原创论文
2021-10-28
Single-Use bags are very well-establisehd technology and have been used to replace traditional rigid walled plastic and glass tubes, flasks, bottles and carboys in many bioprocessing areas. They are available in various size, shapes, configurations, plastic films and accessories. Single-use bags are available both in two-dimensional (2D) and three-dimensional (3D) styles, both needs outer support containers for usage. Although many suppliers provide single-use bags in today’s market, single-use bags are still limited in the size and technical operation, major extractables/leachables concern, and have higher operational handling risks.
| Benefits | Applications | Desirable Features |
| Pre-assembled and sterilized High quality barriers to minimize O2, CO2, and moisture transmission Single-use to avoid cleaning and cross-contamination. Minimal setup timeEasily integrated in automated systems | Media and buffer preparation, storage and delivery Intermediate process material hold and storageSamples and waste storage Intermediates mixingFreezing/thawing if bulk drug substances and intermediates Shipping and transportation Sterile Filling | Available in both 2D and 3D configurations Standard design optionCustomized design option Custom options in tubing, connector and filter assemblies Hanging design Tolerance to broad range of temperatures |
Holland Mitos DuraPure™ bags are available in pillow and 3D styles. Mitos DuraPure bags offer a high-purity contact surface with a durable exterior to protect your product (Download MItos DuraPure Bag Brochure). Mitos klave-it® bags are made from a select Kynar™ PVDF film designed to maintain flexibility, strength and impact resistance after sterilization by autoclave. Other benefits include chemical and solvent resistance, low TOC (total organic carbon) and low permeability. Downlaod Mitos Klave-It Bag Brochure
GE ReadyCircuit bag assemblies come in a variety of configurations to facilitate transfer to production. Products include ReadyCircuit 3D Bag Assemblies ReadyCircuit Hanging Pillow bags Assemblies ReadyCircuit Pillow bag assemblies M*Bag, etc. The bags are available in 2D hanging pillow format for small scale bioprocessing production and 3D assembly for large scale production. Learn More
Saint-Gobain Bioprocess Containers
Saint-Gobain Performance Plastics offers a complete line of single-use bioprocess bags, liners and tanks for the preparation, collection, storage and transport of biopharmaceutical liquids. Featured products include Bioprocess containers (2D and 3D bags) with multilayer film structure , Bioprocess Bags 50 ml to 20 Liter Small Volume Bioprocess Bags, Bioprocess Bags 50 Liter to 500 Liter Bioprocess Bags for Cylindrical Tanks, Bioprocess Bags 200 Liter to 500 Liter Bioprocess Bags for Rectangular Tanks, Bioprocess Bags Single-Use BioProcess Bags 50 ml to 3,000 liters
Sartorius Single-Use Bioprocess Bags
Sartorius flexible bags are designed to meet a wide range of Biopharmaceutical processes and applications. Flexel® bag range is designed for processing, storage, mixing and transportation, with choices of Flexel® 3D Bioprocessing Scalable Flexel 3D bags, Flexel 3D bags for palletank, drum, and 3D tank Liner. Flexboy® Bags are ideal for preparation, storage and transportation of biopharmaceuticals, intermediates and final bulk products ( also see Flexboy® Bioprocessing Standard bags). FlexSafe® bags made of the new polyethylene S80 film, product include Standard Flexsafe® 3D Bags for Storage and Shipping for Palletank® , Standard Flexsafe® 3D Bags for Storage in Drum, Flexsafe® 2D Validation Bags, and Flexsafe® RM Bags (bioreactor bag).
Millipore Mobius 2D and 3D Assemblies and Storage Systems
Mobius® 2D and 3D Assemblies and Storage Systems consist of a series of PE drums, stainless steel bins, collapsible bins, container carts, and 2-D and 3-D single-use assemblies, Mobius® Assemblies and Storage Systems are designed to reduce operator error and improve process efficiency. Products include Mobius® 2D and 3D Assemblies (also see Mobius® 2D and 3D Assemblies and Storage Systems data sheet), Mobius 2D and 3D storage systems, bins, and container carts. More products may also found from Mobius FlexReady® Solution for Buffer and Media Preparation. Mobius® 2D and 3D Assemblies and Storage Systems, they feature a PureFlex™ and PureFlex™ Plus single-use films, fittings, C-Flex® and silicone tubing with pinch clamps on each line.
ThermoFisher Bioprocess Containers (BPCs)
ThermoFisher scientific Bioprocess containers (BPCs) offers expanded expertise in BPC film for bulk liquids, choices include Aegis5-14 and CX5-14 Films, ASI 26/77 Film; ASI 28 Film and ASI 26/77 film. Bioprocessing Films Engineered to meet the most demanding requirements of bioproduction processes. Products selections from Standard Thermo Scientific BPC systems to Custom Thermo Scientific BPC systems, and Custom BPC and Cell Culture Bags.
Charter Medical Bio-Container Systems
Charter Medical designs custom bio-container systems for bioprocessing applications. Products include FP-FLEX™ Cold chain tubing and containers designed for cryogenic storage and transport applications enabling closed-system continuous processing. Tubing and containers tested and validated to -196°C. FP-FLEX™ tubing compatible with C-Flex®. Freeze-Pak™ Bio-Containers Freeze-Pak™ Bio-containers are designed for use in ultra-low temperature applications as low as -196°C. Freeze-Pak™ STS Single-Use Storage and Transport Solution Bio-Containers have been validated to -80°C while the film itself is rated to as low as -196°C. Bio-Pak® 3D Gusset Bio-Containers are constructed with Clear-Pak® film which has excellent gas barrier properties. Bio-Pak® Small Volume Bio-Container Systems are designed for bioprocessing applications with cusom boat port design.
Meissner One-Touch Single-Use Systems Portfolio
Meissner’s One-Touch® single-use systems portfolio include several products to deliver high fluid integrity performance, TepoFlex® polyolefin-based biocontainers are available in 2D and 3D configurations for R&D through production needs. BioFlex® fluid path assemblies provide convenient, secure fluid transfer flexibility for single-use systems, as well as traditional conventional systems. FluoroFlex® PVDF-based biocontainers are available in 50 mL to 20 L configurations for use in applications beyond the capabilities of PE-based biocontainers. TepoFlex® Biocontainers are available in 2D end-ported designs, face-ported 2D designs , and 3D designs, they can be ordered with BioFlex® fluid path/tubing assemblies to provide maximum flexibility. FluoroFlex® Biocontainers FluoroFlex® biocontainers employ a PVDF product contact layer for its inherent purity. It also offers thermal stability, chemical resistance and robustness that is beyond traditional PE-based films. FlexFill® Biocontainer Transfer Assembly ideally suited in applications where fast and dependable aseptic transfer of small process volumes are required. The FlexFill® assembly provides a convenient way to aseptically transfer bottled cell culture media, sera, reagents, supplements, buffers and microcarriers to bioreactors.
Entergris Sinlge-Use Assemblies
Aramus™ assemblies offer increased confidence, safety and performance with one gamma-stable single layer fluoropolymer film, a wide temperature range and universal application – protection, purity and flexibility. Aramus™ 2D Single-Use Assembly Providing a new level of assurance for frozen product storage (to -85°C [-121°F] or lower), final fill, process sampling and archiving, peptide synthesis and buffer and media prep processes. See more Aramus™ Single-Use 2D Bag Assemblies product datasheet.
FlexBiosys has developed bags for almost all Bioprocessing applications. Single-use bioprocess containers are available in both standard designs and customer specific designs in 2-D pillow style and 3-D drum and tank styles. Flextreme™ 2-D Bioprocessing bags (Flextreme™ bags) are manufactured from FLEXCLR™ film with an inert LDPE product contact layer and EVOH gas barrier layer. Flextainer™ 3-D Bioprocessing bags ( Flextainer™ 3-D bags) are manufactured from FLEXCLRTM film with an inert LDPE product contact layer and EVOH gas barrier layer. FlexBiosys also offers Custom Bioprocess Systems & Containers based on customer volume, width, length and special film requirements.
Corning® cellgro® flexible packaging systems are available in multiple formats. This includes custom configurations to meet customer exact requirements, with a variety of bag sizes and tubing/connector configurations available. These containment and delivery systems designed to preserve the physical, chemical, and functional characteristics of sterile fluids. Bag types include Collection containers , Tank liners, Cryopreservation bags, Cell expansion bags, Bags for HYPERStack®, and Rocker cell culture bags.
ILC Dover Biopharm Containment and Processing
ILC Dover Pharm/Biopharm containment and processing combine processing systems with Dover Powder containment capabilities. Flexible Intermediate Bulk Containers (FIBCs) or bulk bags are large woven polypropylene bags designed for storing and transporting dry flowable bulk products. There are several bag designs available: spout top, duffel top or open top and flat bottom, discharge spout or port hole bottom.
Sani-Tech West Applied Bioprocess Containers’ single-use bags are constructed of multilayer films optimized for bioprocess production applications. Film materials are consistent throughout the product range, with LDPE as the fluid contact material and EVOH as the gas barrier layer. Small Volume Bags – 50ml to 20L feature integrated handles, integrated hanging capability, and needle-free sampling ports. Cylindrical & SS Tank Bags – 50 to 2,500L have 2D and 3D designs designed to fit your existing tank with top or bottom drain options. See more for Applied Bioprocess Containers Overview .
Parker Durapure Bioprocess Containers
Variety of bioprocess containers available include: 2D and 3D in a variety of sizes from 1L to 1,000L configurable for customer’s process. Film offering include: DuraPure™ C93 film, DuraPure™ film (also see Mitos DuraPureTM bags) and Kynar® PVDF film. Hanging bioprocess containers are also available with PVC hanging bar to support weight.
Pall Biocontainers & Single-Use Systems
Pall’s Allegro™ biocontainer range provides storage solutions that can be applied from upstream through downstream, to formulation and filling. All Allegro biocontainers are available with the same film at all sizes, which simplifies validation from clinical manufacturing to commercial operations. Featured products include Allegro™ 2D Biocontainer with Powder Port and Allegro™ 3D Biocontainers and Standard Systems. More information also see Integrity™ 2D and 3D bioprocess Vessels and Wand Mixer System made of TK8 films.
Paw BioScience RIM Bio BioProcess Bags
BioProcess Bags from RIM Bio are optimized for specific container applications. RIM’s bags provide maximum flex-cracking resistance, strength and durability and are well suited for cell culture applications. Each container product is constructed using NxFlex F1000C1 film. RIM utilizes both RF and Heat Impulse Sealing depending on the size and type of bag. The bags typically have ports on one end and handles on the opposing end. RIM offers one and three port designs.
RIM Bio manufactures a wide variety of bioprocess containers such as 2-D “Pillow” Bags (125ml to 100L), The $99.00 Rocker Bag™, Bags for Cell Culture, 3-D Bags (100L to 1000L), Multi-Bag Manifolds, and Blood Collection Bags. The Tube Set Assemblies are also available in the RIM bio single-use product line.
PBS Biotech Single-Use Assembly
PBS biotech single use vessels and bags are designed to be compatible with all popular reusable and single use pH and DO probes. The PBS MINI and PBS 3 units use a polycarbonate (PC) plastic vessel, while the PBS 15, PBS 80, and PBS 500 single use products consist of bags made of PVDF that provides chemically inert and superior in strength, resulting in ultra-low surface binding, minimal leachables and extractables, and enhanced durability.
Sentinel Process Systems Bio Bags
Sentinel supplies Flex Concepts’ disposable single use containment systems in many styles required with a full array of customer options for ports, filters, tubing, etc. The 3D Bio Bags (Up to 2000L) offer a triple barrier containment system for single use, biopharm applications. Rocker and Motion Bio Bags (2L – 500L) offer full material traceability with leachables and extractables data. Flex concepts also offers Tank Liners with multiple layer films.
JM BioConnect®’s Disposable bags program consists of the following product lines: Pillow Bags (50 ml – 50 L), 3D Cubic or Cylindrical Bags (50 L – 3.500 L), Carrier Bags, Bag and Tubing Manifolds, Mixing Bags, Tank Liners. JM Bioconnect® bags are also available at CPI Technology.
ESI Ultrapure Single-Use Bioprocess Bags
ESI Ultrapure offers a wide range of Single-Use Bioprocess Bags. They can be customised to have specific port configuration, tubing and connectors. Single-Use Bag types include: Klave-It Bags, DuraPure Bags, 2D Bags – Single Layer & Custom, 3D Bags, Wave / Rocker Bags, Single Use Mixing System, Filter Bag System
References:
Single-Use Bioprocess Technology (Disposable Biotechnology Products)
Cytotoxicity Risks in Single-use Media and Bioreactor Containers
