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


BioPharm International


37. ISO 15106-1, Plastics—Film and sheeting—Determination of water vapour transmission rate–Part 1: Humidity detection sensor method.

38. ISO 15106-2 "Plastics—Film and sheeting—Determination of water vapour transmission rate–Part 2: Infrared detection sensor method,

39. ISO 15106-3, Plastics—Film and sheeting—Determination of water vapour transmission rate–Part 3: Electrolytic detection sensor method.

40. ICH Q1A(R2), Stability testing of new drug substances and products, International Conference on Harmonization, 2003 Feb 6.

41. ASTM D3985, Standard test method for oxygen gas transmission rate through plastic film and sheeting using a coulometric sensor.

42. ISO 15105-1, Plastics—Film and sheeting—Determination of gas-transmission rate–Part 1: Differential-pressure method.

43. ISO 15105-2, Plastic—Film and sheeting—Determination of gas-transmission rate—Part 2: Equal-pressure method.

44. Van Krevelen D.W., Properties of polymers, 3d ed, New York, Elsevier; 1997, Chapter 18.

45. ISO 14782, Plastics—Determination of haze for transparent materials.

46. ASTM D1003, Standard test method for haze and luminous transmittance of transparent plastics.

47. ASTM D543, Standard practices for evaluating the resistance of plastics to chemical reagents.

48. Uettwiller I, Dubut D, Voute N, Quantification of protein adsorption onto the surface of single-use flexible containers, BioProcess Int. 2006 June, 4(6): S22–S26.

49. ASTM F1980, Standard guide for accelerated aging of sterile medical device packages.


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