{"product_id":"single-use-bioprocess-bag-assemblies","title":"Custom Single-Use Bioprocess Bag Assemblies","description":"\u003ch2\u003eProduct description\u003c\/h2\u003e\n\n\u003cp\u003e\n  Custom single-use bioprocess bag assemblies are configurable disposable fluid\n  handling systems for pharmaceutical and biotechnology applications. They can\n  combine a flexible 2D or 3D process bag with tubing, connectors, couplings,\n  filters, ports, sensors and other fluid-path components according to the\n  requirements of the process.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Bag assemblies can be configured for applications ranging from small-volume\n  sampling and media handling to large-volume buffer storage, product transfer,\n  cell culture, filtration and mixing. Available bag formats include both\n  2D and 3D constructions with nominal volumes up to 4,000 litres.\n\u003c\/p\u003e\n\n\n\u003ch3\u003eTechnical overview\u003c\/h3\u003e\n\n\u003cp\u003e\n  A single-use bag assembly provides a preconfigured process container and fluid\n  path that can be designed around the intended pharmaceutical or bioprocess\n  operation. The bag geometry, volume, film construction, port positions,\n  tubing arrangement and process connections can be selected according to the\n  required application.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Connections may be positioned on the face or surface of the bag depending on\n  the bag design. Assemblies can incorporate different tubing types, filters,\n  sterile connectors, quick couplings, sanitary interfaces and other process\n  components.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Available configurations include media bags, sampling bags, filtration bags,\n  rocking bioreactor bags, buffer storage bags and recirculation bags. Custom\n  assemblies can also be developed where a standard bag configuration does not\n  match the required fluid path.\n\u003c\/p\u003e\n\n\n\u003chr\u003e\n\n\n\u003ch2\u003eOperating principle\u003c\/h2\u003e\n\n\u003cp\u003e\n  The process bag acts as a flexible disposable container within a defined\n  fluid path. Liquid enters and leaves the bag through ports connected to\n  tubing, sanitary fittings, sterile connectors or other process interfaces.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  The operating principle depends on the selected bag configuration. A sampling\n  bag may collect a defined sample volume from a process line, while a buffer\n  bag may be used for storage and transfer of larger liquid volumes. A\n  recirculation bag can incorporate a lower outlet and return line so that a\n  pump circulates liquid through the bag for mixing.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Filtration bag assemblies can incorporate an internal filtration mesh or\n  tissue. Process liquid enters the bag and passes through the internal\n  separation medium before being discharged through the appropriate outlet.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Rocking bioreactor bag assemblies are designed to operate on a moving platform.\n  The controlled rocking motion supports fluid movement and cell cultivation,\n  while configurable ports can be provided for media addition, ventilation,\n  sensors and other process connections.\n\u003c\/p\u003e\n\n\n\u003chr\u003e\n\n\n\u003ch2\u003eMaterial options\u003c\/h2\u003e\n\n\u003cp\u003e\n  Different film constructions are available depending on the application,\n  required barrier properties, chemical compatibility and sterilisation method.\n\u003c\/p\u003e\n\n\u003ch3\u003eMultilayer LDPE process films\u003c\/h3\u003e\n\n\u003cp\u003e\n  LDPE-contact bag constructions are available in several film formats.\n  Depending on the selected construction, additional barrier and protective\n  layers can include EVOH gas-barrier material and nylon reinforcement.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Configurations include standard process films as well as reinforced\n  multi-layer films intended for applications where additional mechanical\n  protection during processing, handling or transportation is required.\n\u003c\/p\u003e\n\n\u003ch3\u003eFluoropolymer contact films\u003c\/h3\u003e\n\n\u003cp\u003e\n  Fluoropolymer-contact bag materials can be specified for applications\n  requiring increased chemical resistance or different product-contact\n  characteristics.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  PVDF-contact film is available for suitable applications and provides a\n  chemically resistant product-contact surface. Suitable configurations can\n  also be selected for autoclave applications.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  The appropriate film material should always be selected according to the\n  process fluid, temperature, sterilisation method, storage conditions and\n  required material documentation.\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\u003eNo standard micron rating applies to the general bag assembly.\u003c\/strong\u003e\n  Standard media, sampling, buffer, mixing and bioreactor bags are process\n  containers rather than filtration media.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Filtration bag assemblies can incorporate an internal filtration mesh or\n  separation material. The required mesh or filtration specification is\n  configuration-dependent and should be defined according to the particles,\n  cells, microcarriers or other material that needs to be retained or separated.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  If a defined membrane micron rating is required for sterile or particulate\n  filtration, an appropriate inline filter can also be integrated into the\n  complete single-use fluid path.\n\u003c\/p\u003e\n\n\n\u003chr\u003e\n\n\n\u003ch2\u003eDesign and construction\u003c\/h2\u003e\n\n\u003cp\u003e\n  Single-use bag assemblies are available as both flat 2D bags and\n  three-dimensional 3D process bags. Designs can be configured from relatively\n  simple single-port bags to complex assemblies incorporating multiple tubing\n  lines, manifolds, filters, connectors and process interfaces.\n\u003c\/p\u003e\n\n\u003ch3\u003e2D bag configurations\u003c\/h3\u003e\n\n\u003cp\u003e\n  \u003cstrong\u003e2D media bags\u003c\/strong\u003e provide a flat flexible container for media,\n  buffer and general process-fluid handling. Tubing and process connections can\n  be positioned according to the required fluid path.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  \u003cstrong\u003e2D sampling bags\u003c\/strong\u003e can be supplied as individual sample\n  containers or as part of a multi-bag sampling manifold. A sampling manifold\n  typically connects several bags through a common tubing distribution system.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  \u003cstrong\u003e2D filtration bags\u003c\/strong\u003e incorporate an internal separation mesh\n  or filtration tissue. They can be configured with one or more inlet and\n  outlet connections for separation applications.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  \u003cstrong\u003e2D rocking bioreactor bags\u003c\/strong\u003e incorporate attachment points for\n  use on a rocking platform and can include configurable connections for media,\n  ventilation and process sensors.\n\u003c\/p\u003e\n\n\n\u003ch3\u003e3D bag configurations\u003c\/h3\u003e\n\n\u003cp\u003e\n  \u003cstrong\u003e3D buffer bags\u003c\/strong\u003e are intended for larger storage and transfer\n  volumes. Port positions can be configured around the geometry of the support\n  vessel or tank in which the bag will be installed.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  \u003cstrong\u003e3D recirculation bags\u003c\/strong\u003e can incorporate a bottom outlet and\n  return fluid path. When connected to a pump, liquid can circulate from the\n  lower section back to the upper section of the bag to support mixing.\n\u003c\/p\u003e\n\n\n\u003ch3\u003eAvailable volume range\u003c\/h3\u003e\n\n\u003cp\u003e\n  Bag assemblies can be configured in a wide range of volumes with\n  \u003cstrong\u003e2D and 3D systems available up to approximately 4,000 litres\u003c\/strong\u003e.\n  The practical volume range depends on bag geometry, film construction,\n  application and supporting equipment.\n\u003c\/p\u003e\n\n\n\u003ch3\u003ePackaging, sterilisation and conformity\u003c\/h3\u003e\n\n\u003cp\u003e\n  Depending on the final assembly configuration, available production and\n  conformity characteristics include:\n\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003eFDA CFR 21 material conformity\u003c\/li\u003e\n  \u003cli\u003eUSP Class VI\u003c\/li\u003e\n  \u003cli\u003eGMP-related conformity documentation\u003c\/li\u003e\n  \u003cli\u003eEndotoxin statement\u003c\/li\u003e\n  \u003cli\u003eBSE\/TSE documentation\u003c\/li\u003e\n  \u003cli\u003eIrradiation compatibility up to 40 kGy\u003c\/li\u003e\n  \u003cli\u003eAutoclavable configurations\u003c\/li\u003e\n  \u003cli\u003eISO Class 7 cleanroom production\u003c\/li\u003e\n  \u003cli\u003eHydrostatic and tensile-strength testing\u003c\/li\u003e\n  \u003cli\u003eSecure closure of open tubing ends\u003c\/li\u003e\n  \u003cli\u003eDouble packaging as standard\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003e\n  Conformity and sterilisation suitability depend on the complete configuration.\n  Bag film, tubing, connectors, filters and other fluid-contact components\n  should therefore be reviewed together when specifying the assembly.\n\u003c\/p\u003e\n\n\n\u003chr\u003e\n\n\n\u003ch2\u003eTypical applications\u003c\/h2\u003e\n\n\u003cp\u003e\n  Custom single-use bag assemblies can be configured for a broad range of\n  pharmaceutical and bioprocess operations.\n\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003eBioreactor and cell cultivation processes\u003c\/li\u003e\n  \u003cli\u003eMedia preparation and handling\u003c\/li\u003e\n  \u003cli\u003eBuffer preparation, storage and transfer\u003c\/li\u003e\n  \u003cli\u003eProcess sampling\u003c\/li\u003e\n  \u003cli\u003eMulti-bag sampling manifolds\u003c\/li\u003e\n  \u003cli\u003eFormulation\u003c\/li\u003e\n  \u003cli\u003eFeed processes\u003c\/li\u003e\n  \u003cli\u003eWaste collection\u003c\/li\u003e\n  \u003cli\u003eFilter wetting and rinsing\u003c\/li\u003e\n  \u003cli\u003eBuffer handling in filling processes\u003c\/li\u003e\n  \u003cli\u003eRocking bioreactor applications\u003c\/li\u003e\n  \u003cli\u003eCell and microcarrier separation\u003c\/li\u003e\n  \u003cli\u003eProcess fluid mixing and recirculation\u003c\/li\u003e\n  \u003cli\u003ePurification processes\u003c\/li\u003e\n  \u003cli\u003eProduct transfer\u003c\/li\u003e\n  \u003cli\u003eIntermediate product storage\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\u003eCustom fluid-path configuration:\u003c\/strong\u003e\n    bag geometry, ports, tubing and process connections can be specified\n    around the application.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003e2D and 3D formats:\u003c\/strong\u003e\n    different bag geometries are available for sampling, processing, storage,\n    transportation and large-volume applications.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eWide volume range:\u003c\/strong\u003e\n    configurations are available from small process and sampling bags through\n    systems with volumes up to approximately 4,000 litres.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eMultiple film constructions:\u003c\/strong\u003e\n    LDPE-contact multilayer films and fluoropolymer-contact options can be\n    selected according to process requirements.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eIntegrated fluid-path components:\u003c\/strong\u003e\n    tubing, connectors, couplings, filters, flanges and other components can\n    be incorporated into the complete assembly.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eApplication-specific designs:\u003c\/strong\u003e\n    bag systems can be configured for sampling, cell culture, filtration,\n    mixing, buffer storage and other process operations.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eSterilisation options:\u003c\/strong\u003e\n    suitable configurations can be selected for irradiation or autoclave\n    processing.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eCleanroom production:\u003c\/strong\u003e\n    assemblies are manufactured under ISO Class 7 cleanroom conditions.\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  Single-use bag assemblies should be specified around the complete process\n  rather than by bag volume alone. The intended application determines the\n  appropriate bag geometry, film construction, tubing, connection technology\n  and additional fluid-path components.\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\u003eApplication or process step\u003c\/li\u003e\n  \u003cli\u003eRequired 2D or 3D bag format\u003c\/li\u003e\n  \u003cli\u003eNominal bag volume\u003c\/li\u003e\n  \u003cli\u003eProcess fluid\u003c\/li\u003e\n  \u003cli\u003ePreferred or required bag-film material\u003c\/li\u003e\n  \u003cli\u003eNumber and position of inlet and outlet ports\u003c\/li\u003e\n  \u003cli\u003eTubing material and dimensions\u003c\/li\u003e\n  \u003cli\u003eRequired sterile connectors, couplings or sanitary interfaces\u003c\/li\u003e\n  \u003cli\u003eFilters, sensors, valves, clamps or other integrated components\u003c\/li\u003e\n  \u003cli\u003eOperating temperature\u003c\/li\u003e\n  \u003cli\u003eOperating pressure, where applicable\u003c\/li\u003e\n  \u003cli\u003eRequired sterilisation method\u003c\/li\u003e\n  \u003cli\u003eStorage and transport conditions\u003c\/li\u003e\n  \u003cli\u003eRequired conformity and validation 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  Where no existing design is available, the assembly can be developed from\n  the process description and required connection points. Existing drawings\n  and component specifications can also be used as the basis for a replacement\n  or modified single-use bag assembly.\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 bioprocess bag assembly?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"A single-use bioprocess bag assembly is a configurable disposable fluid-handling system that combines a flexible process bag with components such as tubing, connectors, couplings, filters and process ports for pharmaceutical and biotechnology applications.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What is the difference between a 2D and 3D single-use bag?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"A 2D bag has a relatively flat geometry and is commonly used for applications such as sampling, media handling and smaller-volume processes. A 3D bag expands into a three-dimensional shape and is generally suited to larger-volume storage, transfer, buffer handling and recirculation applications.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What sizes are available for single-use bag assemblies?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Single-use bag assemblies can be configured in multiple 2D and 3D formats with available volumes extending up to approximately 4,000 litres. The suitable size depends on the bag geometry, process application and supporting equipment.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What materials are available for single-use process bags?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Available constructions include LDPE-contact process films with different barrier and reinforcement structures as well as fluoropolymer-contact film options for applications requiring different chemical or product-contact properties.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Can tubing and sterile connectors be integrated into a bag assembly?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Yes. Single-use bag assemblies can incorporate tubing, sterile connectors, quick couplings, filters, flanges, clamps and other fluid-path components according to the required process configuration.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What applications use single-use bag assemblies?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Typical applications include cell cultivation, bioreactors, sampling, buffer and media handling, formulation, filtration, mixing, product transfer, feed processes, waste collection and purification.\"\n      }\n    }\n  ]\n}\n\u003c\/script\u003e","brand":"Filtra International","offers":[{"title":"Default Title","offer_id":57310462607686,"sku":null,"price":0.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0975\/2985\/6326\/files\/single-use-bag-assembly-in-support-container.webp?v=1788960347","url":"https:\/\/filtrainternational.com\/products\/single-use-bioprocess-bag-assemblies","provider":"Filtra International","version":"1.0","type":"link"}