Bioneau™ NeauFlux™ SUIS designs and system integrates both single-use process skids and assemblies for world leading Biopharmaceutical companies. Using global technology platforms, we integrate SUIS for both the skids we design and build as well as for site-wide consumption during routine GMP production - as Aseptic Connector, 2D Bags, 3D Bags, Tubing-Silicone or TPE, Reinforced Hose silicone or TPE, Single Use Assembly, Filters Capsules, Polypropylene Cross, Y, T, Reducer, Straight coupler, Sanitary Tri clamps couplings, jumper manifolds, general transfer sets, sampling sets, pump transfer manifolds and a multiple of other various designs.
As a dedicated and integrated facility, our offering to customers is unique in that we provide a turnkey solution. Single-use assemblies which are manufactured in an Class 7 qualified cleanroom facility to strict GMP processes, Gamma Irradiated between 25kgy to 40kgy with materials stocked in a GMP temperature monitored warehouse.
For single use system integration, 2D/ 3D storage holders are composed of five layered PVDF-based film, ‘which offers long term aseptic storage of sterile media, buffers and drug substances at low temperatures, transfer of sterilo media, process intermediates © drug substances to finished dosage facilities. It also combines inherent purity with high gas barrier properties and industry-leading fluid integrity characteristics.
NeauFlux™ Single Use Integrated System comes with standard neauFlux™ 5600 TPE or neauFlux™ 2560 Platinum-cured silicone tubing. Tubing's are available in a variety of lengths and diameters to suit customer customized RFQ and application requirements. Tubings come with integrated Pinch clamps for liquid cut off.
Bioneau NeauFlux™ Aseptic Bottle Cap Assemblies are designed specifically for the most demanding bio- pharmaceutical applications. Unique stopper configurations and designs offer multiple tubing possibilities which can be customized as per application requirements.
Global renowned absolute dual membrane capsule filters integration is available for use with NeauFlux™ SUIS. Capsule filters combine a full range of filter media, pore size ratings and surface areas to satisfy numerous applications. Compact and easy to use, capsule filters are engineered to satisfy the highest standards of filtration reliability and convenience. neauFlux™ SUIS can also accommodate customer validated filters for quick change over from individual sterile sourcing to system integrated filtration & storage systems.
Bioneau™ NeauFlux™ SUIS form key end connections to complex designs of SUIS. can be ordered with a wide range of connectors or end fittings to address the desired process connectivity and integration assembly.
Wide variety of sampling bags with different vent / syringe. filter options can be integrated which immensely help in batch sampling without impacting overall process batch as whole. Sampling bags are made available From 5ml— 100mlorabove.
Bioneau™ NeauFlux™ SUIS designs and system integrates both single-use process skids and assemblies for world leading Biopharmaceutical companies.
NeauFlux™ SUIS: Fluid Transfer Assemblies reduce process train & optimizes flow path while providing an enhanced level of convenience that maximizes flexibility in the deployment of single-use systems, as well as conventional systems.
Using global technology platforms, we integrate SUIS for both the skids we design and build as well as for site-wide consumption during routine GMP production—as Aseptic Connector, 2D Bags, 3D Bags, Tubing-Silicone or TPE, Reinforced Hose silicone or TPE, Single Use Assembly, Filters Capsules, Polypropylene Cross, Y, T, Reducer, Straight coupler, Sanitary Tri clamps couplings, jumper manifolds, general transfer sets, sampling sets, pump. transfer manifolds and a multiple of other various designs. Globally renowned filtration technology capsules can be integrated to cater to applications ranging from process stream sterilization and clarification to sterile venting applications.
The fluid path assembly configurations illustrate a variety of common applications, although they have unlimited permutations. Assemblies are configured from our comprehensive library of pre-qualified components. For applications which require filtration, we offers capsule filters from reputed filter manufacturers for processing volumes from 10 mL to over 10,000 Linawide variety of filtration media.
As a dedicated and integrated facility, our offerings to the customers is unique in what we provide as a turnkey solution. Single-use assemblies which are manufactured in an Class 7 qualified cleanroom facility to strict GMP processes, Gamma Irradiated between 25kgy to 40kgy with materials stocked in a GMP temperature monitored warehouse.
NeauFlux™ SUIS: Fluid Transfer Assemblies fluid path assemblies are supplied with comprehensive documentation and traceability. Each assembly is serialized, which may reduce batch record requirements in some cases. When the fluid path assembly includes a filter, the filter serial number s linked to the assembly’s serial number. Bioneau provides a single cohesive certification package for the complete fluid path assembly which includes component specific lot number information, TSE risk and qualification status as well as applicable filter certification material and specific gamma irradiation dosage between 25kg to 40kg with materials stocked in a GMP temperature monitored warehouse.
Batch number, part number, manufacturing date and any desired customer information can be laser marked onto every finished product.
All products are packaged in accordance with regulatory req and carry detailed product/ material information including batch numbers and production dates & specific SKU ID.
Manufacturing takes place understrictly supervised mfg . conditions and does not involve the use of potentially cytotoxic mould release agents or bonding agents.
Every ingredient is screened to ensure full compliance with
FDA 21 CFR 177.2600 and finished parts are tested to
USP Class VI.
Written assurances throughout the raw material supply chain confirm that no animal derived elements.
A comprehensive certification pack can be supplied for each product covering material and product testing, statements of compliance and material data.
The exact weight and lot number
of each individual ingredient is
recorded for every batch
of compound.
A lot number is created that can be linked back to the in-housecontrolled mixing of each batch of compound, detailing the fullingredient mix.
Connecting Stainless Steel Process Equipment to Stainless Steel Process Equipment
Connecting a Single-Use System to Stainless Steel Process Equipment
Connecting a Single-Use
System to a Single-Use System
Connecting Stainless Steel Process Equipment to a Single-Use System
Filling Assemblies and Manifolds
Fluid Transfer with Sampling ‘and/or Flushing Functionality
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