Monitoring scheme for non-volatile content of co-extruded infusion film bags

Abstract: The content of non-volatiles is an important performance index of co-extruded infusion film bags, which greatly affects the content of foreign matter in the liquid and the quality of the liquid. In this paper, Labthink ERT-01 evaporation residue constant weight instrument for a brand coextrusion infusion membrane pocket nonvolatiles were detected, by the introduction of the test process, device parameters, application range of content, package materials enterprise monitoring used The content of non-volatile substances is provided as a reference.

Key words: co-extruded film, infusion bag, non-volatile matter, dissolved matter, evaporation residue constant weight meter, evaporation residue, constant weight

1. significance

China is a large infusion country. The annual production of infusions reaches 10 billion bags / bottle. The packaging forms used are usually glass bottles, plastic bottles, infusion bags, etc. In these infusion packages, co-extruded plastic film infusion bags are used. It is gradually becoming the main position due to its simple manufacturing, small production area, light weight, pressure resistance, convenient transportation and quick infusion. Infusion is a large-dose injection that is injected into the human body by intravenous drip. Because of its large amount and direct entry into the blood, the quality of the liquid should be high. For the co-extruded infusion film bag for infusion packaging, direct contact with the drug solution is an inseparable part of the infusion. With the whole process of production, distribution and use of the drug solution, it is essential to ensure the stability and safety of the drug solution. Important role. Due to the difference in raw materials, composition and production process of the co-extruded film infusion bag, some components in the package may be dissolved by the contacted liquid solution, affecting the quality of the liquid, laying a hidden danger to the health of the human body, or It interacts with the active ingredients in the liquid to affect the efficacy. Therefore, reasonable control of the total amount of soluble matter in the infusion bag ( characterized by the content of non-volatile matter ) is one of the important prerequisites for ensuring the quality of the drug solution and the safety of the drug.

Figure 1 infusion bag

2. Standard situation

The standards for the detection of non-volatile content in co-extruded infusion film bags include YBB00102005 "Three-layer co-extrusion film ( I ) , bag", YBB00112005 "Five-layer co-extrusion film ( I ) , bag", YBB00342002 "General film and bag for multi-layer co-extrusion infusion". The standard referenced herein is YBB00342002 "Multilayer Coextrusion Infusion Membrane, Bag General".

3. Test sample

The test sample used in this test is a multilayer co-extruded film for infusion packaging.

4. Test equipment

The test equipment for testing the non-volatile content of the sample in this paper is the ERT-01 evaporation residue constant weight instrument independently developed by Jinan Languang Electromechanical Technology Co., Ltd.

Figure 2 ERT-01 evaporation residue constant weight meter

4.1 Test principle

After soaking the sample with the soaking solution as required, take a certain amount of soaking liquid, place it in an evaporating dish that has been dried to a constant weight in a high-temperature oven, and then place the evaporating dish containing the soaking liquid on the water bath. It was evaporated to dryness and then placed in an evaporation residue constant weight meter for constant weight. After the constant weight requirement is reached, the weight of the empty dish is subtracted from the weight of the empty dish as the weight of the non-volatile matter, and the infusion solution of the unsoaked sample is used for the blank test.

4.2 Equipment parameters

  • Can test 0 ~ 80 g residue quality, test accuracy 0.3 mg ;
  • The temperature control range is 100 ~ 130 °C , and the temperature control accuracy is ± 0.2 °C ;
  • The hot air circulation wind speed is 0.2 m/s and the sample volume is 0 ~ 200 mL .
  • The independent test and automatic test process of eight samples of single machine greatly improve the detection efficiency.
  • Adopt automatic lifting mechanism design and intermittent weighing measurement method to effectively reduce system error;
  • Test chamber hot air circulation system, unique design for automatic temperature control and moisture removal;
  • Weighing can be carried out directly under high temperature conditions to avoid the influence of human factors and ensure the accuracy of test results;
  • Three test modes: proportional, fuzzy, and difference, to meet different test needs of users;
  • With the user-friendly operating interface and intelligent data processing functions, it can be connected to the Lystem TM laboratory data sharing system to manage test results and test reports.

4.3 Scope of application

(1) It is suitable for testing the properties of packaging films, non-volatile content, evaporation residue, etc. of pharmaceuticals, foods, food utensils, etc. made of polyethylene, polypropylene, polystyrene, etc.

(2) It is applicable to the test of evaporation residue of gaskets and gaskets, such as natural rubber as the main raw material, for sealing of bottled and canned foods, such as various juice drinks, wines, seasonings, etc.

(3) It is suitable for the evaporation residue test of food containers, container interior coatings, coating iron sheets, plant fiber food containers and other materials with perchloroethylene resin as the main raw material in direct contact with food.

(4) It is suitable for the evaporation residue test of chemical reagents which can be volatilized and removed in the boiling water bath temperature.

(5) The instrument meets various national standards, such as GB/T 5009.60 , GB/T 5009.64 , GB/T 5009.68 , GB/T 5009.69 , GB/T 5009.203 , GB/T 9740, etc.

5. Test process

(1) Take the inner surface area of 600 cm 2 sample 3 parts, each sample was cut into 5 cm × 0.5 cm pieces, washed with water and dried at room temperature, it was placed in three 500 mL Erlenmeyer flask in the three Erlenmeyer flasks were added 200 mL of water, sealed and placed in a high-pressure digester, heated for 30 min at 121 deg.] C, the other to take a conical flask was added 200 mL of water blank test in the same manner. After the cooking is completed, it is allowed to cool at room temperature.

(2) The empty evaporating dish is placed on the corresponding evaporating dish holder in the evaporation residue constant weight meter according to the label for constant weight, and the device will automatically record the weight of the evaporating dish after constant weight.

Figure 3 Evaporating dish drying process inside the equipment

(3) are cooled from room temperature to the above-described four conical flasks placed shifter 50 mL of soaking solution after evaporating dish 4 in a constant weight.

(4) The evaporating dish is placed on a water bath and evaporated to dryness, placed on a corresponding evaporating dish holder, and the test chamber door is closed. The drying temperature is set to 105 °C , the weighing interval is 0.5 h , the test mode is in the difference mode, the magnitude difference is set to 0.3 mg , and the evaporating dish containing the blank water is set as the reference cup, and the other evaporating dish settings are set. For the test cup. Turn on the test.

(5) The equipment automatically performs drying and weighing. When the weight difference between the two weighings before and after the same evaporating dish is not more than 0.3 mg , the constant weight is reached, and the test ends automatically. Device automatically calculates the three test cup nonvolatile weight.

6. Test results

The average value of the non-volatile content of the multi-layer co-extruded infusion film in this test is 1.9 mg . According to the relevant regulations in YBB 00342002 , the non-volatile content should not exceed 2.5 mg , so the non-volatile content of this sample is consistent. standard requirement.

7. Conclusion

The non-volatile content is calculated by simulating the material migration process of the infusion packaging material in contact with the chemical solution, and calculating the total amount of substances that may migrate into the chemical solution. The less the content of non-volatile matter, the lower the total amount of the material that may migrate when the coating material contacts the liquid medicine, and the interference to the liquid medicine when the packaging material is used is small. Therefore, by monitoring the non-volatile content of the infusion packaging material, the risk of contaminating the coating liquid can be effectively reduced. ERT-01 Evaporation Residue Constant Weight Instrument is a test equipment specially used for the detection of evaporation residue and non-volatile content of packaging materials. The configuration of automatic intermittent weighing function avoids the cumbersome artificial constant weight process and can be directly weighed at high temperature. There is no need to take out the evaporating dish and dry and cool the characteristics, so the efficiency of the test is greatly improved. The equipment is equipped with a high-precision weighing device to ensure the accuracy and accuracy of the test results. Jinan Languang Electromechanical Technology Co., Ltd. is a high-tech enterprise specializing in R&D and production of testing equipment. It is committed to providing high-end advanced packaging testing equipment and intimate, accurate and efficient packaging testing services to customers all over the world. Covering food, medicine, health care products, daily chemical products, automobiles, third-party testing institutions, universities and other fields. To find out about the testing equipment and services, you can visit Jinan Languang Company for specific information or call us . The more you understand, the more you trust! Labthink is willing to promote technical exchanges and cooperation with enterprises and institutions in the industry.

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