- Preparation of media and buffers before filtration
- Pooling process intermediate solutions
- Waste collection from downstream purification processes
Construction | ||||||||||||||||||
Materials of Construction | $('textarea[name="product_attribute[1][product_attribute_description][1][text]"]').attr('title', 'Double Click for HTML').on('dblclick', function(){ htmlProductAttribute($(this)); });$('textarea[name="product_attribute[2][product_attribute_description][1][text]"]').attr('title', 'Double Click for HTML').on('dblclick', function(){ htmlProductAttribute($(this)); });$('textarea[name="product_attribute[3][product_attribute_description][1][text]"]').attr('title', 'Double Click for HTML').on('dblclick', function(){ htmlProductAttribute($(this)); });$('textarea[name="product_attribute[4][product_attribute_description][1][text]"]').attr('title', 'Double Click for HTML').on('dblclick', function(){ htmlProductAttribute($(this)); });$('textarea[name="product_attribute[5][product_attribute_description][1][text]"]').attr('title', 'Double Click for HTML').on('dblclick', function(){ htmlProductAttribute($(this)); });$('textarea[name="product_attribute[6][product_attribute_description][1][text]"]').attr('title', 'Double Click for HTML').on('dblclick', function(){ htmlProductAttribute($(this)); });$('textarea[name="product_attribute[7][product_attribute_description][1][text]"]').attr('title', 'Double Click for HTML').on('dblclick', function(){ htmlProductAttribute($(this)); });$('textarea[name="product_attribute[8][product_attribute_description][1][text]"]').attr('title', 'Double Click for HTML').on('dblclick', function(){ htmlProductAttribute($(this)); });$('textarea[name="product_attribute[9][product_attribute_description][1][text]"]').attr('title', 'Double Click for HTML').on('dblclick', function(){ htmlProductAttribute($(this)); });$('textarea[name="product_attribute[10][product_attribute_description][1][text]"]').attr('title', 'Double Click for HTML').on('dblclick', function(){ htmlProductAttribute($(this)); });
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Dimension |
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Physical Properties of Film | ||||||||||||||||||
Tensile Strength | >20 N/mm² when tested as per ASTM D-882 | |||||||||||||||||
Elongation @ Break | >280% when tested as per ASTM D-882 | |||||||||||||||||
Operational | ||||||||||||||||||
Sterilization | Gamma Irradiated @25 kGy | |||||||||||||||||
Assurance | ||||||||||||||||||
Bacterial Endotoxin | Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP<85> | |||||||||||||||||
Bioburden | Bioburden level is < 1000 cfu/liner as perISO 117371: 2018 | |||||||||||||||||
Fiber Release | Passes microscopic test for fibers | |||||||||||||||||
Particle Release | The filtrate complies with USP <788> test for particulate matter in injections | |||||||||||||||||
Extractables with WFI | Does not affect the quality of Water for injection (passes test as per USP) | |||||||||||||||||
Biosafety | Passes the Biological Reactivity Tests, In Vivo for Class VI plastics as described in USP<88>. Passes the Biological Reactivity Tests, In Vitro for Cytotoxicity as |
For 50L AseptiLiner™ | AL13HXXXXXXS302 |
For 100L AseptiLiner™ | AL14IXXXXXXS302 |
For 200L AseptiLiner™ | AL15JXXXXXXS302 |
For 500L AseptiLiner™ | AL16KXXXXXXS302 |
File Type | Download |
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Datasheet | Download |
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