{"product_id":"single-use-fluoropolymer-freeze-bag","title":"Single-Use Fluoropolymer Freeze Bag Assembly","description":"\u003ch2\u003eProduct description\u003c\/h2\u003e\n\n\u003cp\u003e\n  Single-use fluoropolymer freeze bag assemblies are designed for the freezing,\n  storage, transport and handling of pharmaceutical and bioprocess liquids.\n  The fluid-contact bag is manufactured from a single-layer fluoropolymer material\n  and can be configured as part of a disposable fluid path with tubing and\n  connection components.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  The combination of chemical resistance, low-temperature flexibility and\n  single-layer construction makes this type of process bag particularly suitable\n  for frozen drug substance, intermediates, cell culture materials and other\n  process fluids requiring controlled storage or transportation.\n\u003c\/p\u003e\n\n\n\u003ch3\u003eTechnical overview\u003c\/h3\u003e\n\n\u003cp\u003e\n  Unlike multilayer process films constructed from several polymers, adhesive\n  layers and barrier materials, the bag film consists of one fluoropolymer\n  material. This monolayer construction eliminates delamination between film\n  layers and avoids the use of interlayer adhesives within the bag film.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  The specified working temperature range is approximately\n  \u003cstrong\u003e-85 °C to +40 °C\u003c\/strong\u003e. This allows the bag to remain suitable for\n  demanding low-temperature applications where conventional flexible materials\n  may become less elastic.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Assemblies can be supplied for gamma sterilisation and are intended for\n  pharmaceutical and bioprocess applications where cleanliness, material\n  compatibility and controlled fluid handling are important.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Available test and conformity information includes biological safety,\n  endotoxin, particle and extractables data. Extractables and leachables test\n  data following BPOG guidelines can be made available for technical review.\n\u003c\/p\u003e\n\n\n\u003chr\u003e\n\n\n\u003ch2\u003eOperating principle\u003c\/h2\u003e\n\n\u003cp\u003e\n  The bag functions as a flexible single-use process container within a closed\n  or controlled fluid path. Process liquid enters or leaves the bag through\n  tubing and connection components selected for the required application.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  During freezing, the liquid and flexible container are cooled together.\n  The fluoropolymer film is selected for its ability to remain functional at\n  low temperatures down to the specified operating limit. After freezing, the\n  assembly can be used for controlled storage and subsequent transport before\n  thawing or further downstream processing.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Depending on the configuration, the bag may be supplied as a complete assembly\n  with tubing and connections or as a bag without tubing. The exact fluid path\n  should be defined around the intended filling, freezing, storage, transport\n  and discharge procedure.\n\u003c\/p\u003e\n\n\n\u003chr\u003e\n\n\n\u003ch2\u003eMaterial options\u003c\/h2\u003e\n\n\u003cp\u003e\n  The bag film is manufactured from a\n  \u003cstrong\u003esingle-layer fluoropolymer material\u003c\/strong\u003e.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  The monolayer construction does not rely on a combination of PE, EVOH,\n  nylon and adhesive layers commonly used in some multilayer process films.\n  The bag film also does not require plasticisers or colouring additives as\n  part of its stated construction.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Tubing, connectors and other assembly components are configuration-dependent.\n  Required component materials should therefore be specified and verified\n  during assembly selection.\n\u003c\/p\u003e\n\n\n\u003chr\u003e\n\n\n\u003ch2\u003eAvailable micron ratings\u003c\/h2\u003e\n\n\u003cp\u003e\n  \u003cstrong\u003eNot applicable.\u003c\/strong\u003e This product is a single-use process bag\n  assembly rather than a filtration medium and therefore does not have a micron\n  or pore-size rating.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Where filtration is required within the same fluid path, a suitable filter\n  can be specified separately as part of the complete single-use assembly.\n\u003c\/p\u003e\n\n\n\u003chr\u003e\n\n\n\u003ch2\u003eDesign and construction\u003c\/h2\u003e\n\n\u003cp\u003e\n  The process bag uses a monolayer fluoropolymer construction and is available\n  in multiple nominal volumes for laboratory, process development and production\n  applications.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Standard listed volumes range from \u003cstrong\u003e50 mL to 20 L\u003c\/strong\u003e.\n  Additional 20 mL and 50 L configurations are available on request.\n  Further sizes and assembly designs may also be specified according to the\n  application.\n\u003c\/p\u003e\n\n\u003ctable style=\"width:100%; border-collapse:collapse; margin:24px 0;\"\u003e\n  \u003cthead\u003e\n    \u003ctr\u003e\n      \u003cth style=\"text-align:left; padding:10px; border-bottom:1px solid #ddd;\"\u003e\n        Nominal volume\n      \u003c\/th\u003e\n      \u003cth style=\"text-align:left; padding:10px; border-bottom:1px solid #ddd;\"\u003e\n        Approx. length\n      \u003c\/th\u003e\n      \u003cth style=\"text-align:left; padding:10px; border-bottom:1px solid #ddd;\"\u003e\n        Approx. width\n      \u003c\/th\u003e\n    \u003c\/tr\u003e\n  \u003c\/thead\u003e\n\n  \u003ctbody\u003e\n    \u003ctr\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e50 mL\u003c\/td\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e120 mm\u003c\/td\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e100 mm\u003c\/td\u003e\n    \u003c\/tr\u003e\n\n    \u003ctr\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e100 mL\u003c\/td\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e160 mm\u003c\/td\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e100 mm\u003c\/td\u003e\n    \u003c\/tr\u003e\n\n    \u003ctr\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e250 mL\u003c\/td\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e240 mm\u003c\/td\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e100 mm\u003c\/td\u003e\n    \u003c\/tr\u003e\n\n    \u003ctr\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e500 mL\u003c\/td\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e210 mm\u003c\/td\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e158 mm\u003c\/td\u003e\n    \u003c\/tr\u003e\n\n    \u003ctr\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e1 L\u003c\/td\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e285 mm\u003c\/td\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e178 mm\u003c\/td\u003e\n    \u003c\/tr\u003e\n\n    \u003ctr\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e2 L\u003c\/td\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e354 mm\u003c\/td\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e254 mm\u003c\/td\u003e\n    \u003c\/tr\u003e\n\n    \u003ctr\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e5 L\u003c\/td\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e470 mm\u003c\/td\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e323 mm\u003c\/td\u003e\n    \u003c\/tr\u003e\n\n    \u003ctr\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e10 L\u003c\/td\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e570 mm\u003c\/td\u003e\n      \u003ctd style=\"padding:10px; border-bottom:1px solid #eee;\"\u003e383 mm\u003c\/td\u003e\n    \u003c\/tr\u003e\n\n    \u003ctr\u003e\n      \u003ctd style=\"padding:10px;\"\u003e20 L\u003c\/td\u003e\n      \u003ctd style=\"padding:10px;\"\u003e718 mm\u003c\/td\u003e\n      \u003ctd style=\"padding:10px;\"\u003e483 mm\u003c\/td\u003e\n    \u003c\/tr\u003e\n  \u003c\/tbody\u003e\n\u003c\/table\u003e\n\n\u003cp\u003e\n  Smaller bag assemblies from 50 mL to 250 mL and larger assemblies from\n  500 mL to 20 L can be configured with the required fluid-path components.\n  Bags without tubing are also available in non-sterile configurations.\n\u003c\/p\u003e\n\n\u003ch3\u003eCompliance and technical properties\u003c\/h3\u003e\n\n\u003cp\u003e\n  The available technical documentation for the fluoropolymer bag includes\n  the following stated tests and conformity references:\n\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003eUSP Class VI\u003c\/li\u003e\n  \u003cli\u003eUSP \u0026lt;87\u0026gt;\u003c\/li\u003e\n  \u003cli\u003eUSP \u0026lt;88\u0026gt;\u003c\/li\u003e\n  \u003cli\u003eUSP \u0026lt;85\u0026gt;\u003c\/li\u003e\n  \u003cli\u003eEP 2.6.14 with stated endotoxin level below 0.125 EU\/mL\u003c\/li\u003e\n  \u003cli\u003eISO 10993-4, non-haemolytic\u003c\/li\u003e\n  \u003cli\u003eUSP \u0026lt;661\u0026gt; extractables testing\u003c\/li\u003e\n  \u003cli\u003eUSP \u0026lt;788\u0026gt; particle testing\u003c\/li\u003e\n  \u003cli\u003eEP 2.9.19 particle testing\u003c\/li\u003e\n  \u003cli\u003eCleanroom Class 5 production\u003c\/li\u003e\n  \u003cli\u003eGamma-sterilisable construction\u003c\/li\u003e\n  \u003cli\u003eSpecified working temperature: -85 °C to +40 °C\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003e\n  Exact documentation requirements should be confirmed for the final assembly\n  configuration, including all tubing, connectors and other fluid-contact\n  components.\n\u003c\/p\u003e\n\n\n\u003chr\u003e\n\n\n\u003ch2\u003eTypical applications\u003c\/h2\u003e\n\n\u003cp\u003e\n  Single-use fluoropolymer freeze bag assemblies are primarily intended for\n  pharmaceutical and biotechnology processes involving low-temperature storage,\n  fluid handling and product transfer.\n\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003eFreezing of pharmaceutical intermediates\u003c\/li\u003e\n  \u003cli\u003eFrozen drug substance storage\u003c\/li\u003e\n  \u003cli\u003eDownstream bioprocessing\u003c\/li\u003e\n  \u003cli\u003eFreezing and storage of cell culture material\u003c\/li\u003e\n  \u003cli\u003eStem-cell freezing and storage\u003c\/li\u003e\n  \u003cli\u003eStorage and transport of active pharmaceutical ingredients\u003c\/li\u003e\n  \u003cli\u003eStorage and transport of chemically aggressive media\u003c\/li\u003e\n  \u003cli\u003eStorage and transportation of binding media\u003c\/li\u003e\n  \u003cli\u003ePharmaceutical filling processes\u003c\/li\u003e\n  \u003cli\u003eCritical process sampling\u003c\/li\u003e\n  \u003cli\u003eLow-temperature product transfer\u003c\/li\u003e\n  \u003cli\u003eIntermediate storage before Fill \u0026amp; Finish\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\n\u003chr\u003e\n\n\n\u003ch2\u003eKey benefits\u003c\/h2\u003e\n\n\u003cul\u003e\n  \u003cli\u003e\n    \u003cstrong\u003eLow-temperature operation:\u003c\/strong\u003e\n    specified for use down to approximately -85 °C.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eMonolayer fluoropolymer film:\u003c\/strong\u003e\n    constructed from a single polymer material rather than a multilayer\n    film system.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eNo film delamination:\u003c\/strong\u003e\n    the single-layer construction eliminates delamination between\n    individual bag-film layers.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eChemical resistance:\u003c\/strong\u003e\n    fluoropolymer construction supports applications involving demanding\n    pharmaceutical and process media.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eGamma sterilisation:\u003c\/strong\u003e\n    suitable configurations can be supplied for gamma-sterilised\n    single-use applications.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eClean manufacturing environment:\u003c\/strong\u003e\n    bag production is specified as taking place under ISO Class 5\n    cleanroom conditions.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eExtractables documentation:\u003c\/strong\u003e\n    test data following BPOG guidelines is available for technical review.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eMultiple process volumes:\u003c\/strong\u003e\n    standard sizes cover small laboratory volumes through larger\n    process-scale assemblies.\n  \u003c\/li\u003e\n\u003c\/ul\u003e\n\n\n\u003chr\u003e\n\n\n\u003ch2\u003eConfiguration and quotation\u003c\/h2\u003e\n\n\u003cp\u003e\n  Freeze bag assemblies should be specified around the complete process rather\n  than bag volume alone. The required fluid path, storage conditions and\n  connection interfaces determine the final assembly configuration.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  For technical selection and quotation, provide the following information\n  where available:\n\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003eRequired nominal bag volume\u003c\/li\u003e\n  \u003cli\u003eProcess fluid or product\u003c\/li\u003e\n  \u003cli\u003eMinimum and maximum operating temperature\u003c\/li\u003e\n  \u003cli\u003eFreezing and thawing procedure\u003c\/li\u003e\n  \u003cli\u003eRequired tubing type and dimensions\u003c\/li\u003e\n  \u003cli\u003eRequired inlet and outlet connections\u003c\/li\u003e\n  \u003cli\u003eNumber of fluid-path ports\u003c\/li\u003e\n  \u003cli\u003eFilling and discharge method\u003c\/li\u003e\n  \u003cli\u003eGamma sterilisation requirement\u003c\/li\u003e\n  \u003cli\u003eStorage and transport conditions\u003c\/li\u003e\n  \u003cli\u003eRequired technical or conformity documentation\u003c\/li\u003e\n  \u003cli\u003eAnnual demand and prototype quantity\u003c\/li\u003e\n  \u003cli\u003eExisting assembly drawing or process sketch, if available\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003e\n  Custom configurations and additional bag sizes can be evaluated where a\n  standard assembly does not match the required process.\n\u003c\/p\u003e\n\n\u003cscript type=\"application\/ld+json\"\u003e\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"FAQPage\",\n  \"mainEntity\": [\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What is a single-use fluoropolymer freeze bag?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"A single-use fluoropolymer freeze bag is a disposable process container designed for freezing, storing, transporting and handling pharmaceutical or bioprocess liquids. The bag uses a monolayer fluoropolymer film and can form part of a configured single-use fluid path.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What temperature range can a fluoropolymer freeze bag operate at?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"The specified working temperature range for this fluoropolymer bag is approximately -85 °C to +40 °C, making it suitable for low-temperature pharmaceutical storage and transport applications.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What material is the single-use freeze bag made from?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"The bag film is manufactured from a single-layer fluoropolymer material rather than a multilayer film consisting of several polymers and adhesive layers.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What sizes are available for single-use freeze bags?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Listed standard volumes include 50 mL, 100 mL, 250 mL, 500 mL, 1 L, 2 L, 5 L, 10 L and 20 L. Additional 20 mL and 50 L sizes are available on request.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Can fluoropolymer freeze bag assemblies be gamma sterilised?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Yes. The fluoropolymer bag construction is suitable for gamma sterilisation and can be configured as a pre-sterilised single-use assembly.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What are single-use fluoropolymer freeze bags used for?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Typical applications include frozen drug substance and intermediate storage, downstream processing, cell culture and stem-cell freezing, active ingredient storage and transport, filling, critical sampling and handling of chemically demanding process media.\"\n      }\n    }\n  ]\n}\n\u003c\/script\u003e","brand":"Filtra International","offers":[{"title":"50 mL \/ Bag Assembly \/ Gamma Sterilised","offer_id":57300241580358,"sku":null,"price":0.0,"currency_code":"EUR","in_stock":true},{"title":"50 mL \/ Bag Assembly \/ Non-Sterile","offer_id":57300241613126,"sku":null,"price":0.0,"currency_code":"EUR","in_stock":true},{"title":"50 mL \/ Bag 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