六种药用包材在非聚氯乙烯软袋输液生产线的应用及质量考察

目的考察6种药用包材的质量,选择热合性能好和上机适应强的包材,提高非聚氯乙烯软袋大输液质量稳定性。方法通过比较包材的物理性能和上机适应性,确定生产用包材并对此包材包装的电解质输液进行稳定性实验。结 果重量差异小的组合盖和接口在设备上运行顺畅,3层与5层共挤输液用袋物理、化学性能及此包装的四种电解质输液稳 定性试验均符合规定,但3个规格的3层共挤输液用袋成品得率均低于5层共挤输液用袋。结论5层共挤输液用袋成品率 高,应作为该院大输液生产首选包材;3层共挤输液用袋灭菌后透光率好,可以作为备用包材。

Six Kinds of Medicinal Packaging Materials in the Application of the non-PVC Soft Bag Infusion Production Line and Quality Inspection

Objective To investigate the quality of six types of pharmaceutical packaging materials in order to improve the stability of quality of non-PVC soft bag infusion. Methods Packaging materials for production were chosen by comparing the physical properties of these materials and their adaptability to equipment. The electrolyte fluids inside the packaging materials were subjected to a stability test. Results Assembly covers and interfaces which had small weight difference ran smoothly on the device. The physical and chemical properties of bags of 3-layer and 5-1ayer co-extrusion infusion and the stability test of four electrolyte fluids inside the bags all met the requirements. However, the finished product yield of 3-layer co-extrusion infusion bags of three specifications was lower than that of the bags of 5-layer co-extrusion infusion. Conclusion Bags of 5-layer co-extrusion infusion should be the first choice for large volume infusion production while bags of 3-layer co-extrusion infusion can be used as spare packaging materials thanks to their good light transmittance after sterilization.