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Research on Single Use Bioprocess Components
Introduction to Single Use Bioprocess such as sampling bags, liquid storage bags, sampling bags and magnetic stirring bags.
What is a single use bioprocess component?
single use bioprocesss components are assembled from polymer materials such as bags, pipes, fittings, flow clamps, and clamps, and can be used in processes such as liquid storage, transfer, formulation preparation, cultivation, and sterile filtration in the biopharmaceutical field. The bag is made of multi-layer co extruded film, ensuring extremely low water vapor and oxygen permeability, high physical properties, excellent chemical compatibility, and biocompatibility. Extraction research is conducted according to USP<665>. At the same time, after irradiation with gamma rays (25-40KGy), the product is tested for endotoxins (<0.25EU/ml), sterility (10-6SAL), insoluble particles (meeting USP<788>requirements) and other indicators as factory indicators, so that it can be safely used for transportation and storage in biopharmaceuticals.
What are the main ones?
single use bioprocesss components mainly include 2D and 3D single use liquid storage bags, 2D and 3D single use dispensing bags, 3D single use magnetic stirring /mixing bags, 2D single use feeding bags, 2D single use sterile sampling bags, frozen storage bags, cell culture bags, rocking bag, setc.
Product Introduction and Solutions:
single use bioprocesss mixing bags Product Introduction ◗
2D and 3D single use bioprocesss mixing bags are suitable for uniform mixing and stirring of liquid-liquid and solid-liquid mixtures, greatly improving work efficiency. Customized modules can be used, and customers can choose different specifications of blades, bags, and support containers according to their needs, providing various solutions for different pharmaceutical processes.
Advantages ◗
Compared to closed bag type, it is more economical.
Open design facilitates rapid input of large quantities of materials.
Flexible customization of sizes, pipelines, and fittings.
Multiple specifications, customizable from 5L to 2000L.
Application ◗
Preparation of buffer solution and mixing of intermediates.
Single use bioprocesss liquid storage bags Product Introduction ◗
Single use bioprocesss liquid storage bags can achieve the storage and transfer of large volume solutions in biotechnology. Can be independently used for storage of buffer solutions, culture media, intermediates, and stock solutions. The inlet and outlet pipelines can use Luer connectors, CPC quick connectors, Tri clamp sanitary connectors, or sterile connectors. Provide multiple sampling methods, such as needle free samplers, Luer connectors, and medical heparin caps.
Advantages ◗
Suitable for storage and transportation of solutions in various stages of biotechnology
Flexible customization of dimensions, piping, fittings, and other configurations.
Application ◗
Storage and transportation of large volume buffer solution and culture medium
Intermediate storage and transfer
Collect purified components
Harvesting, storage, and transfer of raw materials
Final product storage.
Single use bioprocesss magnetic stirring bags Product Introduction ◗
The single use bioprocesss magnetic stirring bags mainly consists of imported 9101 film, stirring blade, feeding port, inlet pipe, outlet pipe, temperature electrode interface and other accessories. The magnetic stirring blade is built inside the bag and can be customized into two categories: suspended magnetic stirring blade and bearing connected stirring blade according to customer needs. The bearing type mixing blade is composed of a bottom tray central shaft, ceramic bearings, and blades. The blades do not come into contact with the bag body or other accessories during operation. Magnetic levitation is composed of a bottom concave chassis and propeller blades. The magnetic levitation type adopts superconducting drive, and after forming a magnetic field, the stirring blade will suspend and rotate for stirring and mixing, without the need for bearing connection and will not come into contact with the bag or other accessories, nor will it generate any friction with other parts. The 3D disposable magnetic stirring bag requires a fixed shaped three-dimensional container to support it. Generally, there are two types of supporting containers: square and cylindrical.
Liquid preparation, culture medium preparation, intermediate mixing, virus inactivation, semi-finished product preparation, vaccine adjuvant mixing;
Multiple specifications, customizable from 10L to 3000L.
Application ◗
The driving unit transmits power through magnetic coupling, without direct contact with liquid, ensuring sterility;
The size and speed of the stirring blade can be adjusted according to the process to ensure more thorough and uniform mixing of the solution;
The mixing bag is disposable, requires no cleaning, improves efficiency, and saves costs.
Single use bioprocesss sampling bags Product Introduction ◗
The single use bioprocess sampling bag is suitable for sterile and safe sampling in different containers and different process stages. It adopts a design that combines a needle free sampling valve and a Ruhr connector, and can be used as needed. Safe, fast, and easy to operate. Effectively avoid potential risks such as cross contamination during the sampling process. Flexible customization of single or multiple units can be made according to process requirements to achieve one or multiple sampling.
Advantages ◗
The design of needle punched flat installation can ensure zero risk of cross contamination.
Needle free sampling valve design, safe and convenient to use.
Flexible selection of three disconnection methods: sterile disconnect ring, sterile disconnect device, and welded tube.
Multiple specifications, customizable from 50ml to 500ml.
Application ◗
It can be applied to sampling in all biological process stages such as cell culture, microbial fermentation, stainless steel liquid preparation system, storage, culture, purification, etc.
Enterprise standards
All products are produced in clean workshops that comply with ISO 14644 CLASS 7 standards, and follow the requirements of ISO 9001:2015 quality management system and GMP related regulations. Every link from design and development, material selection, production and manufacturing to finished product inspection and release is strictly controlled. The product has established enterprise standards according to USP, FDA, ISO, ASTM, Chp, Ep, YBB and other requirements, and has been validated by qualified third-party testing laboratories. The validation results all meet the requirements of Chp, YBB, USP<661>, USP<665>, USP<85>, USP<87>, USP<88>Class VI, USP<788>, ISO<10993>, ISO<11137>, ASTM 1980-16, FDA CFR 177.2600, and European Pharmacopoeia 3.1.9 standards. We can provide complete system verification files and technical support services to meet the needs of drug registration.
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