三层共挤输液用袋标准英文版.doc

The State food and Drug Administration National drug packaging containers (material) standard (interim) YB3-layer Co-extrusion Films and Bags Used for Infusion Polypropyrene/ polypropyrene/ polypropyrene three-tier film refers to polypropyrene as the main body to adopt the coextrusion process, do not use adhesive, formed by the three-tier IV film. Bags is made of polypropyrene / polypropyrene / polypropyrene three-tier IV film by rahfu used for infusion. [Appearance] regulations appearance an adequate amount of light in the nature of the rink, the Department should be addressed in a transparent and smooth, non-visible foreign matter. [Identification] * (1) Microscopic characteristics of this product by just the right amount, and cut into appropriate thickness is microscopically, cross section should display a clear third floor. (2) The product is Infrared Spectra taken in moderation, with the thickness of the slicer cut into colussoma (less than 50 μm) adjustableplate, situated at a micro-infrared instrument observation sample cross section. According to the packaging material infrared spectrometry (YB method for the determination, each layer should be substantialagreement and electrophoretograms. [Sterilizaion adaptability of bags] except where otherwise provided, the product is a number, and by 0.45 μm pore size filtration of water for injection to nongraphite capacity, and seal. Use the method of sterilization (standard sterilizaion F0 value = 8, such as sterilization of 121 Temperature adaptability said samples or 25℃ ±2 ℃, placed under the condition of a 24-hour, and then in the 50℃ ±2 ℃ to continue to be placed under 24 hours, and then on the 23℃ Resistance to drop the said samples or 25℃ ±2 ℃, placed under the condition of a 24-hour, and then in the50℃ ±2 ℃ to continue to be placed under 24 hours, and then on the 23 Table 1 drop height nongraphite capacity (ml) drop height(m) 50~749 1.00 750 ~ 1 499 0.75 1500~2499 0.50 ≥2500