Abstract: Solvent residue is a common problem in dry composite film or printing soft plastic packaging. Packaging materials with high solvent residue tend to contaminate the packaged content products. In this paper, the aluminum-plated composite film material for granule drug packaging is used as the test sample. The amount of solvent remaining in the sample is detected by Labthink - GC-7800 gas chromatograph, and the test principle, equipment parameters, application range and test process are carried out. Introduction, which provides a reference for companies to monitor the solvent residue of soft plastic packaging materials for pharmaceutical products.
Key words: solvent residue, soft plastic packaging, aluminized composite film, granule drug, gas chromatograph
1. significance
For the dry composite film-like flexible plastic packaging, in the composite film, it is necessary to dissolve the composite adhesive in the corresponding organic solvent, and then apply the adhesive to the surface of the film to be composited; Similar to the adhesive, the printing ink generally needs to be dissolved in a solvent and then printed. Therefore, how the various processes ( such as drying, curing process, etc. ) for promoting solvent volatilization after compounding and printing are important factors affecting the amount of organic solvent remaining in the soft plastic package. In general, the organic solvents used in compounding or printing are mainly divided into four categories, namely alcohols, esters, ketones and benzenes. These solvents are harmful to the human body, especially the benzene solvents have been used in the world. The WHO identified it as a carcinogen.
At present, the relevant domestic standards have strict requirements on the solvent residue in soft plastic packaging. The total solvent residue is ≤ 5.0 mg/m 2 , and the benzene solvent should not be detected. (The detection amount is less than 0.01 mg/m 2 . Detected ) If the amount of solvent remaining in the soft plastic package is large, the residual solvent will gradually migrate to the contents during the long-term contact with the contents, contaminating the contents, and causing the contents to appear similar to paints. The odor and the health of the consumer. Therefore, strengthening the monitoring of solvent residues in the soft plastic packaging materials used is an important basis for ensuring the safety of the packaging materials.
2. Test sample
The test sample tested in this paper is an aluminized composite film for packaging granules.
3. Detection basis
The test procedure for testing the solvent residue in the above test samples is based on YBB00132002 "Composite film for pharmaceutical packaging, bag general rule".
4. Test equipment
The test equipment used in this test was Labthink - GC-7800 gas chromatograph.
4.1 Test principle
The organic solvent has a volatile property, and a certain area of ​​the soft plastic packaging sample to be tested is placed in a sealed container and volatilized at a certain temperature, and then a certain amount of volatile sample gas is taken from the container and injected into the gas chromatograph. In the middle, the detection and analysis of each component in the sample gas is completed, thereby obtaining the solvent residual amount of the sample.
In a gas chromatograph, the sample gas is carried to the column as an inert gas of the mobile phase. Since the partition coefficients of the components in the sample gas are different in the column, the flow rates of the components in the column are different. Thereby the separation of the components is achieved. The separated components leave the column at different times to enter the detector, and are converted into electrical signals in the detector and sent to the data processing station for analysis of peak time, peak area or peak height of each component. A quantitative and qualitative analysis of each component in the sample is achieved.
4.2 Equipment parameters
- The two samples were prepared in a constant temperature chamber, and the temperature control range was room temperature +5 °C ~ 200 °C, and the temperature control accuracy was ±0.1 °C.
- In order to prevent the sample from condensing, the injection valve and sample transfer line can set the temperature and heat it. The temperature control range of both is room temperature +5 °C ~ 150 °C, and the temperature control accuracy is ±0.5 °C.
- The equipment has a loop of 1.0 mL . Users can choose 0.5 mL , 2 mL , and 3 mL as needed.
- The sampling line and the injection valve have a back-flushing function, which can effectively avoid cross-contamination of the sample.
- The patented automatic sample introduction sampling system has a sampling system with sampling pump and injection valve. Negative pressure sampling, constant sampling pressure, accurate quantitative, good reproducibility and high sensitivity.
- The gasification chamber and the detection chamber are in the temperature control range from room temperature +5 °C to 200 °C, the temperature control accuracy is ±0.1 °C, and the temperature control range is greater than 200 °C, the temperature control accuracy is ±0.2 °C.
- The detector adopts a unitized combination design, adopts the plug-and-play extended control mode, and is equipped with a hydrogen flame ion detector and a thermal conductivity pool detector, which can be configured and selected according to the analysis needs.
- The instrument can be operated at constant temperature and temperature, and the column chamber is equipped with a flexible rear door automatic temperature control system to achieve true near-room temperature operation.
- The instrument has a low-pressure, gas-breaking protection function for the carrier gas path, and has a high-temperature protection function. When any temperature control exceeds a certain range of the set temperature, the instrument will be powered off and alarmed.
4.3 Scope of application
(1) The equipment can be used for the analysis of solvent residues in various packaging materials, and can be used for the analysis of the purity and moisture content of various packaging printing solvents.
(2) The equipment can also be used for the analysis of vinyl chloride monomer content by reforming or adding special accessories.
5. Test process
(1) A sample piece having an area of 0.2 m 2 was cut out from the sample to be tested, and it was quickly cut into pieces of 10 mm × 30 mm .
(2) Place the cut pieces in a clean glass bottle and seal them with a rubber stopper.
(3) Place the sealed glass bottle in an automatic sample introduction device that has been heated to 80 °C and heat for 30 minutes.
(4) After the heating time is reached, remove the glass bottle, shake it quickly to make the gas in the bottle mix evenly, and quickly insert the autosampler into the bottle.
(5) The sampler automatically takes a certain amount of sample gas from the sealed bottle, and the sample gas enters the gas chromatograph along the insulated pipe of the device for detection.
(6) The gas chromatograph analyzes and calculates the content of each component in the sample gas according to the spectrum of the standard sample.
6. Test results
The residual methanol in the aluminized composite film for granule drug packaging is 0.3041 mg/m 2 , isopropanol is 0.1681 mg/m 2 , and ethyl acetate is 0.4196 mg/m 2 , so the total solvent residue is 0.8918 mg/m 2 , in which benzene solvent was not detected.
7. Conclusion
Solvent residue is an important performance indicator related to the safe and hygienic use of packaging, which seriously affects the food and safety of the products packaged inside the package. In this paper, the GC-7800 gas chromatograph was used to detect the solvent residue of the aluminum-plated composite film sample of a granule drug. The test process was simple, the degree of automation was high, the test result was high precision and the stability was good. Labthink is a high-tech enterprise specializing in R&D and production of packaging testing equipment. It also has a professional packaging testing and safety center to provide customers with high-quality, efficient and intimate packaging testing services. Currently, customers have served food and medicine. , packaging materials production, automobiles, health products, daily chemicals, third-party testing institutions, universities, research institutes and other industries and fields, and received unanimous praise. For more information about related instruments, you can visit Jinan Languang for specific information or call us. The more you understand, the more you trust! Jinan Languang Electromechanical Technology Co., Ltd. is looking forward to enhancing technical exchanges and cooperation with enterprises and institutions in the industry!
Dropping Bottle,Amber Dropping Bottle,Amber Dropping Bottle Pipette,Amber Glass Dropping Bottle
Yancheng Rongtai Labware Co.,Ltd , https://www.shtestlab.com