, intramuscular, and intravenous injection. After the ampoule is filled with the drug, the heat sealing is sealed to achieve the purpose of sealing , and the whole package forms a closed space, which is beneficial to the storage and transportation of the contents of the medicine. Usually the glass container is an isotropic homogeneous material that exhibits anisotropy when stress is present.
Figure 1 Ampoules water injection
2, the implementation of standards
YBB00332002-2015 "Low borosilicate glass ampoule"
YBB00322005-2015 "Chinese borosilicate glass ampoule "
YBB00162003-2015 "Internal stress measurement method"
3, test samples
3 bottles of different specifications of ampoules in 1ml, 2ml, 3ml, 5ml, 10ml, 20ml and 25ml provided by a pharmaceutical company .
4, test equipment
4.1 Jinan Saicheng Electronic Technology Co., Ltd. independently developed and designed the YL Y-0 5 polarized stress meter .
Figure 2 YL Y-0 5 polarized stress meter
4.1 .1 Test principle
An instrument for examining the effect of glass internal stress or crystal birefringence by applying the principle of polarized light interference. Since the instrument is equipped with sensitive color patches and uses the 1/4 wave plate compensation method, the instrument can not only measure the internal stress of the glass qualitatively or semi-quantitatively according to the interference color sequence in the polarization field, but also accurately and quantitatively measure The internal stress value of the glass.
4. 1.2 Scope of application
Suitable for pharmaceutical companies, glass products factories, laboratories to measure the stress values ​​of optical glass, glass products and other optical materials .
Stress detection of pharmaceutical glass containers such as medical infusion bottles, ampoules, vials, and oral liquid bottles.
4. 1. 3 Equipment parameters
Instrument indication: 0.1 nm
Polarization field diameter: 150 mm
Measurement accuracy: 1~10 grades (in accordance with GB4545-84)
Polarization plate value : 7.5 ã‚š (corresponding stress level)
Adjustable range from polarizer to analyzer : 280mm (mm)
Polarizer rotation angle: 360°
Light intensity of the light field: not less than 800 lux
4.2 Race to Jinan Electronic Technology Co., WBT-G wall thickness of independent research and development design thickness.
Figure 3 WBT-G wall thickness gauge
4. 2.1 Instrument characteristics
◆ Auxiliary measuring disc can be rotated 360°, auxiliary measuring disc comes with scale marking to ensure accurate measurement return
â—† Electronic digital display measurement results, convenient for recording
â—† Meet the test method of glass bottle bottom thickness and wall thickness
4. 2.2 Scope of application
It is suitable for measuring the thickness of glass bottle bottom and bottle wall in the pharmaceutical, food, pharmaceutical and other industries. It can meet the test of wall thickness of test infusion bottles, beer bottles, oral liquid bottles, ampoules, vials and other products .
4. 2. 3 Equipment parameters
Instrument range: 0-12.7mm
Graduation value: 0.001mm
Sample diameter: 5-30mm
Sample height: ≤150mm
- Experimental procedure
- Ampoule low internal stress test
(1) Place the quarter-wave plate into the field of view and adjust the zero point of the polarization stress meter to make it a dark field of view.
(2) Put the test piece into the field of view and observe the bottom from the mouth. At this time, a dark cross will appear in the field of view (Fig. 4).
(3) Turn the polarizer to separate the dark cross into two arcs moving in opposite directions (Fig. 5).
(4) Observe that blue gray will appear on the concave side of the arc, and brown will appear on the convex side.
(5) Rotate the test piece around the axis, find the large stress point of zui, rotate the polarizer until the blue-gray is replaced by brown, record the rotation angle of the analyzer at this time, and measure the thickness of the point.
Figure 4 Figure 5
B, Anzhen bottle wall internal stress test
(1) Place the quarter-wave plate into the field of view and adjust the zero point of the polarization stress meter to make it a dark field of view.
(2) Put the test object into the field of view so that the axis of the test piece is at 45° to the plane of polarization
(3) Observe the large ziza large stress area where the light and dark are different on the side wall.
(4) Record the angle of the analyzer placement measured in the large stress zone of zui, and measure the thickness (sum of) of the two side walls respectively.
- test results
Standard requirements: [Internal stress] Take the appropriate amount of this product, according to the internal stress measurement method ( YBB00162003-2015 ) , the optical path difference caused by the large permanent stress of Zui after annealing shall not exceed 40n m / min. If the stress of the test article is small, the dark cross will be blurred.
Result calculation: result calculation δ=T/t=θX3.14/t
Where δ is the internal stress of the test piece, nm/mm;
T is the optical path difference of the part to be tested, nm;
t is the total thickness of the light passing through the tested part, mm;
θ is the angle of rotation of the analyzer (when large stress is measured);
3.14 is a constant when using a white light source (effective wavelength is about 565 nm)
Test results: 1ml, 2ml, 3ml, 5ml, 10ml specifications ampoule internal stress is very small, the observed color change is not obvious. The rotation angle is between 5° and 7°, the internal stress is within 1 level, and the thickness is different. The optical path difference of the formula is not more than 40nm/min.
The color change of 20ml and 25ml ampoules can be observed. The rotation angle is about 8°~10°. The thickness parameters are different in thickness. It is calculated by the formula that the optical path difference does not exceed 40nm/min.
7. Conclusion
YL Y-0 5 strain gauge for testing the polarization ampule stress test operation simple, less time consuming, high efficiency, can accurately reflect the performance of the internal stress ampoules polarization. By detecting the ampoule different specifications comply with all packing found in the optical path difference zui large permanent stresses caused after annealing not more than 40n m min standards /. Pharmaceutical enterprises shall conduct random inspections during the acceptance inspection of Ampoule packaging to prevent batch products from being affected due to quality problems of ampoules . In addition, it is necessary to strengthen the testing of key items such as the ampoule breaking force test and the ampoule round jump test .
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