{"product_id":"single-use-bottle-assemblies","title":"Custom Single-Use Bottle Assemblies","description":"\u003ch2\u003eProduct description\u003c\/h2\u003e\n\n\u003cp\u003e\n  Custom single-use bottle assemblies are configurable fluid-handling systems\n  that combine a plastic bottle, flask, vial or container with tubing,\n  connectors and other process components. They are used in pharmaceutical\n  and biotechnology applications where liquids need to be sampled, transferred,\n  mixed, filled, stored or handled within a defined fluid path.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Assemblies can range from a simple bottle with one tubing connection to\n  more complex multi-port and manifold configurations. Bottle type, material,\n  volume, tubing layout and connection technology can be selected according\n  to the individual process requirements.\n\u003c\/p\u003e\n\n\n\u003ch3\u003eTechnical overview\u003c\/h3\u003e\n\n\u003cp\u003e\n  Single-use bottle assemblies provide an alternative to conventional reusable\n  glass bottle systems where cleaning and repeated sterilisation of the container\n  are undesirable. A plastic bottle can be integrated directly into a closed\n  or controlled fluid path and, depending on the selected materials and\n  components, supplied in a configuration suitable for gamma sterilisation.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  The bottle acts as the central process container while tubing, filters,\n  connectors, couplings and other components define how product enters,\n  leaves or circulates through the system.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Configurations can be developed for both small-scale laboratory and sampling\n  applications and larger production-scale processes. Large-volume carboys can\n  also be incorporated where increased storage or transfer capacity is required.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Assemblies are batch traceable and can be supplied with a certificate of\n  conformance. Exact certifications and conformity documentation depend on the\n  materials and components selected for the final assembly.\n\u003c\/p\u003e\n\n\n\u003chr\u003e\n\n\n\u003ch2\u003eOperating principle\u003c\/h2\u003e\n\n\u003cp\u003e\n  A bottle assembly creates a defined connection between a process container\n  and the surrounding fluid path. Liquid enters or leaves the bottle through\n  tubing and process interfaces integrated into the closure or bottle assembly.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  In a sampling application, the bottle can form part of a closed sampling\n  line so that a process sample is transferred directly into the collection\n  container. In transfer or filling applications, the bottle may function as\n  a source or receiving vessel connected to process equipment, filters, pumps\n  or other single-use components.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  More complex systems can incorporate several bottles within one manifold.\n  This makes it possible to distribute fluid to multiple containers or connect\n  several collection bottles to a common process line.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  The exact operating principle therefore depends on the intended application,\n  number of ports, tubing configuration and integrated components.\n\u003c\/p\u003e\n\n\n\u003chr\u003e\n\n\n\u003ch2\u003eMaterial options\u003c\/h2\u003e\n\n\u003cp\u003e\n  Multiple bottle materials are available to support different pharmaceutical,\n  bioprocess and chemical compatibility requirements.\n\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003e\u003cstrong\u003ePolypropylene (PP)\u003c\/strong\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003cstrong\u003ePolycarbonate (PC)\u003c\/strong\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003cstrong\u003ePETG\u003c\/strong\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003cstrong\u003ePFA fluoropolymer\u003c\/strong\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003cstrong\u003eETFE fluoropolymer\u003c\/strong\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003cstrong\u003eFEP fluoropolymer\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003e\n  Standard polymer bottles are suitable for many general pharmaceutical and\n  biotechnology applications, while high-purity fluoropolymer bottles can be\n  considered where increased chemical resistance, temperature capability or\n  specialised product-contact properties are required.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Certain PFA, ETFE and FEP bottle configurations can also be considered for\n  demanding low-temperature applications, including flash-freezing processes.\n  Suitability must be confirmed for the selected bottle, closure and complete\n  fluid-path configuration.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Tubing, seals, connectors, filters and other assembly components may use\n  different materials. Compatibility and conformity should therefore always\n  be evaluated for the complete assembly.\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 to the bottle assembly itself.\u003c\/strong\u003e A bottle\n  assembly is a fluid handling and storage system rather than filtration media\n  and therefore does not have a micron or pore-size rating.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Where venting, particulate filtration or sterile filtration is required,\n  a suitable filter can be integrated into the bottle assembly. The membrane\n  material and micron rating are then specified separately according to the\n  filtration requirement.\n\u003c\/p\u003e\n\n\n\u003chr\u003e\n\n\n\u003ch2\u003eDesign and construction\u003c\/h2\u003e\n\n\u003cp\u003e\n  Bottle assemblies are individually configured around the application rather\n  than supplied as one fixed design. The container type, material, volume,\n  closure, tubing arrangement and process connections can all be selected\n  according to the required fluid path.\n\u003c\/p\u003e\n\n\u003ch3\u003eAvailable container types\u003c\/h3\u003e\n\n\u003cp\u003e\n  Typical bottle and container formats include:\n\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003eStandard plastic bottles\u003c\/li\u003e\n  \u003cli\u003eErlenmeyer flasks\u003c\/li\u003e\n  \u003cli\u003eVials\u003c\/li\u003e\n  \u003cli\u003eCentrifuge bottles\u003c\/li\u003e\n  \u003cli\u003ePFA bottles\u003c\/li\u003e\n  \u003cli\u003eFEP bottles\u003c\/li\u003e\n  \u003cli\u003eOther fluoropolymer containers\u003c\/li\u003e\n  \u003cli\u003eLarge-volume carboys\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eAssembly configurations\u003c\/h3\u003e\n\n\u003cp\u003e\n  The bottle can be equipped with tubing and additional fluid-path components\n  according to the process requirements. Configurations may include simple\n  single-line bottle systems or more complex multi-port assemblies.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Typical integrated components can include:\n\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003ePharmaceutical and bioprocess tubing\u003c\/li\u003e\n  \u003cli\u003eSterile or aseptic connectors\u003c\/li\u003e\n  \u003cli\u003eQuick disconnect couplings\u003c\/li\u003e\n  \u003cli\u003eHose barb fittings\u003c\/li\u003e\n  \u003cli\u003eSanitary process connections\u003c\/li\u003e\n  \u003cli\u003eFilters and vent filters\u003c\/li\u003e\n  \u003cli\u003eClamps and flow-control components\u003c\/li\u003e\n  \u003cli\u003eSampling lines\u003c\/li\u003e\n  \u003cli\u003eMulti-bottle manifolds\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003e\n  Existing assembly drawings can be reproduced or modified, while new systems\n  can be developed from a process description and required connection points.\n\u003c\/p\u003e\n\n\n\u003ch3\u003eSterilisation and conformity\u003c\/h3\u003e\n\n\u003cp\u003e\n  Depending on the selected bottle material and fluid-path components,\n  assemblies can be configured for gamma sterilisation or autoclave processing.\n  Sterilisation suitability must be confirmed for the complete assembly.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  Available conformity and production documentation can include:\n\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003eFDA CFR 21 material conformity\u003c\/li\u003e\n  \u003cli\u003eUSP Class VI \u0026lt;88\u0026gt; Biological Reactivity\u003c\/li\u003e\n  \u003cli\u003eUSP \u0026lt;87\u0026gt; Cytotoxicity\u003c\/li\u003e\n  \u003cli\u003eUSP \u0026lt;85\u0026gt; Endotoxins\u003c\/li\u003e\n  \u003cli\u003eBSE\/TSE statement\u003c\/li\u003e\n  \u003cli\u003eCertificate of Conformance\u003c\/li\u003e\n  \u003cli\u003eBatch traceability\u003c\/li\u003e\n  \u003cli\u003eGamma-resistant configurations\u003c\/li\u003e\n  \u003cli\u003eAutoclavable configurations\u003c\/li\u003e\n  \u003cli\u003eISO Class 7 cleanroom manufacturing\u003c\/li\u003e\n  \u003cli\u003ecGMP-related production standards\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003e\n  Certificates and conformity statements can vary according to the selected\n  bottle, tubing and other fluid-contact components and should be confirmed\n  for the final assembly configuration.\n\u003c\/p\u003e\n\n\n\u003chr\u003e\n\n\n\u003ch2\u003eTypical applications\u003c\/h2\u003e\n\n\u003cp\u003e\n  Custom bottle assemblies are used throughout pharmaceutical and biotechnology\n  processing wherever a configurable container needs to form part of a defined\n  fluid path.\n\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003eClosed process sampling\u003c\/li\u003e\n  \u003cli\u003eAseptic sampling\u003c\/li\u003e\n  \u003cli\u003eFill \u0026amp; Finish\u003c\/li\u003e\n  \u003cli\u003eMedia fill assemblies\u003c\/li\u003e\n  \u003cli\u003eBuffer storage\u003c\/li\u003e\n  \u003cli\u003eBuffer and media preparation\u003c\/li\u003e\n  \u003cli\u003eMixing applications\u003c\/li\u003e\n  \u003cli\u003eCell culture\u003c\/li\u003e\n  \u003cli\u003eProduct transfer\u003c\/li\u003e\n  \u003cli\u003eWaste collection and storage\u003c\/li\u003e\n  \u003cli\u003eMulti-bottle manifolds\u003c\/li\u003e\n  \u003cli\u003eBulk drug substance processing\u003c\/li\u003e\n  \u003cli\u003eFreezing applications\u003c\/li\u003e\n  \u003cli\u003eIntermediate product storage\u003c\/li\u003e\n  \u003cli\u003eSmall-scale and production-scale processing\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 configuration:\u003c\/strong\u003e\n    bottle type, material, tubing and process connections can be selected\n    around the application.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eClosed fluid-path capability:\u003c\/strong\u003e\n    bottle systems can be configured for controlled sampling, transfer,\n    filling and storage operations.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eWide container selection:\u003c\/strong\u003e\n    standard bottles, flasks, vials, centrifuge bottles, fluoropolymer\n    bottles and carboys can be incorporated.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eMultiple material options:\u003c\/strong\u003e\n    PP, PC, PETG, PFA, ETFE and FEP provide different process and\n    compatibility characteristics.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eSimple to complex assemblies:\u003c\/strong\u003e\n    configurations range from individual sampling bottles to multi-container\n    manifold systems.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eSingle-use processing:\u003c\/strong\u003e\n    disposable plastic bottle systems can reduce dependence on cleaning and\n    repeated sterilisation of reusable glass containers.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eSterilisation options:\u003c\/strong\u003e\n    suitable configurations can be selected for gamma irradiation or\n    autoclaving.\n  \u003c\/li\u003e\n\n  \u003cli\u003e\n    \u003cstrong\u003eTraceability:\u003c\/strong\u003e\n    bottle assemblies are batch traceable and can be supplied with\n    certificates of conformance.\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  A bottle assembly should be specified around the complete process rather\n  than by bottle volume alone. Container material, process connections,\n  tubing and sterilisation requirements all influence the final design.\n\u003c\/p\u003e\n\n\u003cp\u003e\n  For technical configuration and quotation, provide the following information\n  where available:\n\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003eProcess application\u003c\/li\u003e\n  \u003cli\u003eRequired bottle, flask, vial or carboy type\u003c\/li\u003e\n  \u003cli\u003eRequired nominal container volume\u003c\/li\u003e\n  \u003cli\u003ePreferred or required bottle material\u003c\/li\u003e\n  \u003cli\u003eProcess fluid\u003c\/li\u003e\n  \u003cli\u003eNumber of bottle ports\u003c\/li\u003e\n  \u003cli\u003eTubing material and dimensions\u003c\/li\u003e\n  \u003cli\u003eRequired tubing lengths\u003c\/li\u003e\n  \u003cli\u003eSterile connectors or quick couplings\u003c\/li\u003e\n  \u003cli\u003eSanitary or hose-barb process interfaces\u003c\/li\u003e\n  \u003cli\u003eFilters or vent filters\u003c\/li\u003e\n  \u003cli\u003eSingle-bottle or manifold configuration\u003c\/li\u003e\n  \u003cli\u003eOperating temperature\u003c\/li\u003e\n  \u003cli\u003eOperating pressure, where applicable\u003c\/li\u003e\n  \u003cli\u003eFreezing requirements, where applicable\u003c\/li\u003e\n  \u003cli\u003eRequired sterilisation method\u003c\/li\u003e\n  \u003cli\u003eRequired conformity and traceability 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 bottle assembly can be developed\n  from the application description, required process interfaces and operating\n  conditions.\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 bottle assembly?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"A single-use bottle assembly is a configurable plastic bottle, flask, vial or container equipped with tubing and other fluid-path components for pharmaceutical and biotechnology applications such as sampling, transfer, filling, storage and processing.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What bottle types can be used in a custom bottle assembly?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Available container formats include standard plastic bottles, Erlenmeyer flasks, vials, centrifuge bottles, fluoropolymer bottles and large-volume carboys.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What materials are available for single-use bottle assemblies?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Available bottle materials include polypropylene, polycarbonate, PETG and high-purity fluoropolymers such as PFA, ETFE and FEP. The appropriate material depends on the process fluid, temperature, sterilisation method and application.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Can bottle assemblies be gamma sterilised or autoclaved?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Suitable bottle assembly configurations can be designed for gamma sterilisation or autoclave processing. Compatibility must be confirmed for the bottle, tubing, connectors and all other components in the final assembly.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What are single-use bottle assemblies used for?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Typical applications include closed sampling, Fill \u0026 Finish, buffer storage, preparation, mixing, cell culture, waste storage, media fill assemblies, manifolds, freezing applications and bulk drug substance processing.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Can multiple bottles be connected in one assembly?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Yes. 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