Properties of Materials Used in Single-Use Flexible Containers: Requirements and Analysis - - BioPharm International

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Properties of Materials Used in Single-Use Flexible Containers: Requirements and Analysis


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8. EMEA/410/01, Note for guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products. European Agency for the Evaluation of Medicinal Products, London, UK, 2004 Jan.

9. See European Pharmacopeia monographs specific to the chosen material, such as E.P. 3.1.13. "Plastic additives, E.P. 3.1.5, Polyethylene with additives for containers for preparations for parenteral use and for ophthalmic preparation" or E.P. 3.1.9. "Silicone elastomer for closures and tubing" etc. European Directorate for the Quality of Medicines, Strasbourg, France.

10. ANSI/AAMI/ISO 11137, Sterilization of healthcare products, Association for the Advancement of Medical Instrumentation, Arlington, VA, 2006.

11. USP Chapter <788>, Particulate matter in injections.

12. EP 2.9.19, Non visible particulate contamination, Assay A and B.

13. USP <85>, Bacterial endotoxins test.

14. E.P. 2.6.14, Bacterial endotoxins–Method D.

15. ISO 15747, Plastics containers for intravenous injection.

16. E.P. 3.2.2.1, Plastic containers for aqueous solutions for parenteral infusion.

17. E.P. 3.2.2., Plastic containers and closures for pharmaceutical use.

18. EMEA/CVMP/205/04, Guideline on plastic primary packaging material.

19. ASTM D882 "Standard Test Method for Tensile Properties of Thin Plastic Sheeting, ASTM International, Conshohocken, PA.

20. ISO 527-3, Plastics—Determination of tensile properties.

21. ISO 7765-1, Plastics film and sheeting—Determination of impact resistance by the free-falling dart method–Part 1: Staircase methods.

22. ISO 7765-2, Plastics film and sheeting—Determination of impact resistance by the free-falling dart method–Part 2: Instrumented puncture test.

23. ASTM D1004 Standard Test Method for Initial Tear Resistance of Plastic Film and Sheeting.

24. ASTM D1922, Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method.

25. ISO 6383-1, Plastics—Film and sheeting—Determination of tear resistance–Part 1: Trouser tear method.

26. ISO 6383-2, Plastics—Film and sheeting—Determination of tear resistance–Part 2: Elmendorf method.

27. ASTM F392, Standard test method for flex durability of flexible barrier materials.

28. ASTM E1640, Standard test method for assignment of the glass transition temperature by dynamic mechanical analysis.

29. ASTM D3418, Standard test method for transition temperatures and enthalpies of fusion and crystallization of polymers by differential scanning calorimetry.

30. ISO 11357-2, Plastics—Differential scanning calorimetry (DSC)–Part 2: Determination of glass transition temperature.

31. ISO11359-2, Plastics—Thermomechanical analysis (TMA)–Part 2: Determination of coefficient of linear thermal expansion and glass transition temperature,

32. ISO 8570, Plastics—Film and sheeting— Determination of cold-crack temperature.

33. ASTM D746, Standard test method for brittleness temperature of plastics and elastomers by impact.

34. ASTM D1790, Standard test method for brittleness temperature of plastic sheeting by impact.

35. Hmel P, Kennedy A, Quiles J, Gorogias M, Seelbaugh J, Morrissette, et al. Physical and thermal properties of blood storage bags: implications for shipping frozen components on dry ice, Transfusion, 2002 Jul; 42.

36. ASTM F1249, Standard test method for water vapor transmission rate through plastic film and sheeting using a modulated infrared sensor,


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