Disposable 3D storage and transportation bags are generally used in large volume production processes. The shape and size of the bag can be customized according to customer requirements, making it convenient to use. The raw materials are made of high-quality and high-strength biopharmaceutical films, which have passed 100% integrity testing and meet the requirements of USP class VI and no animal sources. Double layer sterile packaging for easy use.

The film used for making disposable storage and transportation bags is a five layer co extruded film for biopharmaceuticals, which has characteristics such as high strength, high barrier, and chemical resistance. The total thickness of the film is 0.325mm, and the main components of the material are PE and EVOH. ULDPE, as the inner surface contact layer, complies with the general pharmacopoeia regulations and has strong cleanliness and chemical resistance. EVOH, as an intermediate layer material, has high barrier properties against gases such as oxygen, carbon dioxide, and water vapor.

机械强度 Physical Property
拉伸强度 Tensile strength at break	13MPa	ASTM D-882
断裂伸长率 Elongation at break	300%	ASTM D-882
弹性系数 Elastic modulus	350%	ASTM D-882
冷冻断裂温度 Break at cold temperature	<-45℃	ISO 8570

阻隔性能 Barrier Property
水蒸气透过率 Water vapor transmission rate	0.32 g/（m².day） （23°C, 100%RH）	ASTM D-1249
氧气透过率 Oxygen permeability	0.05cm3/（m².day.bar） （23°C, 0%RH）	ASTM D-3985
二氧化碳透过率 Carbon dioxide permeability	0.2cm3/（m².day.bar） （23°C, 0%RH）	ASTM F-2476

生物相容性&溶出 Biocompatibility & Extractables
溶血测试 Hemolysis	Complies	ISO 10993-4
细胞毒性 Cytotoxicity	Complies	ISO 10993-5
刺激和致敏性测试 Irritation and Sensitization tests	Complies	ISO 10993-10
急毒测试 Acute Systemic Toxicity test	Complies	ISO 10993-11
内毒素测试 Bacterial Endotoxins-LAL test	Complies	USP<85>
生物反应性测试，体内，VI级 Biological reactivity testing，in vivo，class VI	Complies	USP<88>
溶出测试-USP<661>理化测试Extractables-USP<661> physical-chemical test	Complies	USP<661>
溶出测试-EP 3.1.5 理化测试 Extractables-European Pharmacopeia，Ch.3.1.5	Complies	EP Ch.3.1.5

Product item number	Specifications	Size（W*D*H, cm）	Configuration description	Product diagram
2131-0100-01	100 L	74*54*30	Pipeline 1:1/2 "ID * 3/4" OD silicone hose 100cm+1/2 "ID * 3/4" OD C-Flex pipe 50cm MPX quick connector male+dust cap Pipeline 2: 1/2 "ID * 3/4" OD silicone hose 100cm+1/2 "ID * 3/4" OD C-Flex pipe 50cmMPX quick connector male+dust cap Pipeline 3: 1/4 "ID * 3/8" OD silicone hose 15cm needle free sampling valve+dust cap
2131-0200-01	200 L	74*54*60
2131-0200-11	200 L	78*58*64
2131-0250-11	250 L	113*73*67
2131-0500-01	500 L	113*73*67
2131-0500-11	500 L	110*108*50
2131-1000-11	1000L	110*108*94