三层共挤输液用袋标准英文版.doc

The State food and Drug AdministrationNational drug packaging containers (material) standard(interim) YBB001020053-layer Co-extrusion Films and Bags Used for InfusionPolypropyrene/ 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 m) adjustableplate, situated at a micro-infrared instrument observation sample cross section. According to the packaging material infrared spectrometry (YBB00262004) 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 m 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 for 15 minutes) to sterilizaion, make the following experiment: 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 2 , placed under 24 hours, the sample is placed between two parallel plates, 67KPa of hyperteution, the maintenance of up to 10 minutes. Should have no liquid. 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 2 in 24 hours will be placed in the condition, according to table 1 drop drop height, respectively, in a stereoplasm on rigid smooth surface without rupture and leak. Table 1 drop heightnongraphite capacity (ml)drop height(m)507491.00750 1 4990.75150024990.5025000.25Transparency the said samples or another empty bag, mount the level number is 4 turbidimetrv of the standard solution, contrast bags; a black background, with gluehlampenwerk to 2000 lx to 3000 lx irradiation experiment (avoiding exposure), the persons eyes, should be able to distinguish between bag with a control. Particulate matter the said samples a few, as far as packaging material for determination of particulate matter (YBB00272004) infusion bottles and infusion bag under the method for the determination of the particle diameter 5, 10, 25 m particles number not 100, 20, 2 pc/ml. Using adaptive test (bags) piercing except where otherwise provided, take the product, subject to a number of single-use infusion set gravity transfusion standards (GB8368-2005)puncturation, 200mm/min20mm/min a puncturation of the pericardiocentesis, the plastic puncturation for piercing should be less than 100N, the metal puncturation for piercing should be less than 80N. Puncturation for retention and the insertion point is not permealbe except where otherwise provided, something like a liquid bag, in line with the single-use infusion set gravity transfusion standards (GB8368-2005) of puncturation with puncturation bag insertion point, and then to 200mm/min 20mm/min speed unplug puncturation, the plastic puncturations separator force more than 5.0N, the metal puncturations separator force shall not be less than 1.0N. Pull-out puncturation for then bag placed between two parallel plates, 20kPa hyperteution, the maintenance of 15 seconds, and the insertion point there shall be no leakage of liquid. Injection point airproof something like a liquid bag, with the outer diameter as 0.6mm injection needle aspiration injection point and 15 seconds, and unplug the needle, and then set the bags reset between two parallel plates, 20kPa hyperteution, the maintenance of 15 seconds, and injection point shall not be leak. Something like the hoisting of the force a liquid bag, imposed in accordance with table 2, uponsize shall not break within 60 minutes. Table 2 uponsizenongraphite capacityuponsize250ml7N250ml15NPhysical properties WVT (film): as water vapor transmission measurements (YBB00092003) the first method for the determination. Temperature of 38 0.6 and relative humidity 90% 2% of the condition, not more than 5.0g /(m224h). (bags) by liquid bag several, as far as water vapor transmission measurements (YBB00092003) the third method for the determination. Each bag shall not reduce the weight of over 0.2%. The amount of oxygen through (film) according to the gas through measurements (YBB00082003) the first determination, not more than 1200cm3/ ( m224h0.1MPa). The amount of nitrogen through (film) according to the gas through measurements (YBB00082003) the first determination, not more than 600cm3/ ( m224h0.1MPa). Tensile strength (film) by the amount of the product, according to the determination of tensile properties (YBB00112003), type, rheomolding choice test speed (loadless) to select a 500 mm/min 50 mm/min, vertical and lateral tensile strength shall be more than the average 20MPa. Rahfu strength (bags) according to the rahfu method for determination of strength (compaund YBB00122003) for the determination of the bag, each rahfu parts shall not be lower than the average of 20N/15mm.Light transmittance provisions the product area, and cut into five sections of 0.9 respectively cm4cm, vertically along the incident light into absorption, fill it up with water in the pool, with water as the blank, as far as UV-vis spectrophotometry (PRC Pharmacopoeia 2005 appendices A), in the determination of the transmittance of 450nm Department shall not be less than 75%. Residue on ignition provisions Alex this product 5.0g accurate, placed has constant weight of crucible. Heating to 100 drying 1 hour later slowly Chi-amustion to the complete carbonification, cold, 550 at the Chi-amustion a full ashing, move to the dryer, inside, when accurate, and then on to 550 at the Chi-amustion, that is, the constant heavy. Metallic elements* regulations metals butter under the rasidues and add chemonucleolysis(12) 25ml, according to the atomic absorption spectrometry (PRC Pharmacopoeia 2005 part 2 appendices D) determination, should satisfy the following requirements: Office of copper in 324.8nm wavelength, calculated at 3 shall not be more than 106; Cd in 228.8nm wavelength measurement shall not be more than 106 at 3; chromium in the determination of 357.9nm wavelength division shall not be more than 106 at 3; lead in 217.0nm wavelength division less a million determination shall be calculated at 3; Tin determination in 286.3nm wavelength division shall not be more than 106 at 3; barium 553.6nm wavelength measurement at the less than 106 shall be calculated at 3. Dissolved matter test regulations opinins experiments of article skinpass part of the surface area of 600cm2, and cut into small pieces of 5cm0.5cm to post-drying at room temperature, situated at a 500 ml bottle of cone-shaped, add water 200ml, airproof, reset the high pressure steam sterilizer, 121 for 30 minutes of heating, cooling and at room temperature, as oleiferous and as obtainingwater with the manipulation, as blank-control solution, make the following experiment: Clarity by oleiferous, as far as clarity inspection method (PRC Pharmacopoeia 2005 part 2 appendices B), the solution should be clarified; Colour such as chloroben muddily, and turbidimetrv No. 2, the volume may not be standard solutions. Color opinins oleiferous (according to the law of the peoples Pharmacopoeia 2005 appendices a), the solution should be achromatous.pH value add 20 ml potassium chloride solution (11000) dispensable 1 ml, according to the determinationd method (PRC Pharmacopoeia 2005 part 2 appendices VI H) determination of the pH value should be 5.0 7.0. Ultraviolet absorption by oleiferous, with a blank solution for the control. According to the UV-vis spectrophotometry (PRC Pharmacopoeia 2005 part 2 appendices A), wavelength of 220 350nm carried out by the scan. 220 240nm biggest absorption value should 0.08; 241 350nm biggest absorption value not 0.05. Non-volatile matter opinins oleiferous 50ml, reset has been constant heavy handled, dehydrated, shuiyu and eyecoat 105 dry to constant weight, with the blank controlled trial. The difference of residue between the text solution and the control fluid doest exceed 2.5mg.Easy-to-oxide precision measuring 20 ml opinins oleiferous, detrmincd precision by adding potassium permanganate solution (0.002mol/L) MB-amoxycillin and dilute sulfuric acid solution 10.0ml, 3-minute micro-boiling heat, cooling to room temperature. Plus 0.1g potassium iodide, Sodium Thiosulphate solution (tirtate 0.01mol/l) tirtate to light brown, and then add five drops of liquid starch indicates to achromatous after tirtate. At the same time carry out a blank test, oleiferous and blank titration with sodium thiosulfate reference consumption (liquid 0.01mol/L) of not 1.5ml. Ammonium 50ml oleiferous opinins alkline iodisatum multicomponeut 2ml, mercury potassium placed 15 minutes (or, in color, and ammonium chloride solution (opinins 31.5mg no ammoniawith water ammonium chloride and an adequate amount of diluting the dissolution and 1000ml) 4.0ml, 46ml with a blank solution and alkaline potassium iodide mercury multicomponeut 2ml made of reference comparison, not better. (0.00008 per cent) Barium ion * opinins oleiferous in moderation, if necessary, can be concentrated, as far as the determination of metals, believing that it is not in a million.Copper ion * opinins oleiferous in moderation, if necessary, can be concentrated, as far as the determination of metals, believing that it is not in a million.Cadmium * opinins oleiferous just the right amount, necessary, concentration, according to the determination of metal elements shall not be under, over a ten-thousand. Lead ions * opinins oleiferous in moderation, if necessary, can be concentrated, as far as the determination of metals, believing that it is not in a million. Tin oleiferous ion * take just the right amount, necessary, concentration, according to the determination of metal elements shall not be under, over a ten-thousand. Chromium ion * opinins oleiferous in moderation, if necessary, can be concentrated, as far as the determination of metals, believing that it is not in a million.Aluminium ion * opinins oleiferous just the right amount, necessary, concentration, according to the atomic absorption spectrometry (PRC Pharmacopoeia 2005 part 2 appendices D) determination of wavelength at 309.3nm, and 0.5 shall not be more than one million. Heavy metal precision measuring 20 ml opinins, and oleiferous acetate buffer (pH3.5) 2ml (according to the law of the peoples Pharmacopoeia 2005 part 2 appendices H first method), not in a million. Foam test oleiferous 5 ml, situated at the inner diameter of the test tube with stopper (15mm -200mm) and a height of about, severe oscillation in the 3min, the resulting foam disappearing within should be 3min. Bacterial Endotoxin (bag) provisions, by adding an empty bag by nongraphite capacity noheat raw water, seaming, placed high pressure steam sterilizer, 121 2 in sterilizaion for 30 minutes, inside, alternate, and a trial solution, as far as the bacterial endotoxins (PRC Pharmacopoeia 2005 part 2 appendices Appendix XI E) determination of method 1 gel, it may not have 0.25EU/ml. biological test * provisions cytotoxicity according to cytotoxicity testing method (YBB00012003) the first determination to contain UN-treated for condations media; samples of surface area and condations media is 6cm2/ml, should conform to the requirements. Sensitization to test according to maximization test (YBB00052003), type reaction should. Intradermic challenge test according to the intradermic stimulation with (YBB00062003) should be no irritation. Acute systemic toxicity test according to acute systemic toxicity testing method (YBB00042003), samples of surface area and condations media is 6cm2/ml, the temperature is 37 1 in condations time for 24h 2 h should be no acute. systemic toxicity. According to the lysophosphatidyl test (lysophosphatidyl) with YBB00032003, not lysophosphatidyl rate of 5%. storaging provisions inner packaging with low density polyethylene bags, medical remains at cleaning, ventilate. Attachment： checking rule1, product testing is divided into parts of all tests and inspections. 2. any of the following circumstances, should be based on standards for all surveys. (1) packsproduct (2) product material quality accident back production (3) inspection (4) product after regaining production of 3, one of the following by standards nullahs “*” project. (1) inspection (2)