Abstract : Most of the medicinal infusion bags are made of a composite film formed by co-extruding polyolefin and polyamide resin materials. They have the advantages of high hygienic safety, no precipitation particles, high barrier properties, and are not easily broken, but they are sealed. Sexuality is the performance index that zui affects the quality of the liquid and destroys the sterile environment. In this paper, Labthink's self-developed MFY-01 seal tester is used to test the sealing performance of the infusion bag, and the test principle and detailed test process of the instrument are detailed, so as to seal the sealing performance of the infusion bag and the like for pharmaceutical companies and other industries. Monitoring provides a reference.
Key words : infusion bag, medicine, medicinal, soft plastic packaging, sealing performance, seal tester, leak, gas leak, air bubble
1 , meaning
The medicinal infusion bag includes polyvinyl chloride (PVC) material and non-PVC composite film material. At present, most of the three-layer or five-layer co-extruded composite film made of non-PVC composite film material is mainly made of polypropylene (PP) and polyethylene. (PE), polyamide (PA) and a variety of elastic materials (SEBS), is one of Zui's safe infusion packaging materials, does not contain any plasticizer, and has no reaction or adsorption between itself and the liquid. The problem of alkali precipitation in glass bottles is good in low temperature resistance and is a high quality material.
The good quality pharmaceutical infusion bag should not be easily broken, its gas barrier property and water resistance are high, and the internal liquid solution is not easy to deteriorate or leak, which can meet the demanding aseptic environment. However, the medicinal infusion bag relies on heat sealing to seal the sealing edges around it, and the heat sealing parameter is not suitable in the heat sealing process, which causes the heat sealing to be not tight or the heat sealing is excessive. For example, if the heat sealing temperature is too high, the sealing is caused. The root is prone to breakage or gas leakage, or the surface of the heat sealer is not flat, resulting in the edge of the seal wrinkles containing leak points that are not sealed. If the sealing property of the infusion bag is not good, the water vapor, oxygen and other gases in the external environment will easily penetrate into the inside of the infusion bag, causing bacteria to invade, causing deterioration and oxidation of the drug solution, and even leakage during transportation or use. This article uses a professional sealing performance tester to introduce relevant test solutions for the sealing performance of infusion bags to relevant pharmaceutical manufacturers.
Figure 1 Pharmaceutical infusion bag packaging
2 , standard
At present, the sealing performance test of soft plastic packaging mainly refers to GB/T 15171-1994 "Test method for sealing performance of flexible packaging parts", which is applicable to the sealing performance test of sealed flexible packaging parts made of various materials.
3 , test samples
A brand of sodium chloride infusion bag finished packaging.
4 , test equipment
In this paper, the sealing performance of the infusion bag samples was tested using the MFY-01 seal tester independently developed by Labthink.
Figure 2 MFY-01 seal tester
4.1 Test principle
The MFY-01 seal tester determines the sealing performance of the sample by taking a vacuum in the vacuum chamber to generate a pressure difference between the inside and the outside of the sample immersed in the water, thereby determining the sealing performance of the sample; or without adding water. By vacuuming the vacuum chamber, the sample is subjected to internal and external pressure difference, and the shape expansion of the sample after expansion and release of the vacuum is observed, thereby determining the sealing performance of the sample and accurately finding the position where the sample is prone to leakage.
4.2 Scope of application
- This equipment is suitable for packaging bags, bottles, tubes, cans, boxes and other closed products made of glass, plastic, metal materials, etc. in the pharmaceutical, food, medical equipment, daily chemical, automotive, electronic components, stationery and other industries. The sealing performance test is also applicable to the test of the sealing performance of the sample after the test such as drop, pressure, high temperature or cooking.
- This equipment complies with a number of national and international standards, such as GB/T 15171, ASTM D3078 and so on.
4.3 Equipment parameters
- The degree of vacuum is 0 ~ -90 KPa.
- The effective size of the vacuum chamber is available in three options: 270 mm (diameter) × 210 mm (height), 360 mm (diameter) × 585 mm (height), 460 mm (diameter) × 330 mm (height).
- The system uses digital preset test vacuum and vacuum hold time to ensure the accuracy of test data.
- The use of automatic constant pressure air supply technology further ensures that the test can be carried out under preset vacuum conditions.
- Professional software supports automatic backflush unloading and automatic end-of-test functions to ensure a smooth test process.
5 , test steps
(1) Place an appropriate amount of distilled water in a vacuum sealed tank (ie, a vacuum chamber) and immerse the infusion bag sample in water. At this time, the distance between the tip of the specimen and the water surface must not be less than 25 mm.
(2) Cover the sealing cover to ensure that there is no air leakage around the sealing cover and the sealed can is well sealed.
(3) Set the test parameters such as the vacuum degree (ie, the negative pressure value) required for the test and the dwell time in the vacuum tank through the microcomputer operation interface.
(4) Turn on the vacuum pump and click the test button to start the test.
(5) Observe the leakage of the sample during vacuuming and pressure keeping, and observe whether there is continuous bubble generation.
(6) If there are continuous bubbles on the surface of the sample, record the pressure value at which the continuous bubble appears and the position at which the bubble is generated.
(7) Close the vacuum pump, open the vacuum chamber to the atmosphere, open the sealing cover, take out the sample, wipe the surface water, and open the seal if necessary to check whether there is test water infiltration inside the sample.
(8) Turn off the instrument.
6 , test results
In this test, a total of 5 blister package samples were tested, and no air leakage occurred at zui high negative pressure -90 KPa. It has good sealing performance and can ensure the quality of the liquid is not affected by external bacteria or air.
7 , conclusion
The sealing property of the medicinal infusion bag is an important performance index for ensuring that the drug solution is not contaminated and does not deteriorate. MFY-01 Seal Tester (Labthink) has the advantages of high accuracy, easy operation and tight sealing when monitoring this performance. It can not only determine the position where the package is prone to air leakage, but also establish the quantitative limit of product quality. Thereby assisting the improvement of the product packaging process. In order to overcome the shortcomings of the traditional seal tester manual recording test results, the risk of transcription errors, data storage difficulties, difficult to access, poor traceability, Labthink is improved on the basis of the MFY-01 seal tester. Developed i-Process 6200 Seal Tester and Data Processing System, which is specially used for the detection of sealing performance of on-site products. It can automatically judge whether the test results are qualified or not. The test data can be automatically uploaded to the data management center for data. Management and storage, which is convenient for users to manage and control the sealing performance of product packaging on the production site.
Figure 3 i-Process6200 seal tester and data processing system
In addition to the sealing performance, the heat-sealing strength, puncture resistance, water vapor transmission rate and oxygen transmission rate of the medicinal infusion bag are also important performance indicators of the product. You can visit the Jinan Languang Company to view or call the corresponding testing equipment. advisory. The more you understand, the more you trust! Labthink is looking forward to enhancing technical exchanges and cooperation with enterprises and institutions in the industry!
Specifications:
High Resolution Image
Liner Scanning Method
100% Bandwidth with Short-Pulse Technology
Safe in Operations
No Abrasion of Cornea
No Cross Infection
Convenient
More Probe Shells Offered
Easy to Exchange Probe Shell
Adjustable Focus by Probe Shell
Transducer: 35MHz/50MHz
Scan: Linear scan
Scanning Range: 16mm*10mm 35MHz
10mm*6.5mm 50MHz
Image pixel: 1024*655
Resolution: axial≤0.05mm, lateral≤ 0.1mm
Gain: 30-105 dB
SAB-200 A/B Scan with normal, vitreous body enhancement, retina observation mode, mainly used for diagnosis of intraocular diseases, display the location, shape range of the focus of infection and the relationship with the surrounding tissue. Can be diagnosed vitreous opacity, retinal detachment, eye base tumors etc. eye diseases. A scan is used to measure anterior chamber depth, lens thickness, axial length, calculate diopter of implant IOL as well.
B scan:
A scan:
Frequency: 10MHz/20MHz (optional) ,Magnetic driven, noiseless
Scanning Mode: Sector Scanning
Magnify:Multi continuous magnification,Real-Time magnification
Resolution: Lateral ≤0.3mm;Vertical≤0.2mm
Geometry position precision: Lateral ≤10%;Vertical≤5%
Depth:60mm
Enhance the part of vitreous body and retina
Gain of probe:30dB-105dB
Scanning Angle:53°
Gray Scale: 256
False Color: Multi colors. OCT
measurement type: multigroup distances, perimeters and areas
Image postprocessing: multiple curves processing, Pseudo-color processing curve
Movies: 100 images movie review, AVI JPG format image output
Frequency:10MHz, with LED
Depth: 40mm
Precision:±0.05 mm
Measurement: Anterior chamber depth, lens thickness, vitreous body length, total length and average
Eye mode: Phakic / Aphakic / Dense / Various IOL
IOL Formula: SRK-II, SRK-T, HOFFER-Q, HOLLADAY,BINKHORST-II, HAIGIS
Stat. Calculation: Average and standard deviation
Store: 10 Scanning results for each eye
Others:
Display Mode :B.B+B.B+A.A
Hint: preset keyword
Case Search:Multi-keywords
Working Platform: Windows XP.VISTA.WINDOWS7
User-defined report template poor credit secured loans
Ubm Ultrasound Machine For Eyes,Ultrasound Biomicroscopy Microscope,Ultrasound Biomicroscopy And Pachymetry,Ultrasound Biomicroscopy System
Guangzhou Sonostar Technologies Co., Limited , https://www.sonoeye.com