Non-volatile content monitoring program for co-extruded infusion film bags

[Chinese Packaging Network News] Non-volatile content is an important performance index of co-extruded infusion film bags, which greatly affects the content of foreign substances in the liquid and the quality of liquid medicine. In this paper, Labthink ERT-01 Evaporative Residue Constant Weight Meter was used to detect the non-volatile matters of a certain brand of co-extruded infusion film bags. Through the introduction of the test process, equipment parameters, application scope, etc., the company used to monitor the packaging materials used. The content of non-volatile substances provides a reference.

China is a large infusion country and its annual infusion volume reaches 10 billion bags/bottle. The packaging used is usually glass bottles, plastic bottles and infusion bags. In these infusion packaging, co-extruded plastic film infusion bags are used for Easy to manufacture, small footprint, light weight, pressure resistance, convenient transportation, fast infusion and other characteristics gradually occupy the main position. Infusion is a large-dose injection into the human body by intravenous drip. Because of its large amount and direct access to the blood, the quality of the liquid should be high. For co-extruded infusion film bags for infusion packaging, direct contact with the drug solution is an integral part of the infusion solution. With the entire process of production, distribution, and use of the drug solution, it is essential to ensure the stability and safety of the drug solution. The important role. Due to the differences in the raw and auxiliary materials, composition formulas, and production processes of co-extruded film infusion bags, certain components in the package are likely to be dissolved by the contacted liquids and affect the quality of the liquids, posing hidden dangers to human health, or Interaction with the active ingredients in the liquid affects the efficacy. Therefore, reasonable control of the total amount of solubles in the infusion bag (characterized by the content of non-volatiles) is one of the important prerequisites for ensuring the quality of the drug and the safety of the drug.

Figure 1 Infusion bag

2. Standard situation

The standard for the detection of non-volatile content in co-extruded infusion film bags includes YBB00102005 "Three-layer co-extrusion infusion film (I), bag", YBB00112005 "Five-layer co-extrusion infusion film (I), bag", YBB00342002 "General Requirements for Films and Bags for Multilayer Co-Extrusion Infusions". The standard referenced in this article is YBB00342002 "General Requirements for Films and Bags for Multilayer Co-Extrusion Infusions."

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 article is the ERT-01 Evaporative Residue Constant Weight Meter independently developed by Jinan Languang Electromechanical Technology Co., Ltd.

Figure 2 ERT-01 Evaporation Residue Constant Mass Meter

4.1 Test principle

After soaking the sample with the soaking solution as required, take a certain amount of the soaking solution, place it in an evaporating dish that has been dried in a high-temperature oven until constant weight, and then place the evaporating dish containing the soaking solution on the water bath pot. Evaporate and then place constant weight in an evaporation residue constant weight apparatus. After reaching the constant weight requirement, the weight of the empty dish is subtracted by the weight of the constant weight, which is the weight of non-volatile matter, and blank test is performed using the soaking solution of the unimmersed sample.

4.2 Equipment Parameters

l can test 0 ~ 80 g residue quality, test accuracy 0.3 mg;

l Temperature control range 100 ~ 130 °C, temperature control accuracy ± 0.2 °C;

l Hot air circulation wind speed 0.2 m/s, sample volume 0 ~ 200 mL;

l Stand-alone eight-sample independent testing and automatic test process, greatly improve the detection efficiency.

l Adopt automatic lifting mechanism design and intermittent weighing measurement method to effectively reduce system error;

l Test chamber hot air circulation system, the unique design of automatic temperature control and dehumidification;

l Weigh directly under high temperature conditions, avoid the influence of human factors, and ensure the accuracy of test results;

l Three test modes: proportional, fuzzy and differential, to meet different testing needs of users;

l With operating software with user-friendly operation interface and intelligent data processing functions, LystemTM laboratory data sharing system can be connected to manage test results and test reports.

4.3 Application

(1) It is applicable to the testing of packaging films such as pharmaceuticals, foodstuffs, foodstuffs, etc. made of polyethylene, polypropylene, polystyrene, etc., as well as non-volatile content and evaporation residue of containers.

(2) Suitable for the testing of evaporating residues such as gaskets, wines, seasonings, etc. using natural rubber as the main raw material for the sealing of bottles and canned foods.

(3) It is suitable for the testing of evaporating residues of food containers, inner paints for containers, paint tins, plant fiber food containers and other materials which are made of vinyl chloride resin as the main raw material and are in direct contact with food.

(4) Evaporative Residue Test for chemical reagents that can evaporate and remove the body at boiling bath temperature.

(5) The instrument satisfies 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 and so on.

5. Test process

(1) Take 3 specimens with an inner surface area of ​​600 cm2, and cut each specimen into 5 cm × 0.5 cm pieces. After washing and drying at room temperature, place them in 3 500 mL Erlenmeyer flasks. Add 200 mL of water to each of the three Erlenmeyer flasks. Seal and place in a high-pressure cooker. Heat at 121 °C for 30 min. Take another Erlenmeyer flask and add 200 mL of water. Use the same method for blank testing. After cooking, cool at room temperature.

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

Figure 3 The drying process of the evaporating dish inside the device

(3) Pipette 50 mL soaking solution into 4 evaporating dishes after constant weight from the above four conical flasks cooled to room temperature.

(4) Place the evaporating dish on the water bath and evaporate it, place it on the corresponding evaporating dish rack, and close the test chamber door. The drying temperature was set to 105 °C, the weighing interval was 0.5 h, the test mode was in difference mode, the difference between the values ​​was set to 0.3 mg, and the evaporating dish containing the blank water was set as the reference cup, and other evaporating dish settings For the test cup. Open the test.

(5) The equipment is automatically dried and weighed. 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 is automatically ended. The device automatically calculates the weight of nonvolatiles in the 3 test cups.

6. Test results

The average non-volatile content of the multi-layer co-extrusion transfusion membrane for this test was 1.9 mg. According to the relevant regulations in YBB, the non-volatile content should not exceed 2.5 mg, so the non-volatile content of the sample was in accordance with standard requirement.

7. Conclusion

Non-volatile content is calculated by mimicking the migration process of the infusion packaging material in contact with the liquid, and calculating the total amount of substances that may migrate into the liquid. The lower the content of non-volatile matter, the lower the total amount of substances that may migrate during the exposure of the packaging material to the liquid chemical, and the less interference with the liquid medicine when the packaging material is used. Therefore, by monitoring the non-volatile content of the infusion packaging material, the risk of contamination of the packaging material can be effectively reduced. ERT-01 Evaporation Residue Constant Weight Meter is a professional test equipment for evaporation residue and non-volatile content detection of package materials. The automatic intermittent weighing function configuration avoids the tedious man-made constant weight process and can directly weigh at high temperature. No need to take the evaporating dish out of the dry cooling features, so that the test efficiency is greatly improved, the device 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 always committed to providing high-end advanced packaging testing equipment and intimate, accurate and efficient packaging testing services to customers worldwide. The existing customer base has Covers food, medicines, health products, daily chemical products, automobiles, third-party testing agencies, and universities. Learn about related testing equipment and services. You can log in to view specific information or to inquire. The more you understand, the more you trust! Labthink is willing to take this opportunity to enhance technical exchanges and cooperation with enterprises and institutions in the industry.