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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
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